AI Act Compliance for Healthcare
Healthcare is one of the most heavily impacted sectors under the EU AI Act. AI systems used in medical devices, patient diagnostics, treatment recommendations, and hospital resource allocation are classified as high-risk under Annex III. Medical device manufacturers must also comply with the Medical Device Regulation (MDR) alongside the AI Act.
High-Risk AI Use Cases in This Industry
- AI-assisted medical diagnostics and imaging
- Clinical decision support systems
- AI in medical devices (Annex I, Section A)
- Patient triage and prioritization systems
- Drug discovery and clinical trial matching
- Surgical robots and AI-guided procedures
Key Compliance Requirements
- Risk management system (Article 9) integrated with MDR requirements
- Data governance ensuring training data quality and representativeness (Article 10)
- Technical documentation including Annex IV requirements (Article 11)
- Record-keeping and automatic logging (Article 12)
- Transparency to healthcare professionals using the system (Article 13)
- Human oversight by qualified medical professionals (Article 14)
- Accuracy, robustness, and cybersecurity appropriate for medical context (Article 15)
Recommended Tools
sepp.med
DeepGerman AI quality assurance and EU AI Act compliance testing. Gap analysis for MedTech, automotive, and finance.
Modulos AG
DeepETH Zurich spin-off and first AI governance platform to receive ISO 42001 product conformity certification. Full AI Act and ISO 42001 compliance with automated risk management.
KLA Digital
DeepPurpose-built conformity assessment tool with runtime policy enforcement, human approval queues, and integrity-verified evidence packs. Deep focus on AI Act Articles 12 and 14.
IBM watsonx.governance
DeepEnterprise AI governance from IBM with EU AI Risk Assessment capability, compliance accelerators, and fairness/quality/explainability monitoring across any AI platform.
OneTrust
DeepLeading GRC platform with comprehensive AI governance module. Offers AI system inventory, algorithmic impact assessments, and cross-functional compliance coordination.
FairNow
DeepAI governance platform automating compliance with 38+ global frameworks. Strong HR technology focus with EU AI Act compliance workflows and bias detection.
DAIKI
DeepVienna-based AI governance platform with AI registry, quality management system, and risk classification. Strong focus on MedTech, healthcare, and manufacturing compliance.
trail
DeepMunich-based AI Governance Copilot with pre-filled risk libraries and lifecycle compliance tracking. Backed by Mozilla Ventures. Claims 80% reduction in compliance time.