innovation action plan dmd patel digital health... · 2019-12-18 · narrow tailored approach to...
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INNOVATION ACTION PLANDigital Health
www.fda.gov
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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/
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Smart Regulation Principles
Risk Based
Functionality Focused
Platform Independent
Promote Innovation
Narrowly Tailored
Promote Patient
Engagement
Protect Patient Safety
www.fda.gov
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Narrow Tailored Approach to Mobile Apps
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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
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Balancing Innovation and Patient Safety with Foundational Policies
www.fda.gov
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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
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Unique Aspects of Digital HealthCurrent Regulatory Paradigm
Rapidly Evolving Situation
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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
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An Opportunity to Foster Digital Health Innovation and Further Public Health
Considering current FD&C act authorities and
implementing regulations
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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)
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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
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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.
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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
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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
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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
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• Provide Technical Expertise• Coordinate center-wide DH
efforts• Training• Outreach• Develop DH Policies • Participate in creating a New
Paradigm
Roles and ResponsibilitiesExpertise Areas