Why Take Action Now?
The AI Act has major impact on the healthcare sector
August 2025
First obligations for high-risk AI systems come into effect
Medical AI = High-risk
AI for diagnosis and treatment automatically falls under strictest rules
Overlap with MDR
Medical devices with AI must comply with both MDR and AI Act
Physician Remains Responsible
Human oversight requirement demands clear protocols
High-risk AI in Healthcare
These AI applications fall under strict AI Act requirements (Annex III)
Diagnostic AI
AI systems that analyze medical images or support diagnoses — from X-ray analysis to pathology.
Treatment Support
Systems providing treatment advice, medication dosing or therapy selection support.
Triage & Care Allocation
AI determining which patients get priority or which care is allocated.
Predictive Models
Systems predicting patient outcomes or assessing risks.
Specific Challenges for Healthcare Institutions
The AI Act brings unique compliance questions for the healthcare sector
MDR and AI Act Alignment
Medical devices with AI must comply with both. How to integrate requirements?
Information Security Integration
How does AI Act compliance fit into existing healthcare information security?
Clinical Validation
AI systems must be clinically validated. What evidence is needed?
Physician in the Loop
Human oversight is mandatory. How to ensure physicians make informed decisions?
Vendor Management
Much AI comes from external vendors. What guarantees to request?
Patient Rights & Transparency
Patients have right to explanation. How to communicate about AI use in care?
AI Act Compliance Roadmap
Practical steps for healthcare institutions
AI Inventory
2-4 weeksMap all AI systems. Which systems influence patient care?
Classification & MDR Check
2-3 weeksDetermine AI Act classification and potential MDR class per system.
Gap Analysis
4-8 weeksCompare current documentation with AI Act and MDR requirements.
Clinical Governance
2-4 monthsImplement protocols for human oversight and clinical decision-making.
Monitoring & Vigilance
OngoingSet up post-market surveillance for continuous AI performance monitoring.
What Makes Healthcare AI Different?
Sector-specific considerations
Triple Regulated
Healthcare AI falls under AI Act, MDR and national healthcare legislation
Clinical Evidence Required
Technical compliance alone is not enough — clinical validation is essential
Human Lives at Stake
Errors in medical AI can directly lead to harm or death
Doctor-Patient Relationship
AI must not undermine the therapeutic relationship