Observed Signal · Sep 15, 2026 · Market Signal · Source: KFF · Impact: 5/5
FDA Regulation and the Dynamic Nature of AI
Dr. Brian Miller has seen medical technology regulation from every side — as a hospitalist, a former FDA official, and now an associate professor at Johns Hopkins University, where he leads a research group on market-driven approaches to FDA regulation and Medicare payment policy. In this episode, Chip talks with Miller about what happens when the FDA applies its 1976 medical device framework to AI — a technology that learns and changes.
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Pharma as Model for AI in Regulated Marketing
At Cannes Lions, Tom Richards (global chief creative officer at 21GRAMS, part of Real Chemistry) and Camilla Griffiths (president for Europe at 21GRAMS) told The Drum that the pharmaceutical sector offers a useful blueprint for marketing with AI under tight regulation. They argue that regulatory constraints can sharpen creative briefs and that involving compliance, legal and regulatory teams from the start produces better work. They also warn that AI changes how audiences discover health information — calling AI “an audience in and of itself” — and that brands must prioritise trustworthy, useful guidance to help empowered patients navigate conflicting online advice. The pair suggest healthcare’s regulated experience can help other industries adapt to AI, trust and scrutiny in marketing.
Agentic AI in healthcare means governing action, not just access
New blog post by Dr. Sean Kelly, Chief Medical and Growth Officer and Sr. VP, Customer Strategy, Healthcare, Imprivata, discussing the need to govern AI agent actions in healthcare beyond just access control.
AI Regulation Debate: Congress Blocked, States Advance
This opinion piece critiques the US federal government's inaction on AI regulation, contrasting it with the iterative 'rough consensus and running code' approach that built the internet. It argues that Congress, led by Speaker Mike Johnson, is using industry disagreement as an excuse not to legislate, while the White House, via AI czar David Sacks, champions self-regulation. The article highlights the EU's AI Act, state-level initiatives in 45 US states, and Colorado's recent repeal-and-replace of its AI law as examples of regulatory iteration. It also warns that poorly designed interfaces, as seen with GDPR consent banners, can undermine regulatory intent, and it draws parallels to the social media self-regulation failures exposed by Frances Haugen. The author calls for Congress to act as a competent 'product owner,' shipping narrow, honest rules and revising based on real-world impact.
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