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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more
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
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
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
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
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