Clinical Decision Support (CDS)
AI systems that recommend clinical actions to physicians — automatically Annex III high-risk under the EU AI Act and increasingly regulated by the FDA and MHRA as software-as-a-medical-device.
What Clinical Decision Support (CDS) means in practice
Clinical Decision Support systems recommend clinical actions to physicians: diagnostic suggestions, treatment options, medication-interaction warnings, risk stratification. The regulatory posture in 2026 is converging: the EU AI Act classifies CDS as Annex III high-risk; the FDA's Software-as-a-Medical-Device guidance increasingly catches LLM-driven CDS; the UK MHRA has signalled similar treatment under the Medical Device Regulations. The engineering implications are substantial: every recommendation must be explainable, the underlying model lifecycle artefacts must be captured for regulator review, and the physician's authority to override must be preserved with full audit. MindMap's clinical-coding-assist and clinical-pathway-recommendation deployments at NHS and US healthcare customers are architected for this regime.
Related terms
EU AI Act →
The European Union's AI Act — risk-tiered regulation of AI systems, with high-risk-system requirements that effectively mandate auditability, human oversight and conformity assessment.
Annex III high-risk AI →
The schedule in the EU AI Act listing AI use cases automatically classified as high-risk — biometric ID, credit scoring, HR screening, healthcare diagnostic support, critical infrastructure, education, justice.
Article 14 (Human Oversight) →
The EU AI Act provision requiring high-risk AI systems to be designed for effective human oversight, including the human's ability to fully understand, decide not to use, and override the system's output.
HIPAA →
The US Health Insurance Portability and Accountability Act — sets the rules for handling Protected Health Information (PHI) and shapes how US healthcare can use AI on clinical data.
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The Sovereign AI Playbook.
Enterprise generative AI that runs on your servers.
- 01Definition. The four non-negotiable properties of a sovereign deployment — and the three patterns that look sovereign but aren't.
- 02Why now. Three forces that converged in 2026: regulator pressure, the open-weights capability gap closing, and unit economics flipping.
- 03Reference architecture. The five-layer stack we deploy: applications → agent runtime → sovereign LLM → RAG + KB → data stores. With model and tooling choices for each.
- 04The regulators. SAMA · RBI · UK ICO · EU AI Act · DPDP · HIPAA — what each requires and how it maps to architecture.
All 62 terms, in plain language
Sovereign AI, RAG, agentic AI, IDP, MLOps and the regulations that shape enterprise AI.