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docs(healthcare): add US FDA, UK NHS, and Singapore MOH regulatory variants#24

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docs/contribution-scope
Jun 12, 2026
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docs(healthcare): add US FDA, UK NHS, and Singapore MOH regulatory variants#24
imran-siddique merged 1 commit into
mainfrom
docs/contribution-scope

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Summary

Adds three jurisdiction-specific policy + TRACE record variants to the healthcare demo, showing how the same cMCP + TRACE architecture maps to different regulatory frameworks. The Cedar policy rules and TRACE record fields change per jurisdiction; the runtime architecture does not.

Variant Jurisdiction Regulatory focus
us-fda-samd/ United States FDA AI/ML SaMD Action Plan -- cleared-scope enforcement (imaging modality gate), 21 CFR Part 820, HIPAA 164.312
uk-nhs/ United Kingdom UK GDPR Art. 22 -- DSPT token enforced at call layer, MHRA AI as medical device, clinician-review gate
sg-moh/ Singapore IMDA AI Governance Framework Tier 1/2 -- consequential-decision gate, PDPA consent reference, MOH guidelines

Updates the healthcare README with a variant index table.

What each variant includes

  • policy/<name>.cedar -- Cedar policy bundle with jurisdiction-specific forbid rules and @regulation annotations
  • trace-output/example-<name>-trust-record.json -- TRACE Trust Record with runtime.region, runtime.provider, and compliance_domains_touched set for that jurisdiction
  • README.md -- what the policy enforces, key TRACE fields for that regulator, and a cross-reference table

Key policy differences

  • US FDA: out-of-scope-modality forbid rule blocks inference on imaging types outside the device's cleared indication of use -- unique to this jurisdiction
  • UK NHS: DSPT access token is a runtime gate on every PHI call (dspt-required forbid), not just a configuration check; UK GDPR Art. 22 uses a "clinical significance" field rather than EU's risk-category model
  • Singapore: imda_tier is an explicit context field on every call; Tier 1 (consequential) requires a human_review_token unconditionally; PDPA consent reference enforced at call time, not just data collection

Relationship to existing demo

The base demo (healthcare/README.md) covers EU AI Act Art. 14 + HIPAA and remains unchanged. These variants are additive subdirectories following the same file structure.

…ry variants

Three new subdirectories each contain a Cedar policy file and a TRACE Trust
Record showing how cMCP + TRACE maps to jurisdiction-specific regulatory
requirements:

- us-fda-samd/: cleared-scope enforcement, HIPAA attestation, FDA SaMD
  Action Plan 2021 and 21 CFR Part 820
- uk-nhs/: UK GDPR Art. 22 clinician-review gate, NHS DSPT token, UK
  data residency (uk-south)
- sg-moh/: IMDA AI Governance Framework Tier 1/2 consequential-decision
  gate, PDPA consent reference enforced at call layer, Singapore data
  residency (ap-southeast-1)

healthcare/README.md gains a Regulatory Variants index table.
@imran-siddique imran-siddique force-pushed the docs/contribution-scope branch from 3e9cd10 to d1d1f6e Compare June 12, 2026 21:03
@imran-siddique imran-siddique merged commit 2684e9c into main Jun 12, 2026
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