FDA s approach to AI in healthcare: New wine in an old wineskin?

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Walter King
5 years ago
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2 Agenda st Century Cures Act 2. FDA Regulation of CDS 3. FDA s Pilot Program: Precertification Of Software Vendors 2

3 Overview: 21st Century Cures Act Sec Signed December 13, 2016 Exemptions Clawback Report Cures Act (new 520(o)) exempts from FDA regulation software used for: Administrative purposes Wellness Certified EHRs Medical Device Data Systems CDS that is transparent 520(o) gives FDA authority to clawback software for regulation. The agency must follow a notice and comment type process to find that the software would be reasonably likely to have serious adverse health consequences FDA must report to Congress every two years the agency s experience with software covered by this section 3

5 What is Clinical Decision Support? Regulated CDS is software that is: Not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system; Intended for the purpose of analyzing patient medical information or other information (such as peer-reviewed clinical studies and clinical practice guidelines); and Intended for the purpose of supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease. December 2017 FDA Proposed Guidance 5

6 Impact of 21 st Century Cures Act and FDA Guidance Unregulated CDS is CDS software that is: Intended to enable the health care professional to independently review the basis for its recommendations; o Does the professional need to be able to reach the same conclusion as the software? Not intended for the health care professional to rely primarily on the recommendations to make a clinical diagnosis or treatment decision. December 2017 FDA Guidance 6

7 New Category: Patient Decision Support Software PDS software is unregulated if: The intended patient can reach the recommendation on her own without primarily relying on the software. December 2017 FDA Guidance 7

8 2017 Industry Guidelines CDS Coalition published guidelines that set the bar for empowering healthcare professionals to review the basis for a recommendation 1 Competent decision-maker 2 Accessible information patient-specific information clinical knowledge 3 Adequate time to reflect Machine learning makes this difficult but not impossible 4 The degree to which the user will have access to information outside the software. 8

9 CDS Coalition Comments Due February 6, 2018 FDA should revise its proposal to: Base the threshold for regulation on the 2014 IMDRF risk model, i.e. o Significance of the information provided, and o State of the healthcare situation or condition Not require that the user be able to reach the same conclusion, but rather a competent conclusion on the same question Acknowledge that machine learning raises unresolved complex questions Borrow some of the detailed industry guidelines for additional guidance Develop guidance for software that guides pharmaceutical use 9

10 In the meantime Comment by February 6 Take an honest and in depth look at your product s risk Look at what FDA has regulated in the past o So far no clear evidence FDA intentionally expanding regulation Follow the statute; the CDS guidance is only a proposal Try to make your software as transparent as possible Consider the CDS Coalition guidelines at Listen for FDA reaction to comments, via speeches 10

12 Concept A Reimagined Approach Using FDA Pre-Cert 12

13 Possible framework to measure excellence Culture of Quality and Organizational Excellence (CQOE) Perspectives Organizational Resources KPI that demonstrates outcome measures in leadership, employee training, organizational support, infrastructure, employee empowerment, etc. Customer KPI that demonstrates outcome measures in revenue, marketing, suport, etc. Aggregate KPI Learning and growth KPI that demonstrates outcome measures in product support, innovation, employee training, stakeholder engagement, etc. Internal process KPI that demonstrates outcome measures in product engineering, management support, risk management commitment, efficiency, revenue, etc. Providing safe patient experience. Being clinically responsible. Delivering highest product quality. Being cybersecurity responsible. Being proactive v/s reactive. 13

14 Appraisal Model Excellence Principles Common Validating Perspectives Appraisal Questions Rationale KPIs Patient Safety Product Quality Clinical Responsibility Cybersecurity Responsibility Proactive Culture Organized Resource Perspective Customer Perspective Learning and Growth Perspective Process Perspective Organized Resource Perspective Customer Perspective Learning and Growth Perspective Process Perspective Organized Resource Perspective Customer Perspective Learning and Growth Perspective Process Perspective Organized Resource Perspective Customer Perspective Learning and Growth Perspective Process Perspective Organized Resource Perspective Customer Perspective Learning and Growth Perspective Process Perspective 14

15 Process Perspective Example Appraisal Questions Out of roughly 150 questions presently For proactive culture Is there a formal program and process to encourage a proactive corporate culture? How often are the goals and vision for a proactive culture communicated to the organization? How does your organization recognize and address potential areas for improvement related to building a proactive corporate culture? How does your organization prioritize a culture of proactivity? How are new processes aimed at encouraging proactivity integrated into employee practices and behavior? 15

16 Predicted Burdens of Participation 1. Undergo a rigorous application process that looks at the company s capabilities well beyond the quality system. 2. Report KPIs on those capabilities for the duration of the company s participation in the program. 3. Collect substantial, meaningful real-world data on the performance of your software, both clinically and operationally, and share it all with FDA. 4. Allow FDA to inspect your operations beyond inspections presently allowed by law to address these KPI areas. 16

In the meantime Stay informed; public workshop next week on January 30-31 at FDA. Recognize it is unclear how small, foreign firms would directly participate in this program.

17 In the meantime Stay informed; public workshop next week on January at FDA. Recognize it is unclear how small, foreign firms would directly participate in this program. This new approach has significant competitive implications to consider Consider an alliance with a U.S. firm that intends to qualify or consider opening a U.S. subsidiary that could qualify. Don t panic. This will take a while. 17