STAT+: Are AI scribes medical devices? UK regulator weighs in.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has weighed in on whether AI scribes are medical devices, a decision that could shape how these tools are regulated in healthcare. The regulator's stance is significant for developers and clinicians using AI documentation tools, as it determines whether they must meet medical device standards. STAT's Health Tech newsletter reports on the controversy and also covers Dexcom's FDA pilot and the integration of scribes into medical education.

Y ou’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday. Good morning, health tech readers Today, controversy over a regulator’s decision on AI scribes. Plus, a little more detail on Dexcom’s FDA pilot and an enlightening look at how scribes are working their way into medical education. This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in /login/ View All Plans https://www.statnews.com/stat-plus/