www.fda.gov/digitalhealth

Welcome to today’s 

FDA/CDRH Listening Session

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www.fda.gov/digitalhealth

Digital Health Center of Excellence (DHCoE) 

Listening Session

Bakul Patel, MSEE, MBA

Director, Digital Health 

Center for Devices and Radiological Health (CDRH)

November 12, 2020
www.fda.gov/digitalhealth 3

Objectives

• Provide an overview of the FDA’s Digital Health Center of 

Excellence (DHCoE)

– Goals

– Outcomes

– Areas of Focus

– Roadmap

• Opportunity to gain insight and input from stakeholders as the 

Digital Health Center of Excellence is built and begins to 

prioritize efforts while maintaining standards of safety and 

effectiveness
July, 2020

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www.fda.gov/digitalhealth

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Digital Health

The convergence of connectivity, data and computing power for healthcare and 

related uses across the life of an individual or a patient.

Leveraging computing power, sensors, connectivity and software

Moving health care from 

the Clinic to the 

Patient

Understanding patient’s 

behavior and physiology 

“In the wild”

Focusing on prevention for 

early/smaller 

interventions

Healthy living Prevention Diagnosis Treatment Recovery Home care
Digital Health Technology

Convergence of 

computing power, 

connectivity, sensors, 

and software used in 

healthcare.

Used as a medical product

Incorporated into a medical product 

(include a pharmacologic product)

Used to develop a medical product

Used to study a medical product

Used as a companion or adjunct to a medical product, 

including diagnostics and therapeutics.

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Healthy living Prevention Diagnosis Treatment Recovery Home care Management
Why a Digital Health Center of Excellence?

• Part of the planned evolution of the digital 

health program

• Intent to 

• Drive synergy for digital health efforts

• Align strategy with implementation

• Prepare the FDA for the digital health 

future

• Protect patients and maintain the FDA 

standards of safety and effectiveness

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www.fda.gov/digitalhealth

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Develop novel, 

efficient regulatory 

approaches that are 

least burdensome

Connect

Build partnerships, 

new networks to 

accelerate and scale

Share

Gather, simplify, and 

share information to 

increase awareness 

and understanding 

FDA’s Digital Health Center of Excellence

Empowering All to Advance Healthcare

Our goal: Empower stakeholders to advance health 

care by fostering responsible and high-quality 

digital health innovation that meets FDA standards 

of safety and effectiveness.

The Digital Health Center of Excellence aims to: • Connect and build partnerships to accelerate 

digital health advancements.

• Share knowledge to increase awareness and 

understanding, drive synergy, and advance best 

practices.

• Innovate regulatory approaches to provide 

efficient and least burdensome oversight.
www.fda.gov/digitalhealth 9

Anticipated Outcomes

• Strategically advance science and evidence for digital

health technologies that meets the needs of

stakeholders.

• Efficient access to a highly specialized expertise,

knowledge, and tools to accelerate access to digital

health technology that maintain standards of safety and

effectiveness.

• Aligned regulatory approach to harmonize international

regulatory expectations and industry standards.

• Increased awareness and understanding of digital health

trends.

• Consistent application of digital health technology policy

and oversight approaches.

• Reimagined medical device regulatory paradigm tailored

for digital health technologies.
www.fda.gov/digitalhealth 10

DHCoE Functional Areas Coordinated by Digital Health Center of Excellence

Dedicated functions + Virtual functions 

Regulatory 

Innovation/Strategic 

Initiatives

• Pre-Cert

•Wearables

• Interoperability

•Digital Biomarkers

DH Technology Support

• Submission policy support

• Wearables

• Software development practices

• Software and digital health standards 

DHCoE Operations & 

Coordination/Partnerships

• Internal: Steering Committee, 

Advisory Group

• External: collaborations and 

partnerships

DH Policy Development/ 

Support

• Policy development and support

• DH inquiries

• Guidance/Policy development

• Submission support

AI/ML in Medical Products

• Policy development and 

support

• IMDRF collaborations

• External engagement/ 

collaboration

Advancing Regulatory 

Science

• Digital Pathology

• Patient-Generated Data

• Virtual Reality/Augmented Reality

Advanced Manufacturing

• Case for Quality (Software in 

Manufacturing)

• Software used to manufacture 

medical device

• Digital twin for manufacturing

Regulatory Review Support

• Day – day review support for OHTs

• Implement DH policies

• Training for reviewers

• Implement competency tiers

Advanced Clinical Studies 

and RWE

• In silico modeling

• Use of RWE in DH devices 

• RWE from digital health 

technology

Medical Device 

Cybersecurity

• Policy development and support

• IMDRF collaborations

• External engagement/ 

collaboration

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www.fda.gov/digitalhealth 11

Concept of Operations

CDRH Digital Health 

Steering Committee

Objectives:

• Provide input to DH Policy

agenda

• Provide input to Horizon

scanning

• Align External partnerships

agenda

• Provide input to regulatory

science agenda

FDA DH Advisory Group 

Objectives:

• Provide Advice to DHCoE

• Identify common interest topics

• Develop FDA regulatory science

agenda

• Identify and staff strategic

partnerships

Aligning strategies 

Within FDA

Aligning strategies 

Within CDRH

Coordinating DH efforts

DHCoE Operations &

Coordination/ 

Partnerships

Dedicated DHCoE Resources

Regulatory 

Science and 

Research

Regulatory 

Review support

Advanced 

Manufacturing

RWE and 

Advanced clinical 

studies

Medical Device 

Cybersecurity

DH Policy 

support

DH Technology 

Support

Regulatory 

innovation 

/Strategic 

initiatives

Virtual DHCoE Resources

AL/ML in medical 

products 
www.fda.gov/digitalhealth 12

Digital Health Center of Excellence Services
www.fda.gov/digitalhealth 13

Digital Health Center of Excellence Services

 Set and lead strategic direction in digital health

 Launch strategic initiatives

 Establish and promote best practices 

 Enable efficient, transparent, and predictable product review with 

consistent evaluation quality 

 Build new capacity to oversee and leverage DH technologies

 Create more shared resources

 Coordinate the development of cross cutting DH policies
www.fda.gov/digitalhealth 14

Digital Health Center of Excellence Services

 Provide scientific expertise across the Agency

 Offer training opportunities for FDA staff

 Disseminate shared resources

 Foster collaboration across FDA in common interest areas

 Facilitate synergies in regulatory science research in digital health

 Leverage, share, and avoid duplication of work

 Promote and showcase existing work at the Centers
www.fda.gov/digitalhealth 15

Digital Health Center of Excellence Services

 Provide clarity on regulation

 Advance international harmonization on device regulatory policy

 Facilitate and build strategic partnerships

 Communicate FDA research interests 

 Advance digital health device international standards
www.fda.gov/digitalhealth 16

Phase I: Communication

Fall 2020

• Stakeholder Listening Sessions

• Update and develop resources for

FDA staff

• Begin operationalizing the DHCoE

and outcome measurement

• Amplify current work being done at

FDA in digital health

Phase II: Coordinate

Fall and Winter 2020

• Build strategic partnerships for

policy, regulatory science, and

fellowships

• Develop resources for external

stakeholders

• Create a digital health community

of practice

• Assemble FDA and CDRH advisory

groups

Phase III: Amplify

Winter 2021 onwards

• Continued strategic partnership

building and communication

• Update and implement regulatory

framework for digital health

• Harmonization with other regulators

Following is our roadmap for bringing the benefits of digital health 

to all Americans, efficiently and collaboratively:

Raise Awareness and 

Engage Stakeholders

Build Partnerships 

Build and Sustain 

Capacity

Digital Health Center of Excellence Roadmap
www.fda.gov/digitalhealth 17

Further Questions or Feedback

DigitalHealth@fda.hhs.gov 

www.fda.gov/digitalhealth

Bakul Patel, Director of Digital Health Center of Excellence / Division of Digital Health

Bakul.Patel@fda.hhs.gov

Anindita Saha, Senior Advisor for Digital Health (detail)

Anindita.Saha@fda.hhs.gov

Center for Devices and Radiological Health, U.S. Food and Drug Administration

Slide Presentation, Transcript and Webinar Recording will be available at:

http://www.fda.gov/training/cdrhlearn Under the Heading: Specialty Technical Topics; Sub heading: IT and Software

Please complete a short survey about your FDA CDRH webinar 

experience. The survey can be found here

immediately following the conclusion of the live webinar
www.fda.gov/digitalhealth 18

Panelists

Topics for Discussion: Collaboration and Goals

Panelists (in alphabetical order):

• Amy Abernethy, MD, Ph.D., Principal Deputy Commissioner, FDA

• Ray Dorsey, MD, MBA, David M. Levy Professor of Neurology and Director of the Center for Health

+ Technology, University of Rochester Medical Center

• Jesse Ehrenfeld, MD, MPH, Board of Trustees, AMA

• Rob Kowalski, Pharm.D., EVP, Head of Regulatory Affairs and US Head of Development, Novartis

• Leslie Saxon, MD, Professor of Clinical Medicine, Keck School of Medicine of USC

• Nilay Shah, Ph.D, Co-Lead, Yale University-Mayo Clinic CERSI

Moderator: Bakul Patel, MSEE, MBA, Director, Digital Health Center of Excellence, FDA