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FDA Regulation of Digital Health and AI
Intro: Israel is a world-leader in digital health innovation, with many machine learning products being developed annually. However, artificial intelligence (AI) and digital health present many unique, regulatory questions. Given by a former FDA reviewer, this course focuses on digital health products:
- regulatory framework
- summarizes FDA’s key guidance documents on this topic
- Clarifies how to meet FDA’s current expectations...Continue reading
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Issues to be covered
FDA regulation of digital health and artificial intelligence
- What digital health means to the FDA
- How FDA regulates digital health products
- Regulation of software and addressing cybersecurity
- Summary of key guidance documents
- Regulation of Computer-aided detection (CAD) software
- FDA’s points of focus for devices that use AI
Who should attend
- Regulatory affairs professionals and decision makers (such as CEOs, CTOs, founders, etc.
- Everyone who is involved with digital health products that are intended to be marketed in the US
Benefits to the Participants
Goals: After this course, the participant should understand:
- when FDA does and does not actively regulate a digital health product,
- the regulatory framework when digital health is regulated, and
- Current FDA requirements for software validation and cybersecurity
- FDA expectations for CAD software validation
- FDA’s points of focus for devices that use AI
About The Lecturer
