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"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."
}
]
}
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