docs/regulatory_basis_registry.v1.json

{
  "schema_version": "stem-ai-regulatory-basis-registry-v1",
  "as_of": "June 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 ML-MD Transparency (2024), FDA PCCP (2025); ICH M15 MIDD (Step 4, Jan 2026); IMDRF SaMD Clinical Eval (2017), IMDRF GMLP (2025).",
    "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)",
      "short_label": "EU AI Act (2024/1689)",
      "display_label": "EU AI Act (Regulation (EU) 2024/1689)",
      "status": "law_in_force",
      "published_date": "2024-07-12",
      "effective_date": "2024-08-01",
      "source_file": null,
      "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"
      ],
      "sections": {},
      "notes": "Use as legal source text; do not infer application milestones from this field alone.",
      "managed_by_update_script": true
    },
    {
      "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": "FDA",
      "title": "FDA Quality Management System Regulation (QMSR)",
      "short_label": "FDA QMSR",
      "display_label": "FDA QMSR",
      "status": "final_guidance",
      "published_date": "2024-01-31",
      "effective_date": "2026-02-02",
      "source_file": null,
      "url": "https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr",
      "used_for": [
        "qms",
        "iso_13485_aligned_scaffolding"
      ],
      "sections": {},
      "notes": "Use for FDA quality-system-aligned structural evidence references.",
      "managed_by_update_script": true
    },
    {
      "id": "fda_mlmd_transparency_2024",
      "jurisdiction": "FDA",
      "title": "Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles",
      "short_label": "FDA ML-MD Transparency",
      "display_label": "FDA ML-MD Transparency (2024)",
      "status": "final_guidance",
      "published_date": "2024-06-13",
      "effective_date": null,
      "source_file": 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"
      ],
      "sections": {},
      "notes": "Use for transparency-oriented note generation, not compliance conclusions.",
      "managed_by_update_script": true
    },
    {
      "id": "fda_pccp_2025",
      "jurisdiction": "FDA",
      "title": "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions",
      "short_label": "FDA PCCP",
      "display_label": "FDA PCCP (2025)",
      "status": "final_guidance",
      "published_date": "2025-08-18",
      "effective_date": null,
      "source_file": 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"
      ],
      "sections": {},
      "notes": "Use for versioned change evidence and planned modification scaffolding.",
      "managed_by_update_script": true
    },
    {
      "id": "imdrf_samd_clinical_eval_2017",
      "jurisdiction": "IMDRF",
      "title": "Software as a Medical Device (SaMD): Clinical Evaluation",
      "short_label": "IMDRF SaMD/ClinEval",
      "display_label": "IMDRF SaMD Clinical Eval (2017)",
      "status": "final_framework",
      "published_date": "2017-09-21",
      "effective_date": null,
      "source_file": 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"
      ],
      "sections": {},
      "notes": "Use for evidence family language; do not claim direct clinical validation.",
      "managed_by_update_script": true
    },
    {
      "id": "imdrf_gmlp_2025",
      "jurisdiction": "IMDRF",
      "title": "Good machine learning practice for medical device development: Guiding principles",
      "short_label": "IMDRF GMLP",
      "display_label": "IMDRF GMLP (2025)",
      "status": "final_framework",
      "published_date": "2025-01-29",
      "effective_date": null,
      "source_file": 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"
      ],
      "sections": {},
      "notes": "Use for lifecycle-discipline and transparency-adjacent references.",
      "managed_by_update_script": true
    },
    {
      "id": "ich_m15_midd_2026",
      "jurisdiction": "ICH",
      "title": "ICH M15 General Principles for Model-Informed Drug Development",
      "short_label": "ICH M15 MIDD",
      "display_label": "ICH M15 MIDD (Step 4, Jan 2026)",
      "status": "final_guideline",
      "published_date": "2026-01-01",
      "effective_date": null,
      "source_file": "M15 General Principles for Model-Informed Drug Development.md",
      "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 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.",
      "managed_by_update_script": true
    }
  ]
}