The US Food and Drug Administration (FDA) recently issued new draft guidance on clinical decision support (CDS) software that revamps the agency’s interpretation of the 21st Century Cures Act and proposes new policies of enforcement discretion for some categories of CDS software. In a recent LawFlash, Morgan Lewis partner Michele Buenafe details key takeaways from the revised guidance, which is a significant departure from the 2017 draft.
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.
Did you catch our most recent edition of Fast Break? If not, we had an awesome extended session with Michele Buenafe on May 16 that was also part of our annual Technology May-rathon series. Michele described how the FDA is treating various types of software and hardware that may have healthcare functions as well as certain clinical decision support systems. Michele discussed some of the new and innovative ways that the FDA is trying to regulate—perhaps with a lighter hand—various AI and software systems that have historically had challenges with FDA oversight.
We had a successful Fast Break on HealthTech Startups last month. The program, led by Morgan Lewis corporate partners Andy Ray (@AMRayEsq) and Jeff Bodle (@jeffbodle), explored a lot of the things that might affect the relationship between capital investors, including corporate venture capital and startup entrepreneurs. We discussed a bit about the background of how a startup begins and explored the process through which a successful startup begins to obtain capital, especially when integrating vertically with potential buyers of their products (not just their business). This Fast Break also touched on some of the common healthcare regulatory issues we have to contend with on both the startup and the corporate side during diligence. If you’d like to take a listen, here is a recording of the program.