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How AI gets approved, governed, and deployed in healthcare: FDA pathways, the EU AI Act, prescribing rules, and the policy debates that decide what reaches patients. The regulatory frame around the technology.
Healthcare AI is colliding with rules written for a different era, and the central question is who decides what counts as safe. These essays track the same technology splintering into incompatible playbooks across the US, EU, Gulf markets, and China, making a single global strategy hard to imagine. The recurring argument: regulation should follow patient impact, not software labels. Test cases, from FDA Breakthrough status for a generative chatbot to bills letting AI prescribe, show where theory meets practice.
5 Mar 2026 · 3 min read
The FDA quietly granted Breakthrough Device Designation to a generative AI chatbot — not a diagnostic, not a scoring tool. An LLM that talks to post-surgical patients twice daily and escalates red flags. No GenAI device has ever received FDA authorization. This becomes the test case.
4 Dec 2025 · 1 min read
I joined a Health Tech Forward panel in Barcelona on AI regulation in healthcare, where I argued that outcome-based regulation — focused on what AI actually does for patients — is far more effective than layering a second horizontal tech framework on top of existing medical device rules.
27 Nov 2025 · 1 min read
I'm seeing AI strategy in healthcare fragment into at least four distinct regulatory realities — the US, EU, emerging Gulf markets, and China — and I'll be diving into what this means for innovation at Health Tech Forward in Barcelona on December 3rd.
24 Nov 2025 · 1 min read
I'm asking whether a truly "global" AI strategy is even possible in healthcare right now, given the increasingly incompatible regulatory playbooks emerging across the US, EU, and China. I'll be exploring this live at Health Tech Forward in Barcelona on December 3rd.
18 Feb 2025 · 1 min read
A proposed US bill could allow AI to legally prescribe medications — a significant shift beyond today's administrative and decision-support roles. I see this as a potential turning point in how AI is integrated into clinical practice, though regulatory and safety challenges remain.
16 Oct 2024 · 1 min read
I fed Google's NotebookLM the entire 144-page EU AI Act and the result was a genuinely jaw-dropping podcast-style conversation that made learning feel effortless — this might just be the future of learning with GenAI.
8 Oct 2024 · 1 min read
Being the Health Care AI Czar of the most powerful economy in the world sounds impressive — but maybe think twice. I share a great STAT podcast episode on Micky Tripathi, the acting HHS Chief AI Officer, and the daunting reality of his role.