Insights / Geography
Posts carrying the United States tag.
30 Apr 2026 · 3 min read
The FDA's first real-time clinical trials don't just promise faster reviews — they insert a new infrastructure layer between sponsors and the agency. I break down what that architectural shift means for clinical development.
28 Apr 2026 · 4 min read
OpenEvidence has withdrawn from the EU and UK citing regulatory uncertainty around the EU AI Act, making the geography of clinical AI access officially American. I break down what this means for US and European pharma, and why the AI Act's first observable market effect may be pushing physicians toward less-grounded AI alternatives.
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.
23 Oct 2025 · 1 min read
The Menlo Ventures report on AI in healthcare confirms that the sector is now one of the fastest adopters of enterprise AI, with ambient scribes leading the charge — but commoditization and pricing pressure are already reshaping the competitive landscape. My bet for the next battlefield is RCM.
18 Mar 2025 · 1 min read
AI in healthcare shouldn't aim to replace professionals — its true potential lies in enhancing their ability to deliver quality care. I explore how Wysa's merger with April Health exemplifies the broader industry trend of combining human empathy with AI-enabled tools in mental healthcare.
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.
6 Aug 2024 · 1 min read
A US judge has just ruled that Google is a "monopolist" — and I find it interesting that this judgment is arriving at a time when Google is probably challenged more than ever across its core business segments. It highlights both the importance of tech regulation and how slow the antitrust machinery moves compared to the speed of evolution in the tech sector.
19 Jul 2024 · 1 min read
CB Insights has just released a report on the AI readiness of different hospital systems in the US, and I'd love to see a similar study done for Europe. From my experience working with startups in the field, France, Spain, and several Scandinavian markets appear ahead of places like Germany or Switzerland.