INNOVATION ACTION PLANDigital Health

www.fda.gov

2

Digitization Across the Health Care Continuum

www.fda.gov

Leveraging computing power, sensors, connectivityand 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.

3www.fda.govDigital health, biotech and medical device trends 2017, CB Insightshttp://healthstandards.com/blog/2017/10/25/digital-health-trends-2025/

4

Smart Regulation Principles

Risk Based

Functionality Focused

Platform Independent

Promote Innovation

Narrowly Tailored

Promote Patient

Engagement

Protect Patient Safety

www.fda.gov

5

Narrow Tailored Approach to Mobile Apps

5

No regulatory requirements

• Patient self-management apps• Tools to organize and track their health

information (not for treating or adjusting medications)

• Tools to access to health information document and communicate with health care providers

• Tools that automate simple health care providers tasks

Not Subject to Enforcement

Mobile apps not considered

“medical devices”

MMA

Lower risk mobile apps that

meet “device” definitionbut not considered “MMA”

Mobile apps that meet “device” definition that are either intended• To be used as an accessory to

already regulated medical device, or

• To transform a mobile platform into a regulated medical device.

focus of oversight

6

Balancing Innovation and Patient Safety with Foundational Policies

www.fda.gov

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7

Leading International Convergence effort on Software as a Medical Device (SaMD)

IMDRF goal - a converged SaMD framework and associated controls.

www.fda.gov

A prioritized building blocks

strategy

8

Unique Aspects of Digital HealthCurrent Regulatory Paradigm

Rapidly Evolving Situation

8

Premarket timeline suited for hardware based products

software development timelines + software development practices + rapid iterations

Deterministic risks, known responsibilities, physical products

Emerging issues – (cybersecurity; distributed responsibilities, non-physical products)

Potential for exponential increase in volume of submissions

Program capacity manages – 3,500 510(k) submissions / 2200 pre-submissions

9

An Opportunity to Foster Digital Health Innovation and Further Public Health

Considering current FD&C act authorities and

implementing regulations

10

21 Century Cures Act – Codifies FDA PoliciesAmended the definition of “device” in the Food, Drug and Cosmetic Act to exclude certain software functions intended...

FDA Policies affected/codified

www.fda.gov

Administrative Functionality

(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;

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

(A) for administrative support;

FDA Policy for Low risk general wellness products

Health Management functionality

Policy for Clinical Decision Support Software included in

Health Management functionality

Medical Device Data System

(MDDS)

11

A Framework for Software as a Medical Device (SaMD)

www.fda.gov

Categorization Based on definition statement

SaMD definition statement:• Criticality of Context• Significance of recommendation

2

31

12

Pathway for Continuous Learning Leveraging Real World Performance Data

SaMD manufacturers are encouraged to leverage SaMD’s technology capability to capture real world performance data to understand user interactions with the SaMD, and conduct ongoing monitoring of analytical and technical performance to support

future intended uses.

1. Additional clinical data is gathered.

2. The data may create and support new intended use(s).

3. The SaMD manufacturer will update the clinical evaluation and generate a new definition statement.

4. Then the cycle repeats.

13

Digital Health Innovation Action Plan

www.fda.gov

Revise regulations for products that are not devices post 21st Century Cures

Building bench strength and expertise

Explore new streamlined pathway for software

Refine policies & provide guidance

An Integrated ApproachIssue guidance conforming to software

provisions of the 21st Century Cures legislation

Launch an innovative pilot Precertification (Pre-Cert) program to build a new

approach to digital health technology, working with our customers and leveraging

internationally harmonized principles for software regulation

Build Digital Health unit with right technical expertise

Launch digital health Entrepreneurs-in-Residence program for building the new

paradigm

#FDAPreCert 14www.fda.gov

FDA Pre-Cert Program

An organization-based streamlined regulatory approach

for Software as a Medical Device

that relies on a demonstrated Culture of Quality and Organizational Excellence

15

FDA Pre-Cert Concept

www.fda.gov

Clinical Trials

Outcomes research

Commercial Distribution &

Real-World Use

e.g. lower-risk software, certain modifications

Real World Data

Collection

Based on SaMD Risk +

Pre-Cert levelStreamlined Premarket

Review

FDA Pre-Cert level

#FDAPreCert 16

All of our work stems from five Excellence Principles

Demonstration of a commitment to providing a safe patientexperience, and to emphasizing patient safety as a critical factor in all decision-making processes.

Demonstration of a commitment to the development, testing, and maintenance necessary to deliver SaMD products at the highest level of quality.

Demonstration of a commitment to responsibly conduct clinical evaluation and to ensure that patient-centric issues including labeling and human factors are appropriately addressed.

Demonstration of a commitment to protect cybersecurity, and to proactively address cybersecurity issues through active engagement with stakeholders and peers.

Demonstration of a commitment to a proactive approach to surveillance, assessment of user needs, and continuous learning.

Patient Safety

Product Quality

Clinical Responsibility

Cybersecurity Responsibility

Proactive Culture

www.fda.gov

#FDAPreCert 17

2018 2019

Pre-Cert Program Roadmap

JanDec

www.fda.gov

Dec

Jan

Build - Test - Iterate Integrate Pre-launch Launch

18

OCD DH Unit - Expertise Requirements and Expectations

1. Software Life Cycle Management Processes

2. Mobile Medical Application3. Interoperability4. Cybersecurity5. Wireless6. Cloud7. Machine Learning/Artificial

Intelligence

18

• Provide Technical Expertise• Coordinate center-wide DH

efforts• Training• Outreach• Develop DH Policies • Participate in creating a New

Paradigm

Roles and ResponsibilitiesExpertise Areas