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Health tech

AI medical-device startup

An AI diagnostic device company selling to hospitals and processing EU health data.

Profile Lex scans

We build an AI-powered diagnostic device for hospitals and process patient health data in the EU.

Exposure areas

4

EU files

3

First checks

3

Top EU files

AI Act

Application in phases

Likely high-risk AI obligations affect risk management, documentation and monitoring.

Map obligations by application date

European Health Data Space

Adopted

Changes health data access, secondary use and interoperability expectations.

Track implementation guidance

Cyber Resilience Act

Implementation

May affect connected-device security-by-design and vulnerability handling.

Prepare security evidence

Who matters

  • ENVI committee
  • IMCO committee
  • Commission DG SANTE

First checks

  • Create AI Act obligation map
  • Brief clinical/product leadership
  • Prepare evidence checklist

Friday Brief preview

AI Act and medical-device obligations need one integrated evidence plan.
Health-data rules are strategic because hospital procurement will ask for interoperability and governance.
The first useful check is a leadership brief on dates, evidence and product-owner accountability.