The functionality of artificial intelligence and automatic learning (AI / ML) in medical devices and software has been a field of interest for regulators, as these tools represent a growing digital health border.
Greg LevinePartner and World President of the FDA regulatory group, and Lincoln TsangPartner and head of the European Company Sciences of Life Sciences, presented an HLTH webinar on April 30 on “Regulatory problems surrounding AI and machine learning devices: American FDA and European perspectives. “”
Greg moderated the webinar with the presenters Lincoln and Sonja Fulmer, deputy director, FDA Digital Health Center of Excellence.
The HLTH webinar has examined subjects such as approvals and releases of AI / ML devices and status in the United States and Europe; Life cycle management considerations and pre-commercial submissions recommendations for AI / ML compatible device software functions; and the EU AI Act, including a proposal for financial sanctions for the regulatory violation and the legislative proposal for non -contractual civil liability rules to AI.
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