Digital Health Initiatives at FDA

Heather Agler, Ph.D.Senior Science Health AdvisorInnovation Program, EMCM

Office of the Center Director/CDRH/FDA

FDA Update December 12, 2017

Digital Health - a convergence of people, information, technology and

connectivity in healthcare

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What is included in Digital Health

• Mobile Platforms

• Interoperability

• Cybersecurity

• Telemedicine

• Advanced Analytics

• Software

• Wireless

• Machine Learning

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Why do we talk about it?

• Transforming society– Cell phone usage

• 77% of US adults have smartphone*• Phone ownership

– Broadband availability• 73% of American adults have a high-speed broadband connection at

home**

– Technology ownership• >75% own a computer*

– Information Sources• Social Media• Online publications

* http://www.pewinternet.org/fact-sheet/mobile/** http://www.pewresearch.org/data-trend/media-and-technology/internet-penetration/

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Digital Health Technologies

• Have potential to:

– Get to market faster

– Provide innovative care paradigms

– Support chronic disease management

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FDA Mission

• The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

• FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

• FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

• FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

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CDRH• In keeping with our mission, the Center for Devices and Radiological

Health (CDRH) is responsible for protecting and promoting the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

• We seek to continually improve our effectiveness in fulfilling our mission by planning strategically and regularly monitoring our progress.

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Innovation

• In Indications

– New device, new treatment, new diagnostic, new patient population

• In Implementation

– Smaller, battery powered, user interface, new platform

• Both can be facilitated by digital technology

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FDA Digital Health Approach

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Risk Based

Narrowly Tailored Approach

Functionality Based

Platform Independent

Promote Innovation

Patient-Centric

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21 CENTURY CURESSEC. 3060. CLARIFYING MEDICAL SOFTWARE REGULATIONDraft Guidance, “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act,” published on Dec 8, 2017

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Impact to device definition

The new law amended the definition of “device” in the Food, Drug and Cosmetic Act to exclude certain software functions intended...

• (A) for administrative support;

• (B) for maintaining or encouraging a healthy lifestyle;

• (C) to serve as a electronic patient records;

• (D) for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results and certain other related information; and

• (E) to provide recommendations to health care professionals for clinical decisions, where the user can independently review the basis of the recommendation.

Interpretation of A through D in new guidance. Part E covered in a separate guidance

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Affected FDA Guidances

Upon finalization, the concepts detailed in the draft guidance will also be made to the following

guidance documents:

• General Wellness: Policy for Low Risk Devices, available at

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDoc

uments/ucm429674.pdf

• Mobile Medical Applications, available at

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDoc

uments/ucm263366.pdf

• Off-The-Shelf Software Use in Medical Devices, available at

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDoc

uments/ucm073779.pdf

• Medical Device Data Systems, Medical Image Storage Devices, and Medical Image

Communications Devices, available at

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDoc

uments/ucm401996.pdf

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Impact to Oversight

• Multiple Functions

– Defined by 21 Century Cures as product with:

• At least one function meets the definition of a device

• At least one function that does not meet the definition of a device

– FDA oversight will only focus on device function unless non-device function has an impact on the device function

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Policy Impact

• Modifies device definition to embrace technological advances

• Codifies what was typical practice

• Guidance forthcoming on impact of 21 Century Cures

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MOBILE MEDICAL APPLICATIONS (MMA) GUIDANCE DOCUMENTPublished Feb 9, 2015Available here: https://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf

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Mobile Medical App

A “Mobile Medical App” is a software application that can be executed (run) on a mobile platform (i.e. mobile app) that meets the definition of device, and is either intended to:

• be used as an accessory to a regulated medical device; or

• transform a mobile platforminto a regulated medical device.

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MMA’s Intended Use

The intended use of a mobile app determines whether it meets the definition of a device. As stated in 21 CFR 801.4, intended use may be shown by labeling claims, advertising materials, or oral or written statements by manufacturers or their representatives

In general, if a mobile app is intended for use in performing a medical device function (i.e. for diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease) it is a medical device, regardless of the platform on which it is run

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Functionality focused

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Mobile Medical Apps

• Guidance issued Feb 9, 2015 https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf

• Focuses only on traditionally regulated functionality

• Identifies types of apps that FDA does not intend to enforce regulatory requirements

• Clarifies what is not a device –(Outside of FDA’s Jurisdiction)

Mobile apps not

considered

“medical devices”

MMA

Lower risk

mobile apps that

meet “device” definition

but not considered “MMA”

Mobile Medical

Apps

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Policy Impact

• Encourages use of digital health technology by providing CDRH view of appropriate level of oversight

• Clarifies platform independence

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MMA Examples on our Website• More information on MMA website:

https://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/ucm255978.htm

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MEDICAL DEVICE DATA SYSTEMS

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Medical Device Data System (MDDS)Original Definition (2011)

MDDS is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices:

– The electronic transfer of medical device data;

– The electronic storage of medical device data;

– The electronic conversion of medical device data from one format to another format in accordance with a preset specification;

– The electronic display of medical device data.

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MDDS and the 21 Century Cures Act

Section 3060 (a)(o)(1)(D) amends the Food, Drug, and Cosmetic Act (FDCA) to exclude from the definition of a “device” software intended

‘‘for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device, unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, and findings;

Following the 21st Century Cures Act functionality that meets the definition of MDDS will NOT be considered medical devices

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Policy Impact

• Encourages seemless sharing of data by removing regulatory burden

• Guidance forthcoming on impact of 21 Century Cures

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GENERAL WELLNESS

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General Wellness Devices

• Final Guidance Published July 29, 2016– Defines General Wellness Products as those which meet the

following two factors:• Intended for only general wellness use• Present a very low risk to users safety

– https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM429674.pdf

• Proposes a policy that- Does not intend to examine low risk general wellness products

to determine whether they are “devices” within the meaning of the FD&C Act, or

- If they are “devices”, FDA does not intend to enforce compliance to regulatory requirements for devices under the FD&C Act

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General Wellness vs Actively Regulated Medical Device

General Wellness Devices Actively Regulated Medical Device

Intended for health and wellness Intended for medical purpose

Very Low Risk Low to high risk

May or may not meet the definition of a device

Meets the definition of device

May include a disease-related general wellness claim that contains references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition.

May make disease-related claim and medical claim with appropriate performance testing

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Devices with Wellness claims following 21 Century Cures Act

• Section 3060 (a)(o)(1)(B) amends the Food, Drug, and Cosmetic Act (FDCA) to exclude from the definition of a “device” software that meets the following:

‘‘(B) for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition

Following the 21st Century Cures Act any product that meets the above definition will NOT be

considered a medical devices

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Wearable Technologies

32https://hbr.org/2016/11/simple-digital-technologies-can-reduce-health-care-costs

ACRP Blog, Nov 2016

Nearly 98% of clinical research professionals

plan to use digital technologies to collect

patient data within the next five years…

https://www.acrpnet.org/2016/11/22/survey-digital-tech-use-clinical-trials-concerns-remain/

http://jamanetwork.com/journals/jamacardiology/article-abstract/2566167

JAMA Cardiology, Oct 2016

Nov 2016

IfHow

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Summary

• Wearable Technology may qualify as a medical device depending on the indications

• FDA is committed to establishing policies for digital health and wearable technology that promote innovation while maintaining patient safety

• FDA has resources available to help determine if and how products are regulated

• Never too early to seek FDA input

– Pre-submission– 513(g)– Call or email us!

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INTEROPERABLE MEDICAL DEVICES AND CYBERSECURITY

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Medical Device Interoperability

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FDA’s Involvement in Medical Device Interoperability

FDA hosted the Second Meeting of the Medical Device PNP Interoperability Project

Recognized a set of standards that supports Interoperable Medical Devices

FDA, CDC, NLM, ONC, and CMS Workshops on Promoting Semantic Interoperability of Lab Data

2004

2013

2015

2016

Draft Guidance 2017

Final Guidance

2012

FDA/AAMI Summit on Medical Device Interoperability

2010

FDA/Continua/CIMIT Medical Device Interoperability Workshop

PNP: Plug-and-PlayCIMIT: Consortia for Improving Medicine with Innovation and TechnologyAAMI: Association for the Advancement of Medical Instrumentation CDC: Centers for Disease ControlNLM: National Library of MedicineONC: Office of the National CoordinatorCMS: Center for Medicare and Medicaid Services

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Purpose of the Guidance

• To promote the availability of safe and effective interoperable medical devices.

• To provide considerations to use in the development and design of interoperable medical devices.

• To clarify the contents to submit in a pre-market submission to support interoperable medical devices.

• To provide recommendations for labeling.

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Consider the Following When Designing a Device to be Interoperable

• What is the purpose of the interface? How is the interface meant to be used?

• Who are the anticipated users of the interface?

• Have foreseeable risks been mitigated (ex. inappropriate access).

• Has the interface specification been tested/verified and shown that it performs as intended.

• Is there appropriate labeling?

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FDA Pre-Market Recommendations

• Encourage manufacturers to provide information on their electronic data interfaces so that users or other devices can use them properly.

• Provide appropriate labeling.

• FDA recognizes there are different levels of risk based upon the device type, the interoperable scenario, and the clinical application.

• FDA is trying to find ways to balance our regulatory oversight with encouraging innovation, without overlooking the overall goal.

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Balancing Innovation with Security

Interoperability

Remote Monitoring

Wireless Monitoring

Telemedicine

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FDA Cybersecurity Work Products

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FDA’s Approach to Cybersecurity

Executive OrdersFDA Safety CommunicationDraft Premarket GuidanceBegin Coordination with DHSRecognize StandardsEstablish Incident Response Team

Final Premarket GuidanceMOU with NH-ISACPublic Workshop

Product-Specific Safety CommBuild Ecosystem/Collaboration

2013

2014

2015

2016

Draft and Final Postmarket GuidancePublic WorkshopMOU with NH-ISAC/MDISS

2017

2005: Issued guidance 2008: Halpern, et.al. 2009: Issued safety communication2011: “Hacking” of implantable insulin pump (Radcliffe)2012: First recall of vulnerable software (Roche - PC Anywhere)2013: Recall of TNS-listener (Roche)

Product-Specific Safety Comm

1st Cybersecurity WL

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Premarket Cybersecurity Guidance

• Published in October 2014

• Key Principles:– #1 Shared responsibility between stakeholders, including

health care facilities, patients, providers, and manufacturers of medical devices

– #2 Address cybersecurity during the design and development of the medical device

– #3 Establish design inputs for device related to cybersecurity, and establish a cybersecurity vulnerability and management approach as part of the software validation and risk analysis that is required by 21 CFR 820.30(g)

www.fda.gov

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Published in December 2016

Key Principles:

• Use a risk-based framework to assure risks to public health are addressed in a continual and timely fashion

• Articulate manufacturer responsibilities by leveraging existing Quality System Regulation and postmarket authorities

• Foster a collaborative and coordinated approach to information sharing and risk assessment

• Align with Presidential EOs and NIST Framework

• Incentivize the “right” behavior

www.fda.gov

Postmarket Cybersecurity Guidance

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Key Messages

▪ Implement a proactive, comprehensive risk management program

▪ Apply the NIST voluntary cybersecurity framework

▪ Establish and communicate processes for vulnerability intake and handling

▪ Adopt a coordinated disclosure policy and practice

▪ Deploy mitigations that address cybersecurity risk early and prior to exploitation

▪ Engage in collaborative information sharing for cyber vulnerabilities and threats

www.fda.gov

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SOFTWARE MODIFICATIONS GUIDANCE

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Software ModificationsPolicy Overview

• Most changes to improve Cybersecurity will NOT require new 510(k)

• Most changes to return a device to specifications will NOT require new 510(k)

• Changes that do not significantly impact safety or effectiveness do NOT require new 510(k)

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Policy Impact

• Encourages cybersecurity vigilance

• Provides risk-based framework for assessing software modifications

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RECENTLY RELEASED GUIDANCESDraft Guidance published on December 8, 2017, “Clinical and Patient Decision Support Software.” https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM587819.pdf

Final Guidance published on December 8, 2017, “Software as a Medical Device (SAMD): Clinical Evaluation.” https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm524904.pdf

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CLINICAL AND PATIENT DECISION SUPPORT SOFTWARE

Draft Guidance published on December 8, 2017, “Clinical and Patient Decision Support Software.” https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM587819.pdf

Clinical Decision Support (CDS) software functions that meet the following criteria from Section 520(o)(1)(E) of the FD&C Act are by definition not considered a device:

1) Not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system;

2) intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information;

3) intended for the purpose of supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition

4) intended for the purpose of enabling such health care professional to independently review the basis for such recommendations…

However, CDS that does not satisfy #4 would still be considered a medical device.

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CLINICAL AND PATIENT DECISION SUPPORT SOFTWARE

Patient Decision Support (PDS) software is defined the same as CDS except that the software is intended for patients or caregivers instead of healthcare professionals.

• FDA intends to adopt an enforcement discretion policy for PDS that generally parallels the CDS for health care professionals excluded from the device definition under section 351520(o)(1)(E) of the FD&C Act. Meaning that the software would satisfy all 4 criteria.

The intended user should be able to reach the recommendation on his or her own without primarily relying on the software function

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CLINICAL AND PATIENT DECISION SUPPORT SOFTWARE

In Summary, this draft guidance:

• Clarifies the types of clinical decision support software that would be regulated by the Agency, post-21st Century Cures Act.

• Explains enforcement discretion for lower-risk decision software that is intended to be used by patients or caregivers, known as patient decision support software.

• Provides examples of each type.

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SOFTWARE AS A MEDICAL DEVICE (SAMD): CLINICAL EVALUATION

Final Guidance published on December 8, 2017, “Software as a Medical Device (SAMD): Clinical Evaluation.” https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm524904.pdf

• This guidance adopts the internationally converged principles agreed upon by the IMDRF

• This guidance does not provide recommendations for FDA Staff and Industry to apply to specific regulatory situations, nor does it modify current regulatory expectations, including those for regulatory submissions.

• It adopts an overall risk based approach for analyzing and assessing SaMD.

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Determining Classification and Regulatory Requirements

• Device Regulations– 21 CFR parts 800-898

• FDA Web site including– Product Classification Database (Classification DB)– 510(k) Clearance Database (510k)– Device Guidance Documents (Guidance)

• 513(g)– Written request for agency’s views about the classification and

regulatory requirements that may be applicable to your device– http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidan

ce/GuidanceDocuments/ucm209841.htm

Never too early to seek FDA input

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Where to go for helpGeneral Questions:

– FDA Medical Device website (www.fda.gov/medicalDevices/)• Guidance Documents• Public information on cleared or approved devices• Regulations

– Heather.Agler@fda.hhs.gov

Division of Industry and Consumer Education (DICE)▪ If you have a question – Email: DICE@fda.hhs.gov▪ Phone 1(800) 638-2014 or (301) 796-7100 (Live Agents 9am – 4:30pm EST)Web Homepage:http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ContactUs--

DivisionofIndustryandConsumerEducation/default.htm

Digital Health related questions

– DigitalHealth@fda.hhs.gov

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Questions?