FDA's Digital Health Guidelines for Safer Healthcare Innovation

1. June 6, 2019 digital Health @ FDABakul Patel

2. Effects of Moore’s Law Image Credit: Time Magazine

3. FDA Recognizes Increasing Digitization Across the Healthcare Continuum Moving healthcare from the clinic to the patient. Understanding patient’s behavior and physiology “in the wild.” Focusing on prevention for early/smaller interventions. Leveraging computing power, sensors, connectivity, and software.

4. Digital Health Team Vision Prepare the FDA for the Digital Health future by promoting innovation and ensuring all Americans have timely access to high-quality, safe and effective digital health products. ____

5. Digital Health Technology Digital health technology is the 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.

6. EmbracingDigital Health Innovation What qualifies as a digital health product? Digital tools can provide consumers with valuable health information. Consumers who are better informed about health make better decisions. What digital health technologies need regulation?

7. Goals for a Tailored Regulatory Framework Fostering Responsible Digital Health Innovation Enhance patients access to high quality digital medical products Enable manufacturers to rapidly improve software products with minor changes Maintain a reasonable assurance of safety and effectiveness Minimally burdensome

8. FDA approach to regulation of digital health products

9. A Risk-Based Approach… Increasing Risk Classification determines extent of regulatory control (Risk Based) Class III General controls Premarket approval (PMA) Class II General controls Special controls Class I General Controls • Special Controls (addressing Risk) • Guidelines (e.g., Glove Manual) • Mandatory Performance Standard • Recommendations or Other Actions • Special Labeling • General Controls • Electronic Establishment Registration • Electronic Device Listing • Quality Systems • Labeling • Medical Device Reporting (MDR) • Premarket Notification [510(k)] (unless exempt)

10. …Aimed At Smart Regulation • Risk Based • Narrowly Tailored • Functionality Focused • Platform Independent

11. Focus on Higher-Risk Functionalities Lower risk functionalities FDA does not intend to enforce applicable regulatory requirements Higher risk functionalities FDA provides appropriate oversight to ensure patient safety while support timely access to innovative products

12. Mobile Medical Apps (MMA) Focus of oversight MMA Lower risk mobile appsthat meet the definition of a medical device Mobile apps that do not meet the definition of a medical device A “Mobile Medical App” is a mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); and either is intended: • to be used as an accessory to a regulated medical device; or • to transform a mobile platform into a regulated medical device MMA Guidance Document

13. Tools available from FDA https://www.fda.gov/MedicalDevices/DigitalHealth/ucm562577.htm

14. Global Convergence    

15. 21st Century Cures Act • Codifies current policies and excludes certain software products from medical device definition: • Medical device data systems • EHR certified by ONC • General wellness products • Administrative products • Excludes certain types of clinical decision support products from the definition of a medical device. Excluded products must meet all of the following criteria: • Does not acquire or analyze physiological signals; • Is intended to display information about a patient; • Provides recommendations to physicians; and • Allows health care professionals to independently review the basis for such recommendations. For products with multiple functions, allows FDA to regulate only those functions that meet the definition of a medical device

16. FDA Pre-Cert Program An organization-based streamlined regulatory approach for Software as a Medical Device (SaMD) that relies on a demonstrated Culture of Quality and Organizational Excellence

17. Five Excellence Principles Proposed Patient Safety Demonstration of a commitment to providing a safe patientexperience, and to emphasizing patient safety as a critical factor in all decision-making processes. Product Quality Demonstration of a commitment to the development, testing, and maintenance necessary to deliver SaMD products at the highest level of quality. Clinical Responsibility 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. Cybersecurity Responsibility Proactive Culture Demonstration of a commitment to a proactive approachto surveillance, assessment of user needs, and continuous learning.

18. Our Goals For a New Model How can a pre-certification program address the evolving needs of SaMD products? Enable a tailored, pragmatic, and least burdensome regulatory oversight that • Assesses organizations to establish trust that they have a culture of quality and organizational excellence such that they can develop high quality SaMD products; • Leverages transparency of organizational excellence and product performance across the entire lifecycle of SaMD; • Uses a tailored streamlinedpremarket review; • Leverages unique postmarket opportunities available in software to verify the continued safety, effectiveness, and performance of SaMD in the real world.

19. Digital Health Center of Excellence “ We’re building our Digital Health Center of Excellence to develop more efficient ways to ensure the safety and effectiveness of technologies like smart watches with medical apps. Our Software Precertification Pilot Program is allowing us to test a new approach for product review. ” Dr. Scott Gottlieb, FDA Commissioner April 2, 2019

20. Concept: A Reimagined Approach Using FDA Pre-Cert Commercial Distribution & Real-World Use e.g. lower-risk software, certain modifications Based on SaMD Risk + Pre-Cert level Assessment effectiveness feedback FDA Pre-Cert level FDA Pre-Cert effectiveness feedback Streamlined Premarket Review Real World Data Collection Real-World Evidence Regulatory Science DH feedback Patient Preference Clinical Trials Outcomes research

21. Reimagining the Regulatory Approach While maintaining reasonable assurance of safety and effectiveness Today’s Device World (Hardware-based) Digital Health Device World (Software-Based) Leverages real world performance data Go-To-Market Shortens the timeline for premarket product review Pre-Market Organization-Level Data Pre-Market Product-Level Data Post-Market Data Adds appraisal of company’s culture of excellence

22. Get More Information www.fda.gov/digitalhealth DigitalHealth@fda.hhs.gov Bakul Patel Bakul.Patel@fda.hhs.gov Follow me on Twitter @_BakulPatel