pwc mhealth how supportive is the regulatory framework for mobile health applications

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mHealthinsightsJanuary 2013

How supportive is the

regulatory framework formobile health applications?

Mobile health (mHealth) is having a significant impact globally on the delivery ofcare but most regulators around the world are still uncertain how to address this

phenomenon. While regulatory bodies in the United States (US) and theEuropean Union (EU) are beginning to increase scrutiny over mobile health(mHealth) solutions, over 150 countries have yet to develop regulatoryframeworks or guidance. Some countries appear to be following a 'one-size-fits-all' approach where the rigorous standards of healthcare are being applied tonon-intrusive, non-critical mHealth services and applications.1 In otherinstances, other regulations, such as telecommunication requirements, are beingapplied to mHealth solutions even though phone device manufacturers andnetwork operators have entirely different risk factors from mHealth providers.

Uncertainty in regulatory requirements would likely dampen the growth ofmHealth, one of the most powerful emerging tools available to enable greater

access to more affordable quality care. According to the PwC-commissionedEconomist Intelligence Unit report,Emerging mHealth: Paths for growth,45% of payers and doctors believe that the application of inappropriateregulations from earlier technologies are hindering the innovation of mHealth.Regulatory support to facilitate the approval of devices and medical apps, andthe development of an interoperability standard, is a key factor in gaining thetrust and confidence of healthcare providers, patients and payers of mHealthsolutions.

Yet there is some progress. The Global Harmonization Task Force (GHTF) andits successor the International Medical Device Regulators Forum, whosemembership includes GHTF delegates such as the US, EU, Canada, Japan,

Australia and Brazil, have made progress in harmonising and simplifying

medical device regulation. A key challenge for regulators as they continue todevise regulatory frameworks will be fostering innovation without sacrificing

Highlights

Regulatory bodies in the

United States and theEuropean Union arebeginning to increasescrutiny over mHealthsolutions but over 150countries have yet todevelop regulatoryframeworks or guidance

However, while theregulatory environmentand healthcare systems

vary from region to

region, current healthcareindustry players or newentrants can still followcertain principles whendeveloping or adoptingmHealth solutions

1 PwC, GSMA, "Touching lives through mobile health:Assessment of the global market opportunity", February2012, p. 31.

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safety, complementing data privacy and securityrules in accordance to the laws of the land, andaligning regional approaches to create a uniformsystem.

A global snapshot of current mHealth

regulations

In the US

The US is advancing regulatory policy andlegislation for mobile health. On 9 July, 2012,President Barack Obama signed the Food and Drug

Administration Safety and Innovation Act (FDASIA)that provides the Food and Drug Administration(FDA) with the authority to continue developingmHealth regulations. The Act also enables the FDAto accelerate the approval process for mHealth

solutions that function as devices.

Past proposed legislation in this area could seerenewed efforts in the new Congress. RepresentativeMike Honda (D-CA) introduced the HealthcareInnovation and Marketplace Technologies Act(HIMTA H.R. 6626) on 3 December, 2012 in the112th Congress to clarify existing regulations andprovide support for entrepreneurs. The bill wouldestablish an mHealth developer support program atthe Department of Health and Human Services tohelp mobile application developers build theirdevices in compliance with current privacyregulations. It would also establish a nationalhotline, an educational website and an annual reportthat would translate privacy guidelines into commonEnglish. The legislation would include the creationof a small business loan program for clinics andphysician offices to purchase new health informationtechnologies. Tax incentives and grant programs arealso envisioned to accelerate the adoption of healthinformation technology. However, for this Act tomove forward, Rep. Honda would have to introduceit to the 113th Congress, which was sworn in on 3January, 2013.

In the EU

Although the European Medicines Agency has issuedguidance on how they intend to regulate themHealth application market, the final guidance2 on

2 EMA, MEDDEV 2.1/6, "Guidelines on the Qualification andClassification of Stand Alone Software Used in Healthcare within theRegulatory Framework of Medical Devices", 2012.

stand-alone software has a smaller scope thanproposed FDA regulations.3 For example, the FDAregulation on Medical Data Device Systems, whichdisplays, stores or transmits medical device data inits original format does not have a counterpart in EUregulation.

Furthermore, in the EU most medical apps usuallyqualify for the lowest risk class of medical devices(class 1), which involves only a small number ofregulatory requirements. Applicants receive aEuropean Conformity (CE)4-mark for a class 1 device

by registering at the competent national authoritybased on a self-declaration. They must also ensurethat the device or app complies with national dataand security laws.

Other territories including Africa, Asia-Pacific and

Latin America

Despite the emergence of regulatory frameworks inthe EU and the US, other countries face major gapsin the regulation of mobile medical applications.They either follow a model similar to the US and theEU's or some, such as China and India, do not havespecific mHealth guidelines at all.

Navigating the changing regulatorylandscape

While the regulatory environment and healthcaresystems vary from region to region, currenthealthcare industry players or new entrants can stillabide by certain principles when developing oradopting mHealth solutions, especially whenmaking an assessment in the context of the globalmarket.

The following checklist outlines basicrecommendations manufacturers (e.g., medicaldevice companies), healthcare providers and payersand developers (e.g., software and hardwaremanufacturers and telecommunication companies)

could consider when working with regulators. Thiscould be a developer or manufacturer obtainingmarket clearance for an app, or a provider or payerconsidering the viability of an approved mHealthsolution for their market.

3 FDA (2011): Draft Guidance for Industry and Food and DrugAdministration Staff - Mobile Medical Applications4CE-mark is the mandatory conformity mark for products placed on

European markets and shows manufacturer ensures that the productconforms with the essential requirements of the applicable EC directives

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Six principles for successful mHealthsolutions

PwC research has found that mHealth solutions thatembrace the following six principles have a higherlikelihood of success:

Interoperability- interoperable with othermobile/non-mobile devices to capture data and has

the ability to share that data other applications,such as electronic health records.

Integration - integrated into existing activities ofpatients and workflows of providers.

Intelligence - use the data collected and analyticsto provide real-time, qualitative solutions.

Socialisation - share information with designatedor appropriate parties to provide support, coaching,recommendations and other forms of assistance.

Outcomes - support the collection of relevantinformation for outcomes based on reimbursementmodels.

Engagement - enable and encourage patient andprovider usage to provide feedback and realise

better care outcomes.

mHealth regulatory checklist

Assess which regulatory market bestconforms to the stakeholder's businessinterests.

Ensure that the solution enhances theexisting physician and hospitalinfrastructure.

Develop a plan for greatest penetration ofmobile adoption with stakeholders.

Ensure that the solution is easy to use bypatients and physicians.

Establish a reimbursement model thatbenefits all stakeholders and encourages

patient and practitioner usage to improveoutcomes.

Confirm that the mHealth solution integrateswith current technology platforms and iscompatible with other types of relevantdevices/software.

Develop a strategy for the app to becompatible with other online retailers orecommerce solutions such as banking.

Ensure that the app follows the six principlesof interoperability, integration, intelligence,socialisation, outcomes and engagement (seesidebar).

Confirm that the app can securely transmitsensitive information, such as health patientrecords, and transactions e.g., severalmHealth apps help patients managediabetes, allowing patients to log in theirglucose and other self-care data whileproviding their physicians with access to

monitor progress.

Also ensure that the app complies with theregion's security and privacy laws.

For US applicants, confirm if the solution ordevice is in scope of the FDA's MedicalDevice Regulation. If so, submit the app tothe FDA using the 510k for apps that eitherassists in the development of clinicaldecisions for health issues or causes the appto be used as a medical device.

For EU applicants, submit the medical deviceto the national regulator using the CE-Declaration of Conformity. Also determinethe risk class of the app or medical device.

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Contacts

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This content is for general information purposes only, and should not be used as a substitute for consultation with professional advisors. PwC helps organisations andindividuals create the value theyre looking for. Were a network of firms in 158 countries with more than 180,000 people who are committed to delivering quality in assurancetax and advisory services. Tell us what matters to you and find out more by visiting us at www.pwc.com.

For a deeper discussion please contact:

mHealth Team for PwCGlobalDavid Levy, MDGlobal Health Industries Leader+1 646 471 1070david.l.levy@us.pwc.com

Michael F. SwanickGlobal Pharmaceutical and LifeSciences Industry Leader

+1 267 330 6060michael.f.swanick@us.pwc.com

Christopher Wasden, EdDGlobal Healthcare Innovation Leader+1 646 471 6090christopher.wasden@us.pwc.com

Dan DiFilippo, EdDGlobal Technology, Communicationsand Entertainment & MediaLeader+1 646 471 8426dan.difilippo@us.pwc.com

Pierre-Alain SurGlobal CommunicationsIndustry Leader+1 501 907-8085pierre-alain.sur@us.pwc.com

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+44 (0) 121 265 5901stephen.mcmillan@uk.pwc.com