AI/ML Regulatory Masterclass from Orthogonal, UCLA Biodesign and HealthXL

Bernhard Kappe
Bernhard Kappe

Event Description:

For over 10 years, Artificial Intelligence (AI) and Machine Learning (ML) have been radically impacting every industry. Yet it still sometimes seems like it should be so difficult to bring AI and ML to market as a component of FDA-regulated medical devices. Given how deep AI has penetrated into many other industries outside of MedTech, this begs a few questions:

  • What does it require to achieve regulatory approval for innovative and transformational AI/ML in Software as a Medical Devices (SaMD), digital therapeutics (DTx) and connected medical devices in the US? 
  • What recommendations would you make to the FDA to help advance the regulation and adoption of learning and non-learning AI?
Orthogonal-HealthXL-Biodesign Program

Orthogonal in partnership with UCLA Biodesign and HealthXL will be leading an executive Masterclass and roundtable discussion of experts in HeatlhXL’s Member Community to discuss and develop solutions to the following questions:

  • What are the best and worst practices for obtaining FDA regulatory approval for AI/ML SaMD?
  • What are the crossroads between guidance documents versus company-specific FDA requirements for companies to attain regulatory decisions for AI/ML? 
  • How should learning algorithms be regulated in comparison with non-learning algorithms? 
  • If AI/ML SaMD companies were given responsibility to develop guidance documents for learning algorithms, what would be the contents of those guidance document?s

The discussions and insights gathered in this Masterclass (which is only open to HeathXL Community Members) will help inform UCLA Biodesign’s major industry study on regulation and reimbursement in the MedTech and Digital Health industry. For this landmark study, UCLA Biodesign’s Jennifer McCaney and Christian Johnson are creating benchmarks and analysis for these kinds of questions:

  • How long does it really take innovations to get to market?
  • Do digital health and AI/ML have a clear path to market?
  • Is breakthrough designation breaking down regulatory barriers to access?
  • Is reimbursement the new barrier to innovation?
  • Is the U.S. keeping pace with Europe, Japan, and China?
  • What is next on the regulatory and reimbursement horizon?

Interested in Attending?

Regulation of AI and AI/ML Software as a Medical Device Masterclass UCLA

If you are interested in attending and are already a HealthXL Community Member, click here to register. If you are not already a HealthXL member, you can follow the same link to learn more about HealthXL and express your interest in this event service.

Any insights you provide during this roundtable will inform the study, but will also remain fully anonymous.

As an added bonus, by participating in this Masterclass, you will receive an informal sneak preview of this important study.

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