Over The Counter 7 Aug 2023: What Happens To Software As A Medical Device Under The EU AI Act? With Bristows’ Jamie Hatzel
Executive Summary
In the second part of HBW Insight’s interview with Bristows' digital health regulatory expert Jamie Hatzel, we talk about artificial intelligence. Hatzel discusses what happens to Software as a Medical Device within the incoming EU artificial intelligence legislation, which has now entered trilogue negotiations. Issues such as the meaning of “high risk” within the proposed AI Act, in contrast to its meaning in the existing Medical Device Regulations, highlight the importance for manufacturers in this space, or thinking about entering it, of getting good advice, Hatzel points out.
Further Reading
EU AI Act Proposal Adopted By Parliament In Landslide Plenary Vote
Artificial Intelligence In Consumer Health: Reality, Challenge And Opportunity
Bayer Consumer Health’s Evendon-Challis On The ‘Huge Potential’ Of OTC Digital Therapeutics, AI
UK’s Maxwellia Creates AI Influencer To Counter Hormonal Contraception Misinformation
Chatbots Are Not Ready To Be Medical Devices, Experts Argue
Further Listening
Over The Counter 9 June 2023: Embracing AI/AR In Beauty, While Navigating Its Hurdles
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Over The Counter Theme Music:
Warm Vacuum Tube by Admiral Bob (c)
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