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Regulatory Oversight › Algorithms › Digital Health

Hogan Lovells

AI wellness or regulated medical device? A lawyer's guide to navigating FDA rules—and what could change next

Hogan Lovells on

As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that launch with the best of...more

Epstein Becker & Green

HealthBench: Exploring Its Implications and Future in Health Care

Epstein Becker & Green on

As we noted in our previous blog post, HealthBench, an open-source benchmark developed by OpenAI, measures model performance across realistic health care conversations, providing a comprehensive assessment of both...more

Stinson LLP

FDA Proposes Pathway for Artificial Intelligence/Machine Learning Software

Stinson LLP on

Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more

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