draft background document for preparing the position paper ... background paper.pdf · health...

Draft Background Document for Preparing the Position Paper of the

Telemedicine Society of India on Telemedicine/TeleHealth Guidelines

Position Paper of Telemedicine Society of India on Telemedicine Guidelines

Note:

As most of us will be collaborating on this position paper, remotely, and communication will

be restricted to online means, it is best suited that we have a common/ shared document on

Google Drive that we all can work on together/simultaneously.

The following issues have been highlighted for the purposes of consideration and

contribution. We would appreciate it if people could identify themselves to be considered for

the specific topic they would want to work on. Dr. Jaiya, Colonel (Dr) Ashvini Goel and Ms.

Puhan will be part of all the sub-committees for parity.

Please note that the following list is only indicative in nature, and we would appreciate any

suggestions to further the cause by way of introduction of new topics to the fold. However,

once your suggestion is received, we will review it in order to ensure that timelines can be

met and that the topic gets appropriate deliberation and consideration within the broad

scheme of the position paper.

1. HIPAA – HITECH: reference to the several international/ foreign legislations for

the jurisprudence and the implementation. The position paper will also present a

view whereby it would attempt to entail the socio-economic conditions of the

country, prior to making radical suggestions;

2. Privacy and Informed Consent – IT Act/Rules, GDPR, HIPAA, PDP Bill;

3. Standard of Care / Duty of Care – Common law jurisprudence – American /

European, judicial precedents;

4. Liability of the stakeholders – foreign jurisprudence, consumer awareness and

tools, rights of care recipients and caregivers, duties of care recipients and

caregivers;

5. Ethics and Medicine – evaluate the distinction between medical law and medical

ethics basis court responses and scholarly research;

6. Insurance and reimbursement.



1. Introduction

1.1 In September 2015, the world came together to launch an ambitious Agenda for

Sustainable Development. People, planet, peace, prosperity, and partnership were

prioritized, with a commitment to leave no one behind. Evidence-based health workforce

plans and policies carry with them the potential to deliver benefits across the Sustainable

Development Goals: improving health, creating employment, and generating inclusive

economic growth, particularly for women and youth. Healthcare, however, is only one

determinant of better health at the individual, family or community/population levels.

1.2 Effective care at a primary care unit in rural or urban areas is one of the significant

keys, which can improve the quality of health and healthcare services to the community.

Common barriers to national health initiatives include lack of healthcare access and lack of

resources. In the USA, "Primary care has all kinds of benefits," Ganguli says, "both for

patients but also for populations." Research shows that people are healthier when they see a

primary care doctor, rather than a specialist, for their routine care. Where there are more

primary care providers per capita, death rates drop for cancer, heart disease and stroke,

among other illnesses — and life spans lengthen. Checking in with a doctor by email is

popular with some patients, as is turning to an urgent care clinic for health needs. However,

Ganguli says, there's no substitute for building a trusting relationship with a discerning

provider — someone who knows your medical history, and might be more likely to screen

you for depression when a sore throat doesn't seem to be your only problem, or schedule you

for bloodwork, a PAP smear, or vaccines that you need. The consistency of the decline in

such visits across all demographics was surprising, Rask says. People with low incomes and

younger people had especially large decreases, but the drop in primary care visits showed up

across all age groups and income levels. Interestingly, preventive checkups actually

increased, perhaps, the scientists speculate, because the Affordable Care Act made such

appointments free, or at least cheaper, for more Americans. But problem-based visits – for a

sore throat, flu or other symptoms of sickness or injury — fell by more than 30%. "There is a

lot of data showing that when you raise health care costs, people will receive less care," Rask

says. "But it doesn't mean that they only stop unnecessary care. They will reduce both

necessary and unnecessary care." "When patients have to pay more, they may pause, and they

may not go in if they don't think it's that urgent," says Nadereh Pourat, a professor of health

policy and management at UCLA's Fielding School of Public Health. But health problems

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2690145/

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2724393

https://www.npr.org/sections/health-shots/2010/07/08/128383840/doctor-patient-email-exchanges-can-help-heal

https://www.npr.org/sections/health-shots/2016/03/07/469196691/cant-get-in-to-see-your-doctor-many-patients-turn-to-urgent-care

https://ph.ucla.edu/faculty/pourat



can worsen, she adds. "You don't want them to wait til things get really bad."In a developing

country like India the situation is far worse as there is widespread poverty with no insurance

cover for outpatient or preventive healthcare.

https://www.npr.org/sections/health-shots/2020/02/03/801351890/as-out-of-pocket-health-

costs-rise-insured-adults-are-seeking-less-primary-care?ft=nprml&f=1001

1.3 The total number of doctors available to serve more than 833 million rural population

in the country in 2011 was a measly 45,062 while, in 2007, this figure was only 27,725. It is

sobering to note that, in 2007, the number of Indian medical graduates working in the USA

alone was more than 50,000 when the population of the USA was just above 300 million.

AIIMS, the medical institute modeled along the lines of John Hopkins Institute to train the

model modern doctors for India, has indeed led from the front in bolstering the trend of

migration of Indian doctors to greener pastures in the West. From 1989 to 2000, nearly 54%

of the medical graduates from the institute migrated out of the country. From within these

graduates, also, the ones from more well to do social backgrounds (the general category

graduates were twice more likely to migrate than those coming from reserved categories) and

the ones who performed better academically had a 35% greater chance of migrating

compared to those who performed not so well. Of the remaining graduate doctors in the

country, nearly 74% live in urban areas serving a mere 28% of the population, assuming that

the urban poor have the wherewithal to access their services. The elite capture of medical

education has meant that doctors being produced in the country are largely from the

privileged sections of the bigger cities. Present medical education inculcates in them an

affiliation for technology driven costly curative care in the increasingly corporatized

healthcare of the cities in India or the western shores. The rather drab illnesses of the rural

folk that have their origins mainly in their poverty and malnutrition naturally fail to attract

attention. The careerist and commercial motivations inherent in such an education naturally

undermine the more holistic concerns like the impact of poverty, caste, class, gender, and

ethnic discrimination on health. This situation can only worsen further due to increasing

commercialization of higher education that has already made it almost an exclusive preserve

of the rich. There have been murmurs of ―reorienting‖ medical education and improving the

clinical skills of medical graduates to address the health needs of the poor. However, these

promises have proved illusionary till now.

https://www.npr.org/sections/health-shots/2020/02/03/801351890/as-out-of-pocket-health-costs-rise-insured-adults-are-seeking-less-primary-care?ft=nprml&f=1001

https://www.npr.org/sections/health-shots/2020/02/03/801351890/as-out-of-pocket-health-costs-rise-insured-adults-are-seeking-less-primary-care?ft=nprml&f=1001



https://www.hindawi.com/journals/aph/2014/898502/

1.4 Physicians have been caring for patients outside of the traditional office visit since the

creation of the telephone. Compared with a phone, it‘s even easier to have a ―trusting, warm

relationship‖ with patients via video conferencing, though it‘s not as solid as in-person

interaction. The practice of Telemedicine, or literally ―healing at a distance,‖ is also not new.

Telemedicine has evolved over the past 50 years and helped alter health care delivery to

patients around the globe, albeit more so in the developed countries. It is a tool well-suited to

reduce the barriers of access and resource constraints in every country. The practice of

Telemedicine, especially when integrated with the healthcare system of a country, can not

only enhance access but also the continuity of care and that too in a manner which enhances

the safety and quality of healthcare services through timely and effective collaboration

between a primary care unit and a hospital unit with specialists.

1.5 The HealthTech industry relies on the latest advancements in technology, including

smartphones, cloud computing, IoT, Artificial Intelligence, 3D printing, Augmented Reality,

Virtual Reality, Robotics, Cyber-Physical Systems, Blockchain technologies, etc. to create

integrated solutions using cyber-physical systems for bridging the information and service

gaps in wellness promotion and healthcare for democratic, fast-track care delivery in a

patient-centric care paradigm that serves both rural and urban primary care units and big

hospitals. Telemedicine/TeleHealth is a specific form of HealthTech. To ensure that the most

appropriate and efficacious care is provided where and when it is needed and offer the

potential of better health outcomes and greater control over time, resources and other costs,

there is an absolute need to redirect healthcare interventions away from expensive hospital

settings through the use of telemedicine/TeleHealth in any country, including India, with an

increasing focus on prevention of disease and promotion of healthy lifestyles at all ages.

https://akademia.nfz.gov.pl/wp-content/uploads/2016/07/Accenture-Connected-Health-

Global-Report-Final-Web.pdf

1.6 Solutions for live and store-and-forward telemedicine have evolved significantly.

Most early telemedicine studies used point-to-point ISDN (Integrated Services Digital

Network) and T-1 (Terrestrial-1) connections for live telemedicine. Although ISDN provided

acceptable bandwidth and image quality, developments over the past 5 years have made this

technology obsolete. IP (Internet Protocol) allows multipoint connectivity from anywhere on

https://www.hindawi.com/journals/aph/2014/898502/

https://akademia.nfz.gov.pl/wp-content/uploads/2016/07/Accenture-Connected-Health-Global-Report-Final-Web.pdf




any device that is connected to a network that is able to run video-conferencing software.

Today, this includes room and desktop telemedicine systems, personal computers, tablets,

and smartphones. Store-and-forward telemedicine is also greatly enhanced by modern

technology and high-speed connections. Studies can be transmitted over secure FTP (file

transfer protocol) and VPN (virtual private network) or accessed via remote connection to

PACS (picture archiving and communication system) networks through client or Web-based

programs. Cloud servers are enabling echocardiograms to be transmitted and accessed from

anywhere in the world. This expansion of technology mandates a need for diligent attention

to security and a dramatic increase in dependence on technical support staff.

https://www.ahajournals.org/doi/full/10.1161/CIR.0000000000000478

1.7 Health apps are closely linked to the concept of mHealth, defined by the World

Health Organization as ―medical and public health practice supported by mobile devices,

such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and

other wireless devices.‖ Health apps serve many different functions, including promoting

physical fitness and health living, facilitating remote monitoring, providing medication and

appointment reminders, and serving as diagnostic aids and as reference tools.

https://www.cma.ca/sites/default/files/pdf/health-advocacy/activity/2018-08-15-future-

technology-health-care-e.pdf

1.8 Virtual and mobile care now serve as a primary health resource for many patients. In

fact, over the next five years the global mobile health market is expected to have a compound

annual growth rate of 29%. When asked to name the top advantage of AI in healthcare, over a

quarter of consumers cite having their own health care specialist available at any time, on any

device.

1.9 As available personal health applications increase exponentially, the line between

entertainment and health care continues to blur. Approximately one third of the >25 000

healthcare mobile health applications are specifically for physicians. Examples in cardiology

include texting programs for teenagers living with congenital heart disease and several

examples to improve lifestyle and to decrease risk in adults with cardiovascular disease.

Mobile health applications for personal monitoring of cardiac electrical activity exist for the

detection of arrhythmias and myocardial infarction. In a prospectively recruited cohort of 76

participants undergoing cardioversion for atrial fibrillation, a novel algorithm analyzing


https://www.cma.ca/sites/default/files/pdf/health-advocacy/activity/2018-08-15-future-technology-health-care-e.pdf




signals recorded with a smartphone accurately distinguished pulse recordings during atrial

fibrillation from sinus rhythm with excellent sensitivity (0.96), specificity (0.98), and

accuracy (0.97). The FDA has cleared an automated algorithm for identifying atrial

fibrillation from its single-lead electrocardiographic tracing. This is based on the SEARCH-

AF trial (Screening Education and Recognition in Community Pharmacies of Atrial

Fibrillation to Prevent Stroke in an Ambulant Population Aged ≥65 Years) from Australia

evaluating nearly 1000 patients with a single-lead electrocardiographic device built into a

smartphone case. The technology was accurate and cost-effective and has the potential to

prevent stroke.


1.10 It has been said by many that the patient is the most underutilized resource in

medicine. How can we accelerate the adoption of virtual care and the expanded capability

EHRs so that patients‘ time is valued and they are enabled to be more actively engaged in

their health and health care?

1.11 There is little doubt that these barriers will be overcome in time. In the future, most

physicians will be engaged in the provision of virtual care through some means.

Nochomovitz and Sharma have proposed a new specialty called the medical virtualist that

would describe physicians who spend most or all of their time providing patient care through

virtual means. They suggest that specific competencies and curricula will be required,

including knowledge of the legal and clinical limitations of virtual care, competencies in

virtual examination and ―virtual visit presence training.‖ Most recently Bhatia and Falk have

put forward what they call practical steps toward the ―virtualization‖ of health care in

Canada, which include suggestions such as making e-health practice part of accountability

agreements and a ―digital health by design‖ lens that would apply a ―digital first‖ philosophy

across the payment and delivery system.

https://med.stanford.edu/content/dam/sm/school/documents/Health-Trends-Report/Stanford-

Medicine-Health-Trends-Report-2018.pdf



2. Policy and Regulation


https://med.stanford.edu/content/dam/sm/school/documents/Health-Trends-Report/Stanford-Medicine-Health-Trends-Report-2018.pdf






2.1 Policy makers and regulators have enormous influence over the healthcare industry

and its trajectory, and this isn‘t likely to change on the path to democratization. The

regulatory environment greatly affects investment decisions: policy and regulatory factors

rank third in importance when making a health care-related investment decision. The status

of tech partnerships or advances in healthcare, as a result, may be dependent on the decisions

of those in government. We see this clearly with the European Union‘s General Data

Protection Regulation (GDPR), a new regulation that fundamentally calls into question

previous notions about data ownership in health care. In May of 2018, organizations with

business ties to the EU were required to comply to GDPR standards or face fines, prompting

any organizations who treat patients from any of the 28 EU nations to gain affirmative

consent for any data collected from people who reside in the EU. Now more than ever,

healthcare institutions will need to consider data flows, cross-border data transfer, privacy,

and security monitoring to ensure their policies are compliant with the law. The Personal

Data Protection Bill in India, which is currently with the Joint Select Committee of both

Houses of Parliament will, similarly, affect the healthcare providers in India, as soon as the

law is enacted and made operational/effective. What‘s clear is that proactively engaging

regulators and policymakers will be increasingly important to achieve the trust and support

needed to push the boundaries of health care while ensuring adequate standards are in place

to protect patient privacy and safety.

https://med.stanford.edu/content/dam/sm/school/documents/Health-Trends-Report/Stanford-

Medicine-Health-Trends-Report-2018.pdf

2.2 As policymakers across the world look for ways to redirect healthcare interventions

away from expensive hospital settings, telemedicine, remote care and m-health will become

increasingly important, both as ―stand-alone‖ solutions for individuals, and integrated

approaches that blend these technologies with EMR and holistic monitoring systems.

Deployment of HealthTech is not a one-time investment; it is a permanent and evolving part

of operations, which requires sustained financial backing, technical expertise, organizational

change and political will.

2.3 Digital health can have an impact on all areas of healthcare delivery across both

public and private health sectors. It can impact all levels of care from the smallest PHC

(Primary Health Centre) and H&WC (Health and Wellness Centre) to district hospitals to the





largest quaternary academic hospitals. It should ideally 77 reach all pharmacies and

diagnostic centres . It would connect the requisite health providers as well as finance agents

and institutions such as those who oversee the flow-of-funds used to finance health

expenditures, including public and private health insurers and their designated TPAs (Third-

Party Administrators).(Page 243)

2.4 Why emphasize digital health now?

2.4.1 Digital health is a potent lever for improving the health system. It is said that ―health

is an information intensive industry‖ perhaps more intense than any other enterprise. Patient

flows, doctor workflows, care plans, medication and supply flows, appointments/admissions/

discharges, diagnostic results all generate crucial information flows. These are at the core of

the information processes in health. Putting order into these transactions could strongly

influence the ability of healthcare workers to deliver quality care while minimizing

inconvenience and annoyance to patients. As India ponders what its revamped healthcare

delivery and new health finance regimes might look like, it would be wise to accelerate work

on digital health now, as the resulting no-regret moves will be applicable to almost any

imaginable path that India might take in the future. (Page 246)

2.4.2 Digital health may be able to help improve the productivity of physicians as one way

of mitigating India‘s perennial shortage of doctors. Once foundational information systems

are in place in facilities it will be possible to continue to develop them to include

sophisticated AI (Artificial Intelligence) routines and thereby increase the use of Clinical

Decision-Support Systems (CDSS) capabilities to aid the physician in many of his/her

clinical tasks. The impact in farflung, underserved areas may be particularly helpful. (Page

247)

2.4.3 A vision for digital health in India To achieve India‘s aspirations for Universal health

Coverage (UHC), over time the health industry with all its diverse stakeholders will need to

be ―rewired‖, that is interconnected digitally in whole new ways. This will enable everyone

in the health sector (patients, providers, payers and governments) to be linked digitally. It will

streamline operations as well as allow information about the patient to be accessed where

needed, when needed, as needed, with privacy and confidentiality maintained. It will power

business transactions linking the providers of service (the ―sellers‖) with the payers of care

(―the buyers‖). As an important by-product, the data produced by these systems can provide a



valuable stream of information which can be analysed to assess the overall performance of

the health system. To fine-tune its components and put resources where they are needed, and,

most importantly, to provide empirical analysis of quality and efficacy. And, given the times

in which we live, we can apply innovation, thus leapfrogging existing modalities wherever

possible – creatively using mobile technologies, telemedicine applications, cloud-based

technologies, and employing Artificial Intelligence techniques to their fullest advantage.

(Page 249)

2.4.4 Analogous to the eDischargeSummary for inpatient stays is the eEncounter Form for

outpatient encounters. The goal here is for every outpatient encounter in the country to result

in the production of an eEncounter Form. The definition of an Encounter requires some

considerable discussion. However, in ideal terms, an Encounter is defined 102 as one patient

receiving services from one provider on one specific date-of-service. In this case, the

standard segment would contain patient identification, provider identification, facility

identification, date-of-service, reason for the encounter, today‘s diagnosis, and the patient

disposition upon leaving. (Page 260)

2.4.5 Telemedicine: The rise of telepresence in healthcare

2.4.5.1 While we now have some interesting telemedicine applications we do not yet have

true tele-presence. In tele-presence the walls of a hospital/medical centre disappear and no

longer becomes a physical place. When we truly can remove the barriers of technology, then

we can imagine that health can be managed in wholly new ways, where the physical laying-

on-of-hands is no longer paramount. There are more examples of where this can be applied

than one might first imagine – including tele-radiology, tele-pathology, tele-psychiatry (and

behavioural health), tele-dermatology, tele-cardiology. (Page 278-279)

2.4.5.2 Mobile technologies will continue to offer the potential for enormous change to the

health sector. The real question is will we use telepresence and mobile technology to improve

health? Many of the existing attempts to use these technologies have been interesting, but

they have thus far had limited clinical impact. We are still waiting for one or more killer apps

which will truly change our perception of what can be accomplished when we employ these

technologies. (Page 279)

https://niti.gov.in/sites/default/files/2019-11/NitiAayogBook_compressed.pdf




3. Definitions

3.1 Telemedicine is the traditional term used to describe the use of electronic

communication and information technologies to provide or support clinical care at a distance.

Telemedicine can be used to interact with patients, or with other healthcare professionals,

including students and caregivers. The term is generally associated with the delivery from

afar of clinical diagnosis, prescription and monitoring; it is often seen as a subset of the

services encompassed by the term TeleHealth.

3.2 TeleHealth‘s broader definition encompasses clinical health care as well as a wide

range of other services, including educating patients and providers, and promoting disease

awareness and wellness. Telemedicine (the use of technologies to remotely diagnose,

monitor, and treat patients) and TeleHealth (the application of technologies to help patients

manage their own illnesses through improved self-care and access to education and support

systems) are being applied and combined to create new ways to deliver care.TeleHealth uses

innovative technologies, such as kiosks, website monitoring applications, mobile phone

applications, wearable devices, and videoconferencing, to remotely connect health care

providers to patients/citizens.

3.3 Increasing the terms Digital Health and Connected Health are replacing the use of

the terms Telemedicine and TeleHealth.

3.3.1 Connected Health is an approach to healthcare delivery that leverages the systematic

application of healthcare information technology to facilitate the accessing and sharing of

information, as well as to allow subsequent analysis of health data across healthcare systems.

But Connected Health goes beyond the management of patients‘ clinical data to encourage

communication and collaboration among all of the various stakeholders involved in a

patient‘s health.

3.3.2 Connected Health is achieved with a range of information and collaboration

technologies. Electronic medical records and other clinical applications, data repositories and

analytic tools, connected biomedical devices and telehealth collaboration technologies all

enable Connected Health. Most importantly, those solutions must rest on a foundation of



technology and data standards and security that ensures the confidentiality of personal health

information.

3.3.3 The ambition of Connected Health is to connect all parts of a healthcare delivery

system, seamlessly, through interoperable health information processes and technologies so

that critical health information is available when and where it is needed. By structuring and

exchanging healthcare information to center care delivery around the patient or a defined

population, Connected Health facilitates improved care coordination, disease management,

and the use of clinical practice guidance to help reduce errors and improve care. In so doing,

connected health is a key enabler of integrated healthcare delivery.

https://akademia.nfz.gov.pl/wp-content/uploads/2016/07/Accenture-Connected-Health-

Global-Report-Final-Web.pdf

3.3.4 There is a growing body of literature demonstrating that Connected Health

technologies can make healthcare more effective and efficient by electronically connecting

clinicians to clinicians, patients to clinicians, and even patients to other patients. This

approach facilitates remote diagnosis and treatment, continuous monitoring and adjustment of

therapies, support for patient self-care, and the leveraging of providers across large

populations of patients. Because these technologies improve the sharing of data and tasks

among teams, they also allow team members to practice at their highest levels of skill and

training. Physicians and nurses can then work more efficiently by allocating their time to the

patients who most need attention. The promise of these technologies will be further extended

as devices become smaller; are powered by longer-lasting sources of energy; and are

connected more effectively to other devices and to repositories of data, such as electronic

health records. Stated another way, Connected Health can extend access to care to a large

population of people while improving quality and reducing costs.

https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2013.0992

4. Barriers to widespread adoption of Telemedicine and Connected Health

4.1 The hallmarks of excellent health care are that it is accessible, safe, accurate, and

timely. The overall vision is of “Better health and well-being for all through increased

personal responsibility and connectivity as well as improved care delivery enabled by

technology.”






https://www.pchalliance.org/sites/pchalliance/files/PCHA_StrategySlideDeck_FINAL.p

df

4.2 There are major barriers that can stand in the way to Telemedicine and Connected

Health. These barriers include:

● Systems and policies—including the absence of coherent strategies,

misaligned financial incentives and a lack of adequate interoperability

standards.

● Organization and management— including prohibitive costs, lack of

collaboration between organizations, technical limitations of existing systems

and poor project management.

● Clinicians and end users—including physician resistance to technologies and

changes to working practices that burden their productivity or add to costs.

● Patients and the public—including concerns over privacy and data security

and a lack of appropriate regulation.

● Reimbursement—In the absence of a universally accepted definition of

telemedicine/telehealth/digital health/connected health, it is important to

determine how health policymakers and health insurance payers define the

terms when considering integration of these options into medical practice.

4.3 Many healthcare stakeholders in the public, private and NGO sectors in countries

around the world are working towards overcoming the barriers in deploying integrated health

technologies for connected health by using a range of tools, including:

● strategic planning and change management,

● extensive stakeholder engagement,

● clinical governance,

● policy development,

● legislative changes, and

● financial incentives, among others.

https://www.pchalliance.org/sites/pchalliance/files/PCHA_StrategySlideDeck_FINAL.pdf

https://www.pchalliance.org/sites/pchalliance/files/PCHA_StrategySlideDeck_FINAL.pdf

https://www.ama-assn.org/system/files/2018-12/digital-health-implementation-playbook.pdf



5. Integrated healthcare delivery: Saves time, improves access, improves

convenience while improving quality of care

5.1 Historically, telemedicine‘s importance was appreciated primarily in a geographical

context, namely, to provide timely access to quality healthcare to underserved patients

residing in remote geographic locations. Over time, with technological developments in the

field of information and communication technologies, the advent of the internet, smart

mobile phones, etc the advantages of telemedicine have become obvious in the urban settings

too. As we are living in an increasingly electronically/digitally networked/connected world,

the number of use cases have grown exponentially in a data-driven, real-time access

paradigm based on 24/7 health care and monitoring at home, at work, at play and at leisure.

In a technologically integrated environment, not only can information be made available at

the point of care but also value can be added to it in real time by processing big data through

ML/AI driven analytics for delivering care that is evidence-based and tailored to the needs of

individuals and population cohorts. There are several ways in which the IoT (connected

devices), is enhancing telemedicine, helping providers offer a quality of care that‘s

potentially better than many in-person treatment modalities. One example of at-home,

wireless monitoring devices is the glucometer connected to an auto inject insulin pump, a

pocket-sized meter that wirelessly connects to the phone and pump to regulate delivery of

rapid- or short-acting insulin 24 hours a day through a catheter placed under the skin. One of

the important benefits of telemedicine is immediate remote access to medication in life-

threatening situations. For example, a drug dispensing solution with audio-video

conferencing capabilities. Just imagine if you or any person around you suddenly encounter

an allergic reaction at a public place and requires a doctor prescribed medication. How about

a drug dispensing solution which can connect you to a doctor through video-conferencing for

remote diagnosis and drug prescription.

https://www.einfochips.com/blog/the-future-of-healthcare-iot-telemedicine-robots-artificial-

intelligence/

5.2 Integrated healthcare deliverylinks multiple levels of care management, coordinates

services and encourages professional collaboration across a range of care delivery. Integrated

healthcare is not about structures or common ownership or bearing insurance risk; it is about

https://www.einfochips.com/blog/remote-drug-dispensing-systems-a-new-paradigm-in-healthcare/?utm_source=EIblog&utm_medium=BlogPost26Aug16Aarohi&utm_campaign=BlogReferralTraffic

https://www.einfochips.com/blog/the-future-of-healthcare-iot-telemedicine-robots-artificial-intelligence/

https://www.einfochips.com/blog/the-future-of-healthcare-iot-telemedicine-robots-artificial-intelligence/



networks and connections—often between separate organizations—that focuses the

continuum of healthcare delivery around patients and populations.

5.3 The convenience revolutionhas further challenged the traditional health care delivery

and business models. The continuous flow of communication amongst healthcare

professionals is motivated by the growing complexity of medicine, which forces doctors to

consult with more experienced colleagues or experts in a particular field or just to request a

second opinion. All of these behaviours are considered good medical practice (provided that

they do not delay an urgent procedure, nor constitute defensive medicine), and actually the

absence of such contacts is what may hold the doctor liable for his disinterest and

carelessness. On the other hand, patients – that are nowadays more aware of their rights and

more alert on the risks of medical faults – also look for second opinions, sometimes from

doctors that they have never actually met, by simply using a smartphone App, tablet, e-mail

or a website. https://www.rand.org/blog/2013/11/quick-takes-the-convenience-

revolution-in-the-treatment.html

6. Importance of Telemedicine/TeleHealth in the Indian context

6.1 In this above perspective, on the positive side, in India the expansion and streamlining

of telehealth services is expected to improve access of citizens to public health programmes

of the Central and State Governments/UT administrations, but also open for the private sector

and the not-for-profit sector healthcare providers the possibility to expand their geographical

reach and spectrum of medical services, while improving efficiency, timeliness and chances

for greater benefits for all healthcare stakeholders. At the same time, more, varied and better

telehealth options will enable closer collaboration amongst the health professionals and

healthcare services providers in the public, private and not-for-profit sectors.

6.2 Above all, telemedicine facilitates patient‘s direct access to a distant doctor, without

requiring the displacement of any of the participants, allowing access to some forms of

modern medical care that otherwise would not be accessible. Also, it is tempting for those

patients that may feel more comfortable to ask questions about sensitive issues (as addictions

or venereal diseases) to a distant doctor.

6.3 Telehealth services are potentially very useful in promoting health by sharing

appropriate awareness and educational content and in preventive medicine, by providing

https://www.rand.org/blog/2013/11/quick-takes-the-convenience-revolution-in-the-treatment.html





patients with useful and practical information about their health conditions. These can be

particularly relevant for controlling chronic conditions (such as diabetes, hypertension, heart

conditions) – a growing public health issue motivated by the increase in life expectancy and

the growing size of the elderly population, though these diseases are also rising in the young

population – without keeping the patient in a hospital (telemonitoring).

6.4 Telemedicine also has a great potential regarding patient‘s safety, by avoiding some

human mistakes. For example, electronic prescription may promote safety, for example, by

preventing many errors resulting from difficulties in reading a doctor‘s poor handwriting.

6.5 Compared with India, the developed countries have made much better progress in

adoption of Telemedicine/TeleHealth services.

6.5.1 Despite considerable progress, because of regulatory, cultural, financial/insurance

related barriers, in the USA, the 2016 Physician Practice Benchmark Survey of the AMA

provides the most complete picture yet on adoption of Telemedicine.

6.5.1.1 Specialty determines use

The researchers found that in the USA specialists using telemedicine the most to

interact with patients are:

● Radiologists—39.5 percent.

● Psychiatrists—27.8 percent.

● Cardiologists—24.1 percent.

Specialists whose practices are using telemedicine the least to interact with patients

are:

● Allergists/immunologists—6.1 percent.

● Gastroenterologists—7.9 percent.

● Ob-gyns—9.3 percent.

Almost an entirely different set of specialists used telemedicine for interacting with

other health professionals. Specialists whose practices are doing this the most are:

● Emergency physicians—38.8 percent.



● Pathologists—30.4 percent.

● Radiologists—25.5 percent.

6.5.1.2 To assess interactions with patients, physicians in practices that used telemedicine

were asked if it was used for diagnosing or treating patients, following up with patients, or

managing patients with chronic disease. To assess interactions with peers, they were asked if

it was used for having a specialty consultation or getting a second opinion. They were also

asked which telemedicine modalities their practice used: videoconferencing, remote patient

monitoring (RPM), or storing and forwarding data.

6.5.1.3 Videoconferencing is employed by the practices of 31.6 percent of emergency

physicians and about 25 percent of psychiatrists‘ and pathologists‘ practices. Cardiologists

and nephrologists are the biggest RPM users, while radiologists and pathologists are the

biggest users of telemedicine‘s data storing-and-forwarding function.

https://www.ama-assn.org/practice-management/digital/which-medical-specialties-use-

telemedicine-most

6. Benefits and Use Cases of Telemedicine/teleHealth:

6.1 Using Telehealth Technology for Care Coordination During a Disaster

6.1.1 When disaster strikes (such as floods, mass casualty events and pandemics)

healthcare providers are usually among the first to arrive, carrying whatever they need to

deliver quick and urgent care. Telehealth is now a critical part of the first responder toolkit,

giving providers the help they need to create connected care platforms that improve care

coordination and management.

6.1.2 Emergency medical technicians, fire and rescue crews, Red Cross personnel and the

military are now armed with technology that goes far beyond the first-aid kits and walkie-

talkies of days past. Smartphones and specially-designed rugged tablets can improve

communication, clinical decision support and data capture, and wireless devices capture vital

signs and other biometric information.

https://www.ama-assn.org/practice-management/digital/which-medical-specialties-use-telemedicine-most

https://www.ama-assn.org/practice-management/digital/which-medical-specialties-use-telemedicine-most



6.1.3 In addition to first responders, hospitals and health systems are now developing

telemedicine networks to stay operational during disasters or to facilitate care coordination

and management when they‘re forced to evacuate patients and suspend operations. These

same networks enable health systems to triage care at the scene of a large accident or mass-

casualty event, or coordinate care and treatment during a pandemic.

6.1.4 On a more wide-ranging level, the Red Cross and various international relief

organizations are using telemedicine platforms to deliver care to regions of the world hit by

disasters, ranging from hurricanes and earthquakes to drought and famine.

https://mhealthintelligence.com/features/using-telehealth-technology-for-care-coordination-

during-a-disaster

6.2 School telehealth clinics reduce missed classroom days

Cuts and abrasions, rashes, pink eye, coughs, colds, strep throat, earaches or flu-like

symptoms all can be examined and treated remotely. If necessary, prescriptions can be filled

at a local pharmacy for school personnel to pick up.

https://www.heraldbulletin.com/community/school-telehealth-clinics-reduce-missed-

classroom-days/article_31b3ea0b-b02f-5ab5-bc43-7a356a7b4089.html

https://www.tribstar.com/news/local_news/rural-school-telehealth-clinics-boost-medical-

access/article_5a10c633-d7d6-5521-b3ea-0b1e660dc316.html

6.3 Follow Up Visits

Readmission rates to hospitals are a leading cause of unnecessary health care spending and

can be easily reduced by use of telemedicine services. Even multiple trips to the local family

doctor can be a costly burden to the patient and care provider. These readmissions and trips

can often be eliminated by making the follow-up visit more convenient to the patient.

If a physical exam is not necessary, a video-based visit can be sufficient to see how the

patient is doing, address the patient‘s questions, and to confirm the patient is following the

prescribed course of action. The use of telemedicine for follow-up visits is a great way to

maintain or increase the level of patient engagement in their own healthcare.

https://mhealthintelligence.com/news/red-cross-turns-to-telehealth-for-emergency-care

https://mhealthintelligence.com/features/using-telehealth-technology-for-care-coordination-during-a-disaster

https://mhealthintelligence.com/features/using-telehealth-technology-for-care-coordination-during-a-disaster

https://www.heraldbulletin.com/community/school-telehealth-clinics-reduce-missed-classroom-days/article_31b3ea0b-b02f-5ab5-bc43-7a356a7b4089.html

https://www.heraldbulletin.com/community/school-telehealth-clinics-reduce-missed-classroom-days/article_31b3ea0b-b02f-5ab5-bc43-7a356a7b4089.html

https://www.tribstar.com/news/local_news/rural-school-telehealth-clinics-boost-medical-access/article_5a10c633-d7d6-5521-b3ea-0b1e660dc316.html

https://www.tribstar.com/news/local_news/rural-school-telehealth-clinics-boost-medical-access/article_5a10c633-d7d6-5521-b3ea-0b1e660dc316.html

https://webrtc.ventures/?s=readmission



6.4 Pre-Screenings

Sometimes the patient just needs a reassuring conversation with the care provider, or to ask a

few quick questions. Especially during off-hours, this could be done via video to help a

patient determine if an emergency room visit is necessary or how bad that cough sounds.

Telehealth pre-screenings via video can also be used prior to surgery, mental health therapy

and a number of other medical appointments.

6.5 Safety

Telemedicine encounters prevent the possible transmission of infectious diseases and

parasites between the patient and remote health professionals.

6.6 Remote Experts

At times, healthcare providers who are considered experts in a particular medical specialty

may be located in a completely different part of the state or even country. A patient may not

be able to travel easily for a quick consultation, and a telehealth solution provides more

convenient, accessible care. Secure data exchange means that the patient records could be

shared with only the remote specialist during the call, ensuring patient privacy.

6.7 Telehomecare

For patients who are immobile or for whom travel is difficult, many medical practices include

in-home visits by care specialists or nurses. That in-person care provider may want to bring

in another physician remotely to talk with the patient over video and help answer any

questions the in-home care provider cannot answer. These are just a few examples of how

telemedicine applications can be hugely beneficial to both patients and providers alike. In the

United States, for example, Kaiser Permanente reported in 2016 that 52% of the 110 million

physician– patient interactions in the previous year took place through virtual means. By

comparison, according to the 2015 Canadian Telehealth Report there were 411,778 telehealth

clinical sessions in 2014, representing just 0.15% of the 270.3 million billable services

reported by the Canadian Institute for Health Information in 2015–16.

https://webrtc.ventures/2018/06/4-most-common-telehealth-use-cases/









6.8 Tele-ultrasound: How ultrasound in telemedicine is changing education,

training, and patient care

Ultrasound is an effective diagnostic tool and its application within telemedicine (―tele-

ultrasound‖) has advanced substantially in recent years, particularly in high-income settings.

Advancements in telemedicine technology have greatly increased its use over the past few

years, as more physicians and clinicians are finding new ways to utilize remote diagnosis and

provide interactive care through telecommunications. One modality that has seen a large

uptick in telemedicine usage is ultrasound, as experts are able to access ultrasound exams

from all over the world at any time. Whether from the back of an ambulance, the site of a

natural disaster, or simply as a means to teach medical residents, this new technology is

revolutionizing ultrasound training, education, and patient care.

6.9 GPS Positioning Applications for Patients With Heart Disease

6.9.1 Each person needs to build their health database. If a sufferer of heart disease has

created their digital health file, then, as soon as their heart begins to behave abnormally or

poses an immediate risk, the relevant data will be immediately passed to the system that can

use GPS positioning to call the necessary emergency services from the nearest hospital.

6.9.2 This may be a simple IoT application, but, in the future, we may all have our own

check-up devices at home. The Internet of Things (IoT) can be defined as a collection of

―smart‖ devices and ―wearables‖ that collect and communicate data. All we need to do is

place our palm on the device that will then collect blood pressure, heart rate, pulse, and body

temperature. Perhaps the latest smart device is the first digital drug, which was approved in

the United States in 2017. This is an antipsychotic pill with an embedded that mixes with

stomach acids when swallowed and sends a signal to an adhesive patch on the patient that

records the dosage and time of ingestion and relays it to a smartphone app. In the future, it

might even be able to perform chemical tests. This data will be automatically passed to the

hospital‘s data center, and, if necessary, a doctor will ask us to come into the hospital for

further evaluation or go to a nearby treatment center to receive treatment.

https://dzone.com/articles/applications-of-the-internet-of-things-in-the-medi

6.10 Critical Care Telemedicine

https://dzone.com/articles/applications-of-the-internet-of-things-in-the-medi



6.10.1 Critical care telemedicine uses a remotely located support centre housing a critical

care team who are networked with a number of bedside critical care unit teams and patients

via audio-visual communication and computer systems over the 24-h period. It offers the

potential for multiple opportunities for safety and quality improvement on account of off-site

support provided by intensivists and critical care nurses, continuous monitoring with early

warning capabilities, rounding tools to monitor at-risk patients, inbuilt clinical decision

support, and prompts regarding adherence to best practice. In addition to potentially

providing an additional safety net to ward-based teams, critical care telemedicine could

provide a mechanism for near real-time feedback to improve situational awareness and

accountability for individual actions.

6.10.2 In the early 1900s, Einthoven had a telephone cable laid to the hospital a mile away

and demonstrated the ability to make recordings remotely. These days, digital

electrocardiography and Holter monitor data are shared via fax, Internet, and mobile devices

with high resolution. Starting in the 1990s, digital telemetry systems allowed computerized

electrocardiography signal recording, storage, and retrieval and now are standard of care for

patients in the ICU. This has led to the establishment of tele-ICUs and facilitates remote real-

time monitoring and recommendations by electrophysiologists.

6.10.3 Mobile monitoring devices are now commonly used for patients for up to 30 days of

ambulatory telemetry. These devices provide telemetry monitoring 24 hours/day via the small

sensor and monitor the patient wears as the patient continues with his or her normal daily

routine. As events occur, patient activity is instantly transmitted to a central monitoring

center via a cellular signal for analysis and response. In 1 study, mobile telemetry was

superior in confirming the diagnosis of clinical significant arrhythmias compared with

memory loop recorders. Two recent studies showed that a single-lead, FDA-approved

adhesive patch monitor for continuously recording and detecting cardiac arrhythmias in an

ambulatory setting detected more arrhythmias than conventional Holter monitors.


6.10.4 Several studies conducted by NEHI (Network for Excellence in Health Innovation)

and the University of Massachusetts Memorial Medical Center have shown that ICU care

provided remotely by physicians trained as intensivists can decrease mortality by more than

20 percent, decrease ICU lengths-of-stay by up to 30 percent, and reduce the costs of care.




Additionally, the supply of intensivists is not adequate to meet the needs of the ICUs across

the country, leaving critical care at many small community and rural hospitals to be provided

primarily by community physicians and ICU nurses.

6.10.5 Tele-ICU technologies can leverage intensivist coverage over more ICU beds and

increase productivity by providing direct consultation and management of ICU patients at a

distant site through remote two-way audio, visual, and physiologic monitoring. Central tele-

ICU units are typically staffed with one or more intensivists, critical care nurses, and other

specialists, who observe patients in distant hospital units; provide proactive care by

anticipating crises before they happen through sophisticated computerized physiologic,

laboratory, and medication monitoring; and provide direct consultation to on-site nurses and

physicians.

6.10.5 Approximately 13 percent of ICU beds in the United States are currently supported by

tele-ICU technologies. Given the positive system and financial improvements resulting from

this remote monitoring, the expansion of effective implementation of tele-ICU care will

substantially benefit patients and providers across the country.


6.11 Patient medication adherence

6.11.1 This is another example of a pervasive problem that can benefit from telehealth

support. Although millions of Americans suffer from chronic illnesses that could be

effectively managed with prescription drugs, on average, patients take their medications as

prescribed only about half the time. Yet compelling data show that patients who adhere to

treatment regimens for chronic illnesses have fewer clinical problems and are less costly to

care for over time compared with non-adherent patients.

6.11.2 There are a number of technologies that help patients better adhere to their medication

regimens, although these technologies have different mechanisms of action. For example,

smartphone applications remind patients to take their pills and can help order refills. Internet-

connected pill caps alert patients (through music, ringtones, and flashing lights) to take their

medications and often have the ability to send email to remote caregivers, create adherence

reports, and refill prescriptions. As another example, pharmaceutical packages designed to




improve patient adherence have dated calendars printed on medication cards (or ―blisters‖)

that help patients take their drugs as prescribed.

6.11.3 In the future, technology-enabled medication reminders may be built into automatic

pill dispensers, watches, and alarm clocks and potentially encapsulated in sensor-enhanced

pills that can track when the patient swallows the medication.

6.11.4 The Center for Connected Health, a division of Partners Healthcare, conducted a

randomized clinical trial using a wireless electronic pill bottle to remind patients with high

blood pressure to take their medication. Initial findings demonstrated a 68% higher rate of

medication adherence in patients using the Internet-connected medication packaging and

feedback services compared to controls.

6.11.5 Although these technologies are relatively new, initial evaluations suggest that

connected health technologies can prove useful in the context of well-managed medication

care, increasing patient self-management, improving outcomes, and lowering costs.


6.12 Reducing referral wait times

Referral is a service model for referrals and consultations through which primary care

providers can exchange privacy-protected, templated email messages with specialists. The

program was developed at San Francisco General Hospital in 2005, when wait times for

specialty appointments ranged from seven to eleven months. The program now covers more

than forty specialties and services. Similar programs have since been established at the Los

Angeles County Department of Health Services, the Mayo Clinic, and at UCSF and UCLA.

In each implementation, use of this telemedicine technology has produced shorter wait times,

reduced the number of in-person specialty visits by 20 percent or more, improved preparation

of patients for specialty visits when required, and strengthened primary care provider-

specialist collaboration and satisfaction. Because the rate of outpatient specialist referrals has

almost doubled in the United States over the past decade, this application may become an

important means of leveraging specialist capacity.






6.13 Telepathology

Telepathology is of great benefit to underserved and rural areas where there is a significant

shortage of pathologists. In these areas, not only is there a high demand for diagnostic

consultation, but also a need for continuing education and guidance on patient management.

Technologies utilized to practice international telepathology have evolved since their

inception in the late 1980s. Initial efforts relied on store-and-forward systems where static

images were the mainstay of image exchange. By 2001, the transplant pathology service at

UPMC had accumulated experience with teleconsultation for over 3,000 static images.

Digital consultation for these cases demonstrated acceptable diagnostic concordance between

digital and glass diagnoses. More contemporary telepathology platforms have adopted WSI.

WSI enables remote viewing in one of two ways: digital files can either be accessed on a

remotely shared server owned by the host facility (or third party), or transmitted and

uploaded (e.g. via a web portal) to a server that is owned by the consultant group. The former

arrangement requires strong cooperation between medical, administrative and information

technology (IT) divisions on both ends, in addition to permission to access foreign servers.

The latter arrangement may result in time delays due to image transmission; however, image

viewing is less likely to suffer from network delays or firewall issues.Newer platforms to

support telepathology have begun using diagnostic viewers, cloud services, more open access

platforms, plug-in technology and even mobile cellular devices. Over the last two decades,

there has been a significant shift in the types of technologies deployed in the practice of

telepathology. The Weinstein Telepathology System Classification describes 12 distinct

classes of telepathology systems. For simplicity, these modes can be divided into static

(store-and-forward), dynamic (aka real-time) or hybrid systems that combine elements of

both static and dynamic imaging. Apart from financial and technology barriers (e.g.

electricity supply and reliable telecommunication bandwidth in rural or underserved areas),

there are also regulatory and cultural factors that may impede international telepathology.

There is some degree of uncertainty regarding the liability of health professionals when

delivering care across borders. Other important factors to delivering quality care across

borders include local technical support, reliable connectivity, good image quality, quality

assurance measures, monitoring timeliness of reporting, database maintenance and the

availability of bidirectional communication between parties. Many international laboratories

with limited resources encounter difficulties in the production of optimal, high-quality glass



slides that have well-stained tissue. Consequently, telepathology consults may be limited due

to these poor quality slides. Furthermore, poorly prepared tissues and slides (e.g. tissue

present outside the coverslip or tissue folds) may affect optimal scanning and thereby hamper

interpretation. Another limiting factor is when experts do not have additional data about the

case, such as pertinent clinical information, radiology images or measurements, and the

results of ancillary studies (e.g. flow cytometry or molecular information). Lack of these

metadata can make it hard for an expert consultant to provide a comprehensive opinion for

challenging cases.https://www.karger.com/Article/Fulltext/442390

6.14 Teleradiology

6.14.1 The transmission of images between centres has been established for a number of

years and has proved to be valuable for centres seeking expert opinions on emergency and

problem cases. More recently radiological images have been transmitted to main centres from

outlying hospitals in areas of low population density where small radiology departments have

proven unsustainable. The vastly improved capacity of the internet and the speed of

transmission has permitted a much wider use of teleradiology with centres around the world

providing day-time reporting for out of hours imaging services in other countries in differing

time zones. The potential for image transmission is now virtually limitless resulting in major

changes to the way radiological services are provided. This change has advantages but also

has potential threats to the quality of care provided to patients and to the radiologist's

interaction with their clinical colleagues. It is important however, that the quality of

radiological services provided for the patient are of a high standard. It is also important that

those providing the service are properly trained, are registered with the appropriate

authorities and undergo continuing updates through Continuing Medical Education (CME).

The services provided must be open to audit and the ability to discuss cases with those

reporting the studies must be available.

6.14.2 Positives and Negatives of Teleradiology

6.14.2.1 Teleradiology has the potential to bring both positives and negatives to

patient care. Radiologists have used teleradiology to simplify geographic and overnight

coverage challenges as well as to strengthen subspecialty expertise. An important virtue of

teleradiology is that many smaller hospitals that struggle to maintain adequate off-hour and

subspecialty coverage can rapidly provide high-quality interpretations around the clock.

https://www.karger.com/Article/Fulltext/442390



Centralized image distribution hubs allow efficient access to qualified teleradiologists by

hospitals and emergency departments needing quality reports for their imaging services.

These hubs can also assist small groups to match manpower capacity with volume

fluctuations or vacation coverage, obviating the need for more expensive on-site solutions.

Unfortunately, some teleradiology companies focus exclusively on report delivery. Besides

devaluing our specialty and undermining the role of the radiologist as an independent expert

in diagnostic imaging and a fully engaged member of the consulting team, this practice

further commoditizes the product of our efforts. However, effective real-time interactive

multimedia teleradiology systems are on the horizon in developed countries.

6.14.2.2 Recent technological advances introduced a radical change in the modern

health care sector including medical imaging facilities, hospital information system (HIS),

and information management systems in hospitals. Changes in medical imaging facilities in

radiology have acquired sufficient reliability and cost-effectiveness that the film-based

imaging technology has been shifted to filmless techniques for producing digital images on

various devices rather than generating hardcopies. With the use of these digital medical

images, in addition, HIS comprising radiology information system (RIS) and picture

archiving and communication system (PACS) has facilitated offering various eHealth

services. These eHealth services are introducing new practices for the profession as well as

for the patients by enabling remote access, transmission, and interpretation of the medical

images for diagnosis purposes. This has made easy the widespread use of teleradiology with

the potential to improve healthcare access, delivery, and standards, where complex new legal

and ethical issues are also raising. These issues include image retention and fraud, privacy,

malpractice liability, licensing and credentialing, and contracts for PACS, RIS, and

teleradiology.

6.14.2.3 In teleradiology, one of the most successful eHealth services at present,

security and privacy protection has become a critical issue. Providing the required security

and privacy of the radiology information requires the following: (1) a standard set of security

and privacy profile/policy for teleradiology and (2) a set of security measures by which the

security principles in the profile are fulfilled. Various national and international legislative

rules and directives define the security and privacy requirements of medical information.



https://www.acr.org/-/media/ACR/Files/Legal-and-Business-

Practices/ACR_White_Paper_on_Teleradiology_Practice1.pdf

https://www.rcr.ac.uk/system/files/publication/field_publication_files/bfcr181_standards_for_int

erpretation_reporting.pdf

https://www.myesr.org/sites/default/files/ESR_brochure_01_0.pdf

6.15 Teledermatology

Teledermatology enables the transmission of a patient‘s clinical history and skin images to a

dermatologist, who then provides a diagnosis and management plan. The teledermatology

modalities are (1) store-and-forward, which uses still photographic images that are typically

evaluated by a dermatologist at a separate time and location from the patient‘s visit and (2)

live interactive video conferencing, which enables real-time evaluation when the patient and

dermatologist are in separate locations. https://link.springer.com/article/10.1007/s13671-019-

0252-2

6.16 Telecardiology

Telecardiology (in the form of telemetric functional analysis) not only protects against the

risks of malfunction of the device but may also support the treatment of the patient. Because

in addition to the technical data of the device, depending on the model being used, additional

information can also be relayed, such as course and frequency of atrial fibrillation, average

heart rate, heart rate variability etc. This is known in this context as intricate, complete

remote monitoring of technical and clinical patient data. A number of studies provide

evidence that telemetric care of patients entails a significant general improvement of care

quality (with regard to the safe operation and the setting of the units and patient

management). The currently applicable guidelines as well as a European-American consensus

document clearly recommend implant-based telemonitoring after evaluation of empirical

data. https://www.openaccessjournals.com/articles/telemetric-remote-monitoring-of-cardiac-

devices-is-the-future-of-medicine-a-liability-trap-for-the-physician-12537.html

7. National Health Policy 2017 and Telemedicine/TeleHealth

7.1 In the above context, it is important to note the focus of India‘s National Health

Policy 2017 from the following extracted content:

https://www.acr.org/-/media/ACR/Files/Legal-and-Business-Practices/ACR_White_Paper_on_Teleradiology_Practice1.pdf

https://www.acr.org/-/media/ACR/Files/Legal-and-Business-Practices/ACR_White_Paper_on_Teleradiology_Practice1.pdf

https://www.rcr.ac.uk/system/files/publication/field_publication_files/bfcr181_standards_for_interpretation_reporting.pdf

https://www.rcr.ac.uk/system/files/publication/field_publication_files/bfcr181_standards_for_interpretation_reporting.pdf

https://www.myesr.org/sites/default/files/ESR_brochure_01_0.pdf

https://link.springer.com/article/10.1007/s13671-019-0252-2


https://www.openaccessjournals.com/articles/telemetric-remote-monitoring-of-cardiac-devices-is-the-future-of-medicine-a-liability-trap-for-the-physician-12537.html




7.1.1 Leveraging the potential of digital health for two way systemic linkages between the

various levels of care viz., primary, secondary and tertiary, would ensure continuity of care.

(In paragraph 3.3.1: Primary Care Services and Continuity of Care)

7.1.2 National Knowledge Network shall be used for Tele-education, Tele-CME, Tele-

consultations and access to digital library. (In paragraph 11.1: Medical Education)

7.1.3 The policy recommends creation of a large number of distance and continuing

education options for general practitioners in both the private and the public sectors,

which would upgrade their skills to manage the large majority of cases at local level, thus

avoiding unnecessary referrals. (In paragraph 11.3: Specialist Attraction and Retention).

7.1.4 The policy recognizes that human resource management is critical to health system

strengthening and healthcare delivery and therefore the policy supports measures aimed at

continuing medical and nursing education and on the job support to providers,

especially those working in professional isolation in rural areas using digital tools and

other appropriate training resources. (In paragraph 11.9: Human Resource Governance

and leadership development)

7.1.5 The policy supports voluntary service in rural and under-served areas on a pro-

bono basis by recognised healthcare professionals under a ―giving back to

society‟initiative. (In paragraph 13: Collaboration with Non-Government Sector/Engagement

with private sector)

7.1.6 Additionally, sharing information on infrastructure and services deployable for

disaster management would enable the development of a comprehensive information

system with data on availability and utilization of services, for optimum use during golden

hour and other emergencies. (In paragraph 13.5: Disaster Management)

7.1.7 For achieving the objective of having fully functional primary healthcare facilities-

especially in urban areas to reach under-serviced populations and on a fee basis for middle

class populations, Government would collaborate with the private sector for operationalizing

such health and wellness centres to provide a larger package of comprehensive primary

health care across the country. Partnerships that address specific gaps in public services:

These would inter alia include diagnostics services, ambulance services, safe blood services,



rehabilitative services, palliative services, mental healthcare, telemedicine services,

managing rare and orphan diseases. (In paragraph 13.6.3)

7.1.8 Private sector engagement goes beyond contracting and purchasing. Private providers,

especially those working in rural and remote areas, or with under-serviced communities,

require access to opportunities for skill up-gradation to meet public health goals, to serve the

community better, for participation in disease notification and surveillance efforts, and for

sharing and support through provision of certain high value services - like laboratory support

for identification of drug resistant tuberculosis or other infections, supply of some restricted

medicines needed for special situations, building flexibilities into standards needed for

service provision in difficult contexts and even social recognition of their work. (In

paragraph 13.14)

7.1.9 Grading of clinical establishments and active promotion and adoption of standard

treatment guidelines would be one starting point. Protection of patient rights in clinical

establishments (such as rights to information, access to medical records and reports, informed

consent, second opinion, confidentiality and privacy) as key process standards, would be an

important step.

7.1.10 Health Technology Assessment: Health Technology assessment is required to ensure

that technology choice is participatory and is guided by considerations of scientific evidence,

safety, consideration on cost effectiveness and social values. The National Health Policy

commits to the development of institutional framework and capacity for Health Technology

Assessment and adoption. (In paragraph 22)

7.1.11 Digital Health Technology Eco - System: Recognising the integral role of

technology(eHealth, mHealth, Cloud, Internet of things, wearables, etc) in the healthcare

delivery, a National Digital Health Authority (NDHA) will be set up to regulate, develop and

deploy digital health across the continuum of care. The policy advocates extensive

deployment of digital tools for improving the efficiency and outcome of the healthcare

system. (In paragraph 23)

7.1.12 Application of Digital Health: The policy advocates scaling of various initiatives in

the area of teleconsultation which will entail linking tertiary care institutions (medical

colleges) to District and Subdistrict hospitals which provide secondary care facilities, for the



purpose of specialist consultations. The policy will promote utilization of National

Knowledge Network for Tele-education, Tele-CME, Teleconsultations and access to digital

library. (In paragraph 23.1)

7.1.13 Leveraging Digital Tools for AYUSH: Digital tools would be used for generation and

sharing of information about AYUSH services and AYUSH practitioners, for traditional

community level healthcare providers and for household level preventive, promotive and

curative practices. (Paragraph 23.2)

7.14. Right to health cannot be perceived unless the basic health infrastructure like

doctor-patient ratio, patient-bed ratio, nurses-patient ratio, etc are near or above threshold

levels and uniformly spread-out across the geographical frontiers of the country. Further, the

procedural guidelines, common regulatory platform for public and private sector, standard

treatment protocols, etc need to be put in place. Accordingly, the management,

administrative and overall governance structure in the health system needs to be

overhauled. (In paragraph 27).

7.15 The Indian State (GOI, State Governments and UT administrations) in its concerted

efforts to provide quality (cheaper, faster and better), holistic health/wellbeing and healthcare

(promotive, preventive, curative, rehabilitative, palliative) services to all Indian citizens, in a

citizen-centric manner, in the proximity of his/her place of residence, as shown above by the

extracted paragraphs from the National Health Policy 2017, considers the modern

technological ecosystem, centered on the digital communication system environment, to be

an integral component of its policy, implementation framework and strategy.

8 Other Policy Initiatives of GOI relevant also to Telemedicine/TeleHealth

8.1 The creation/promulgation of EHR standard 2016 and the National Digital Health

Blueprint (NDHB) are two major basic steps in this direction. To ensure quality/standard of

care, the GOI has begun the systematic creation and use of Standard Treatment Guidelines

and Standard Treatment Workflows.

8.2 Since 2001, telemedicine in India has made considerable progress. This has largely

happened with the support of the Indian State. Lately, the private sector and the not-for-profit

sector have also become active in providing healthcare services through telemedicine.



8.3 The Ayushman Bharat Scheme is a game-changing initiative in ongoing efforts to

ensure universal healthcare in the country. Focus on areas like strengthening healthcare

infrastructure, holistic and preventive healthcare, digital outreach, and risk cover is critical in

achieving this objective. It will promote wellness, prevent health loss, increase access to

quality care for the most needy as never before, reduce poverty, and help realise the

demographic dividend of India. The Ayushman Bharat National Health Protection Mission

(AB-NHPM), which was announced as part of Union Budget 2018-19, has a significant focus

on the use of telemedicine services, especially in the Health and Wellness Centres at the

grassroot level. It includes a vision for a family health card too, eventually electronic records,

which also will be a vehicle for tele-consultations—wherein a mid-level provider can talk to

the right people and advise patients accordingly. It will be a strong IT enabled system. The

GOI has been increasingly focusing on digital health and employing ICT for improving

efficiency. A National Telemedicine Network (NTN) has been set up, and telemedicine

nodes have been established across the country. Further, there is a National Medical College

Network that brings together 50 government medical colleges for e-education and e-

healthcare delivery. Remote monitoring has also found application in rural areas where

access to hospitals/clinics is limited. Physicians visit rural areas with mobile monitoring

devices that either attach to a mobile to transmit data or transmit data to a mobile device

through communication protocols such as Bluetooth Low Energy. Patient data is transmitted

to physicians sitting miles away and, if needed, tele-consultations are arranged with

specialists.

9. Use of Telemedicine/TeleHealth in Low Resource Settings

9.1 The main advantage of telemedicine is that it can improve access to health care, often

by increasing the speed with which a specialist opinion can be obtained (e.g., tele-stroke) or

by reducing the need to travel (e.g., teledermatology); in certain disciplines, evidence has also

been obtained that telemedicine is cost-effective. Mobile phones have great potential in the

delivery of healthcare in low-resource settings.

9.2 Recently, many state governments (Telangana, Andhra Pradesh, and Delhi among

others) have made a determined push towards digitisation. A vast country like India cannot

deliver ‗universal health coverage‘ through the public health system alone. Private hospitals,



PPP models, NGOs, and CSR have a great role and responsibility towards accomplishing the

vision.

9.3 For some illnesses, it is preferable for patients to stay at home and receive the care

that only their families can provide. However, it is also of utmost importance for patients to

receive the necessary medical care and cleanliness that healthcare service providers offer.

9.4 Krishnan et al reported the technology transition at a single center with >10 000

telemedicine transmissions from 24 sites in 7 states and territories between 2001 and 2012.

Abnormalities were detected in >40% of the studies, including >100 patients with life-

threatening defects. More than 150 patients were transported for surgical, catheter-based, or

medical intervention. Critical heart disease was ruled out in >75 patients, thus preventing

unnecessary transports. Medical management or outpatient follow-up was recommended in

approximately half of the studies. After IP expansion, a significant increase in telecardiology

use took place, with no adverse effect on efficiency or diagnostic accuracy. IP expansion

paralleled a change from a predominance of live transmissions to store-and-forward

transmissions.


9.5 Critical care at home is picking up in India with dozens of companies providing ICU

facilities and critical care treatments at home. While the home provides a convenient

environment for the patient and family members, the service provider ensures that the

patient‘s vitals are continually recorded using IoT devices; the vitals are then transmitted to

physicians at their treating hospital. Physicians thus have continuous access to the patient‘s

vitals and can instruct the attending nurse at the patient‘s home to adjust the dosage, if

required, basis the vitals reported remotely. Remote monitoring also assists in triggering

automated alarms to physicians, ambulance service providers and patient‘s family memb

delivery of health care in low-resource settings. Patterson developed a mobile-phone app to

enable non-doctors to diagnose episodes as epileptic. In a pilot trial with health workers in

Nepal who used the app in small numbers of patients, there were no false diagnoses. This

represents a potential method of empowering health workers to help the millions of people in

the resource-poor world with untreated epilepsy. Ndlovu et al. conducted trials with mobile-

phone telemedicine in Botswana, in four medical specialties: radiology, oral medicine,

dermatology, and cervical cancer screening.




9.6 An alternative method of transmitting video for telemedicine is to make use of free or

low-cost web-based tools. For example, Jefee-Bahloul conducted a pilot trial of

telepsychiatry in Jordan using Skype, while Adambounou et al. used the file transfer facilities

of the LogMeIn web service for tele-ultrasound between Togo and France. Real-time

applications such as Skype, Google Hangout, FaceTime, and WebRTC are excellent

alternatives to face-to-face communication/consultation.

9.7 It is clear from these reports that video telemedicine is possible in low-resource

environments, but it is also the case that non-real-time (store-and-forward) telemedicine is

more common in these settings, not only because it is usually cheaper but also because the

non-synchronous nature of the interaction between the parties makes it easier to organize.

The longest-running such network is probably operated by the US military in the Pacific,

which has used email and web-based communication in the Pacific Island Health Care

Project since the late 1990s. As Person reports, teleconsultation has enabled local treatment in

the Pacific islands, without necessarily requiring transfer to the major medical center on

Hawaii; many of the cases were pediatric.

9.8 Médecins Sans Frontières (MSF), an organization that works mainly in low-resource

settings, developed its own telemedicine tool based on the Collegium Telemedicus model.

The aim was a system that would improve the primary-specialty care interface and allow

their field doctors to obtain an expert opinion within a few hours, wherever they were located

in the world. The MSF experience, and that of others reported here, suggests that store-and-

forward networks are clinically useful, sustainable, and potentially cost-effective. It is also

clear that there is still lingering skepticism from some healthcare staff about the adoption of

telemedicine into routine practice. Apparently, telemedicine is sometimes viewed as a threat

or a competitor to conventional ways of working. Yet, telemedicine is simply another tool for

assisting in the delivery of healthcare, and in low-resource settings there is often no other

way to access the required resources.

As telemedicine matures to become a routine service in low-resource settings, it will

become increasingly important to evaluate the quality of service being delivered and to

demonstrate that this is being maintained.





10. Governance, Quality, Safety and Regulation of Telemedicine/TeleHealth

10.1 Like any other technology, the technology used for telehealth services can and will be

abused. In its current state of play, it has some risks, drawbacks and limitations, which must

be mitigated through appropriate training, codes of ethics, promulgation and

enforcement of standards, protocols, guidelines, regulations, and laws (collectively

called Institutional Framework). Telemedicine policies and procedures should address

the following: licensure; establishment of the physician-patient relationship; issues of

liability and negligence; evaluation and treatment; informed consent; continuity of care;

referrals for emergency services; medical records; privacy and security of the patient records

and exchange of information; disclosures and functionality of online services; prescribing;

and reimbursement.https://www.magmutual.com/learning/article/guidelines-telemedicine-

policies-and-procedures-0/

10.2 Like many other developing countries, India has deployed telemedicine technology in

an ad hoc manner, without a clear policy framework, a set of objectives, or strategy. Despite

more than two decades of adapting telemedicine, like other developing countries, India has

not achieved any significant success in reducing the cost of care or improving the access of

care. According to a study, about 75% of the telemedicine projects are abandoned or failed

outright and called as failed projects and this percentage goes up to 90% in developing

countries. Until we are not able to find out, enlist, analyze, and understand the barriers in the

deployment and development of telemedicine, we cannot ensure success of telemedicine

program. Following crucial barriers are currently working in the field of telemedicine

implantation and operation.

https://www.intechopen.com/books/telehealth/barriers-to-development-of-telemedicine-

in-developing-countries

10.3 Lack of formal organizational structure to deliver telemedicine services is the biggest

barrier for the development of telemedicine services in any country. Because being a hybrid

discipline, it needs collaboration with all possible stakeholders at each level of the healthcare

delivery system. Lack of collaboration between the stakeholders in the absence of specific

policy becomes a bottleneck in the development of Telemedicine/TeleHealth.

https://www.magmutual.com/learning/article/guidelines-telemedicine-policies-and-procedures-0/

https://www.magmutual.com/learning/article/guidelines-telemedicine-policies-and-procedures-0/

https://www.intechopen.com/books/telehealth/barriers-to-development-of-telemedicine-in-developing-countries

https://www.intechopen.com/books/telehealth/barriers-to-development-of-telemedicine-in-developing-countries



10.4 Although Telemedicine/TeleHealth has the potential to improve several aspects of

medical care, such as facilitating physician-patient communication and monitoring treatment

of chronic conditions, telemedicine poses unique challenges in ensuring patient-safety and

privacy of health information. It is, therefore, prudent for telemedicine providers to

implement measures that safeguard the integrity of the care they provide to patients.

Healthcare providers should ensure that their recommendations and treatment plans are

feasible based on the resources available to patients. It is also important that telemedicine

providers get feedback from their patients regarding what they expect during telemedicine

encounters and the aspects of telemedicine in which they wish to participate.

10.5 For Telemedicine/TeleHealth to reach its full potential, three criteria must be met:

● First, enough evidence must be compiled to assure that the new model does not

sacrifice quality or cause harm to patients.

● Second, aligning the incentives of all stakeholders in healthcare, including the

financial incentives of the providers so that they produce desired outcomes.

● Finally, more health policy research that evaluates the quality and cost impacts of

connected health is essential. To demonstrate its value, providers will need to devote

more dedicated leadership, expertise, and time to the implementation of connected

health innovations. This includes changing the provider culture and workflow systems

in order to allow the full incorporation of telemedicine into traditional care. Because

clinicians have historically resisted changes in how care is delivered, physician and

nurse champions will need to take the lead in ensuring that providers embrace these

emerging models of care management.


10.6 Although physicians‘ fundamental ethical responsibilities do not change, the

continuum of possible patient-physician interactions in telehealth/telemedicine give rise to

differing levels of accountability for physicians.

10.7 The development of guidelines and standards for telemedicine is an important and

valuable process to help ensure effective and safe delivery of quality healthcare.

Telemedicine will continue to grow and be adopted by more healthcare practitioners and

patients in a wide variety of forms, not just in the traditional clinical environments, and




practice guidelines will be a key factor in fostering this growth. Creation of guidelines is

important to payers and regulators as well as increasingly they are adopting and integrating

them into regulations and policies. In any field, improving performance and accountability

depends on having a shared goal that unites the interests and activities of all stakeholders.

One of those shared goals should be the development of sound clinical practice guidelines.

Research to date clearly demonstrates that technology-enabled health care is not only feasible

but in some cases can be equal to or better than in-person care. Nearly every clinical specialty

has been evaluated, and found to benefit from telehealth to some degree, whether it be cost

savings, time to treatment as a function of better access to services, or clinical outcomes. One

might even argue that, to some extent, telehealth has been held to a much higher standard

than traditional medicine and has undergone more rigorous evaluations.

10.8 So what makes telehealth so different? In some respects, it is the nature of the

medium and the rapidity with which the technology keeps changing. As technology changes,

it is incumbent on the telehealth community to verify the reliability and validity of these

technologies before use in routine care, and to establish standards and practice guidelines for

their use. The American Telemedicine Association has developed a number of practice

guidelines, and continues to produce more. Important highlights include ―Core Standards for

Telemedicine Operations‖, ―Expert Consensus Recommendation for Videoconferencing-

Based Telepresenting‖, and dedicated specialty guidelines for teledermatology,

telepathology, tele-home health, tele-mental health, tele-rehabilitation and tele-

ophthalmology. Other professional societies have also developed guidelines for telemedicine,

including the American College of Radiology, the American Academy of Dermatology, and

the American Medical Association. There are also many international guidelines, such as the

European Code of Practice for Telehealth, all of which are based on research efforts that

validated the technologies being used, assessed practice protocols, and examined the relative

costs and benefits. All of the ATA guidelines incorporate a preamble that broadly states the

intent of the document and the manner in which it should be used.

10.8.1 Three aspects are worth mentioning.

(a) The first is that guideline compliance does not guarantee accurate diagnosis or

successful outcomes, recognizing that the practice of medicine is both a science and

an art and that the immediate, local circumstances need to be considered in order to



best help the patient. Thus, the goal of the guidelines is to assist the clinical

practitioner in pursuing a sound course of action to provide effective and safe medical

care founded on current information, available resources, and patient needs.

(b) The second follows from the first, and notes that the primary care practitioner

is responsible for all decisions regarding the appropriateness of a specific procedure

or course of action. They must consider all presenting circumstances, and if they

choose to use an approach that differs from the guideline it does not imply that the

approach varied from the standard of care. Reasonable judgment based on local

circumstances and the assessment of what is feasible and practical should be used at

all times.

(c) Finally, the preamble notes that the guidelines are not designed nor

meant to be unyielding requirements of practice and are not meant to serve as or

be used to establish a legal standard of care.

10.9 Clinical guideline use is also influenced by the nature and characteristics of the

guidelines.

10.10.1 A recent study evaluated the use of 47 guidelines and found that the

recommendations were followed in about 61% of decisions. Recommendations that were

controversial were followed only 35% of the time, as were those that were vague and non-

specific (36%). When recommendations required changes in existing routines, they were

followed only 44% of the time. Evidence-based recommendations were used more (71%)

than those not based on research.

10.10.2 Although perhaps not directly related to the adoption of guidelines per se,

there are always the traditional barriers to adopting telemedicine in general that obviously

prevent adoption of guidelines, including the cost of implementation, poor reimbursement for

many clinical encounters (although more states are passing parity legislation that requires

telemedicine encounters to be reimbursed at the same rate as face-to-face encounters), and

lack of regulatory incentives in many venues.

10.10.3 To some extent, telemedicine clinical guidelines are needed to help convince

payers and legislators that telemedicine is just another way to provide patient care and thus

should be reimbursed just like any other medical encounter without excessive regulations.



Guidelines also help define current limitations to the practice of telemedicine, although in the

future it is likely that many of these limitations will fade as even newer technologies emerge

(e.g., tools that make remote real-time palpation with haptic feedback a reality so clinicians

can ―touch‖ patients).

10.10.4 Telemedicine guidelines are also going to see more and more incorporation of

recommendations for patients. Mobile technologies, apps and other digital tools are being

increasingly used by patients in a wide variety of healthcare scenarios and they expect their

healthcare providers to accommodate these devices, tools and data into their diagnostic and

treatment protocols. There are, however, limits to what is feasible and practical, and

guidelines can help define those limits. For example, should patients expect healthcare

providers to diagnose every skin condition captured with a SmartPhone camera? Can patients

just Skype their psychiatrist from home whenever they want? These are just a couple of the

types of questions starting to arise in the healthcare arena. Whether or not we need guidelines

will certainly be addressed soon, but it is clear that at the very least patients and providers

need to be educated about what to expect when various technologies are used—what is

feasible and appropriate and what the limitations are. The most recent ATA telemental health

guideline actually does incorporate some guidance for patients, and the remote data

management guideline being developed will as well.

10.11 Telemedicine/TeleHealth is clearly here to stay and will continue to grow as an

important and viable method for improving access to healthcare throughout the world.

Ideally, there should not be separate guidelines for providing healthcare services in the

traditional manner versus telemedicine, but for the present time guidelines do serve a variety

of very useful functions and, thus, will continue to have a place in telemedicine.


10.12 The guidelines address three aspects of service delivery: clinical, technical, and

administrative. Based upon the quantity and quality of peer reviewed evidence, the guidelines

are classified into four levels of adherence:

● “Shall” indicates required action whenever feasible and/or practical.

● “Shall not” indicates a proscription or action that is strongly advised against.

● “Should” indicates a recommended action without excluding others.




● “May” indicates pertinent actions that may be considered to optimize the

telemedicine encounter or operational process.

11. Basic Elements of the Position Statement on Telemedicine/TeleHealth of The

Telemedicine Society of India (TSI)

11.1. The TSI considers Telemedicine/TeleHealth to be an innovative, rapidly evolving

method/model of healthcare delivery.

11.2. The TSI supports the appropriate use of Telemedicine/TeleHealth as a means of

improving access to duly licensed health professionals to provide high-quality, high-value

and safe care.

11.3. When the only realistic options for a patient are:

(i) to receive care via telemedicine that may be less than ideal, or

(ii) not to receive care at all,

the TSI supports the use of telemedicine services to be considered appropriate even though

the physician, patient, or their surrogate, would prefer that care be provided in person.

11.4.1 The TSI recommends that in consultation with all healthcare stakeholders, the

Ministry of Health and Family Welfare, GOI, develops a set of National Telemedicine

Policies, Strategies, Standards, Legislation(s), Regulations and Guidelines (collectively called

―Institutional Framework‖) for India, to:

(i) ensure patient and provider safety, and

(ii) provide a holistic approach to support the development, expansion, delivery,

research and evaluation of Telemedicine services in India by the public, private and

not-for-profit sectors.

11.4.2 The Institutional Framework should be such as succeeds in allaying all lingering

concerns, misgivings, misperceptions and apprehensions relating to clinical practice, human

resources, as well as organizational and technology issues, while supporting continuing

creativity and innovation in making improvements to the Institutional Framework for



efficient and effective delivery of holistic and integrated healthcare services to all Indian

citizens.

11.5. The TSI recommends that the target groups of the Institutional Framework are

healthcare providers (health professionals and organisations/providers), patients, and

surrogates/carers/caregivers/family members.

11.6. The TSI recommends that the GOI should encourage and support individual

specialties/subspecialties to use flexibilities made available in the proposed Institutional

Framework, so that the specific requirements of the individual specialties/subspecialties are

met to the extent possible.

11.7. The TSI recommends that whether Telemedicine is the reasonable vehicle to deliver

a particular healthcare service be determined by relevant representative bodies such as

professional societies of respective specialties/subspecialties, keeping the clinical contexts,

the technological options, the clinical objectives and the compatibility of technology to meet

these clinical objectives, amongst other considerations as may be deemed fit.

11.8. The TSI recommends that when applying relevant elements of the Institutional

Framework, all telemedicine service providers shall keep their unique facts and

circumstances in view. While doing so, all healthcare providers shall exercise due diligence

and be mindful of all relevant legal and ethical requirements when planning, delivering and

evaluating Telemedicine/TeleHealth services.

11.9.1 The TSI divides/categorises Telemedicine/TeleHealth into four main

dimensions/domains as follows:

(a) Tele-collaboration, which refers to interactions between (facility-based or

mobile) onsite and remote health professionals for clinical purposes, e.g., referral, co-

diagnosis, supervision or case review. The distinguishing feature is that health

professionals are involved at both ends of the interaction and a patient may or may not

be involved in the same Telemedicine/TeleHealth interaction, e.g., radiologist-

clinician as well as consultant-junior-with patient situations. Tele-collaboration is

used in many forms of remote specialty consultations, e.g., Tele-radiology and Tele-

pathology in current practice.



(b) Tele-treatment, which refers to interactions between remote health professionals

and patients and/or surrogates/carers/caregivers/family members for the purposes of

direct clinical care, e.g., triage, history, examination, diagnosis and treatment,

including robotic surgery from a remote location. The distinguishing feature is that a

patient or surrogate/carer/caregiver/family member is involved directly at one end of

the interaction and this creates (or presupposes the existence of) a professional-patient

relationship. Tele-treatment is used in the remote delivery of primary care and many

forms of specialty care, e.g., Tele-dermatology, Tele-neurology, Tele-psychiatry and

also Tele-geriatrics.

(c) Tele-monitoring, which refers to biomedical and other forms of data collection

directly from patients (or through caregivers) by remote systems, which are used by

health professionals for clinical purposes such as vital signs monitoring and home

nursing. Tele-monitoring is used in remote chronic disease management, e.g.,

management of hypertension (blood pressure), diabetes (blood glucose) and coronary

heart disease (weight, ECG). The distinguishing feature is that a health professional or

organisation is engaged at one end, i.e., excludes self-monitoring where the patient or

the caregiver collects health data but does not have a healthcare provider involved at

the other end as part of an organized arrangement. Another feature of Tele-monitoring

is that it need not create (or presuppose the existence of) a professional-patient

relationship even though the healthcare organisation as a whole might owe a duty of

care to the patient.

(d) Tele-support, which refers to the use of online services for non-clinical (i.e.,

educational and administrative) purposes to support the patient, and

surrogate/carer/caregiver/family member. Examples include health education, care

administration and the use of treatment prompts in chronic disease management.

11.9.2 The TSI recommends that tele-support may generally also be addressed in the

Institutional Framework, even it should focus on the key activities that are (or ought to be)

supported or regulated for reducing risks and improving patient safety, i.e., that fall within

the scope of the first three domains.

11.10 The TSI recommends that given the diversity of Telemedicine settings, it is

important to distinguish between the various domains as different considerations may apply



to each. For example, Teletreatment, involving a patient at one end, raises considerations that

may not arise in an interaction involving healthcare professionals only, i.e., Tele-

collaboration. Another example is how certain forms of Tele-monitoring (e.g., 24 hour real-

time surveillance) may not have a direct analogue in the traditional mode of health care

delivery (i.e., face-to-face consultation) which creates uncertainty regarding the applicable

standard of care.

11.11.1 The TSI recommends that another important distinction should be

drawn in the Institutional Framework is that between ―health organisations‖ and ―health

professionals‖ involved in the provision of Telemedicine/TeleHealth Services. Certain

obligations in the Institutional Framework should apply only to individual health

professionals as health professionals while other obligations should accrue only to the

broader health organisation that delivers the overall ―system‖ or ―infrastructure‖ of care for

the patient. For example, health organisations may have specialized non-health staff (e.g., IT

staff) who assume responsibility for certain aspects of a Telemedicine service (e.g.,

maintenance of equipment) which nevertheless plays a critical role in the delivery of high

quality healthcare.

11.11.2 Hence, the TSI recommends that the Institutional Framework

should explicitly differentiate between the duties and responsibilities of ―health

organisations‖ and ―health professionals‖, and refers to ―health providers‖ when, say, a

particular guideline applies to both groups.

11.13 TSI recommends a nuanced Institutional Framework for practice of Telemedicine for

the reasons explained in the following paragraphs.

11.13.1 As the public becomes increasingly fluent in utilizing novel

technologies in all aspects of daily life, evolving applications in healthcare are altering when,

where, and how patients and physicians engage with one another. Prior to recent innovations

in information technology, individuals who had a medical concern turned to hardcopy

publications, spoke with family or friends, or made an appointment to see their physician.

Now, a growing number of these individuals are seeking answers online and can obtain them

at virtually any time from virtually anywhere. Evolving technologies also allow patients to

receive care remotely through telemedicine applications, which offer opportunities for

patients who are homebound, who live in rural or underserved areas, or who face other



impediments that limit their access to care. Likewise, new technologies make it possible for

patients who have rare medical disorders to obtain care from distant specialists. Even patients

who have access to care in person may find telemedicine a welcome convenience. While such

innovations have significant potential to benefit patients, they also raise ethical challenges. In

particular, concerns have been raised that exchanging health information and providing care

electronically could create new risks to quality, safety, and continuity of care, all of which

could weaken patient-physician relationships. In this ever evolving business environment,

invariably the regulatory framework of Telemedicine/TeleHealth lags behind the

development of new technologies or business models for delivery of care. In particular,

―direct to consumer‖ models are inherently atypical from traditional delivery models of

Telemedicine services because there is no ―trusted intermediary‖ (a healthcare provider)

between the Telemedicine/TeleHealth physician and the patient as a remote physician may be

directly engaging with patients, resulting in regulators struggling to find the right balance in

regulation even though real-time applications such as Skype, Google Hangout, FaceTime,

and WebRTC are excellent alternatives to face-to-face communication/consultation.

11.13.2 In Telemedicine/TeleHealth as in other modes of care, patient-

physician interactions give rise to differing levels of accountability for physicians. At one end

of the continuum are health-related websites where any interaction between an individual

seeking health information and a physician who provides it is indirect. The physician has

broad obligations to all website users, but is not specifically accountable to any individual

information seeker. For example, on some websites, physician experts are responsible for

ensuring the accuracy and quality of content, but are not expected to be responsible for how

individuals act on the information they find on the website. The analogy is to seek

information from a book or journal article whose author has ensured the accuracy of the

content but is not held to account for readers‘ individual interpretations.

11.13.3 Farther along the continuum are interactions that are more direct, give

rise to greater accountability, and carry greater potential for unethical behavior. An example

would be an online health website or service where a patient could pose a specific personal

health question to which a physician affiliated with the website or service offers an

individualized response, which, of course, might include a recommendation to see a

physician in person. This interaction might occur in real time or within an established time

frame. In such scenarios, the physician, by tailoring the response specifically to the



individual, takes on a greater accountability than one who posts general health content for

public consumption. This situation might be similar to, though more formal than, a―cocktail

party consult‖ in which a physician is approached for guidance. Disclaimers to the effect that

the consultation does not establish a legally recognized patient-physician relationship, which

some websites provide, do not obviate the physician‘s ethical responsibility.

11.13.4 Still farther along the continuum, in a teleradiology or teledermatology

consultation, for example, a specialist accesses images that are ideally accompanied by

information from the patient‘s history, reviews them, and offers insight in real time or

asynchronously using store-and-forward technology. The underlying expectation is that the

specialist‘s response will directly inform decisions about the patient‘s care, for which the

specialist will then share accountability with the treating physician in keeping with

expectations for in person consultations.

11.13.5 Many of the ethical challenges with telemedicine surround the lack of

face-to-face contact that traditionally takes place in healthcare. The physician takes a chance

when she doesn't know the patient. She has to trust that what a patient is telling her is

accurate and she is getting the full story. Patient compliance with telehealth is an ethical

issue unto itself, Telemedicine requires making ethical and clinical judgments based on the

potential risks of prescribing medication for an unknown patient versus not doing so. If it‘s

late on a Friday night and the patient‘s primary care provider is out of town, could a patient

be harmed by not getting needed medication? Are there times when it is better to tell the

patient that they need face-to-face care? https://link.springer.com/article/10.1007/s11606-

017-4082-2

11.13.6 Good facts make good policy. There simply isn‘t enough empirical

data to prove beyond reasonable doubt whether the doctor-patient relationship is crucial to

good care or whether established patients receive better care through video conferencing than

would new patients.

11.13.7 At the far end of the continuum are interactions in which a physician

participates directly in a patient‘s clinical care in real time via telecommunications and is

held accountable for the care he or she provides as a treating physician. Telepsychiatry is one

example, in which care is electronically mediated, but is not necessarily institutionally based.

Teleoncology provides a second example, in which a specialist provides care for a patient in





a remote clinic or other institutional setting, in coordination with on-site professionals

involved in the patient‘s care team. Physicians are also developing new formats to follow

patients with chronic health conditions that take advantage of asynchronous communication

to enhance care, provide greater convenience for patients or their surrogates, and enable

physicians to make effective use of limited clinical time.

11.13.8.1 Should a patient in a developing country be deprived of a telemedicine

consultation with a specialist because the equipment and techniques used may not meet the

stringent standards set in the developed world, where the standards are influenced by fear of

litigation? Put another way: Is some service better than no service and could a service that

does not meet the standards of the developed world constitute an appropriate standard of care

in the developing world? What if in the absence of a limited access to a specialist the fall

back option is one of the following: a health worker, pharmacist, AYUSH doctor, or a self-

styled allopathic doctor with no medical qualifications? What if the nearest MBBS doctor is

100 km away and there are no reasonable/affordable means of transport?

11.13.8.2 For example, there are internationally accepted norms and standards for the

transmission and compression of digitised X-ray films (DICOM – digital imaging and

communication in medicine). These standards are currently not achievable with commercially

available digital cameras designed for domestic use. If a doctor in a rural hospital in a

developing country, with no access to a specialist radiology service, were to take a

photograph of an X-ray plate with a digital camera and send the image by email to a

radiologist for interpretation, would this be accepted as an appropriate standard of care within

available resources? Further questions arise: Can the referring doctor act on the radiologist‘s

report? If, instead of an X-ray, the rural practitioner had sent a photograph of a

dermatological condition to a dermatologist for advice on the diagnosis and management of

the condition, who would take responsibility for the outcome of that management plan? What

are the responsibilities of both parties for keeping records of the electronic consultation? Are

the responsibilities different when the patient is seen ―face to face‖ in a video-conference

consultation?

11.14 Proponents of telehealth and telemedicine highlight how these technologies open new

channels of access to care and offer new opportunities for truly patient-centered care. Critics

are more cautious, expressing concern about new or exacerbated risks to privacy and



confidentiality, the limitations of electronically mediated interactions for physical

examination, and the potential for disruption of the patient-physician relationship.

11.15 Risks to Privacy and Confidentiality

Telemedicine/TeleHealth encounters involve a wider range of third parties than traditional

health care encounters. Notably, telecommunications service providers and possibly their

business affiliates, in addition to health care personnel at one or both ends of the interaction,

are involved. Some encounters are protected under privacy laws and regulations, but others

may not be protected and may carry additional risks. For example, websites that offer health

information may not actually be as anonymous as visitors think; they may leak information to

third parties through code on a website or implanted on patients‘ computers. Similar concerns

may apply to home monitoring devices and mobile health applications to which current

privacy protections may not apply.

11.16 Matching the Mode of Care to the Patient

11.16.1 Telemedicine will not be the right model of care for every patient. To

begin with, a patient or surrogate must have the resources, including access to and ability to

use requisite technology, necessary health care professionals or others present during

interactions, access to emergency care, and an acceptable level of comfort in obtaining care

in this way.

11.16.2 Despite its promise, telemedicine is not an appropriate model of care

for all medical conditions. For example, telemedicine is inappropriate for encounters when a

hands-on physical examination is crucial or critical data can be gleaned only through direct

physical contact. More broadly, telemedicine is not the preferred approach when the

technology does not allow physicians to meet established clinical standards.

11.16.3 Whether telemedicine is appropriate for a given patient may also

depend on what access the individual otherwise has to health care. For some patients, in some

situations, it simply may not be feasible to receive care in person. When the options for a

patient are to receive care that may be less than ideal via telemedicine or not to receive care

at all, telemedicine services can be appropriate even though the physician, patient, or their

surrogate, would prefer that care be provided in person. For example, for a crew member

aboard a submarine or an astronaut in space, telemedicine—whatever its limitations—may be



the only way to provide medical services. For a person in an isolated rural setting a 6-h drive

from a specialist, telemedicine may be preferable even when an in-person encounter would

be marginally superior.

11.17 Trust and Ethical Practice in Telehealth and Telemedicine

While new technologies and new models of care continue to emerge, physicians‘

fundamental ethical responsibilities do not change. The practice of medicine is inherently a

moral activity, founded in a ―covenant of trust‖ between patient and physician. In any model

of care, patients and their surrogates need to be able to trust that physicians will place patient

welfare above other interests (fidelity), provide competent care, provide the information

patients and their surrogates need to make well-considered decisions about care

(transparency), respect patient privacy and confidentiality, and take steps to ensure continuity

of care. The task is to understand how these fundamental responsibilities may play out

differently in the context of telehealth and telemedicine than they do in in-person patient-

physician interactions.

11.18 Fidelity

The obligation to put patient interests first requires that physicians who participate in

telehealth activities or telemedicine programs take steps to minimize conflicts of interest and

bias. It is important that physicians disclose financial or other interests that may influence

them in their roles with commercial health websites and services and take active steps to

manage or eliminate conflicts of interest.

11.19 Competence

11.19.1 The obligation to provide competent care has different implications at

different points along the continuum of electronic interactions between physicians and

patients or prospective patients. Thus, physicians who provide general health information for

online websites have a responsibility to ensure that the content they provide is accurate and

objective, just as they would for a professional publication. Physicians who provide

personalized responses to individual health queries have additional responsibilities in keeping

with their greater accountability to the individual who is seeking guidance. In this context,

the obligation of competence requires that the physician who responds to an individual query

about a specific health concern have appropriate clinical qualifications and experience and



have some means of obtaining the crucial information needed to offer a well-considered

professional recommendation. Physicians should bear in mind that state law may further

define specific expectations for competence in these situations.

11.19.2 For physicians who provide clinical services, fulfilling the obligation

to provide competent care further entails being proficient in the use of the relevant

technologies and being comfortable using technology to interact with patients. Competency

also includes physicians‘ responsibility to be aware of the limitations of telemedicine

technologies they use and recognition of limitations in caring for an individual patient.

Physicians must use professional judgment in determining what modality of care is best for a

given patient, including determining when to shift from telehealth or telemedicine to in-

person care.

11.19.3 The question of competence of health professionals in India has to be

seen keeping in view the following contextual factors (albeit based on the 2001 national

census data):

(i) Of all doctors, 77.2% were allopathic and 22.8% were ayurvedic,

homeopathic or unani.

(ii) Among allopathic doctors, as many as 31.4% were educated only up to

secondary school level – and as many as 57.3% did not have a medical qualification.

Among nurses and midwives, 67.1% had education only up to secondary school level.

(iii) The education level and medical qualification of urban doctors were much

higher than those of rural doctors. Among allopathic doctors, 83.4% of urban doctors

had higher than secondary schooling compared to 45.9% of rural doctors. Of urban

allopathic doctors 58.4% had a medical qualification, whereas only 18.8% of rural

allopathic doctors had one.

(iv) Although nationally 22.8% of all doctors were ayurvedic, homeopathic or

unani (hereafter referred to as ―AYUSH‖), in some states the fraction of AYUSH

doctors was much higher: 41.7% in Tripura, 40.5% in Orissa and 38.1% in Kerala.

(v) The density of all health workers in a state was positively but imperfectly

correlated with the per capita income of the state (correlation coefficient of 0.76).



Better-off states seem to afford more doctors plus nurses per capita (correlation

coefficient 0.92), and more dentists per capita (correlation coefficient 0.93).

(vi) Of the 593 districts in India (as per the 2001 census data) among the lowest 30

districts ranked by density of allopathic doctors, half are in north-eastern states and

the remainder are in central states. The lowest 30 districts ranked by density of

allopathic doctors with a medical qualification are found mainly in the states of Uttar

Pradesh, Bihar and Madhya Pradesh.

(vii) Among the highest 30 districts ranked by density of allopathic doctors, 18 are

in state capitals or in the national capital (seven are in Delhi). There are 20 districts in

common among the highest 30 ranked by density of all allopathic doctors and

allopathic doctors with a medical qualification.

https://www.who.int/hrh/resources/16058health_workforce_India.pdf

11.19.4 The size and composition of human resources for health (HRH) in

India has significantly changed during the last decade, particularly since the launch of

National Rural Health Mission (NRHM) in 2004. Recently, WHO drawing evidence from the

Organisation for Economic Cooperation and Development (OECD) countries revised the

minimum need as 44.5 health professionals per 10,000 population.The Global Health

Workforce Alliance (GHWA) and WHO categorised India among the 57 most severe crisis

facing countries in terms of availability of human resources for health HRH. From the

updated information in this regard, based on NSS data of 2016, it is clear that the distribution

and qualification of health professionals (Allopathy, Ayurveda, Unani, Siddha, or

Homoeopathy) still has serious problems in India when compared with the overall size of the

health workers. It has to be kept in mind that the registry data of the health professionals is

inadequately updated and the National Sample Survey data provides information on self-

reporting basis. In this context, please see the following information:

(i) About 25% of the currently working health professionals do not have the

required qualifications as laid down by the respective professional councils, while

20% of adequately qualified doctors are not in the current workforce. For physicians,

24% had inadequate or no medical training.

https://www.who.int/hrh/resources/16058health_workforce_India.pdf



(ii) Adjusting for this proportion, the allopathic physician density in India reduced

from 5.9 to 4.5 per 10,000 population. Similarly, the proportion of nurses and

midwives per 10,000 population drops down to 4.2 when adjusted with required level

of education and training. Most of the central and eastern Indian states have low

density of health workers ranging from approximately 23 per 10,000 population in

Bihar and North-East states other than Assam to as low as 7 per 10,000 population in

Jharkhand. The only south Indian states reflecting lower density than the all India

average (29) is Andhra Pradesh (25) and only eastern Indian state having higher

density than the all India average is West Bengal (36). Highest concentration of health

workers is in Delhi (67) followed by Kerala (66), Punjab (52) and Haryana (44).

Considering only doctor, nurse and midwife density per 10,000 population, Delhi and

Kerala numbers are far higher compared to other states with Bihar along with

Jharkhand occupying the lowest position. Density of physician and surgeons

(including AYUSH and dental) per 10,000 population is as low as 1.8 in Assam and

1.9 in Himachal Pradesh. Density of physician and surgeon is also lower than five in

states of Bihar, Jharkhand and Rajasthan. Delhi has the highest density of physicians

and surgeons (34) but the density of nurses and midwives is the highest (38) in

Kerala. The HLEG recommendation for the doctor-nurse ratio in India is 1:3. Other

States with acute adverse ratios (less than 1:1) of nurses to doctors are Bihar,

Chhattisgarh, Goa, Haryana, Jammu and Kashmir, Karnataka, Madhya Pradesh,

Maharashtra, Odisha, Punjab, Uttar Pradesh and West Bengal.

(iii) The uneven distribution of health workers is also reflected across rural-urban

settings. Although rural India constituted approximately 71% of the total population

in 2016, only 36% of all health workers are in the rural areas (Figure3). This

proportion is a little lower for health associates and assistants and pharmacists. The

proportion of physician and nurses in rural areas are 34% and 33% respectively.

(iv) The density of doctors and nurses and midwives per 10,000 population is 20.6

according to the NSS and 26.7 on the basis of the registry data. The density in rural

India and states in eastern India are lower than the WHO minimum threshold of 22.8

per 10,000 population. More than 80% of doctors and 70% of nurses and midwives

are employed in the private sector.



(v) Distribution of all health workers by types of institutions reflect that the

overwhelming majority (53%) of these workers are self-employed in sole

proprietorship or partnership entity. Only 6% of all health workers are employed in

big corporate companies with public or private limited status.

(vi) In general, 45% individuals with some educational qualification are not in the

workforce. This proportion is slightly lower for the individuals with medical or

related degrees. However, approximately 19% individuals with degree in medicine

and 31% individuals with diplomas /certificates in medicine are not in the current

workforce. These proportions are 26% and 46% respectively in the case of females. In

case of vocational training in health and paramedical services, however, a higher

proportion of male (38%) compared to females (26%) are out of the workforce.

11.19.5 It is clear from the above information that the bulk of the doctors and

nurses are located in major cities leaving a significant gap in rural areas and in poorer states.

Moreover, there are also significant problems related to educational qualifications of a large

proportion of health workers. Approximately one-fourth of physicians and approximately half

of the total number of nurses reported inadequate qualifications. Adjusting the total number

of health workers with adequate educational qualification obviously leaves a significant gap

in the availability of quality health workers. In contrast, a sizable proportion of technically

qualified individuals are not in the workforce.

https://bmjopen.bmj.com/content/bmjopen/9/4/e025979.draft-revisions.pdf

11.19.6 Healthcare services in India are offered by a varied range of

professionals trained in different specialties of medicine and healthcare. The entire health

workforce includes many informal medical practitioners, such as registered medical

practitioners (RMPs) (including traditional birth attendants, faith healers, snakebite curers,

bonesetters and so on) with or without any formal education or skills training. RMPs are

often the first point of contact for treatment for a large proportion of the population living in

rural and remote areas.

11.19.7 Among the formal healthcare providers, allopathic doctors, which

include physicians, surgeons, specialists and medical graduates with a bachelor‘s or

postgraduate specialist diploma or degree, are registered with the Medical Council of India

https://bmjopen.bmj.com/content/bmjopen/9/4/e025979.draft-revisions.pdf



(MCI), and dentists hold a similar degree and are registered with the Dental Council (DC) of

India. AYUSH doctors (an indigenous Indian system of medicine comprising Ayurvedic,

Yoga, Unani, Siddha and Homeopathy) are bachelor‘s or postgraduate degree holders in

AYUSH. Their registering institution is the Central Council of Indian Medicine or the

Central Council of Homoeopathy, and they are authorised to dispense medicines and conduct

surgery using their respective fields of specialisation. AYUSH doctors are an integral part of

HRH in India as their professions are recognised by an Act of Indian Parliament.

11.19.8 Another group of health workforce includes subordinate staff which

includes, nurses, auxiliary nurses and midwives (ANMs), physiotherapists, and diagnostic

and other technicians. Nurses have a diploma in general nursing and midwifery or a

bachelor‘s degree or a postgraduate degree registered with the Indian Nursing Council (INC).

ANMs, who mainly work as subordinates to the main nurse, have a diploma in auxiliary

nurse midwifery. In addition there are also community health workers with 10 years of

formal education and have undergone a short training course. Physiotherapists and diagnostic

and other technicians with varied levels of diploma and certificate also perform crucial

activities as healthcare workers.

11.20.1 A report by Klynveld Peat Marwick Goerdeler and the Federation of

Indian Chambers of Commerce and Industry, using data from the Central Bureau of Health

Intelligence, estimated the total size of health workers in India as 4.7 million in year 2015,

consisting of 0.9 million doctors, 0.69 million AYUSH doctors and 1.6 million registered

nurses.

11.20.2 When the estimates on total health workers from NSSO are adjusted

for qualification, the density is reduced from 29 to 16 per 10 000 population. For allopathic

doctors, 24% had inadequate or no medical training. Adjusting for this proportion, the density

of allopathic doctors at the country level declines from 5.9 to 4.5 per 10 000 population.

Similarly, the proportion of nurses and midwives per 10 000 population drops down to 4.2

when adjusted with the required level of education and training.

11.20.3 In general, 45% of all adult individuals are not in the workforce. The

proportion of individuals with medical or related degrees but not in existing workforce is

19% for ‗graduate in medicine‘ and 31% for ‗Diploma/Certificate in medicine‘.



11.20..4 The density of the total health workers is estimated to be 29 per 10 000

population based on NSSO and 38 per 10 000 population based on the registration data. Even

by only considering service delivery workers, the density estimates in this study are close to

WHO‘s minimum threshold of 22.8 health workers per 10 000 population. However, our

estimates also reveal an alarmingly large presence of unqualified health professionals in the

workforce. Adjusting for adequate qualifications of health workers reduced the density from

29 to 16 health workers per 10 000 population. The presence of unqualified health

professionals in the health system is not unique in India. Many low-income and middle-

income countries, particularly China and Africa, report a large presence of such

professionals.21 Unqualified health professionals are usually the first point of contact for

rural and poor population in case of any ailment. Quacks, traditional healers, bonesetters and

so on fall in this category.

11.20.5 Distribution and qualification of health professionals are serious

problems in India when compared with the overall size of the health workers. In contrast, a

large proportion of technically qualified health professionals are not in the current workforce.

Any HRH policy needs to consider these points while considering changes/reforms in the

existing policy.


11.21 In this extremely fragmented provider landscape, the average Indian patient

faces a bewildering set of choices with respect to where and how to get care on their own, in

the context of severe information asymmetry between providers and patients as well as in the

absence of a strategic purchaser that typically provides guidance to patients. The public

sector has multiple levels of care (Sub-Centres, Primary Health Centres, Community Health

Centres, Hospital, District Hospital, Medical Colleges and Super Speciality Tertiary Centres)

similar to the private sector (corporate hospitals, stand alone hospitals, nursing homes,

clinics, informal providers, and chemists). Unclear/uncontrolled referral pathways lead to

zigzagging behaviour of patients among multiple types of providers in search for care. This,

in turn, results in delayed care and unnecessary expenditures, with sub-optional overall

outcomes. A fragmented provider market with unclear referral pathways, weak strategic

purchasing, and weak or no regulatory/insurance oversight, also makes the provider-customer

relationship transactional, with limited accountability for continuity of care and improved

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6549895/%23R21




outcomes over time. It also substantially contributes to a reduced willingness by patients to

participate in risk pooling schemes that are unlikely to change their relationship with

providers.

11.22 Average length of primary care physician consultations

The average consultation length was available in 67 different countries, covering over

28 530 712 consultations. Average consultation length varied from 48 s in Bangladesh, 2.5

min in India to 22.5 min in Sweden. There were 15 countries with their most recently

reported consultation length at <5 min, 25 countries with a consultation length of 5–9.9 min,

11 countries with 10–14.9 min, 13 countries with a consultation length of 15–19.9 min and 3

countries with a consultation length of ≥20 min. It is disconcerting that 18 countries covering

~50% of the world‘s population have a latest reported mean consultation length of 5 min or

less. Such a short consultation length is likely to adversely affect patient care and the

workload and stress of the consulting physician. An average of 5 min may be the limit below

which consultations amount to little more than triage and the issue of prescriptions. A lack of

time in the consultation is a key constraint to delivering expert generalist care. The finding of

the association between shorter consultations and physician burnout due to a lack of personal

accomplishment may indicate that doctors feel less productive and competent at managing

complex multimorbid patients in those settings with short consultation lengths. Addressing

this limitation is necessary if patients with complex needs and multimorbidity are to be

effectively managed within primary care.

https://bmjopen.bmj.com/content/7/10/e017902#F3

11.23 India also faces the additional challenge of a federal decentralized health policy.

Similar to most federal countries, health in India is the primary responsibility of the States.

This increases the complexity of avoiding fragmentation of policy formulation and

implementation, regulation as well as sector and organization governance. Severe

fragmentation, compounded by market failures and governance challenges, at all levels of the

system (financing, service provision, policy formulation, regulation, governance, among

others) determines a vicious circle that fuels low performance across all system functions.

https://bmjopen.bmj.com/content/7/10/e017902%23F3



Telemedicine has the potential of addressing the shortage of healthcare professionals in the

developing World and improving access to quality medical care by allowing distant providers

to evaluate, diagnose, treat and provide follow up care to patients in resource poor settings.

India has a unique opportunity to transform its healthcare system over the next decade or so.

This synthesis provides a high-level overview of the findings and recommendations for

potential options for systemic healthcare transformation in India. Seizing this opportunity

requires action and implementation with respect to six pillars of transformation:

a) Further develop and deliver on the unfinished agenda pertaining to population and

public health

b) Change health system financing structure away from the predominant undesirable

out-of-pocket spending into larger risk pools, with strong strategic purchasing

capabilities

c) Reduce fragmentation of risk pools and health service provision, incentivizing

much needed provider consolidation and organization in networks

d) Empower patients to become better purchasers

e) Harness the power of digital health as a critical enabler for the overall

transformation of the health system (page 11)

f) Implement PM-JAY with an eye on its potential to influence the overall healthcare

transformation in India, beyond its current explicit mandate


11.24 Transparency and Informed Consent

11.24.1 Telemedicine may be used for diagnosis, therapy, follow-up and/or

education, and may include any combination of the following:

(1) patient medical records;

(2) medical images;

(3) live two-way audio and video;

(4) interactive audio; and

(5) output data from medical devices and sound and video files.




11.24.2 There are two primary reasons for obtain informed consent before

offering a telemedicine service:

● "It allows patients to gain an understanding of the risks and benefits of the proposed

treatment, and alternative courses of action.‖

● ―It helps shield providers from legal exposure.”

11.24.3 To many, the term informed consent is mistakenly viewed as

synonymous with obtaining a subject‘s signature on the consent form. FDA believes that

obtaining a subject‘s oral or written informed consent is only part of the consent process.

Informed consent involves providing a potential subject with adequate information to allow

for an informed decision about participation in the clinical investigation, facilitating the

potential subject‘s comprehension of the information, providing adequate opportunity for the

potential subject to ask questions and to consider whether to participate, obtaining the

potential subject‘s voluntary agreement to participate, and continuing to provide information

as the clinical investigation progresses or as the subject or situation requires. To be effective,

the process must provide sufficient opportunity for the subject to consider whether to

participate. (21 CFR 50.20.) FDA considers this to include allowing sufficient time for

subjects to consider the information and providing time and opportunity for the subjects to

ask questions and have those questions answered. The investigator (or other study staff who

are conducting the informed consent interview) and the subject should exchange information

and discuss the contents of the informed consent document. This process must occur under

circumstances that minimize the possibility of coercion or undue influence.

https://www.fda.gov/files/about%20fda/published/Informed-Consent-Information-Sheet-

%28Printer-Friendly%29.pdf

11.24.4 Informed consent is a dynamic and ongoing process and that better

patient education can assist in the decision making, fulfill the ethical principle of respect for

autonomy and engage the patient to maximize compliance and adherence to therapy.

Physicians have a duty to disclose any facts that are necessary for a patient to make an

informed decision regarding treatment. This is important as, legally, it sets the standard for

informed consent as the ‗reasonable patient standard‘. The reasonable patient standard holds

that informed consent requires the physician to disclose to the patient that information which

https://www.fda.gov/files/about%2520fda/published/Informed-Consent-Information-Sheet-%2528Printer-Friendly%2529.pdf

https://www.fda.gov/files/about%2520fda/published/Informed-Consent-Information-Sheet-%2528Printer-Friendly%2529.pdf



a ‗reasonable person‘ would want in order to make a decision. This is contrasted with the

‗reasonable physician‘ standard, which holds that informed consent requires the physician to

disclose that information that a ‗reasonable physician‘ would consider important and

necessary to make a decision. This distinction is important as physicians and patients can

disagree regarding what information is needed to make a decision.

11.24.5 Ethically, informed consent fulfills the ethical principle of respect for

persons. As Jay Katz3 notes, informed consent is a relatively new concept, as paternalism

was the dominant approach through most of medical history. Katz3 describes at length the

ethical development of informed consent as a tension between beneficence, or seeking to

benefit the patient, and autonomy, in his classic book The Silent World of Doctor and Patient.

Beneficence commits a physician to help the patient and not place undue burdens of decision

making, and questions whether the patient can even make a good decision because of the lack

of knowledge and the burden of disease. Autonomy, on the other hand, is committed to

ensuring that a competent patient has the information needed to make an informed decision

and ultimately respecting that decision.

https://www.nature.com/articles/bmt2014207

11.24.6 In Western medicine, the principles of beneficence and non-

maleficence derive historically from the doctor-patient relationship, which for centuries was

based on paternalism. In the last few decades, there has been a change in the doctor-patient

relationship involving a move towards greater respect for patients‘ autonomy, in that patients

play a more active role in making decisions about their own treatment (Mallia, 2003).

According to Kao (2002), this is not the same in non-Western medicine. She explains that in

Islamic medical ethics, a greater emphasis is placed on beneficence than on autonomy,

especially at the time of death. Aksoy and Tenik (2002), who investigated the existence of the

four principles in the Islamic tradition by examining the works of Mawlana, a prominent Sufi

theologian and philosopher, support this claim. They found evidence of all four principles in

one form or another, with a clear emphasis on the principle of beneficence. In China where

medical ethics were greatly influenced by Confucianism, there is also a great emphasis on

beneficence in that Chinese medicine is considered ―a humane art, and a physician must be

loving in order to treat the sick and heal the injured‖ (Kao, 2002).

https://www.nature.com/articles/bmt2014207%23ref-CR3

https://www.nature.com/articles/bmt2014207%23ref-CR3

https://www.nature.com/articles/bmt2014207



https://www.alzheimer-europe.org/Ethics/Definitions-and-approaches/The-four-common-

bioethical-principles/Beneficence-and-non-maleficence

11.24.7 The Indian Society for Critical Care Medicine has developed a position

statement on the patient management of the terminally ill patient in the Intensive Care Unit

(ICU) which states that the society should move from the paternalistic model to the share

based decision model of the West when deciding the fate of such patients. As far as the locus

of control is concerned, the emphasis on individual autonomy is often perceived as isolating

rather than empowering in non-Western cultures. In Asian, Indian and Pakistani cultures,

family members and physicians may share decisional duties.

11.24.8 Language differences between the healthcare professionals and the

patients create considerable barriers in communication. More than one relative is involved in

the care of the patient and they would all like to know the clinical details. In situations where

several family members are present, the health professional may need to identify who the

patient thinks is the key relative or the ‗head‘ of the family, who can then be involved in the

disclosure and discussion process.

11.24.9 Medical teams often collude with patients‘ relatives to keep the former

in the ―dark‖ (e.g., please don‘t tell him/her about the severity of the illness), or the

physicians colluding with patients (e.g., please don‘t tell my spouse or family about my

disease), and not informing the family about the patient's diagnosis or prognosis. In India,

nearly one-half of patients seeking cancer treatment are unaware of their diagnosis or

treatment. However, it has been often noticed that patients are quite aware of the nature and

severity of the illness and they regularly express their need for open communication.


11.24.10.1 Hindus and Sikhs, although their cultural and religious traditions have

profound differences, they both traditionally take a duty-based rather than rights-based

approach to ethical decision-making. These traditions also share a belief in rebirth, a concept

of karma (in which experiences in one life influence experiences in future lives), an emphasis

on the value of purity, and a holistic view of the person that affirms the importance of family,

https://www.alzheimer-europe.org/Ethics/Definitions-and-approaches/The-four-common-bioethical-principles/Beneficence-and-non-maleficence

https://www.alzheimer-europe.org/Ethics/Definitions-and-approaches/The-four-common-bioethical-principles/Beneficence-and-non-maleficence




culture, environment and the spiritual dimension of experience. Physicians with Hindu and

Sikh patients need to be sensitive to and respectful of the diversity of their cultural and

religious assumptions regarding human nature, purity, health and illness, life and death, and

the status of the individual.

11.24.10.2 The notion of karma and a belief in rebirth will be important for many Hindu

and Sikh patients as they make ethical decisions surrounding birth and death. Unlike the

linear view of life taken in Judaism, Christianity and Islam, for Hindus and Sikhs life, birth

and death are repeated, for each person, in a continuous cycle. The fundamental idea is that

each person is repeatedly reborn so that his or her soul may be purified and ultimately join

the divine cosmic consciousness.1 What a person does in each life influences the

circumstances and predispositions experienced in future lives. In essence, every action or

thought, whether good or evil, leaves a trace in the unconscious that is carried forward into

the next life.

11.24.10.3 Another major difference between Hindu and Sikh cultures and Western

cultures concerns the question of identity. Who is the ethical agent in decision-making: the

patient, or the family?

11.24.11.1 In Western secular society the individual person is viewed as having

autonomy in ethical decision-making. In Ayurveda (traditional South Asian medicine) the

person is viewed as a combination of mind, soul and body in the context of family, culture

and environment (nature).3 Thus, the person is seen not as autonomous but rather as

intimately integrated with his or her extended family, caste and environment. This

necessitates a holistic approach to ethical matters such as informed consent, one that includes

the patient's societal context as well as the religious or spiritual dimension of his or her

experience.

11.24.11.2 The ethical theories employed in health care today tend to apply a Western

philosophical framework to issues such as abortion, euthanasia and informed consent. Yet the

diversity of cultural and religious assumptions with respect to human nature, health and

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC80253/%23r1-21

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC80253/%23r3-21



illness, life and death, and the status of the individual demands that physicians be sensitive to

and respectful of the varied perspectives that patients bring to ethical decision-making.

11.24.11.3 If the patient and physician do not speak the same language, every effort

should be made to find a trained and impartial interpreter who is familiar with the patient's

traditions and culture. It is particularly important in issues of consent to ensure that

information given to or received from the patient is not being censored or altered by the

interpreter. Because of their deep sense of modesty and of purity, Hindu and Sikh women

may not feel comfortable with male physicians or interpreters. Family members such as a

teenaged daughter may function well as an interpreter for minor problems; however, an older,

trained Hindu or Sikh woman who understands medical terminology and is not a family

member will make the best interpreter, especially in urological and gynecological matters. In

some circumstances a female relative or the patient's husband may have to serve as an

interpreter, but, in view of the importance of preserving the confidentiality of the physician–

patient relationship, using an interpreter who knows the patient personally is not the preferred

approach.

11.24.12 In many Hindu and Sikh households there is an attachment to traditional

medicines (e.g., Ayurveda and Siddha), which may be used together with modern medicine.


11.24.13 It is increasingly being realized that religion, spirituality and culture play a

role in clinic care.

11.24.14 Hindu ethical principles are embedded in the doctrine of Dharma - a complex

and comprehensive term for ethics, philosophy, law and practice. Even though, unlike

western bioethics, Hindu bioethics lacks a single compilation, bio-ethically relevant Hindu

doctrines are spread throughout their scriptures, legends, and folklores.

11.24.15 In India, free health care services are provided by Government hospitals and

dispensaries while private practitioners and specialists and private hospitals provide health

services for a fee. The services provided by the latter are of better quality which are easily




comparable to the services available in developed countries. However, these services are

beyond the reach of the poor because of the high costs involved. Government hospitals do

provide health services of reasonably good quality but they are over-crowded, have long

waiting lists, and often lack cleanliness and courtesy. Sick patients at times are refused

admission in government hospitals due to lack of beds. Many a time doctors in these

hospitals have to rely on the second or third line of therapy, as the best may not be affordable

by the patient The physicians thus constantly face the ethical dilemma in the choice of

treatment and in the choice of the patient who should receive the available treatment. The

limited number of beds and equipment in the intensive care unit, thus necessitating the doctor

to select from among the many patients who may require these services, exemplify this

situation. It is to the credit of doctors that in most cases they try to choose patients according

to the medical needs. Many of them prefer to use the limited resources for those who have

treatable disorders and a reasonable chance of full recovery without any handicap. On

occasions, patients suffering from disorders where normal mental functions cannot be assured

and who require very expensive treatment are often given only restricted or palliative

treatment. This may appear unethical although there seems to be no other choice.

https://www.who.int/ethics/regions/en/searo_ethics.pdf

11.24.1 6 Informed consent to the use of telemedicine should have the same

prerequisites as those used in traditional medical practice. However, the unusual nature of the

phases of telemedicine require certain additions/changes; the changes include what

information should be discussed with the patient and how the consent for a telemedicine

encounter should be documented. The goals for telemedicine consent should be similar to any

other type of consent, hinging on good communication and documentation. However, that

does not mean that a standard, traditional consent process for treatment is sufficient for

telemedicine. Although some may see telemedicine as an item that can be added to a general

admission consent form, such an approach may be a setup for failure. It is prudent to consider

utilizing specific consent communications and documentation for telemedicine and telehealth

service.

11.24.17 As with all consent processes, informed consent for telehealth must be carried

out by the physician and cannot be entirely delegated. It is advised that informed consent

https://www.who.int/ethics/regions/en/searo_ethics.pdf



should be gained in the patient‘s mother tongue. However, many Indian languages have not

kept pace with technology and lack the words and terms needed to describe computing and

technical terms. Additionally, even when present, patients may not understand these words

and terms. This affects the validity of informed consent given.There is empirical evidence to

indicate that language barriers directly affect healthcare delivery and also interfere with the

doctor-patient relationship, as patients who do not understand the doctor‘s language are less

likely to adhere to their prescribed medication and more likely to miss appointments than

those who share a language with the doctors. In addition, when a technology literate health

professional obtains consent for telemedicine from a technology naive patient through an

interpreter, there is concern about the interpreter‘s understanding of the words and terms, and

their ability to explain these words and terms to the patient if there are no direct translations

available in the indigenous language. The ethical issues of not obtaining valid informed

consent potentially impact on patient autonomy, the right to privacy and confidentiality,

justice, fairness and the quality of care being compromised. The issue of consent for

telemedicine remains unresolved. The World Medical Association‘s stance is pragmatic but

still assumes that consent gained is valid. Intuitively, it remains prudent to gain consent for a

telemedicine encounter, but the validity of such consent must be questioned if people do not

understand the words used to explain what is to happen, especially words and terms related to

data transmission, security and storage. Regulators correctly see guidelines and regulations as

ways of maintaining standard of care and protecting both patients and practitioners, but the

reality is that in developing world countries overburdened doctors and nurses do not

necessarily follow the rules and regulations regarding consent.

11.24.18 Regulators appear to be setting different standards for telemedicine, which is

considered to be new, but it is not. The telephone has been used to seek and give advice on

diagnosis and management since at least 1879. Doctors have not been required to ensure that

the transmission of their voices over landlines are secure from interception so as to maintain

confidentiality. Shared party lines were common, but this was not seen as a major

impediment to the use of ICT for the provision of health services. Likewise, doctors have

written letters seeking advice and sent reports about patients by paper based mail for

centuries. They were not, and are still not required to ensure that their mail could not be read



or intercepted by anyone else, but end to end encryption is considered mandatory for email

communication of patient information.

11.24.19 The issue of understanding telemedicine and its associated terms and the effect

of this on the validity of consent raises an ethical dilemma. If telemedicine is available and

provides rapid access to a specialist and or a level of care not available locally is it ethical for

a doctor not to use it because consent may not be truly informed? Failure to use telemedicine

because of inability to obtain valid consent might impose a lower quality of care on the

patient.

11.24.20 There is a need to find alternative ways to explain the concepts of

telemedicine and associated technology issues in a way and in a jargon-free language that

people understand. We need to go back to the drawing board – the use of comic book cartoon

sequences of what occurs in, and needs to be understood about, a telemedicine encounter may

be a novel way forward. Pragmatic solutions are required.


11.24.21 Patients need to be advised of the material facts, based upon their actual

circumstances, based on community standards, in a way and using terminology that the

patient can reasonably understand. The standards for informed consent are not diminished in

any way because the care is being provided in a telehealth setting, though there are additional

challenges that also must be addressed. The limitations of telemedicine are particularly

important in the consent process. Patients must understand that the physician is unable to

conduct assessments they might see in a traditional face-to-face visit. Specifically, risks

associated with telehealth include technological glitches and failures (including transmission

errors), technology-related privacy and security concerns, and lack of hands-on patient

evaluation.

11.24.22 In a traditional encounter, the physician relies not only on what the patient is

saying but there also is the opportunity to examine the patient and conduct various hands-on

assessments, whereas in telemedicine you don‘t have that option. The physician is limited in




the ability to determine the root cause of the patient‘s problem, but the patient may have a

true physical encounter with a physician later who makes a different assessment, or the lack

of that physical assessment may lead to the patient suffering some type of harm. The patient

who accepts a telemedicine encounter must understand those limitations so that the liability is

limited for the provider.

Telemedicine/TeleHealth providers should carefully consider their informed consent

processes because "failure to properly obtain a patient's informed consent before initiating

telehealth services can increase a provider's risk of facing consent-based negligence claims.

11.24.23 The TSI Recommends that, aside from well-recognized core elements of

consent, telemedicine/telehealth discussions and documentation should address these items:

• an explanation of the process; a description of the telehealth service that will be

performed and the technology that will be used

• who will be involved in the process; The names of all involved healthcare providers

with their credentials and locations, as well as any other staff that may help facilitate

the telehealth service

• the limitation of Telemedicine/TeleHealth; any risks specifically related to the

electronic nature of the care delivery (e.g., technology disruptions, failures, or

limitations)

• the option to seek in-person services;

• access to records by the patient and other care providers;

• any costs to the patient associated with requests to share images or reports with

other care providers;

• measures taken to prevent the risk of hacking telehealth and telemedicine

information; specific security and privacy measures that have been implemented, as

well as any increased privacy risks relative to the telehealth technology

• costs of telemedicine and telehealth services not covered under the individual‘s

health insurance plan, especially for out of network providers, imaging, or

telepathology;

• the potential for delays or errors in interpretation or communication of results and

care provider-patient discussion due to technical limitations/problems;



• A plan for ongoing care, including details about who is responsible for various

aspects of the patient's care

• A plan for alternative care in the case of an emergency or technological malfunction

• specific authorizations for other uses of telemedicine and telehealth images or

information in education, research, or publications.

11.24.23 The TSI recommends that all providers involved in the telehealth program

should have a clear understanding of the informed consent process, and — as with traditional

informed consent — the process should be documented in each patient's record.

https://www.medpro.com/telemedicine-informedconsent

11.25 Risks of Telemedicine

Telemedicine has these risks:

• Delays in medical evaluation and treatment could occur due to deficiencies or

failures of the equipment and technologies.

• In very rare events, security protocols could fail, causing a breach of privacy of

personal health information.

• In rare events, a lack of access to complete medical records may result in adverse

drug interactions or allergic reactions or other judgment errors.

• violation of scope of practice and/or licensure laws regarding which care providers

can participate in such services;

• substandard practice leading to patient injury;

• delays resulting in patient injury;

• negligent treatment;

• negligent credentialing of care providers involved in telemedicine or telehealth

services (note that there is a federal regulation on use of remote provider

credentialing);

• identity theft;

• billing and coding;

• breach of contract;

• providing unauthorized telemedicine or telehealth services;

https://www.medpro.com/telemedicine-informedconsent



• lack of liability, technical errors and omissions, cyber-insurance coverage.

11.26 The technology itself can present liability challenges:

11.26.1 There could be situations where a patient tries to upload photos to

show the doctor something about his condition, the pictures didn‘t upload for some reason,

and the physician chooses to proceed with the treatment without that information. That can

create potential risk, and risk managers need to avoid those situations where care can be

compromised. It‘s one thing where everything is working great and there are no hiccups, but

everyone knows that technology can fail at the worst times.

11.26.2 Even when an organization determines that there is a need for specific

telehealth consent, that consent process can be included in the intake along with other types

of consent, Mazur notes. It is not necessary to wait until a telehealth session is scheduled to

go ahead and educate the patient about that process, she says, although it may also be prudent

to go over the material again for future telehealth appointments.

11.26.3 Some of the same concerns with video telehealth can apply when data

is transmitted from the patient‘s home but without any audiovisual interaction. This may

apply for telemetry of patient vitals and other data. There also can be unique concerns with

telemetry.

11.26.4 It‘s very important when you‘re talking about remote patient

monitoring to provide the patient with information about when the doctor is going to review

the data. You want the patient to understand that the doctor is going to review this data, but

they may not be reviewing it in real time on a consistent and constant basis. If a cardiac

monitor records a cardiac arrhythmia, the doctor may not see that until the next patient visit.

You don‘t want the patient thinking that is constantly monitored in real time.In addition to

the standard components of an informed consent form – the risks, benefits and alternatives of

treatment – the new form should be supplemented by:

● Identifying the treatment provider and any other staff member or provider who may

be present or assist with the telehealth exam/consultation. You will also want to

identify the credentials of these individuals.



● Identifying the possibility that medical information may be shared with third parties if

and when necessary for the continuity of care.

● Describing the telehealth process of how the provider and patient will communicate to

include the technology which will be used.

● Providing a summary of services that may or may not be provided or accomplished

via tele-communications such as prescription refills, education, etc.

● Explaining the risks and benefits of telehealth services as well as how follow up and

monitoring is conducted and when in-person treatment may be necessary.

● Confirming that the physician determines whether the condition can be diagnosed

and/or treated appropriately via telemedicine.

● Detailing what to do if the technology fails (e.g. transmission errors such as denials of

service, slowness and computer or software malfunctions).

● Detailing security measures, such as encryption, for the protection of protected health

information (PHI) and personally identifiable information (PHII).

https://www.psicinsurance.com/posts-articles/physicians/risk-management/what-do-

telemedicine-and-telehealth-mean-for-informed-consent.aspx

https://www.reliasmedia.com/articles/143491-more-robust-informed-consent-needed-for-

telemedicine

11.27.1 Physicians also have a responsibility to be transparent with patients

and prospective patients. At one end of the continuum, this may mean no more than

disclosing one‘s credentials as the author of health information. At the other end, it will entail

obtaining the patient‘s informed consent for clinical services that are delivered electronically.

In the context of telehealth or telemedicine, patients need to have information not only about

medical issues and treatment options, but also about some of the distinctive features of

telemedicine.

11.27.2 For example, patients or their surrogates/carers/caregivers/family

members need to have a basic understanding of the credentials of physicians and other health

professionals who provide telehealth and telemedicine services. Patients also need to be

aware of how telemedicine technologies will be used in their care and the limitations of those

https://www.psicinsurance.com/posts-articles/physicians/risk-management/what-do-telemedicine-and-telehealth-mean-for-informed-consent.aspx

https://www.psicinsurance.com/posts-articles/physicians/risk-management/what-do-telemedicine-and-telehealth-mean-for-informed-consent.aspx

https://www.reliasmedia.com/articles/143491-more-robust-informed-consent-needed-for-telemedicine

https://www.reliasmedia.com/articles/143491-more-robust-informed-consent-needed-for-telemedicine



technologies. Importantly, patients themselves (or their surrogates) or their family members

may be asked to play a different role in telemedicine than in traditional care, for example, by

learning how to use monitoring devices at home, a factor that may influence decision making.

Physicians‘ responsibility to ascertain whether the patient or family has the skills needed to

participate in the care plan may be stronger in the context of telehealth and telemedicine than

in other encounters, especially when telehealth websites or mobile health applications

connect physicians and patients with whom there is no prior relationship and or expectation

of follow-up.

11.28 Increasingly, practice guidelines from the ATA and other professional societies are

recommending that standard consent protocols be followed as with all patients, but that for

telemedicine encounters the ―informed‖ aspect should be focused on educating the patient

about the unique nature of the telemedicine encounter compared to a face-to-face visit.

Patients (and providers) need to understand how telemedicine works: What type of

technology is used; what types of problems to expect (e.g., lost connection) and what to do if

a technology problem arises; what are the limitations with respect to privacy and security;

what happens if an emergency arises during the encounter; how will the teleconsultation be

followed up (with the patient, their local providers, their health records, their pharmacy, their

caregivers, etc.); what are prescribing limitations; and so on.

11.29 Possible Clauses in an Informed Consent Form:

You acknowledge that you understand and agree with the following:

1. I hereby consent to receiving Telemedicine services. I understand that Providers

offer Telemedicine services, but that these services do not replace the relationship

between me and my primary care doctor. I also understand it is up to the provider to

determine whether or not my needs are appropriate for a Telemedicine encounter.

2. I understand that federal and state law requires health care providers to protect the

privacy and the security of my personal health information. I understand that

Providers will take steps to make sure that my health information is not seen by

anyone who should not see it. I understand that Telemedicine may involve electronic

communication of my personal health information to other medical practitioners who

may be located in other areas, including out of state.



3. I understand there is a risk of technical failures during the Telemedicine encounter

beyond the control of Providers. I agree to hold Providers harmless for delays in

evaluation or for information lost due to such technical failures.

4. I understand that I have the right to withhold or withdraw my consent to the use of

Telemedicine in the course of my care at any time, without affecting my right to

future care or treatment. I understand that I may suspend or terminate access to the

service at any time for any reason or for no reason. I understand that if I am

experiencing a medical emergency, that I will be directed to dial 9-1-1 immediately

and that the Providers are not able to connect me directly to any local emergency

services.

5. I understand the alternatives to Telemedicine consultation, such as in-person

services are available to me, and in choosing to participate in a Telemedicine

consultation, I understand that some parts of the services involving physical tests may

be conducted by individuals at my location, or at a testing facility, at the direction of

the Provider (e.g. labs or bloodwork).

6. I understand video images and audio recordings of me may be captured and stored

electronically. I understand that these recordings may be later viewed and used for

purposes of evaluation and training, which may include non-physician personnel of

Provider. I understand and consent to the use of these images and audio recordings for

the Telemedicine consultation and, potentially, evaluation, education and training.

7. I understand that I may expect the anticipated benefits from the use of

Telemedicine in my care, but that no results can be guaranteed or assured.

8. I understand that my personal health information may be shared with other

individuals for scheduling and billing purposes. Persons may be present during the

consultation other than the Provider in order to operate the Telemedicine

technologies. I further understand that I will be informed of their presence in the

consultation and thus will have the right to request the following: (1) omit specific

details of my medical history/examination that are personally sensitive to me; (2) ask

non-medical personnel to leave the Telemedicine examination; and/or (3) terminate

the consultation at any time.



9. I understand that I will not be prescribed any Drug Enforcement Agency controlled

substances nor is there any guarantee that I will be given a prescription at all.

10. I understand that if I participate in a Telemedicine consultation, that I have the

right to request a copy of my medical records which will be provided to me at

reasonable cost of preparation, shipping and delivery.

11. I understand that in the event of any problem with the website or related services,

I agree that my sole remedy is to cease using the website or terminate access to the

service. Under no circumstances will Provider or any of its subsidiaries, affiliates or

vendors be liable in any way for the use of the Telemedicine services, including but

not limited to, any errors or omissions in content or infringement by any content on

the website of any intellectual property rights or other rights of third parties, or for

any losses or damages of any kind arising directly or indirectly out of the use of,

inability to use, or the results of use of the website, and any website linked to the

website, or the materials or information contained on any or all such websites. I agree

that I will not hold Provider, its subsidiaries, affiliates or vendors liable for any

punitive, exemplary, consequential, incidental, indirect or special damages (including,

without limitation, any personal injury, lost profits, business interruption, loss of

programs or other data on my computer or otherwise) arising from or in connection

with my use of a Telemedicine consultation whether under a theory of breach of

contract, negligence, strict liability, malpractice or otherwise, even if we or they have

been advised of the possibility of such damages.

12. I understand that if I access Telemedicine services from a location outside of the

United States, that I do so at my own risk and initiative and that I am ultimately

responsible for compliance with any laws or regulations associated with my use.

13. Additional State-Specific Consents: The following consents apply to my

participation in a Telemedicine consultation, as required by the states listed below:

a. Arizona: Guardian consents to verify his/her identity prior to performing a

mental health screening or mental health treatment on a minor. AZ ST § 36-

2272.



b. Connecticut: I understand that my primary care provider may obtain a copy

of my records of any Telemedicine interaction. CT Public Act No. 15-88

(2015).

c. Iowa: I understand that as necessitated by the availability of resources in the

community where services are delivered, Telemedicine may be used in

delivering and coordinating interventions with appropriate providers for

autism support, subject to the licensure of the participating provider. Iowa

Code Ann. § 225D.2.

d. Kentucky: I understand that I have the right to be informed of any party

who will be present at the site during the Telemedicine consultation and I have

the right to exclude anyone from being present. I also understand that I have

the right to object to the videotaping of the Telemedicine consultation. KY

Admin. Regs. Tit. 907, 3:170.

e. Maryland: I understand that I cannot request Telemedicine services to be

conducted via correspondence only. Code of MD Reg. 10.41.06.04.

f. Nebraska: I understand that I have the right to be informed of any party who

will be present at the site during the Telemedicine consultation and I have the

right to exclude anyone from being present. I understand that any

dissemination of identifiable images or information from a consult requires

my express permission. I understand that I have the right to request an in-

person consultation immediately after the Telemedicine consultation and I will

be informed if such consultation is not available. NE Revised Stat. 71-8505;

NE Admin. Code Tit. 471, Ch. 1.

g. Nevada: I understand that the transmission of any confidential medical

information while engaged in telemedicine is subject to all applicable federal

and state laws with respect to the protection of and access to confidential

medical information. NV Rev. Stat. Ann. § 633.0165.

h. Pennsylvania: I understand that I may be asked to confirm my consent to

behavioral health or telepsych services.



i. Tennessee: I understand that I may request an in-person assessment before

receiving a Telemedicine assessment.

j. Vermont: I understand that I have the right to receive a consult with a

distant-site provider and will receive one upon request immediately or within a

reasonable time after the results of the initial consultation. I understand that

receiving tele-dermatology or tele-ophthalmology services does not preclude

me from receiving real-time telemedicine or face-to-face services with the

distant provider at a future date. VT Stat. Ann. § 9361.

https://ss.globalrescue.com/resources/assets/pdfs/Telemedicine_Services.pdf?v=1

11.30 Privacy and Confidentiality

11.30.1 The obligation to protect privacy and confidentiality is at least as

important in the context of telehealth and telemedicine as in hospital and office settings.

Specific responsibilities vary across the continuum of telehealth/telemedicine interactions.

Thus, health information websites are expected to publish their privacy policies so that users

will know what information is collected from them (if any) and how that information is to be

used. Physicians who provide content for health websites have a responsibility to be satisfied

that websites with which they are affiliated have relevant privacy policies. Physicians should

refrain from participating in websites that do not make these policies available to website

users.

11.30.2 Physicians who answer individual health queries or provide

personalized health guidance electronically must be confident that the websites with which

they affiliate have appropriate mechanisms in place to protect the confidentiality of

individual information exchanged through the website. They should also inform website

users that there are potential risks to privacy when personal health information is

communicated electronically, for example, through a written disclaimer on the site.

11.30.3 Physicians who provide clinical services via telemedicine must adhere

to sound privacy practices themselves and must assure themselves that health care

professionals at remote websites with whom they collaborate do likewise. They must further

assure themselves that the telemedicine services they work with have appropriate protocols to

prevent unauthorized access and to protect the security and integrity of patient information.

https://ss.globalrescue.com/resources/assets/pdfs/Telemedicine_Services.pdf?v=1



Physicians should alert telemedicine patients or their surrogate that issues of data security and

access can arise and inform them of steps taken to protect confidential information.

11.31 Continuity of Care

Fulfilling the obligation not to abandon the patient and to provide for continuity of care may

also take on a new dimension in the context of telemedicine. Physicians who author general

health content do not enter into a patient-physician relationship with information seekers;

they therefore have no specific responsibilities regarding continuity of care. Physicians who

respond to individual health queries should understand that they are responsible for

encouraging the patient to seek in-person care when the physician deems that to be needed.

Some telehealth and telemedicine services may also identify physicians whom service users

can contact to arrange in-person care. Physicians who provide clinical services through

telemedicine should discuss with patients or their surrogates the importance of preserving

information for future episodes of care, and whether patients prefer to take responsibility for

this or want the physician to do so, by communicating directly with the patient‘s primary care

physician. Information should include recommendations for follow-up care when appropriate.

Telemedicine programs that rely on collaboration among the physician, patient, or surrogate

and the telemedicine team and that routinely convey the plan to patients‘ primary physicians

if they are not a member of the team are in a better position to develop plans of care that

ensure appropriate follow-up. Physicians who provide clinical telehealth and telemedicine

services in settings where the encounter will not be documented in an existing medical record

should consider writing a note after each clinical encounter for their own files.

11.32 The Evolving World of Patient Care



11.32.1 Many may feel that telehealth and telemedicine, with their

technological sophistication, continuous change, and rapid expansion, are standing medicine

on its head. However, it may be more appropriate to see the evolution of telecommunications

in patient care as part of the history of technology in medicine, and an opportunity to enhance

access to care, quality of care, and satisfaction for both patients and physicians. Thoughtfully

implemented, telehealth and telemedicine have the potential to enable physicians to use that

most valuable of commodities, time spent in person with patients, to greater effect.

11.32.2 For individuals who are comfortable with electronic technology,

telehealth and telemedicine have the potential to increase access to health care by making

expert attention available to patients who would otherwise have limited or no access to such

care. Yet telehealth and telemedicine cannot enhance access to high-quality care if patients

who might benefit from these innovations do not have access to or the ability to use

telecommunications technologies effectively. These may include elderly individuals or others

who have diminished perceptual, cognitive, or psychomotor abilities, or members of

communities that tend not to have ready access to or to adopt internet technologies. Medicine

as a profession can play an important role in advocating for initiatives that will help make the

needed technologies more readily available to all patient populations who want to utilize

telehealth and telemedicine services.

11.32.3 Achieving the promise and avoiding the pitfalls of electronically

mediated care is not the responsibility of individual physicians alone. It requires coordinated

effort across the profession, active engagement of specialty and professional organizations

not only in medicine but also information technologies, and appropriate education and

support for practicing clinicians.



11.32.4 Often the lynchpin to most health regulatory requirements, the

standard of care in healthcare is a concept that (even apart from telemedicine) constantly

evolves as new research, teaching standards, and procedures make the case for change to

advance positive patient health and wellness. After all, there is no specific definition for the

standard of care; rather, it is a principle arising from years of legal cases. As such, many feel

there is essentially no difference in the standard of care between models using telemedicine

and models that do not, with the standard of care generally necessitating the taking of a

patient history, a physical exam, and the making of an appropriate diagnosis and/or provision

of treatment plan under the circumstances. Under historical constructs for the standard of

care, the notion of physician discretion is central and is judged against whether the data

gathered would reasonably avail a physician of the necessary information given the attendant

facts and circumstances to make an appropriate diagnosis and treatment decision. Despite

this, various country-specific or in the USA, state-specific regulations are attempting to

establish a different standard of care when a physician engages with a patient by means of

telemedicine, thereby limiting how they can establish the physician patient relationship, what

they can prescribe, and how often they must ―see‖ the patient in-person, notwithstanding the

facts and circumstances of the patient situation. While healthcare providers may prefer

silence to specific telemedicine rules, the lack of a specific rule often requires an evaluation

of telemedicine activities using a law or rule written with more traditional, in-person, bricks

and mortar health care concepts in mind. These concepts include topics like supervision and

patient exam standards, which are often tied to patients and practitioners being in the same

physical presence—concepts not conducive to telemedicine and mobile technologies. It is

easy to see how these traditional rules (while not written to limit telemedicine) practically do

so, because they speak to being within the same building or a hands-on-exam.



11.32.5 The TSI recommends that consistent with traditional norms for the

diagnosis and treatment of patients, a health professional should conduct a medical evaluation

and collect relevant clinical history, and then determine whether a diagnosis or treatment is

possible or recommended based upon the patient and the facts and circumstances presented.

Importantly, the GOI should make it clear by issuing Guidelines that an exam can be

conducted using telemedicine technologies and still be within the standard of care so long as

the technology allows the physician to gather the necessary patient information for a

diagnosis under the facts and circumstances.

11.32.6.1 It may be vital for a physician to appreciate cardiac and pulmonary sounds in

his/her patients in order to accurately formulate a diagnosis. Auscultation with a stethoscope

provides clinical information that can assist in diagnosing, and altering and directing patient

care. The ability to do so remotely is widening the scope of physical hands-on examination

with technological developments such as electronic/digital stethoscopes for (auscultation)

listening to heart and lung sounds (these are superior to the earlier analog stethoscopes, as

even without much experience these can be used effectively), and developments in tele-

haptics for palpation.

11.32.6.2 Cardiac auscultation with traditional stethoscopes requires substantial clinical

experience and good listening skills. The emergence of the electronic stethoscope has paved

the way for a new field of computer-aided auscultation as most heart diseases are associated

with and reflected by the sounds that the heart produces. Heart auscultation, defined as

listening to the heart sound, has been a very important method for the early diagnosis of

cardiac dysfunction. The overall sensitivity of cardiac auscultation is high for identification

of congenital heart disease, significant valvular disease, and persistent cardiac arrhythmias.

Sensitivity is lower for primary myocardial or pericardial diseases, unless there are obvious

associated abnormalities such as a murmur, arrhythmia, or prominent friction rub. The

emergence of electronic stethoscope has opened a new field named ―computer-aided

auscultation‖ which overcomes many of the drawbacks and limitations of traditional

stethoscopes. With the recent developments in technology, from acoustic sensor design,

advanced digital signal processing to the computer based machine learning techniques, the

acoustic based automatic diagnosis of cardiac dysfunction by use of electronic stethoscopes

in-person or remotely in telemedicine.

https://www.sciencedirect.com/topics/medicine-and-dentistry/persistent-truncus-arteriosus

https://www.sciencedirect.com/topics/medicine-and-dentistry/cardiac-dysrhythmia

https://www.sciencedirect.com/topics/medicine-and-dentistry/pericardial-disease

https://www.sciencedirect.com/topics/medicine-and-dentistry/cardiac-dysrhythmia



11.32.6.3 Furthermore, another vital component of auscultation is classification of

pulmonary pathology to assist in making correct diagnosis. However, accurate interpretation

of pulmonary auscultation is subjective and largely dependent on the training of the

physician. Auscultation should take place in a quiet room with the patient in a seated

position. Auscultation should be done in a symmetrical fashion starting at the apices

anteriorly moving to the base and then progression to the posterior chest. Patients should be

asked to take deep breaths with their mouth open, while breath sounds should be evaluated

for their quality, intensity, and for the presence of unanticipated sounds.

11.32.6.4 Normal frequency of pulmonary sounds varies from 100 to 1000 Hz.

Moreover, frequency of wheezing ranges from 100 to 5000 Hz, rhonchus is 150 Hz, coarse

crackle is 350 Hz, and fine crackle is 650 Hz. Tracheal sounds that are normal are clearly

heard in both phases of a respiratory cycle, whereas normal lung sound is only heard on

inspiration and early phase of expiration. Wheezing can be heard on inspiration, expiration,

or both, and is musical in nature with a high pitch. Rhoncus may be heard on inspiration,

expiration, or both, and is low pitch in nature similar to snoring. Fine crackles are heard on

mid-to-late inspiration and can be heard on expiration, and are usually not transferred to the

mouth and unaffected by cough. Coarse crackles are heard on early inspiration and

throughout expiration, are affected by cough, and are transferred to the mouth. Pleural

friction rub and stridor are explosive and high-pitched sounds, respectively, which can also

be appreciated during auscultation. Since multiple pulmonary sounds can be appreciated, and

at times simultaneously, digital stethoscope has facilitated in allowing a clinician to

accurately understand the pathology behind the sound. As seen by the information that can be

gleaned as noted above, the stethoscope serves as an important tool to diagnose a plethora of

cardiovascular and pulmonary disease processes by auscultating heart and lung sounds.

11.32.6.5 Currently, almost all available digital stethoscopes allow for selection of

different frequency response modes allowing the listener to better hear sounds from the heart,

lung, and other areas of the body. There are also multiple mechanisms by which a digital

stethoscope can suppress ambient and friction noise to allow the listener to hear sounds that

are as original as possible. For instance, the 3M® Littmann Range offers piezoelectric sensor

which uses the ambient noise reduction as an adaptive noise canceller by which it allows to

amplify sounds up to 24 times. The Thinklabs® One Digital stethoscope is able to amplify

sounds up to 100 times by applying a capacitive transducer. This technology is able to



employ ambient noise reduction but can also use specific heart sound extraction creating a

rigorous tool to hear specific heart sounds such as valvular clicks as well as use specific

computer algorithms to extrapolate frequencies to understand pulmonary pathology. The

Welch-Allyn® Elite Electronic Stethoscope allows for a bell mode ranging from 20 to 420

Hz, specifically for heart sounds, and diaphragm mode ranging from 350 to 1900 Hz, which

is better used for lung auscultation. Furthermore, the Ekoscope® stethoscope offers built-in

ECG capability, and the ViScope® stethoscope can empower a physician with real-time

display of multiple waveforms. A digital stethoscope also allows the operator to record the

heart sounds and upload them to a computer for further visualization, analysis, and

transmission. Additionally, some digital stethoscopes can also be connected to Bluetooth® to

wirelessly transmit sound signals to a remote processing unit.

https://www.reddingmedical.com/documents/3M_Brochure.pdf

11.32.6.6 Aside from providing increased precision and audible advantage over the

conventional stethoscope, digital stethoscopes have also been studied for their utility of

screening for obstructive coronary artery disease. Turbulent blood flow occurs due to

hemodynamically significant coronary artery disease and manifests as intracoronary

murmurs. The promise of this new tool to supplement noninvasive imaging in the diagnosis

of obstructive coronary disease rests on the premise that small audible signals generated by

the turbulent flow in the coronary artery can be appreciated. The CSA, CADence™, and

CADScor®System are a few examples of acoustic detection systems that are currently being

studied to validate against CT and invasive coronary angiography. Furthermore, due to the

innovation of the digital stethoscope and the capability to transmit the heart sounds

wirelessly, there is potential to develop and advance the field of telemedicine. This will allow

physicians to access patients‘ heart sounds live and alter care and trajectory of their health

directly. A real-time tele-auscultation over the Internet is effective medical services that

increase the accessibility of healthcare services to remote areas. However, the quality of

auscultation‘s sounds transmitted over the Internet is the most critical issue, especially in

real-time service. Packet loss and packet delay variations are the main factors.

11.32.6.7 Despite the accuracy and theoretical appeal of tele-auscultation, this approach

has not proliferated in practice. There are likely several reasons for this. First, several

technical and device issues must be overcome for successful tele-auscultation. Because of the

https://www.reddingmedical.com/documents/3M_Brochure.pdf



small size and the limited cooperation of infants and children, they require devices with small

sensor footprints, short acquisition times, and extraneous noise reduction capabilities.

Because most of the acoustic energy of the heart is of very low frequency, simply recording

and reproducing these sounds can be technically challenging. Digitally acquired heart sounds

must first be filtered to reproduce the familiar frequency characteristics of acoustic

stethoscopes. This often results in sound characteristics that are not entirely familiar to

clinicians and may be responsible for the variable tele-auscultation accuracy between

clinicians. Asynchronous review of low-frequency heart sounds is further hampered on most

computer-based systems that are optimized for much higher-frequency music playback.

Second, any telemedicine system is bound to fail if it is not practical and simple to use. To

that end, successful implementation of any telemedicine system requiring remote data

acquisition must address the issues of data capture, transfer, playback/viewing, and reporting.

Reimbursement also plays a role in the proliferation of such an approach. Tele-auscultation

of children with murmurs can improve access for remote patients, but in a fee-for-service

healthcare system, this can provide a negative incentive to telecardiology providers and their

employers. Therefore, tele-auscultation may be best suited financially for government-based

healthcare systems with the specific purpose of augmenting outreach clinics. Finally, despite

the increased costs, many providers and patients simply prefer or expect echocardiography

for murmur evaluation.


11.32.6.8 Digital aspect of pulmonary auscultation involves recording of the pulmonary

sound, computer analysis of the signals obtained, and classification of the sounds based on

the frequency analyses. Computer-based pulmonary sound analysis allows for optimizing and

quantifying auscultated lung sounds based on the lung sound as well as the spectral

characteristics. The Fourier transform has been the most common analysis tool that has been

used to understand pulmonary auscultation. The Fourier transform is able to degenerate the

signal to the frequencies that comprise the signal. Neural network, which is a machine-

learning algorithm, can further process this information and classify the different frequencies

into pulmonary sounds. Gurung et al performed a meta-analysis of studies that have tried to

understand the prognostic power of combining digital pulmonary auscultation with computer-

based algorithms. Although the sample size was limited, they were able to uncover that the




specificity and sensitivity of identifying abnormal pulmonary sounds using computer-based

algorithms were 85% and 80%, respectively.


11.33 Use Cases of Telemedicine/TeleHealth

11.33.1 Echocardiography and Telemedicine

Echocardiography is the most commonly used noninvasive cardiovascular imaging modality

and is considered to be both safe and cost-effective. Tele-echocardiography can be described

as a process in which a provider or a technician obtains cardiovascular ultrasound images

from a given patient and these images are subsequently transmitted to an offsite location

where a cardiologist can provide further analysis and interpretation. Thus, tele-

echocardiography enables expert interpretation and consultation in a rapid and potentially

geographically disparate fashion, enabling prompt and accurate decision making involving

triage, transport, and therapeutic priorities. Tele-echocardiography is now routinely used

across the age and subspecialty spectrum in pediatric cardiology.

11.33.2 Clinical Scenarios: Fetal Echocardiography and Fetal Cardiac

Monitoring

11.33.2.1 Fetal tele-echocardiography increases prenatal detection of critical congenital

heart disease (CCHD). Sharma et al reported that adequate screening for fetal heart disease is

feasible and that community acceptance for telemedicine-assisted fetal cardiac screening and

counseling is not adversely affected by a lack of direct personal contact with a specialist.

Prenatal detection of CCHD in turn has been shown to improve postnatal surgical and heart

transplantation outcomes. Most commonly, fetal tele-echocardiography is used to refer

delivery to a place where a neonatal intervention can be performed. A few centers in North

America also use tele-echocardiography for referral for fetal intervention. However, fetal

tele-echocardiography is also used across all links of the referral chain, from the primary

obstetrician‘s office to the quaternary fetal healthcare facility. It is routinely performed by

obstetricians, maternal-fetal medicine specialists, and pediatric cardiologists to screen for

congenital heart disease and fetal arrhythmias. If pathology is suspected or detected, these

providers can refer patients to a higher level of care. Commonly, a referring clinic or hospital

uploads the fetal ultrasound or echocardiogram images to a secure virtual network or a




computer server of a tertiary care fetal health center. The tertiary care center then provides

consultation and management recommendations. Occasionally, study image disks or

videotapes of echocardiograms are sent for interpretation and reporting. In the current era of

the gigabit Internet, secure digital transfer is much quicker and hence the preferred method of

delivery. Some tertiary care fetal health centers offer a remote fetal tele-echocardiography

service, which enables a hospital or clinic to transmit live echocardiographic images over the

Internet to an attending cardiologist at an external facility. This allows instant feedback and

counseling via audio or both audio and video. Because access to fetal cardiac expertise is

limited for people in remote or rural locations, fetal tele-echocardiography is felt to be very

helpful in these populations. As telemedicine becomes more frequently used in the delivery

of maternal fetal medicine consultations, the use of fetal ultrasound to detect CCHD can also

help pediatric cardiologists prepare families for delivery and treatment options.

11.33.2.2 In cases of fetal arrhythmias, fetal tele-echocardiography can be diagnostic. In

the case of fetal bradycardia secondary to atrioventricular block, tertiary care fetal health

centers can use fetal tele-echocardiography to guide and monitor pharmacotherapy. Periodic

fetal tele-echocardiography monitoring of fetuses with heart block may be useful in

determining the optimal gestational age for a cesarean section at a center where postnatal

permanent pacemaker implantation will occur. Fetal tele-echocardiography similarly can play

a critical role in diagnosing and treating fetal tachycardia. Transplacental or direct fetal anti-

arrhythmia treatment, follow-up evaluations, and delivery plans can be appropriately

determined on review of the images. Of note, several commercial and US Food and Drug

Administration (FDA)–approved handheld Doppler fetal heart rate monitors are readily

available for use. Prospective parents can purchase them at low cost on the Internet. These

devices hold promise, especially if they have Bluetooth or network connectivity. However,

more data is needed to assess the utility of these devices for future home monitoring.

Physician input is critical because inappropriate use of home monitoring can do more harm

than good.


11.34 Telemedicine and Ultrasound




11.34.1 As telemedicine evolved, the field of ultrasonography matured in

parallel. By the 1990s, ultrasound technology had developed into a bedside tool that

physicians, particularly emergency physicians, were routinely utilizing. Ultrasound is a safe

(non-ionizing) and portable tool capable of being used in a diagnostic or interventional

capacity. Ultrasound has both 2D and 3D capabilities, can be analyzed in real-time, and is a

comparatively low-cost imaging modality. Moreover, a growing body of evidence

demonstrates that bedside ultrasound is more accurate than conventional physical exam for

cardiovascular diagnoses. In low- and middle-income countries (LMICs), ultrasound and

plain radiographs are often the only available imaging modalities. As ultrasound machines

became increasingly portable and as technologies to support data transmission became

commercially available, adequate infrastructure could support the emergence of tele-

ultrasound. The tele-ultrasound paradigm involves performing bedside ultrasound at one

location with images transmitted and interpreted by a provider located in a geographically

distant location. This process can be conducted either in a synchronous, or real-time manner,

or in an asynchronous manner. Asynchronous tele-ultrasound utilizes a store-and-forward

technique in which images are captured, stored, and later transmitted for image interpretation.

Tele-ultrasound offered a seamless solution for skeptics of telemedicine who questioned the

ability to ascertain a meaningful physical examination from afar.

11.34.2 Studies based in high-income countries suggest that tele-ultrasound is

clinically valuable. Tele-ultrasound has been successfully used in diverse settings, including

telecardiology consultation for neonatal units in Northern Ireland, airplanes in flight,

Antarctic research stations, even at the International Space Station. Furthermore, studies have

clearly demonstrated that images can be reliably transmitted between geographically distinct

locations without loss of clinically important image quality via commercially available two-

way audiovisual technology. Instrumental to the evolution and global utilization of tele-

ultrasound was the finding that minimally trained sonographers can acquire high quality

images using real-time guidance from experts afar, an infrastructure called remote tele-

mentored ultrasound (RTMUS). RTMUS utilizes a single centrally-located physician trained

in bedside ultrasound who guides a geographically-removed bedside provider in image

acquisition and performs image interpretation from afar. Early work in high-income countries

demonstrated that remote tele-mentored ultrasound was feasible and accurate in cardiac,



trauma, and critical care applications. Based on research not included in this systematic

review, synchronous RTMUS can be successfully performed with <60 min of training.

11.34.3 This systematic review suggests that tele-ultrasound performed in

resource-limited settings can reliably produce satisfactory images with diagnostic utility that

guide clinical management. According to the World Health Organization (WHO), imaging is

needed for diagnosis in 20–30% of clinical cases and ultrasound and/or plain radiographs are

sufficient for 80–90% of those cases. Yet, two-thirds of the world's population remains

without access to medical imaging. Ultrasound, integrated into a telemedicine platform

expands access to a safe, accessible, and affordable diagnostic imaging modality to

populations in resource-limited settings.

11.34.4 Globally, ultrasound is a burgeoning diagnostic tool that often offers

more insight into patient pathophysiology than the stethoscope. Thoracic ultrasound, as

compared to chest radiography, has a high sensitivity and specificity for diagnosing

cardiogenic pulmonary edema, pneumonia, COPD, pneumothorax, and pulmonary embolism

in both the intensive care unit and the emergency department. In fact, lung ultrasound is

superior to chest radiograph in diagnosing pneumonia in the emergency department. In

resource-limited settings, lung ultrasound was more sensitive and specific than chest

radiograph to diagnose pneumonia. Furthermore, point-of-care ultrasound can be

incorporated into a telemedicine platform and performed with relatively little training by non-

physicians located at the bedside under the real-time guidance from ultrasound experts. Thus,

the use of RTMUS obviates the need for a bedside ultrasound expert to acquire images or a

local expert to interpret them. RTMUS is particularly relevant in resource-limited settings in

LMICs, where a scarcity of physicians often exists with expertise in ultrasound or with

training in ultrasound-heavy subspecialties such as cardiology or obstetrics. Task-shifting

ultrasound performance away from formally-trained sonographers and physicians to non-

experts, while maintaining high quality imaging, helps establish a sustainable and cost-

effective telemedicine program. This task-shifting also dramatically expands patient access to

otherwise inaccessible subspecialists.

11.34.5 The studies included in this systematic review reinforce the concept

that adequate ultrasound acquisition techniques can be taught in a remote tele-mentored

manner. In cardiac ultrasound, the high success rates for visualization of anatomic structures



by non-experts allows for changes in medical management in the absence of a bedside

physician. These changes include earlier treatment and appropriate escalation of care to

tertiary centers. By utilizing non-experts as ultrasonographers, a larger population of patients

gains access to ultrasonography as a diagnostic tool and to cardiology expertise. In this

review, non-experts included physicians unfamiliar with a designated ultrasound approach,

nurse research coordinators, a biomedical technician, and an imaging technician. Additional

studies that did not meet the requirements for this review included custodians and medical

interpreters as the non-experts performing the ultrasound. Collectively, these studies inform

the conclusion that the quality of the ultrasound images obtained by non-experts are sufficient

for interpretation by experts remotely.

11.34.6 Our literature review indicates that tele-ultrasound was frequently used

in the field of cardiology. Tele-ultrasound has demonstrated success in producing high

quality, diagnostically significant images which alter management, decrease time to

treatment, and provide more cost-effective care, especially when coupled with supporting

data such as electrocardiogram, chest radiography, laboratory results, and clinical history. In

Aragonda, India, the use of remote tele-mentored echocardiography allowed for the

diagnosis of pediatric cardiovascular pathology, resulting in a 29% referral for cardiac

surgery based on those findings. In Bangladore, India, tele-ultrasound was used to

assess times to treatment and long-term outcomes among children with structural heart

disease. Images were collected in asynchronously and interpreted by a global

consortium of cardiologists. Tele-ultrasound reduced the time to referral for valvular

interventions and reduced the likelihood of both hospitalization and death. Though

uncommon in high-income countries and likely underreported in low-income ones, rheumatic

heart disease (RHD) is a major source of morbidity and mortality in LMICs (49). In the

PROVAR study from Brazil, non-expert ultrasonographers successfully screened

schoolchildren for RHD and images were interpreted by geographically-removed experts.

Collectively, cardiology-based tele-ultrasound studies demonstrate the transformative

potential of utilizing this imaging modality in a resource-limited setting as a tool to better

understand the epidemiological impact of a disease and to improve disease management and

outcomes.

https://www.frontiersin.org/articles/10.3389/fpubh.2019.00244/full%23B49



11.34.7 Obstetrics is an additional medical specialty in which ultrasound is

heavily utilized around the globe. Unfortunately, the supply of ultrasound machines,

sonographers, and radiologists in LMICs is very low. For example, only two radiologists

work in Liberia. In an attempt to overcome such challenges, ultrasound training programs

have taught non-experts either to independently perform obstetric ultrasound to screen for

high-risk pregnancies or to utilize tele-ultrasound. Of the multiple studies addressing the role

of tele-ultrasound in resource-limited countries, the four included in this review focus on the

obstetrics tele-ultrasound evaluation. Ultrasonographers included physicians and midwives

without prior obstetrics ultrasound training, but none of the obstetrics studies utilized

RTMUS. Collectively, these studies concluded that ultrasound acquired accurate fetal

structural views, allowed for the modification of perinatal care, and helped facilitate transfer

to specialty centers when needed. Tele-ultrasound performed by a novice ultrasonographer

prevented the need for additional re-imaging and yielded results available to the patient

within 15 min. Image acquisition can be taught from a distance via the internet and a

telemedicine platform is reliably able to transmit high quality images.

11.34.8 To date, we are unaware of any studies directly comparing

synchronous to asynchronous telemedicine or tele-ultrasound. However, we believe an

implicit benefit exists with using synchronous tele-ultrasound. Real-time image acquisition is

well-suited to be combined with remote tele-mentoring to establish a hub-and-spoke

paradigm whereby a single trained ultrasonographer can mentor numerous geographically

removed ultrasound-naïve bedside providers to maximize the global reach of tele-ultrasound.

By capitalizing on the concept of task-shifting inherent to RTMUS, any person located at the

patient's bedside can function as the bedside ultrasonographer. Furthermore, real-time image

acquisition and interpretation reduces delays in patient care and the need to return for follow

up images, which may occur in an asynchronous point-and-store model of tele-ultrasound.

Synchronous image acquisition also allows for real-time image quality control. As

technology improves, wireless network and mobile phone access become more globally

reliable, and commercially-available real-time audiovisual software (e.g., Skype, FaceTime)

develop HIPAA-compliant platforms, the use of synchronous, RTMUS systems will be

universally within reach.



11.34.9 The potential impacts of tele-ultrasound in LMICs are substantial with

regard to the scope and breadth of both the numerous clinical areas (e.g., respiratory failure,

hemodynamic compromise, procedural guidance) and the stakeholders (e.g., patients,

providers, health systems) affected. The results of this systematic review, however, should be

interpreted within the pre-established boundaries defined by the question we sought to

answer using existing relevant studies. Specifically, this review addresses the feasibility of

tele-ultrasound in LMICs and its clinical benefit to patients. Though certainly relevant to

public health, this review was not intended to analyze the potential economic or workflow

impacts of this technology on the health care providers or the healthcare system within each

country. As public policy lies at the intersection of economic analysis and patient benefit, this

systematic review cannot independently support changes to public policy but instead serves

to further highlight the important clinical impact on patients.

https://www.frontiersin.org/articles/10.3389/fpubh.2019.00244/full

11.35 The TSI recommends that to remain relevant and fit-for-purpose, the Guidelines for

Telemedicine should be regularly updated, preferably annually.

11.36 The TSI recommends that exchanging information for clinical purposes between

providers and patients/caregivers over the telephone, through text messaging (SMS) or other

similar application (e.g., iMessage, WhatsApp) should also falls within the scope and

definition of Telemedicine and therefore the TMG.

11.37 Finally, there is a very diverse spectrum of healthcare organisations, from giant

healthcare conglomerates with multinational operations, to large hospitals with thousands or

hundreds of staff to solo General Practitioners operating out of private medical clinics. While

the Telemedicine Guidelines should aim to be comprehensive in scope and be open to

adoption by all health organisations regardless of size, there can be no ―one-size-fits-all‖

approach. Hence, health organisations are encouraged to tailor the application of the NTG to

their individual circumstances in line with the spirit of what it seeks to achieve.

11.38 The TSI notes that certain obligations in the guidelines should only apply to

individual health professionals while other obligations apply only to the broader health

organisation that delivers the overall ―system‖ or ―infrastructure‖ of care for a patient.

https://www.frontiersin.org/articles/10.3389/fpubh.2019.00244/full



11.39 The TSI recommends that telemedicine should also serve to improve patient care

coordination and communication amongst different levels of care (Primary, secondary and

tertiary) as well as horizontally at each level.

11.40 The TSI strongly supports coverage and payment for telemedicine services provided

by duly credentialed and licensed health professionals when several important criteria are met

as explained later herein. These criteria are essential to ensure that the care provided by

telemedicine is of high quality, contributes to care coordination (rather than fragmentation),

meets licensure and other legal requirements, maintains patient choice and transparency, and

protects patient privacy.

11.41 The TSI recommends that all patients seeking care delivered via telemedicine should

have a choice of provider when possible and be made aware of their cost sharing

responsibility.

11.42 Additionally, the TSI recommends that insurers should not require their members to

use telemedicine in lieu of an in-person service with a community provider.

11.43 While telemedicine is a viable option to deliver high-quality care to patients in some

circumstances, the TSI supports the preservation of a patient‘s choice to have access to in-

person healthcare services services. There are some things for which an in-person

examination by duly credentialed and licensed health professional provides additional

information that may not otherwise be obtainable by telemedicine alone.

11.44 Duty of Care

11.44.1 The nature of a telemedicine encounter has clouded the margins on the

duty of care and has given rise to questions. Who should be the physician ultimately

responsible for the patient? Is it the primary care physician, who attends to the patient face-

to-face, or the remote health professional, who gives his expert opinion on the patient‘s

condition? The duty of care must be established before using telemedicine. Healthcare

professionals involved in telemedicine should collaborate and clearly define their roles and

responsibilities in the care of a patient.

11.44.2 As telemedicine is practised, it will bring about medico-legal

problems. Medico-legally, the traditional principles of tort and negligence apply to

telemedicine. Both the local (primary care physician) and distant (consultant health



professional) care providers owe a duty of care to the patient. Negligence in telemedicine

occurs when there is a breach of this duty of care and damages are suffered as a result of this

breach. As telemedicine is an emerging field, there is a lack of guiding statutes or laws on

medical errors arising from practice of telemedicine. The issue of demarcating the shared

legal responsibility between the primary care physician and the distant consultant health

professional will be a challenge to overcome at this point of time. For example, in what

period of time the doctor needs to respond to telemedical incident notifications in order to

comply with his duty as a doctor and to avoid liability.

11.44.3 It is stressed in medical literature that telemetric remote monitoring of

cardiac-defibrillators and cardiac pacemakers is not ―an emergency response system‖. Thus,

as a guideline, an acceptable time frame needs to be prescribed/indicated (such as the next

business day) and this information on the expected reaction times should be carefully

explained to patients, and they and their caregivers should be instructed on how to react in an

emergency situation. A number of institutions have formalized the process and they ask

patients to sign agreements. These serve as documentation of the patient‘s education process

and reinforce patient expectations. Patients should also be given explicit instructions on how

to interface with the follow-up clinic when experiencing symptoms. Depending on the actual

facts and circumstances of a given case, a failure to act by the doctor or a delayed response

(sometimes even within the expected reaction-time indicated in the guideline) to the alarm

may be deemed to be a treatment error in the form of a therapy error. What must be examined

is whether the doctor must provide an infrastructure in which alarms are registered,

monitored and inspected with regard to their risk situation. From a medical standpoint, this is

certainly desirable, as only through constant monitoring can the potential of the device be

fully exploited. From a factual standpoint, this protection of the patient could be ensured

through cooperation between the doctor and the clinic. From a legal standpoint, no doctor

should be obligated to provide absolute protection. Thus, the extent of the contractually

assumed responsibility, of which the patient must be informed in a patient information talk, is

decisive for liability. It is in the nature of outpatient treatment that healthcare is only ensured

during the consultation hours of the doctor‘s office and that outside of these hours patients

are referred to emergency care/hospitals. The doctor does not have to be accessible either by

phone or personally outside of his consultation hours. In the case of a ―full care assignment

(full time work by the doctor) consultation hours in Germany, for example, must be held at



least 20 hours per week for patients with public insurance. If these criteria which make up the

timeframe for the ―analog‖ treatment of the patient are extrapolated to ―digital‖ readiness it

can be concluded that where the device emits an alarm outside of the times guaranteed by the

doctor and it was not received by the doctor, then the doctor will not be liable or subject to

responsibility if harm or damage is incurred by the patient. However, if the doctor receives

the alarm, he must act according to the principles depicted above. In this context, the

principles and liability benchmarks from the analog setting can be extrapolated to the digital

world. The cardiologist who finds the patient in an acute emergency situation during his

leisure time is obligated to act. The treatment contract with the patient establishes an

increased duty to avert the incident and the doctor can be prosecuted or held liable for failing

to act and not merely on grounds of failure to render assistance. The doctor is obligated to

inform the patient of all circumstances that are essential to treatment. The doctor‘s

information duty comprises the duty to completely inform the patient that he needs to support

the telemedicine treatment if necessary through cooperation. The doctor will only have

complied adequately with this duty if he has gained the impression on the basis of adequate

indications that the patient has understood both his cooperation duty as well as the conduct

recommended by the doctor. The reason for this duty is the doctor‘s superior knowledge to

that of the patient. Where the doctor fails to comply or comply completely with this, this

constitutes a breach of duty which may incur a case of liability.

https://www.openaccessjournals.com/articles/telemetric-remote-monitoring-of-cardiac-

devices-is-the-future-of-medicine-a-liability-trap-for-the-physician-12537.html

11.44.4 The following are some points to be kept in mind:

a) The ―duty of care‖ must be established in all Telemedicine encounters to clarify

any and all ongoing responsibility(s) for the patient/caregiver as well as the roles and

responsibilities of other health professionals involved.

b) Health professionals should collaborate with each other to clearly define their roles

and responsibilities (e.g., who would deliver which aspect of care, ranging from the

responsibility of ordering tests, to follow-up, to keeping a record of the notes, etc).

c) The patient and caregiver should be given clear and explicit direction at the

telemedicine encounter as to who has ongoing or periodic responsibilities for any





required follow-up, ongoing health care. or aftercare as, for example, of inspection or

monitoring of recordings by implanted devices such as pacemakers/defibrillators.

(d) Be proficient in the use of the relevant technologies and comfortable interacting

with patients and/or surrogates electronically.

(e) Recognize the limitations of the relevant technologies and take appropriate steps

to overcome those limitations. Physicians must ensure that they have the information

they need to make well-grounded clinical recommendations when they cannot

personally conduct a physical examination, such as by having another health care

professional at the patient‘s site conduct the exam or obtaining vital information

through remote technologies.

(f) Be prudent in carrying out a diagnostic evaluation or prescribing medication by:

Establishing the patient’s identity

Confirming that telehealth/telemedicine services are appropriate for that patient‘s

individual situation and medical needs

Evaluating the indication, appropriateness and safety of any prescription in keeping

with best practice guidelines and any formulary limitations that apply to the electronic

interaction

Documenting the clinical evaluation and prescription

(g) When the physician would otherwise be expected to obtain informed consent,

tailor the informed consent process to provide information patients (or their

surrogates) need about thedistinctive features of telehealth/telemedicine, in addition to

information about medical issues and treatment options. Patients and surrogates

should have a basic understanding of how telemedicine technologies will be used in

care, the limitations of those technologies, the credentials of health care professionals

involved, and what will be expected of patients for using these technologies.

(h) As in any patient-physician interaction, take steps to promote continuity of care,

giving consideration to how information can be preserved and accessible for future

episodes of care in keeping with patients‘ preferences (or the decisions of their

surrogates) and how follow-up care can be provided when needed. Physicians should



assure themselves how information will be conveyed to the patient‘s primary care

physician when the patient has a primary care physician and other physicians

currently caring for the patient.

Collectively, through their professional organizations and health care institutions,

physicians should:

(i) Support ongoing refinement of telehealth/telemedicine technologies, and the

development and implementation of clinical and technical standards to ensure the

safety and quality of care.

(j) Advocate for policies and initiatives to promote access to telehealth/telemedicine

services for all patients who could benefit from receiving care electronically.

(k) Routinely monitor the telehealth/telemedicine landscape to:

● Identify and address adverse consequences as technologies and activities

evolve

● Identify and encourage dissemination of both positive and negative outcomes

https://www.ama-assn.org/delivering-care/ethics/ethical-practice-telemedicine

11.45 Standard of Care

11.45.1 The classification of telemedicine services as acts of medical practice should

ensure that services offered are at the same level as those offered by the traditional health

service (for example radiology and tele-radiology). This enables the prevention of two risks:

1) that highly regulated health services are substituted by unregulated digital services;

2) discrimination between various suppliers of the same service.

11.45.2 The fact that health services can now be provided digitally undoubtedly calls

into question current health structures, but it also raises the question of responsibility in the

doctor-patient relationship, that of the practicing doctor or doctors and not just the structure

in which they operate.

https://www.ama-assn.org/delivering-care/ethics/ethical-practice-telemedicine



11.45.3 In the traditional sense, the relationship begins only when the doctor

has physical contact with the patient via an examination to form a diagnosis or prescribe a

course of therapy. The American Medical Association defines it in this way: ―A patient-

physician relationship exists when a physician serves a patient‘s medical needs, generally by

mutual consent between physician and patient (or surrogate). In some instances the

agreement is implied,

such as in emergency care or when physicians provide services at the request of the treating

physician‖. In fact, emails are only used for ―supplemental encounters and informing patients

clearly about the inherent limitations of e-mail communication‖ and only after a physical

relationship has been established. In any case the use of email is considered inappropriate to

communicate bad news or abnormal test results, as this is considered to be a possible cause of

confusion.

11.45.24 With regards to the use of the Internet, the Federation of State Medical Boards

(FSMB) shares the above observations and states that the doctor is obliged to provide the

patient with ample opportunity to express their concerns and the right to a timely response.

The Italian National Committee of Bioethics established that diagnosis should always be

carried out by a direct examination and that telemedicine involves exclusively consulting

activities that are necessary for the specifics of each case or to provide further information

and decisional support.

11.45.25 In court, the question is more controversial. In the US, some courts have ruled

that there may be a physician-patient relationship through telecommunication devices even

without direct contact with the patient. Others, however, argue that such a relationship can

not arise when the doctor, without seeing or examining the patient, simply gives the patient a

questionnaire to fill out and then prescribes medicines via the internet.

11.45.26 In our view, one cannot rule out the existence of the doctor-patient

relationship in telemedicine practices. For example, the practise of performing delicate

surgical procedures in which the team is located in one state and the patient in another. Can

one really argue that in such a situation there is no relationship between the patient and the

team for the mere fact that the operators see the patient through machines rather than directly



with their eyes? We think not. In fact, for this reason it is clear that information should be

provided electronically (and consent given) by the surgeon who will perform the surgery,

despite their location in another state. The main criteria to ascertain whether there is a doctor-

patient relationship seems to be based on the fact that the two are connected, possibly

electronically, with a physician for purposes related to the prevention, diagnosis or treatment

of diseases. If then the doctor gives a wrong diagnosis, in spite of the fact that they could

physically visit the patient and/or refer them to other specialists, this means that the doctor is

culpable, not that there is no doctor patient relationship because the relationship was

conducted electronically.

11.45.27 On the other hand the doctor-patient relationship is absent when the patient

downloads apps to self diagnose rather than seeing a doctor. In this situation the patient has

no contact with a doctor, but has contact with an elaborate electronic system based on

scientific knowledge and guidelines, at the very best.

11.45.28 Telemedicine is different from the traditional gold standard of face-to-face

encounters. Given the limitations of two-way audio-visual/multimedia technologies, the

diagnostic and management accuracy in many situations may not be equivalent to an in-

person service. This raises the question of whether telemedicine allows a healthcare provider

to meet a reasonable standard of care. In fact, healthcare providers and regulators dealing

more and more with these recent advancements in telemedicine business models are now

more than ever asking the question, ―can and does the use of such technologies in the practice

of medicine affect or alter the standard of care?‖

11.45.29 In Telemedicine the element of technology in the delivery of healthcare

services sometimes may make it difficult to comprehend concepts which are understood in a

straightforward manner in the traditional mode of healthcare services delivery. One such

concept is the standard of care which is to be understood at a ―systems‖ and at a

―transactional‖ level. At the ―systems‖ level a number of interactions for example in various

settings involving a number of healthcare professionals come together to deliver good quality

care to an individual. The interactions at the individual level can be considered a transaction

and a certain standard of care is to be maintained in all these transactions. Whether or not it is

reasonable to deliver a particular healthcare service by Telemedicine is determined by the



clinical context, the clinical objectives and the compatibility of technology to meet those

clinical objectives.

11.45.30 More traditional use cases for telemedicine typically call for the use of some

form of telecommunications (phone, real-time video, or sharing of images) so that two or

more healthcare providers can collaborate or ―consult‖ across a distance on a patient‘s case.

In some situations this involves a specialist assisting an ER doctor in the evaluation of a

patient. Other models advance multi-specialist and primary care data exchange on unique and

chronic patients requiring recommendations from multiple healthcare providers. Rather than

mobile devices, these models typically involve more advanced hardware, software, and

connectivity needs whereby video/audio carts and digital imaging systems have evolved to

facilitate a free-flow of communications and information exchange primarily between two

healthcare facilities and healthcare providers. Most teleradiology, telepathology, and

teleneurology models function in this manner.

11.45.31 With greater consumer interest in healthcare, employer efforts to contain

insurance costs, and a general desire to align healthcare with more IT and mobile society-

oriented norms demanding convenience, access, and connectivity, evolution continues for

healthcare delivery patterns and models using telemedicine technologies (especially

consumer mobile devices). In particular, ―direct to consumer‖ models bring healthcare

providers of all types to the patient at the patient‘s demand (in the patient‘s home, in the

patient‘s workplace, and in retail locations), often using mobile devices and software

applications for a variety of real-time video, monitoring, secure messaging, and audio tools

for engagement between the healthcare provider and patient.

http://www.aaas.org/sites/default/files/Gilroy-

Telemedicine%2C%20mHealth%20and%20the%20Standard%20of%20Care.pdf

11.45.32 TSI believes that telemedicine services must be provided as part of a

structured and well-organised system and the overall standard of care delivered by the system

must not be any less compared to a service not involving telemedicine.

i. Where a face-to-face consultation is not reasonably practical, it is permitted to

deliver care exclusively via Telemedicine as this is better than not having any access

to care at all.

http://www.aaas.org/sites/default/files/Gilroy-Telemedicine%252C%2520mHealth%2520and%2520the%2520Standard%2520of%2520Care.pdf

http://www.aaas.org/sites/default/files/Gilroy-Telemedicine%252C%2520mHealth%2520and%2520the%2520Standard%2520of%2520Care.pdf



ii. Where face-to-face consultations are reasonably practical, the delivery of care via

Telemedicine must not compromise the overall quality of care provided as compared

with non-Telemedicine care delivery.

11.45.33 The standard of care must be upheld by all health professionals involved in the

Telemedicine interaction. As far as reasonably possible, the technology component of

Telemedicine should be incorporated in the normal workflow of clinical processes by the

healthcare organization so that the quality of care as delivered by Telemedicine is integrated

within the organisation‘s governance and oversight of its other clinical processes.

11.46 Patient autonomy and confidentiality

11.46.1 Patient confidentiality has surfaced as one of the key issues that need

to be addressed. Reasonable care must be taken to ensure confidentiality of medical

information shared through technology. Existing legislations and regulations governing

personal data, such as the under the IT Act (and the proposed Personal Data Protection Act)

and Indian Medical Council‘s (Professional Conduct, Etiquette and Ethics) Regulations,

2016, must be adhered to strictly. As the patient‘s records, images, etc are

transmitted/accessed online to a distant health professional, there is the possibility that the

patient‘s records may be unlawfully accessed. The platform via which the images are

uploaded to must be secured and password protected. If the images are to be used for training

and education purposes, these must be clearly spelt out in the consent form and the patient

must be agreeable.

11.46.2 The patient‘s right to autonomy must be respected. The patient must be

given all the necessary details regarding his care and informed consent obtained. The risks

and benefits of telemedicine must be communicated and documented in an informed consent

duly obtained/recorded and acknowledged/signed by the patient or her carer/proxy. Patients

must also be given the right to decline participation in telemedicine especially if they find

that the technology is too complicated or expensive for them to use. Telemedicine/TeleHealth

can increase access disparities if insurers don‘t cover it and it becomes cost-prohibitive for all

but the wealthy, or if poorer people receive lower-quality care due to limitations of

information and communication networks and/or poor quality or poor maintenance of

telemedicine devices. It is also possible that expanded access to healthcare through

telemedicine may result in people getting care that isn‘t right for them. If however



telemedicine is positioned as a supplement to ―live visits‖ and to be used only in the context

of an existing doctor-patient relationship then it would automatically exclude those living in

remote and underserved areas. While making an institutional framework for regulating

telemedicine/telehealth, cautions must be exercised against getting into a situation where

telemedicine/telehealth is regulated more stringently than are visits with office-based

physicians/health professionals.

11.46.3 Physicians who provide clinical services through

telehealth/telemedicine must uphold the standards of professionalism expected in in-person

interactions, follow appropriate ethical guidelines of relevant specialty societies and adhere to

applicable law governing the practice of telemedicine. In the context of

telehealth/telemedicine they further should

11.47 The TSI supports the use of telemedicine services provided by duly credentialed and

licensed health professionals, as well as coverage and payment for those services, when

several important criteria are met:

1. Health professionals delivering telemedicine services must be duly licensed to

practice in India as evidenced by registration with a State Medical Council.

2. Patients or referring health professionals seeking telemedicine services must have a

choice of health professionals, if possible, and must have access in advance to the

licensure and board certification qualifications of the health professional concerned.

3. Some basics to keep in mind, at least for an initial encounter and maybe periodically

thereafter if there are additional visits, include:

○ Inform patients of their rights when receiving TM, including the right to stop

or refuse treatment

○ Tell patients of their own responsibilities when receiving TM treatment

○ Have a formal complaint or grievance process to resolve potential ethical

concerns or issues that might come up

○ Describe potential benefits, constraints, risks (privacy, security)

○ Inform patients of what will happen in case of technology or equipment

failures during TM sessions, state contingency plan



○ Inform patients & obtain their consent when students or trainees observe the

encounter

○ Obtain patient consent prior to any recording of the encounter (note that the

recording will be made available upon request and that release of the

recording shall require written patient authorization or court order)

○ Adhere to all applicable laws and regional and local practices as to Patient

Informed Consents & Disclaimers

○ Set appropriate expectations regarding TM encounters, including, for example,

prescribing policies, scope of service, communication, and follow-up

○ To reduce risk of overprescribing, follow evidence-based guidelines as well as

all federal, state and local regulations

○ Have a procedure in place for patients who don‘t wish to sign the consent

forms or receive care via telemedicine

https://southwesttrc.org/blog/2017/telemedicine-informed-consent-how-informed-are-

you

https://download.lww.com/wolterskluwer_vitalstream_com/PermaLink/ACADMED/

A/ACADMED_87_8_2012_05_02_MEYER_202957_SDC1.pdf

4. The patient‘s relevant medical history must be collected as part of the provision of

telemedicine services. For teletriage and teleconsultation, appropriate medical records

should be available to the consulting health professional prior to or at the time of the

telemedicine encounter. Consulting health professionals should have a good

understanding of the culture, health care infrastructure, and patient resources available

at the site from which consults are originating.

5. The provision of telemedicine services must be properly documented. These medical

records should be available at the consultant site, and for teletriage and

teleconsultation services, should also be available at the referral site.

6. The provision of telemedicine services should include care coordination with the

patient‘s existing primary care physician, if any. This should include, at a minimum,

identifying the patient‘s existing primary care physician in the telemedicine record,

and providing a copy of the medical record to those existing members of the treatment

https://southwesttrc.org/blog/2017/telemedicine-informed-consent-how-informed-are-you

https://southwesttrc.org/blog/2017/telemedicine-informed-consent-how-informed-are-you

https://download.lww.com/wolterskluwer_vitalstream_com/PermaLink/ACADMED/A/ACADMED_87_8_2012_05_02_MEYER_202957_SDC1.pdf

https://download.lww.com/wolterskluwer_vitalstream_com/PermaLink/ACADMED/A/ACADMED_87_8_2012_05_02_MEYER_202957_SDC1.pdf



team who do not have electronic access to it. This is especially important so that

information about diagnoses, test results, and medication changes are available to the

existing care team, if any.

7. Organizations and clinicians participating in telemedicine services should have an

active training and quality assurance program for both the distant and receiving sites.

In addition, those programs that are using telemedicine services should have

documentation of their training programs for any technician who is capturing clinical

images and for any manager who is handling consults.

8. With all the patient's data being produced straight to the internet, security is a

significant factor. Data must be made secure during transmission and while at rest.

Data security must be a priority at the start of the telemedicine program, not

implemented as an afterthought. Keeping the patient's information private is of utmost

importance to their safety. As health data becomes more fluid, security practices

around that information should be held to the highest standard. Similarly, all

physicians who participate in telehealth/telemedicine must assure themselves that

telemedicine services have appropriate protocols to prevent unauthorized access and

to protect the security and integrity of patient information at the patient end of the

electronic encounter, during transmission, and among all health care professionals and

other personnel who participate in the telehealth/telemedicine service consistent with

their individual roles. Each organization should also maintain documentation on how

the program protects patient privacy, promotes high quality clinical and image data,

continuity of care, and care coordination for patients who may require subsequent in-

person evaluations or procedures.

Telehealth and telemedicine span a continuum of technologies that offer new ways to

deliver care. Although physicians‘ fundamental ethical responsibilities do not change,

the continuum of possible patient-physician interactions in telehealth/telemedicine

give rise to differing levels of accountability for physicians.

All physicians who provide health content for websites or mobile health applications

must ensure that the information they provide or that is attributed to them is objective

and accurate.



Physicians who respond to individual health queries or provide personalized health

advice electronically through a telehealth service should additionally:

● Inform users about the limitations of the relationship and services provided.

● Advise site users about how to arrange for needed care when follow-up care is

indicated.

● Encourage users who have primary care physicians to inform their primary

physicians about the online health consultation, even if in-person care is not

immediately needed.

Physicians who provide clinical services through telehealth/telemedicine must uphold

the standards of professionalism expected in in-person interactions, follow

appropriate ethical guidelines of relevant specialty societies and adhere to applicable

law governing the practice of telemedicine.

9. Organizations and clinicians participating in telemedicine services must have

protocols for local referrals (in the patient‘s geographic area) for urgent and

emergency services.

10. Inevitably, machines will fail without warning, so we must always have backup plans

ready to implement at a moment's notice. Stakeholders in the telemedicine program

must always be kept up-to-date, especially patients, in case of unexpected downtime.

11. All physicians who participate in telehealth/telemedicine have an ethical

responsibility to uphold fundamental fiduciary obligations by disclosing any financial

or other interests the physician has in the telehealth/telemedicine application or

service and taking steps to manage or eliminate conflicts of interests. Whenever they

provide health information, including health content for websites or mobile health

applications, physicians must ensure that the information they provide or that is

attributed to them is objective and accurate.

12. The healthcare professionals-patient relationship:

a. For teletriage and teleconsultation services where a referring provider ultimately

manages the patient (including the prescription of medications), the consulting

(distant/remote) health professional is not required to have a pre-existing, valid



patient-physician relationship. It is optimal, however, if the patient has available

access to in-person follow-up with a local, duly credentialed and licensed health

professional, if needed.

b. For direct-to-patient telemedicine services, the TSI believes that the consulting

telemedicine health professional must either:

i. Have an existing physician-patient relationship (having previously seen the

patient in-person), or

ii. Create a health professionals-patient relationship through the use of a live-

interactive face-to-face consultation before the use of store-and-forward

technology, or

iii. Be a part of an integrated health delivery system where the patient already

receives care, in which the consulting health professional has access to the

patient‘s existing medical record and can coordinate follow-up care.

13. The use of direct-to-patient telemedicine services raises several additional issues (and

all of the above criteria still apply):

a. Providers shall inform users about the limitations of the relationship and

services provided.

b. Providers must exercise caution regarding direct prescribing for patients via

electronic communications in the absence of regulation of e-prescribing.

c. Health professionals providing direct-to-patient telemedicine services must

make every effort to collect accurate, complete, and quality clinical

information. When appropriate, the distant health professional may wish to

contact the primary care providers or other specialists to obtain additional

corroborating information.

d. Mechanisms to facilitate continuity of care, follow-up care, and referrals

forurgent and emergency services in the patient‘s geographic area must be in

place. Any new medications prescribed or changes in existing medications

must be communicated directly to the patient‘s existing care team (unless they

have easy electronic access to the telemedicine record).



e. The TSI believes that when creating directories of participating health

professionals or establishing network adequacy, an insurer should not consider

telehealth access as a substitute for locally available health professionals who

can offer the full spectrum of medical and surgical care.

f. The TSI supports telemedicine services designed and dedicated to

consistently provide demonstrably high-quality patient care.

g. The TSI does not support telemedicine services that offer easy prescriptions

without an adequate history, examination and valid/proper patient-health

professional relationship.

h. The TSI does not support telemedicine services that prioritize business

interests over the quality and safety of patient care.

https://www.moh.gov.sg/docs/librariesprovider5/licensing-terms-and-

conditions/national-telemedicine-guidelines-for-singapore-(dated-30-jan-2015).pdf

https://www.fsmb.org/siteassets/advocacy/policies/fsmb_telemedicine_policy.pdf

https://ijme.in/articles/patients-rights-in-india-an-ethical-perspective/?galley=html

https://www.moh.gov.sg/docs/librariesprovider5/licensing-terms-and-conditions/national-telemedicine-guidelines-for-singapore-(dated-30-jan-2015).pdf

https://www.moh.gov.sg/docs/librariesprovider5/licensing-terms-and-conditions/national-telemedicine-guidelines-for-singapore-(dated-30-jan-2015).pdf

https://www.fsmb.org/siteassets/advocacy/policies/fsmb_telemedicine_policy.pdf

https://ijme.in/articles/patients-rights-in-india-an-ethical-perspective/?galley=html

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