---
title: "Healthcare & Life Sciences AI Governance Hub"
description: "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."
image: "https://healthcare.aiacts.app/og-cover.png"
url: "https://healthcare.aiacts.app"
content_signal: "ai-train=no, search=yes, ai-input=yes"
---

# Healthcare & Life Sciences AI Governance Hub

> Hostname: healthcare.aiacts.app
> Canonical: https://healthcare.aiacts.app

## 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.

## Applicable Frameworks & Regimes
- eu-mdr-2017-745
- eu-ai-act-annex-ii
- fda-samd-pccp
- hipaa-security-rule

## 8-Dimension Evidence-Requirement Matrix
1. **Clinical Evaluation & Diagnostic Accuracy** (Clinical Safety): Clinical investigation dossiers & sensitivity/specificity validation (MDR Annex XIV)
2. **Demographic Diagnostic Bias Auditing** (Fairness): Multi-cohort clinical validation across age, sex, and ethnicity subgroups
3. **Physician-in-the-Loop Clinical Oversight** (Human-in-the-loop): Mandatory licensed clinician sign-off on automated diagnostic recommendations
4. **Clinical Explainability & Diagnostic Saliency** (Transparency): Heatmap and feature importance visual proof for clinical decision support
5. **Patient Data Provenance & HIPAA/GDPR Sanitization** (Data Governance): Strict patient de-identification receipts & synthetic data validation
6. **Post-Market Clinical Follow-up (PMCF)** (Continuous Monitoring): Continuous real-world clinical drift and adverse diagnostic event logging
7. **Medical Device Cybersecurity (MDCG 2019-16)** (Resilience): Clinical device firmware encryption & tamper-resistant telemetry
8. **Cryptographic Clinical Dossier & Conformity SEAL** (Evidence Packaging): Deterministic SEAL receipt for regulatory audit submission

## Proof Passports, 5-Category Archives & Multi-Jurisdiction Specimen (336 Indexed Passports)
- **Multi-Jurisdiction & Sector Specimen Certificate**: [Inspect Specimen Certificate →](https://proof.vantages.app/verify/multi-jurisdiction-ai-evidence-review-specimen?sector=healthcare)
- **MCP Server Passports (`200` Indexed)**: [https://proof.vantages.app/passport/mcp](https://proof.vantages.app/passport/mcp) ([Markdown](https://proof.vantages.app/passport/mcp?format=md))
- **AI Model Passports (`36` Indexed)**: [https://proof.vantages.app/passport/models](https://proof.vantages.app/passport/models) ([Markdown](https://proof.vantages.app/passport/models?format=md))
- **Autonomous Agent Passports (`49` Indexed)**: [https://proof.vantages.app/passport/agents](https://proof.vantages.app/passport/agents) ([Markdown](https://proof.vantages.app/passport/agents?format=md))
- **AI Dataset Passports (`32` Indexed)**: [https://proof.vantages.app/passport/datasets](https://proof.vantages.app/passport/datasets) ([Markdown](https://proof.vantages.app/passport/datasets?format=md))
- **Governed AI Stack Passports (`19` Indexed)**: [https://proof.vantages.app/passport/stacks](https://proof.vantages.app/passport/stacks) ([Markdown](https://proof.vantages.app/passport/stacks?format=md))

## Next Actions
- **Request Sector Evidence Review →** (`€850 · 48h SLA`): https://aiacts.app/evidence-review?source_satellite=healthcare.aiacts.app&target=healthcare.aiacts.app
- **Run 1-Click Scan** (`€0 Free Preflight`): https://aiacts.app/scan?source_satellite=healthcare.aiacts.app

> Disclaimer: VOS supports governance, evidence and audit-readiness workflows. It is not legal advice and does not certify compliance by itself.

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  "url": "https://healthcare.aiacts.app",
  "description": "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.",
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