Insights / Function
Field notes on Regulatory and Compliance in life sciences — FDA, EMA, MDR, and the practical reality of getting AI through.
31 posts in Regulatory / Compliance
23 Jul 2026 · 1 min read
Tempus AI's $1.5B acquisition of Personalis, coming two months after the FDA approved atezolizumab with Signatera as companion diagnostic, looks to me like a bet on longitudinal patient data rather than current test volume—though I'm skeptical about how fast Personalis can replicate that regulatory path.
14 Jul 2026 · 1 min read
I'm marking my own homework on the five AI predictions I made for 2026: two hits, two partials, and one still too early to call at the halfway point.
9 Jul 2026 · 2 min read
In enterprise AI, switching models will soon be trivial — but leaving the platform that holds your organization's memory will be a board-level decision. I argue that the most important question in any AI evaluation isn't about benchmarks: it's about where the memory lives.
7 Jul 2026 · 1 min read
UpDoc has received the first FDA clearance for a patient-facing clinical LLM via the 510(k) pathway — but I see a serious liability gap: when a cleared "concierge doctor" gets an insulin dose wrong, the accountability chain runs back through a device authorization that never contemplated the model making the call.
23 Jun 2026 · 2 min read
Roughly 11,500 Novo Nordisk clinical-trial patient records are allegedly on a leak site, next to the recipe for Ozempic — and the breadth of what was taken is the real story. I argue that the same frontier AI pharma has spent two years asking what it can build is now sharpening the tools that make a terabyte of stolen files instantly usable.
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 · 3 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OpenEvidence has withdrawn from the EU and UK citing regulatory uncertainty around the EU AI Act, making the geography of clinical AI access officially American.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.
23 Mar 2026 · 3 min read
Verily raised $300M, ended Alphabet’s controlling stake, and changed its legal name to Verily Health Inc. The capital matters. The structural change matters more. In healthcare, ownership structure is part of the product. As a personal anecdote, I stopped using my Fitbit the moment Google took over.
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.
19 Feb 2026 · 1 min read
The AI-in-healthcare debate keeps swinging between “AI is going to take over everything” and “AI is useless in a medical setting.” Neither is useful. What the field actually needs are external neutral benchmarks on specific clinical tasks. Congrats to Rory Davidson and team for bringing one to market.
10 Feb 2026 · 3 min read
The Gulf has three things most emerging life sciences ecosystems lack: sovereign capital, speed of decision making, and political will. What it still needs is the operational layer that turns investment into outcomes — and an investor base that understands the life sciences risk profile.
29 Jan 2026 · 3 min read
Hologen, Eric Schmidt’s stealth biotech-AI venture, is raising $150M at an $850M pre-money on a promise of 100% returns in 12 months. The pitch is closer to financial underwriting than AI product development. Here’s what would convince me it’s more than narrative.
20 Jan 2026 · 3 min read
I just completed my first peer review — on a healthcare AI paper — under journal rules that explicitly forbid AI assistance. Peer review is slow, strained, and imperfect. And it now actively forbids the tools that could make it better. Will this model survive the next decade?
8 Jan 2026 · 2 min read
OpenAI just launched ChatGPT Health (waitlisted). I can’t access it from Europe yet, but I’ve been using ChatGPT for surprisingly complex Swiss health insurance reimbursement scenarios. The personal health AI category is emerging in real-time, and OpenAI may have a real shot where Apple has tried for years.
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.
16 Sept 2025 · 1 min read
Healthcare AI is moving from answers to actions — and model evaluation must shift from simplistic multiple-choice testing to comprehensive workflow safety and governance. I'm convinced that agentic workflow automation will be a massive opportunity in healthcare and life sciences.
9 Sept 2025 · 1 min read
In Dubai at WHX Tech, AI in healthcare isn't just being debated — it's being deployed. A new health-data sandbox is launching so startups can work with de-identified EMR under clear governance, build quickly, and prove safety.
5 Aug 2025 · 1 min read
Meta is facing up to $190 billion in damages after users of the period-tracking app Flo alleged their sensitive health data was shared with Meta for targeted advertising. I see this as a timely reminder for all of us to treat our health data with far greater care.
18 Jun 2025 · 1 min read
I joined an interesting discussion on AI in drug discovery and development at HLTHEurope2025 with panelists from Novartis, Roche, and OWKIN. From real-world evidence generation to biomarker development and regulatory considerations, the conversation covered both the opportunities and challenges of bringing AI into pharma.
6 Jun 2025 · 1 min read
I share a quick update on ELSA, the FDA's new GenAI tool powered by Anthropic's Claude, and why I genuinely appreciate the FDA's decision to launch it despite early imperfections — because in healthcare, the biggest challenge with new tech isn't the technology, it's the change management.
3 Jun 2025 · 1 min read
The FDA is now using GenAI to review regulatory dossiers — and I think that's a good thing. Pharma companies have already been using generative AI to craft submissions, so it makes perfect sense for regulators to leverage the same technology on their end.
15 May 2025 · 1 min read
I joined fellow panelists from Saudi FDA, WEF, LEAN, and others at the menatelehealth conference in Riyadh to discuss how AI is reshaping virtual care. We explored Saudi Arabia's regulatory sandbox approach, high-impact use cases from LLMs in critical care to agentic AI, and the infrastructure enabling it all.
20 Mar 2025 · 1 min read
We're increasingly relying on AI and LLMs in medical settings — from self-diagnosis to clinical co-pilots — but there are still no good benchmarks for how well these models actually perform in real clinical practice. I think we have a long way to go before LLMs become truly reliable thought partners in our medical journeys.
6 Mar 2025 · 1 min read
I attended a very insightful panel at the EPA conference in Amsterdam on how global healthcare reforms are impacting local market access strategy. Modeling demands are becoming more challenging, joined Health Technology Assessments are increasingly the rule, and — as Gavin Lewis of Novartis put it — your access strategy is becoming your entire enterprise strategy.
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.
9 Oct 2024 · 1 min read
A great talk from Gilead's Jeremy Zhang at BiotechX on scaling LLMs like OpenAI and Claude to the clinical portfolio — covering key use cases from protocol design to automated document generation, and the real hurdles of stakeholder skepticism and regulatory clarity.
9 Oct 2024 · 1 min read
At BiotechX in Basel, Gilead's Patrick Loerch outlined what it really takes for AI to create value in biopharma — from systemic business impact to decision-making influence. I found his take on centralized vs. distributed AI models, regulatory coordination, and clinical value chain opportunities particularly compelling.
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.
2 Aug 2024 · 1 min read
Microsoft now formally lists OpenAI as a competitor, despite having invested $13 billion into the company — a move that may be tied to SearchGPT or antitrust optics. The strategic manoeuvres around these massive LLM-race investments are captivating.