www.fda.gov/digitalhealth

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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)

October 19, 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

Digital Health Center of Excellence Operations

• Regulatory submissions 

support

• Policy Implementation 

and intelligence

• Identify and develop 

staff training

• Access to digital health 

experts

• Software as a Medical 

Device

• Artificial Intelligence / 

Machine Learning

• Software Policies under 

21st Century Cures Act

• Standards and best 

practices

DIGITAL HEALTH 

CENTER OF 

EXCELLENCE

Unified and collaborative environment; 

applying best practices, conducting research, 

support, training for digital health technologies.

Supplementing bench strength @ FDA

• Reimagining a new 

regulatory paradigm

• Interoperability

• Harmonization through 

IMDRF

• Industry partnership

• Academic partnership

• Federal partnerships: 

POLICY & TECH 

SUPPORT POLICY 

DEVELOPMENT

STRATEGIC 

INITIATIVES

STRATEGIC 

PARTNERSHIP

DHCOE 

OPERATIONS

• Governance, operations

• CDRH DHSC

• FDA Digital Health 

Advisory Board

• Regulatory Research / 

Science coordination

• Strategy alignment and 

coordination
www.fda.gov/digitalhealth 11

Functions Resources coordinated by Digital Health Center of Excellence

Dedicated DHCoE Resources + Virtual DHCoE Resources

• Policy development and support

• DH inquiries

• Submission support

• Guidance/Policy Development

DH Policy Development/ support

• Submission support

• Wearables

• Software development practices

• Software and digital health standards 

• External engagement

DH Technology Support

• Pre-Cert

• Wearables

• Interoperability

• Digital Biomarkers

Regulatory innovation/Strategic initiatives

• Internal: Steering Committee, Advisory Group

• External: collaborations and partnerships

DHCoE Operations & Coordination/ Partnerships

• Policy development and support

• IMDRF collaborations

• External engagement/ collaboration

AI/ML in medical products

• Policy development and support

• IMDRF collaborations

• External engagement/ collaboration

Medical Device Cybersecurity

• Digital Pathology

• Patient-Generated Data

• Virtual Reality/Augmented Reality

Advancing Regulatory Science

• Day – day review support

• Implement DH policies

• Training to front line review

• Implement competency tiers

Regulatory review support

• Case for Quality (Software in Manufacturing)

• Software used to manufacture medical device

• Digital Twin

• Clearinghouse

Advanced Manufacturing

• In silico modeling

• Use of RWE in DH devices 

• RWE from digital health technology

Advanced clinical studies and RWE
www.fda.gov/digitalhealth 12

Concept of Operations

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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 13

Digital Health Center of Excellence Services
www.fda.gov/digitalhealth 14

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 15

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 16

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 17

Current Areas of Focus

Software as a 

medical device 

(SaMD)

Artificial 

Intelligence/ 

Machine Learning

Wearables

Software in a 

medical device 

(SiMD)

Wireless 

Connectivity

Interoperability Medical Device 

Cybersecurity

Virtual Reality/

Augmented 

Reality

Real-world 

Evidence and 

Advanced Clinical 

Studies

Advanced 

Manufacturing

Patient-Generated 

Data Digital Biomarkers Digital Pathology
www.fda.gov/digitalhealth 18

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 19

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

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