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Vital Signs: Digital Health Law Update | Spring 2024

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

Sheppard Mullin Richter & Hampton LLP

AI as an Aid – Emerging Uses in Healthcare: A Discussion with Jim Gatto

Expansion of AI in Healthcare - At its core, AI involves the use of data, computers, and algorithms to mimic aspects of human intelligence. The progression from a rules-driven AI to the less artificial and more intelligent...more

Mintz - Health Care Viewpoints

Coverage of FDA’s AI/ML Medical Devices Workshop - Part 3: A Summary of the Panel Discussions

In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop), we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more...more

Morgan Lewis - Tech & Sourcing

Important Considerations When Tech Service Providers and Life Science Companies Collaborate in the Digital Health Space

When negotiating a digital health collaboration agreement between a tech company and a life sciences company, whether for the development of artificial intelligence or other software, the provision of data hosting and...more

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