# Healthcare AI regulation should follow patient impact, not software labels

> 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.

URL: https://www.ch-healthtech.com/insights/regulate-what-ai-does-patients-not-what-it-paper
Markdown: https://www.ch-healthtech.com/insights/regulate-what-ai-does-patients-not-what-it-paper.md
Published: 2025-12-04
Updated: 2026-05-06
Author: Christian Hein
Tags: technology/artificial-intelligence, function/regulatory-compliance, industry/health-tech, geography/europe, geography/united-states, function/innovation-management

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Regulate what AI does to patients, not what it is on paper.

That was my main point yesterday on the Health Tech Forward panel IN Barcelona about AI regulation in healthcare.

In health, outcome-based regulation works best. FDA SaMD and the EU's MDR aren't perfect, but they focus on the right question: does this system actually do what it claims to do, and therefore hopefully improve outcomes for real patients, under real-world conditions?

The EU AI Act adds a second, horizontal tech layer on top. In healthcare, that could potentially mean weeks and months of additional compliance work under the AI Act, (and I'm glad it seems like a big part of it is currently being delayed).

My concern: regulating AI twice won't make European patients safer. It will make Europe slower, and push innovation to markets where frameworks stay closer to outcomes. The US remains overall pragmatic. The UAE and Saudi Arabia are building regulatory sandboxes specifically designed to attract health AI companies frustrated with European timelines, and have regulators that actually listen.

On the amazing panel, Claudia Ben-Dov Botti, PhD unpacked the reality of navigating EU rules today, Julie Brown-Georgi, MS, CAHIMS brought a pragmatic and insightful US perspective, and Ritesh Patel kept us anchored in what actually matters innovators, and ultimately, patients.

I'm not anti-regulation, but I'm worried that the risks of over-regulation (from delays to not even getting innovative technology out to patients) outweigh the potential benefits. We really need a different mindset in Europe. Please challenge me if you disagree.