Healthcare & Life Sciences AI Governance Hub
What compliance frameworks apply to healthcare and clinical AI?
Clinical AI diagnostics and triage tools fall under EU AI Act Annex II (MDR Regulation 2017/745), requiring clinical evaluation dossiers, post-market surveillance plans, and strict physician oversight pathways.
Clinical Evaluation & Diagnostic Accuracy
Clinical investigation dossiers & sensitivity/specificity validation (MDR Annex XIV)
Demographic Diagnostic Bias Auditing
Multi-cohort clinical validation across age, sex, and ethnicity subgroups
Physician-in-the-Loop Clinical Oversight
Mandatory licensed clinician sign-off on automated diagnostic recommendations
Clinical Explainability & Diagnostic Saliency
Heatmap and feature importance visual proof for clinical decision support
Patient Data Provenance & HIPAA/GDPR Sanitization
Strict patient de-identification receipts & synthetic data validation
Post-Market Clinical Follow-up (PMCF)
Continuous real-world clinical drift and adverse diagnostic event logging
Medical Device Cybersecurity (MDCG 2019-16)
Clinical device firmware encryption & tamper-resistant telemetry
Cryptographic Clinical Dossier & Conformity SEAL
Deterministic SEAL receipt for regulatory audit submission
Foundation models, fine-tunes, and specialized architectures classified for this vertical regime.
Gemini 2.5 Pro surpasses the 10^25 FLOPs threshold, classifying it as a GPAI model with systemic risk under Article 51. Obligations include mandatory model evaluations, adversarial testing, systemic risk assessments, cybersecurity safeguards, and technical documentation for downstream deployers.
Gemini 2.5 Flash operates below the 10^25 FLOPs cumulative computation threshold, classifying as standard General Purpose AI (GPAI). It must maintain technical documentation, comply with EU copyright laws, and supply transparency summaries without systemic risk mitigation burdens.
Gemini 3.7 Flash includes native support for deterministic human-in-the-loop gating when orchestrated via MCP tool calling, allowing downstream providers to fulfill Article 14 oversight requirements in automated decision workflows.
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Interactive Article-by-Article statutory explorer, obligations matrix, compliance timeline, and penalty calculator.
Live insurance risk sandbox testing protected class proxy discrimination, actuarial fairness, and Article 86 denial explainability.