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Industry

AI in Healthcare

AI systems in diagnostics, clinical decision support, and medical devices sit at the intersection of the EU AI Act, MDR/IVDR, GDPR for health data, and clinical trials regulation. No other sector faces this density of overlapping compliance obligations.

AI Applications

How AI is used in healthcare

Six AI applications transforming healthcare, each with distinct regulatory obligations that go beyond the EU AI Act alone.

Diagnostic Imaging

High-Risk

AI-powered radiology, pathology, and ophthalmology screening tools that identify disease from medical images. Classified as high-risk under both the EU AI Act and MDR when used as a medical device.

Drug Discovery

Research Use

AI systems that identify drug candidates, predict molecular interactions, and optimise clinical trial design. While research-phase AI may be exempt, systems that influence treatment decisions carry regulatory obligations.

Clinical Decision Support

High-Risk

AI that recommends treatments, flags drug interactions, or suggests diagnoses to clinicians. When these systems influence clinical outcomes, they face high-risk classification and medical device regulation simultaneously.

Patient Triage

High-Risk

AI systems that prioritise patients based on urgency, predict deterioration, or allocate scarce resources. These systems directly affect access to healthcare, placing them firmly in the high-risk category.

Medical Devices

High-Risk

AI-enabled surgical robots, monitoring systems, and implantable devices. These face the most stringent requirements, EU AI Act conformity plus MDR/IVDR classification, notified body assessment, and CE marking.

Genomics & Precision Medicine

Risk-Dependent

AI systems analysing genomic data to personalise treatment plans. When they process special category health data and influence treatment decisions, GDPR Article 9, the EU AI Act, and IVDR obligations converge.

Regulatory Landscape

The healthcare compliance stack

Healthcare AI faces the densest regulatory overlap of any sector, four frameworks, each with its own conformity pathway.

EU AI Act

Medical AI Systems

AI components in medical devices covered by MDR/IVDR are classified as high-risk (Annex II). The conformity assessment for the AI component must be integrated with, not separate from, the medical device assessment.

MDR / IVDR

Device Classification

The Medical Devices Regulation and In Vitro Diagnostics Regulation establish device classification, clinical evaluation, and post-market surveillance. AI-enabled devices must satisfy both MDR/IVDR and the EU AI Act simultaneously.

GDPR Health Data

Special Category Data

Health data is a special category under GDPR Article 9. AI systems processing patient data need explicit consent or another Article 9 exception, plus a DPIA, plus the EU AI Act's data governance requirements under Article 10.

Clinical Trials Regulation

AI in Research

AI used in clinical trial design, patient selection, or endpoint analysis must comply with the Clinical Trials Regulation (EU 536/2014). Transparency and reproducibility requirements extend to AI-assisted research methodologies.

Healthcare AI Compliance

Navigate the EU AI Act, MDR/IVDR, and GDPR together, structured guidance for healthcare organisations deploying AI in clinical settings.

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