Interesting paper alert - a commentary in Nature Medicine highlights a pivotal tension in healthcare today: while #AIagents promise transformative impacts — from autonomous triage to multi-modal clinical decision support — regulatory frameworks remain built for a different era (a recurring scheme in the world of Health AI which I do not see going away anytime soon: technical progress in AI will always outpace regulatory actions). Here are the take aways from the paper: 🔹 Current state of regulation of AI agents in health and medicine: Most regulatory pathways, like the EU Medical Device Regulation and the U.S. FDA’s 510(k), are optimized for narrow, static, non-adaptive tools. Approval of AI-driven devices with broad scope and high autonomy remains rare and challenging. 🔹 The problem (why existing regulatory frameworks fall short of capturing agentic AI applications): AI agents orchestrate multiple tools, access sensitive data, and make goal-directed decisions autonomously. Their adaptive nature, coupled with non-deterministic outputs and complex multi-component architectures, pushes them outside the assumptions underpinning today’s medical device regulation. 🔹 Proposed solutions (how can we explore and experiment safely with AI agents in clinical settings in the absence of comprehensive regulatory guidance): The paper explores several emerging regulatory strategies, including: Voluntary alternative pathways → tailored approvals for high-risk AI agents Adaptive oversight → dynamic, real-world performance monitoring Regulatory sandboxes → controlled environments to experiment safely Outcome-driven evaluation → focusing on patient-centered results rather than static technical compliance 💡 The takeaway (so where does this leave us): While regulation is still playing catch-up with the risks and complexities of AI agents in healthcare, it is possible to safely experiment and sandbox their use — provided there are clear guardrails, strong oversight, and rigorous evaluation frameworks. This balanced, sandbox-first approach could enable innovation without compromising patient safety. For first hand insights on how this is all playing out in the real world right now, have a read of these two recent papers from Eric Topol, MD (https://lnkd.in/gEycp__S) and Harsha Nori (https://lnkd.in/gKNxpxsA) John Lim Christopher Bain ZongYuan 宗元 Ge 戈 Deval Mehta #AI #Healthcare #Regulation #AIagents #DigitalHealth #NatureMedicine
Regulatory frameworks may lag practice by more than one era - some content currently being reviewed is still grappling with general purpose AI systems and generative AI, let alone agentic AI. I like the progressive idea in the article about making AI systems undergo a structured 'training' process, but unfortunately that is often impossible in practice when parts of the system are not open source. Alternative ideas we are experimenting with are performance, safety and security quality testing ('AI assurance'), strict restriction of egress and tools ('containment') and having fine toothed definitions on the spectrum of human in the loop when assessing agency levels of agents. Glad to see some innovative approaches on the table, but there is a lot of work to do to overcome outdated ways of thinking. As always the most important model might be our mental model.
Thanks for this post. A possible way forward is to open up the structural model of regulation to explore more how we might focus on the input side of innovation rather than just the output, so if regulation can be used to demand more patient centric and societal approaches that might curtail some of the risk, as well as ensuring better understanding of what is realistic so instances where things go wrong don't lead to panic and fixes can be found.
Great post and definitely agree that AI adoption in healthcare and life science has far outpaced regulation. Majority of AI solutions are not independently evaluated or monitored after implementing, the most important time. We at PsychedAboutAI have built evaluation frameworks for this purpose
Thanks for sharing, Stefan Harrer, PhD ! It is urgent‼️ Without this kind of solutions we will all suffer from the shock that relevant care we were used to cannot be given anymore and we will miss the opportunity for real personalized care and prevention. We should not hold ourselves back #transform #health #equality
Thanks for the insightful summary. Not a healthcare person. But I wonder if it’s correct to frame this as health regulations playing catchup, or it should be framed as AI agents not meeting the right standards yet for healthcare, a domain where it is as high stakes as it gets?
One of the most powerful AI agents shaping the healthcare ecosystem is the one integrated into the search engines we all use - and this context faces similar regulatory challenges where the framework is still built for a pre-internet era. Let alone one where Dr Google has evolved into 'Chat GPt'. The relationship between patients and these answer engines is deepening due to the conversational nature of the exchange and the empathy embedded in the language used by AI. Where restrictions prohibit the companies responsible for the quality use of their medicines from offering easily digestible answers in front of firewalls, the default sources are third party websites that largely contain unverified content that is frequently locally irrelevant and often out of date. It's time to permit the open publication on company websites of 'patient responsive content' that answers real-world queries with accurate and accountable advice. This will displace the other sources and offer AI something to grab onto and deliver with confidence into the 'zero click search' experience many patients (and potentially HCPs) engage in now.
Agentic systems are moving much faster than regulation. Sandboxes and adaptive oversight may not just be temporary fixes, they might need to become standard, because static approvals can’t keep up with systems that change and adapt. The real question is how regulation itself can evolve alongside the technology.
Chetna Gakhar S.