# Medical AI Compliance Gate

> Audit a medical/health-AI codebase or data pipeline against GDPR, EU MDR, ISO 27001, and SOC 2 — gated by automated checks that actually run. A stdlib Python scanner runs ~29 heuristics from a 47-control catalog (hardcoded secrets, PII/PHI in logs, encryption at rest, TLS, audit logging, retention/ erasure, RBAC, EU data residency, consent, model cards, data lineage, SBOM, dependency pinning, CI/tests/monitoring), maps each finding to its control + framework + severity, fails the build on blocking gaps, and sends the rest to a mandatory human attestation. Use for a compliance/readiness audit or gap analysis, a healthcare/medical-AI compliance checklist or CI gate, or a DPIA/RoPA starting point. Honest scope: engineering assistance to PREPARE for compliance — NOT legal advice, certification, an MDR conformity assessment/CE marking, or a Notified Body, ISO, or SOC 2 audit. Triggers: "GDPR", "MDR", "medical device software", "MDSW", "ISO 27001", "SOC 2", "compliance gate", "DPIA", "healthcare AI audit".

- Skill: `neuralmedic-de/medical-ai-compliance-gate` (Agent Skill, multi-file: 12 files)
- Install (CLI): `npx skillmds@latest add neuralmedic-de/medical-ai-compliance-gate`
- Raw SKILL.md: https://api.skillmd.com/api/skills/neuralmedic-de/medical-ai-compliance-gate/raw
- Safety review: pending
- Works with: Claude Code, Claude.ai, OpenAI Codex
- Category: DevOps & Infra
- License: MIT
- Author: NeuralMedic-DE (https://skillmd.com/u/neuralmedic-de)
- Updated: 2026-09-17
- Page: https://skillmd.com/skills/neuralmedic-de/medical-ai-compliance-gate

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# Medical AI compliance gate (GDPR · MDR · ISO 27001 · SOC 2, verified)

Prepare a medical/health-AI system for compliance and **prove the
machine-decidable part** — gaps are surfaced by a scanner that runs over the
repo, fixed by severity, and re-scanned until green; then a mandatory human
attestation completes the gate.

## Core principle

**Gaps are measured, not assumed.** The loop is: scan → triage by severity → fix
the cause → re-scan, until the automated gate is green; then complete the manual
attestation before any readiness claim.

**Be honest about scope (this is the rule that keeps the skill correct):** this is
**engineering assistance to prepare for compliance**, nothing more. It is **NOT**
legal advice, **NOT** a regulatory certification, **NOT** an EU MDR conformity
assessment or CE marking, **NOT** a Notified Body audit, **NOT** an ISO 27001
certification, and **NOT** a SOC 2 attestation. MDR conformity for medical-device
software (MDSW) additionally requires a QMS (ISO 13485), risk management
(ISO 14971), a clinical evaluation, and — for most classes — a Notified Body, none
of which this replaces. Heuristics have false positives and negatives. **Passing
the gate ≠ compliant.** Never report "GDPR/MDR/ISO/SOC 2 compliant" on a green
scan — report "0 blocking automated controls; manual attestation
pending/complete." → `references/01-frameworks-and-scope.md`

## When to use vs. not

- Use for: a compliance/readiness **gap analysis** of a health-AI codebase or data
  pipeline against GDPR / MDR / ISO 27001 / SOC 2; adding a compliance CI gate;
  drafting a DPIA / Records of Processing; preparing engineering evidence for an
  upcoming audit.
- Not for: obtaining an actual certification, CE mark, or audit opinion (those need
  external bodies); clinical validation or risk-management file authoring (regulatory
  program work); legal sign-off (needs counsel/DPO).

## Inputs to gather first

1. **What to audit** — path to the repo / pipeline (`targetDir`), and what to skip
   (vendored code, build output). → `references/03-running-the-scan.md`
2. **Which frameworks** — default all four (`GDPR`, `MDR`, `ISO27001`, `SOC2`);
   scope down if, e.g., the product isn't (yet) a medical device. → `references/01-frameworks-and-scope.md`
3. **Is it MDSW?** — does the software diagnose/treat/monitor/predict? That decides
   whether MDR applies and at what risk class (a regulatory call, not a code check).
4. **Gate bar** — default blocks on `blocking` only; add `major` for a release/
   audit-readiness bar.

## Workflow

Load each reference when you reach its step.

1. **Set frameworks & scope; internalize the honest scope.** Confirm which of the
   four apply, whether the software is MDSW, and that a green scan ≠ compliance. → `references/01-frameworks-and-scope.md`

2. **Review the control catalog.** 47 controls grouped by framework; ~29 are
   automated heuristics, the rest are manual attestations. → `references/02-control-catalog.md`

3. **Configure and run the scan** over the target repo; triage by severity. → `references/03-running-the-scan.md`
   ```bash
   cp scripts/compliance.config.example.json scripts/compliance.config.json   # edit targetDir, frameworks, gateSeverities, ignore
   python3 scripts/compliance_scan.py --config scripts/compliance.config.json
   echo "exit code: $?"     # 0 = gate green, 1 = blocking failure(s)
   ```

4. **Fix root causes** — secrets out of source, PII out of logs, encryption/TLS/
   RBAC/audit/retention config present, EU residency, ML artifacts (model card,
   lineage, SBOM, pinning). Re-scan after each fix. → `references/05-remediation-patterns.md`

5. **Re-scan until green** — `RESULT: PASS` and exit 0 on your chosen
   `gateSeverities`. A green run is **necessary, not sufficient**. → `references/03-running-the-scan.md`

6. **Draft the evidence** the audit needs — Records of Processing, a DPIA, and the
   ISO/SOC 2 evidence index. → `references/04-evidence-and-dpia.md`

7. **Complete the manual attestation** — DPIA, DPAs, ISO 14971 risk file, clinical
   evaluation, QMS, access reviews, incident response, vendor management — reviewed
   and signed by the right humans. → `references/06-manual-attestation.md`

## What's in this skill

- `scripts/compliance_scan.py` — the gate backbone: stdlib-only scanner that runs every automated heuristic over `targetDir`, maps findings to control + framework + severity, writes `report.json` + `report.md`, prints PASS/FAIL, and exits non-zero on blocking failures. Lists manual controls for attestation.
- `scripts/controls.json` — the 47-control catalog (GDPR / MDR / ISO 27001 / SOC 2), each `{id, title, frameworks, severity, check, heuristic?, remediation}`.
- `scripts/compliance.config.example.json` — `targetDir`, `frameworks`, `gateSeverities`, `ignore` globs, `outDir`.
- `scripts/requirements.txt` — intentionally dependency-free; the scan is standard-library Python 3.12.
- `references/01–06` — frameworks & honest scope, the control catalog, running/triaging the scan, evidence/RoPA/DPIA, remediation patterns, and the manual attestation with a sign-off record.

## Definition of done

- [ ] `compliance_scan.py` reports **0 blocking** automated controls on the chosen
      `gateSeverities`, and exits **0**, across the in-scope frameworks.
- [ ] Every automated failure was **fixed at the cause** (not silenced); evidence
      lines were checked, and any `ignore`/scope exclusion has a written reason.
- [ ] `major`/`minor` findings triaged into a backlog before external audit.
- [ ] RoPA drafted; DPIA drafted and DPO-reviewed; ISO/SOC 2 evidence index started.
- [ ] **Every `check:"manual"` control attested** by the right human, recorded in
      the sign-off block.
- [ ] Report archived (CI artifact); result stated as "0 blocking automated
      controls; manual attestation complete" — **not** "compliant."

## Guardrails — avoid these mistakes

- **Don't claim "compliant" from a green scan.** Overclaiming is the cardinal error
  here. State "0 blocking automated controls; manual attestation pending/complete."
  Compliance/certification requires external auditors, a Notified Body, and legal
  review — not this gate.
- **A pass is a non-detection, not a guarantee.** Heuristics miss things (false
  negatives) and flag innocents (false positives). Verify the cited evidence; the
  manual controls exist precisely because automation can't decide them.
- **Don't game the gate** — an empty `MODEL_CARD.md` or a `.gitignore` line isn't
  evidence of a real control. Auditors see through evidence theatre.
- **Don't widen `gateSeverities` or over-broaden `ignore`** to go green. Fix the
  cause; reserve scoping for genuine non-applicability, with a reason.
- **MDR is about intended purpose, not tech.** If the software diagnoses/treats/
  predicts, it's likely MDSW — get regulatory/clinical input early; this gate only
  checks engineering artifacts exist.
- **Never put real patient data in the repo** — fixtures, seeds, and notebooks use
  synthetic data only; rotate any secret that was ever committed.