EU AI Act for Healthcare & Medical AI: Practical SME Guide

Healthcare AI often sits in the highest-risk zone under the EU AI Act, especially when systems influence diagnosis, triage, treatment planning, or patient prioritization. For SMEs building or deploying these tools, the key challenge is balancing innovation with strict safety and rights obligations.

Start by mapping each clinical and operational AI use case. Separate systems used for direct medical decisions from administrative automation. Many teams underestimate obligations because they group everything under a single "AI platform" label. Regulators and auditors will evaluate concrete functions, not marketing terms.

Next, align your AI documentation with both AI Act and GDPR expectations. Healthcare data is sensitive by default. You need clear data lineage, retention logic, access controls, and evidence that training and validation data are appropriate for the intended population. Bias testing and performance monitoring are not optional in patient-impact contexts.

If your system qualifies as high-risk, Annex IV technical documentation becomes central. Describe architecture, intended purpose, known limitations, human oversight boundaries, and post-market monitoring procedures. You should also define incident escalation paths early, especially when outputs could affect patient safety.

Finally, plan for organizational readiness: assign owners, review cycles, and decision authorities. Compliance is less about one-time legal review and more about a durable operating model. SMEs that set this foundation now can reduce regulatory risk while preserving deployment speed.