docs/regulatory_basis_registry.v1.json

{
  "schema_version": "stem-ai-regulatory-basis-registry-v1",
  "as_of": "May 2026",
  "display_note": {
    "title": "Regulatory basis note",
    "body_line_1": "Aligned to current official source classes as of June 2026: EU AI Act (Regulation (EU) 2024/1689), FDA QMSR, FDA AI-enabled device guidance themes, IMDRF SaMD/GMLP frameworks, and ICH M15 General Principles for Model-Informed Drug Development.",
    "body_line_2": "This is a traceability aid, not a compliance or clearance determination."
  },
  "sources": [
    {
      "id": "eu_ai_act_2024_1689",
      "jurisdiction": "EU",
      "title": "EU AI Act (Regulation (EU) 2024/1689)",
      "status": "law_in_force",
      "published_date": "2024-07-12",
      "effective_date": "2024-08-01",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689",
      "used_for": ["article_10", "article_11", "article_12", "article_13", "article_14", "article_15"],
      "notes": "Use as legal source text; do not infer application milestones from this field alone."
    },
    {
      "id": "eu_ai_act_timeline_ec",
      "jurisdiction": "EU",
      "title": "European Commission AI Act timeline and implementation page",
      "status": "final_framework",
      "published_date": null,
      "effective_date": "2026-08-02",
      "url": "https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai",
      "used_for": ["application_timeline"],
      "notes": "Use for application dates and phased implementation context."
    },
    {
      "id": "fda_qmsr",
      "jurisdiction": "US",
      "title": "FDA Quality Management System Regulation (QMSR)",
      "status": "final_guidance",
      "published_date": "2024-01-31",
      "effective_date": "2026-02-02",
      "url": "https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr",
      "used_for": ["qms", "iso_13485_aligned_scaffolding"],
      "notes": "Use for FDA quality-system-aligned structural evidence references."
    },
    {
      "id": "fda_mlmd_transparency_2024",
      "jurisdiction": "US",
      "title": "Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles",
      "status": "final_guidance",
      "published_date": "2024-06-13",
      "effective_date": null,
      "url": "https://www.fda.gov/medical-devices/software-medical-device-samd/transparency-machine-learning-enabled-medical-devices-guiding-principles",
      "used_for": ["transparency", "ifu_scaffolding", "workflow_fit", "limitations"],
      "notes": "Use for transparency-oriented note generation, not compliance conclusions."
    },
    {
      "id": "fda_pccp_2025",
      "jurisdiction": "US",
      "title": "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions",
      "status": "final_guidance",
      "published_date": "2025-08-18",
      "effective_date": null,
      "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial",
      "used_for": ["pccp_readiness", "change_control", "impact_assessment"],
      "notes": "Use for versioned change evidence and planned modification scaffolding."
    },
    {
      "id": "imdrf_samd_clinical_eval_2017",
      "jurisdiction": "IMDRF",
      "title": "Software as a Medical Device (SaMD): Clinical Evaluation",
      "status": "final_framework",
      "published_date": "2017-09-21",
      "effective_date": null,
      "url": "https://www.imdrf.org/documents/software-medical-device-samd-clinical-evaluation",
      "used_for": ["scientific_validity_signal", "analytical_validation_signal", "clinical_context_boundary_signal"],
      "notes": "Use for evidence family language; do not claim direct clinical validation."
    },
    {
      "id": "imdrf_gmlp_2025",
      "jurisdiction": "IMDRF",
      "title": "Good machine learning practice for medical device development: Guiding principles",
      "status": "final_framework",
      "published_date": "2025-01-29",
      "effective_date": null,
      "url": "https://www.imdrf.org/documents/good-machine-learning-practice-medical-device-development-guiding-principles",
      "used_for": ["gmlp", "lifecycle_discipline", "human_ai_team", "risk_management"],
      "notes": "Use for lifecycle-discipline and transparency-adjacent references."
    },
    {
      "id": "ich_m15_midd_2026",
      "jurisdiction": "ICH",
      "title": "ICH M15 General Principles for Model-Informed Drug Development",
      "status": "final_guideline",
      "published_date": "2026-01-01",
      "effective_date": null,
      "url": "https://www.ich.org/page/multidisciplinary-guidelines",
      "used_for": [
        "midd_context_of_use",
        "model_verification",
        "model_validation_applicability",
        "model_analysis_plan",
        "model_analysis_report",
        "code_data_submission",
        "regulatory_framework_signal"
      ],
      "sections": {
        "2.1.2": "Context of Use — role and scope of model must be explicitly described",
        "3": "Model Evaluation — Verification, Validation, and Applicability Assessment",
        "4.1": "Model Analysis Plan (MAP) — pre-defined documentation of intended analysis",
        "4.2": "Model Analysis Report (MAR) — results, evaluation, and technical criteria",
        "4.3": "Documentation for Regulatory Submissions — code, data, and scripts must be available for review"
      },
      "notes": "Post-hoc alignment: STEM BIO-AI rubric items were designed before M15 adoption. Alignment is confirmed but not causally derived from M15. Cite as supporting regulatory context, not as compliance determination."
    }
  ]
}