Legal Insights and Perspectives for the Healthcare Industry

We invite you to join us in Houston on September 12 for our Second Cup of Coffee breakfast series covering the latest legal developments in digital health and healthcare innovation. In Siri Goes to Medical School – The Rise of AI in Healthcare, partners Susan Feigin Harris, Michele Buenafe, and Andrew Ray will discuss what is happening in the world of artificial intelligence and healthcare, including recent developments, legal trends, and FDA regulatory hurdles.

If you are interested in registering, please contact Stefani Cornwall. Space is limited—reserve your spot now!

Could a new FDA regulatory approach for postmarket changes to artificial intelligence (AI)/machine learning (ML)–based software devices be in our future? A recent discussion paper offers important insight into the FDA’s thinking on reducing postmarket burdens for FDA cleared or approved AI/ML technologies. Given that the FDA has yet to develop clear guidance on when AI/ML technologies are subject to regulation, could the FDA’s proposal to address postmarket changes for these technologies be putting the cart before the horse?

Read the full LawFlash for more in-depth analysis on FDA’s discussion paper.