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US Food and Drug Administration artificial intelligence US ","u":"/r/fda-ai-guidance","k":"instrument · US Food and Drug Administration","i":"fda-ai-guidance","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA AI device list — FDA list of AI-enabled medical devices with marketing authorisation","b":"A dated and periodically extended list of artificial-intelligence-enabled medical devices that have received FDA marketing authorisation. US Food and Drug Administration medical devices US ","u":"/r/fda-aiml-device-list","k":"instrument · US Food and Drug Administration","i":"fda-aiml-device-list","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA CDRH AI/ML — Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations","b":"FDA guidance addressing artificial-intelligence-enabled device software functions and predetermined change control plans. US Food and Drug Administration artificial intelligence software US ","u":"/r/fda-cdrh-aiml","k":"instrument · US Food and Drug Administration","i":"fda-cdrh-aiml","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA clinical decision support — Clinical Decision Support Software","b":"FDA guidance on clinical decision support software. US Food and Drug Administration  US ","u":"/r/fda-clinical-decision-support","k":"instrument · US Food and Drug Administration","i":"fda-clinical-decision-support","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA CSA — Computer Software Assurance for Production and Quality Management System Software","b":"FDA guidance addressing assurance activities for computer software used in production and quality systems. US Food and Drug Administration computer software quality management software US Computer Software Assurance CSA","u":"/r/fda-csa","k":"instrument · US Food and Drug Administration","i":"fda-csa","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA data integrity — Data Integrity and Compliance With Drug CGMP — Questions and Answers","b":"FDA guidance in question-and-answer form addressing data integrity expectations under the drug CGMP regulations. US Food and Drug Administration data integrity US ","u":"/r/fda-data-integrity","k":"instrument · US Food and Drug Administration","i":"fda-data-integrity","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA device cybersecurity (2026) — Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions","b":"FDA guidance on cybersecurity for medical devices, covering quality management system considerations and the content of premarket submissions. Issued February 2026 under docket FDA-2021-D-1158. US Food and Drug Administration cybersecurity US Quality Management System Considerations","u":"/r/fda-device-cybersecurity-2026","k":"instrument · US Food and Drug Administration","i":"fda-device-cybersecurity-2026","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA device cybersecurity — Cybersecurity in Medical Devices — Quality System Considerations and Content of Premarket Submissions","b":"FDA guidance on cybersecurity expectations for medical devices, covering quality system considerations and the content of premarket submissions. US Food and Drug Administration cybersecurity medical devices US Cybersecurity in Medical Devices premarket cybersecurity","u":"/r/fda-device-cybersecurity","k":"instrument · US Food and Drug Administration","i":"fda-device-cybersecurity","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA electronic systems (clinical) — Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations","b":"FDA questions-and-answers guidance on electronic systems, electronic records and electronic signatures used in clinical investigations. US Food and Drug Administration  US ","u":"/r/fda-electronic-systems-clinical","k":"instrument · US Food and Drug Administration","i":"fda-electronic-systems-clinical","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA/EMA AI principles — Guiding Principles of Good AI Practice in Drug Development","b":"Ten principles jointly issued by the FDA and EMA addressing the use of artificial intelligence across the product lifecycle, including manufacturing. US Food and Drug Administration and European Medicines Agency  International ","u":"/r/fda-ema-good-ai-practice","k":"instrument · US Food and Drug Administration and European Medicines Agency","i":"fda-ema-good-ai-practice","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA ETP — FDA Emerging Technology Program","b":"CDER programme through which companies may discuss novel technology with the agency ahead of a regulatory submission. US Food and Drug Administration  US ","u":"/r/fda-etp","k":"instrument · US Food and Drug Administration","i":"fda-etp","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA GMLP guiding principles — Good Machine Learning Practice for Medical Device Development: Guiding Principles","b":"Guiding principles published by FDA with Health Canada and the MHRA. Admitted from the publisher's own member listing; no status has been read and none is pre-filled. US Food and Drug Administration machine learning medical device US Good Machine Learning Practice for Medical Device Development: Guiding Principles GMLP guiding principles","u":"/r/fda-gmlp","k":"instrument · US Food and Drug Administration","i":"fda-gmlp","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA guidance agenda — FDA CDER Guidance Agenda","b":"Annual list of new and revised draft guidances CDER plans to publish during the calendar year. US Food and Drug Administration  US ","u":"/r/fda-guidance-agenda","k":"instrument · US Food and Drug Administration","i":"fda-guidance-agenda","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA Part 11 scope — Part 11, Electronic Records; Electronic Signatures — Scope and Application","b":"FDA guidance describing how the agency intends to interpret and enforce 21 CFR Part 11. A separate document from the rule text. US Food and Drug Administration electronic records electronic signatures US Part 11 Part 11 Scope and Application Scope and Application","u":"/r/fda-part-11-scope","k":"instrument · US Food and Drug Administration","i":"fda-part-11-scope","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA PCCP — Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions","b":"FDA guidance on predetermined change control plans for artificial-intelligence-enabled device software functions. US Food and Drug Administration software US PCCP Predetermined Change Control Plan","u":"/r/fda-pccp","k":"instrument · US Food and Drug Administration","i":"fda-pccp","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA postmarket cybersecurity — Postmarket Management of Cybersecurity in Medical Devices","b":"FDA guidance addressing the postmarket management of cybersecurity in medical devices. The premarket counterpart is tracked separately. US Food and Drug Administration  US ","u":"/r/fda-postmarket-cybersecurity","k":"instrument · US Food and Drug Administration","i":"fda-postmarket-cybersecurity","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA process analytical framework — PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance","b":"FDA guidance describing a framework for process analytical technology, including how process data may support real-time release testing. US Food and Drug Administration manufacturing US ","u":"/r/fda-process-analytical-framework","k":"instrument · US Food and Drug Administration","i":"fda-process-analytical-framework","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"FDA software validation — General Principles of Software Validation","b":"FDA guidance on validation of software used in medical devices and in the production of regulated products. Predates Computer Software Assurance and remains extant. US Food and Drug Administration validation software US General Principles of Software Validation GPSV","u":"/r/fda-software-validation","k":"instrument · US Food and Drug Administration","i":"fda-software-validation","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Health Canada ML — Health Canada guidance on machine learning medical devices","b":"Health Canada guidance addressing machine-learning-enabled medical devices. Health Canada machine learning medical devices Canada ","u":"/r/health-canada-ml","k":"instrument · Health Canada","i":"health-canada-ml","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ICH E6(R3) — ICH E6(R3) — Good Clinical Practice","b":"ICH guideline on good clinical practice, revised to address data governance and computerised systems in trials. International Council for Harmonisation clinical International E6(R3) GCP Good Clinical Practice ICH E6(R3)","u":"/r/ich-e6r3","k":"instrument · International Council for Harmonisation","i":"ich-e6r3","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ICH Q12 — ICH Q12 — Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management","b":"ICH guideline introducing established conditions and post-approval change management protocols for lifecycle management. International Council for Harmonisation  International ICH Q12 Q 12 Q-12 Q12","u":"/r/ich-q12","k":"instrument · International Council for Harmonisation","i":"ich-q12","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ICH Q13 — ICH Q13 — Continuous Manufacturing of Drug Substances and Drug Products","b":"ICH guideline addressing scientific and regulatory considerations for continuous manufacturing. International Council for Harmonisation manufacturing International ICH Q13 Q 13 Q-13 Q13","u":"/r/ich-q13","k":"instrument · International Council for Harmonisation","i":"ich-q13","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ICH Q14 — ICH Q14 — Analytical Procedure Development","b":"ICH guideline on the development of analytical procedures, adopted alongside the ICH Q2(R2) revision. International Council for Harmonisation  International ICH Q14 Q 14 Q-14 Q14","u":"/r/ich-q14","k":"instrument · International Council for Harmonisation","i":"ich-q14","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ICH Q2(R2) — ICH Q2(R2) — Validation of Analytical Procedures","b":"ICH guideline on the validation of analytical procedures, revised alongside ICH Q14. International Council for Harmonisation validation International ICH Q2(R2) Q2(R2)","u":"/r/ich-q2r2","k":"instrument · International Council for Harmonisation","i":"ich-q2r2","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ICH Q9(R1) — ICH Q9(R1) — Quality Risk Management","b":"ICH guideline on quality risk management, revised to address subjectivity, formality and risk-based decision-making. International Council for Harmonisation risk management International ICH Q9(R1) Q9(R1) Quality Risk Management","u":"/r/ich-q9r1","k":"instrument · International Council for Harmonisation","i":"ich-q9r1","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"IEC 62304 — IEC 62304 — Medical device software life cycle processes","b":"Standard defining life cycle requirements for medical device software, including software safety classification. ISO/IEC software International 62304 IEC 62304 IEC-62304 IEC62304","u":"/r/iec-62304","k":"instrument · ISO/IEC","i":"iec-62304","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"IEC 62443 — IEC 62443 series — Security for industrial automation and control systems","b":"Standard family addressing security for industrial automation and control systems, including secure development lifecycle requirements and component security requirements. IEC / ISA security International 62443 IEC 62443 IEC-62443 IEC62443 ISA-62443","u":"/r/iec-62443","k":"instrument · IEC / ISA","i":"iec-62443","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"IEC 81001-5-1 — IEC 81001-5-1 — Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle","b":"IEC catalogue entry for a standard on security activities in the product life cycle of health software and health IT systems. The text is sold rather than published. IEC security International IEC 81001-5-1 IEC 81001-5-1:2021 81001-5-1","u":"/r/iec-81001-5-1","k":"instrument · IEC","i":"iec-81001-5-1","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"IEEE 7000 — IEEE 7000 series — Ethical and systems standards for AI","b":"Series of IEEE standards addressing ethical and systems considerations in the design of autonomous and intelligent systems. Institute of Electrical and Electronics Engineers  International 7000 IEEE 7000 IEEE-7000 IEEE7000","u":"/r/ieee-7000","k":"instrument · Institute of Electrical and Electronics Engineers","i":"ieee-7000","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"IMDRF AI/ML WG — IMDRF artificial intelligence working group outputs","b":"Outputs of the IMDRF working group addressing artificial intelligence and machine learning in medical devices. International Medical Device Regulators Forum artificial intelligence International ","u":"/r/imdrf-aiml-wg","k":"instrument · International Medical Device Regulators Forum","i":"imdrf-aiml-wg","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"IMDRF SaMD — IMDRF Software as a Medical Device documents","b":"Documents published by IMDRF addressing software as a medical device and machine learning. International Medical Device Regulators Forum software International ","u":"/r/imdrf-samd","k":"instrument · International Medical Device Regulators Forum","i":"imdrf-samd","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO 13485 — ISO 13485 — Medical devices, quality management systems","b":"Standard specifying quality management system requirements for organisations involved in the medical device life cycle. ISO/IEC quality management medical devices International 13485 ISO 13485 ISO-13485 ISO13485","u":"/r/iso-13485","k":"instrument · ISO/IEC","i":"iso-13485","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO 14971 — ISO 14971 — Application of risk management to medical devices","b":"Standard specifying a process for managing risks associated with medical devices, including software. ISO/IEC risk management medical devices International 14971 ISO 14971 ISO-14971 ISO14971","u":"/r/iso-14971","k":"instrument · ISO/IEC","i":"iso-14971","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO 81001-1 — ISO 81001-1 — Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts","b":"ISO Online Browsing Platform entry for the foundational part of the 81001 series on health software and health IT systems safety, effectiveness and security. The full text is not public by licence. ISO health software International ISO 81001-1 ISO 81001-1:2021 81001-1","u":"/r/iso-81001-1","k":"instrument · ISO","i":"iso-81001-1","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO/IEC 22989 — ISO/IEC 22989 — Artificial intelligence concepts and terminology","b":"Standard establishing terminology and concepts for artificial intelligence. ISO/IEC artificial intelligence International IEC 22989 IEC-22989 IEC22989","u":"/r/iso-iec-22989","k":"instrument · ISO/IEC","i":"iso-iec-22989","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO/IEC 23894 — ISO/IEC 23894 — AI guidance on risk management","b":"International standard providing guidance on risk management for artificial intelligence. ISO/IEC risk management International IEC 23894 IEC-23894 IEC23894","u":"/r/iso-iec-23894","k":"instrument · ISO/IEC","i":"iso-iec-23894","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO/IEC 24028 — ISO/IEC 24028 — Overview of trustworthiness in artificial intelligence","b":"Technical report giving an overview of trustworthiness in artificial intelligence systems. ISO/IEC artificial intelligence trustworthiness International IEC 24028 IEC-24028 IEC24028","u":"/r/iso-iec-24028","k":"instrument · ISO/IEC","i":"iso-iec-24028","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO/IEC 27001 — ISO/IEC 27001:2022 — Information security management systems","b":"Standard specifying requirements for an information security management system. Named in the draft revision of EU GMP Annex 11 as an aligned framework. ISO/IEC security information security International 27001 IEC 27001 IEC-27001 IEC27001 ISO 27001 ISO/IEC 27001","u":"/r/iso-iec-27001","k":"instrument · ISO/IEC","i":"iso-iec-27001","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO/IEC 27002 — ISO/IEC 27002:2022 — Information security controls","b":"Companion standard to ISO/IEC 27001 setting out information security controls and implementation guidance. ISO/IEC security information security International 27002 IEC 27002 IEC-27002 IEC27002 ISO 27002","u":"/r/iso-iec-27002","k":"instrument · ISO/IEC","i":"iso-iec-27002","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO/IEC 27017:2026 — ISO/IEC 27017:2026 — Information security controls based on ISO/IEC 27002 for cloud services","b":"Second edition of the ISO/IEC standard setting out information security controls for cloud services, based on ISO/IEC 27002. Recorded from the publisher's catalogue entry; the text is not public by licence. ISO/IEC information security International ISO/IEC 27017:2026 IEC 27017:2026 27017:2026","u":"/r/iso-iec-27017-2026","k":"instrument · ISO/IEC","i":"iso-iec-27017-2026","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO/IEC 27017 — ISO/IEC 27017 — Information security controls for cloud services","b":"A consensus standard published as \"Information security controls for cloud services\". The text is not public by licence; this row tracks the catalogue entry. ISO/IEC security information security International IEC 27017 IEC-27017 IEC27017","u":"/r/iso-iec-27017","k":"instrument · ISO/IEC","i":"iso-iec-27017","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO/IEC 27018:2025 — ISO/IEC 27018:2025 — Protection of personally identifiable information in public clouds acting as PII processors","b":"Third edition of the ISO/IEC standard on protection of personally identifiable information in public clouds acting as PII processors. Recorded from the publisher's catalogue entry; the text is not public by licence. ISO/IEC information security International ISO/IEC 27018:2025 IEC 27018:2025 27018:2025","u":"/r/iso-iec-27018-2025","k":"instrument · ISO/IEC","i":"iso-iec-27018-2025","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO/IEC 27018 — ISO/IEC 27018 — Protection of personally identifiable information in public clouds","b":"Standard giving a code of practice for protection of personally identifiable information processed in public cloud computing services. ISO/IEC  International IEC 27018 IEC-27018 IEC27018","u":"/r/iso-iec-27018","k":"instrument · ISO/IEC","i":"iso-iec-27018","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO/IEC 38507 — ISO/IEC 38507 — Governance implications of the use of AI","b":"Standard addressing the governance implications of organisational use of artificial intelligence. ISO/IEC governance International IEC 38507 IEC-38507 IEC38507","u":"/r/iso-iec-38507","k":"instrument · ISO/IEC","i":"iso-iec-38507","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO/IEC 42001 — ISO/IEC 42001 — Artificial intelligence management system","b":"International standard specifying requirements for establishing and maintaining an artificial intelligence management system. ISO/IEC artificial intelligence International 42001 AI management system IEC 42001 IEC-42001 IEC42001 ISO 42001","u":"/r/iso-iec-42001","k":"instrument · ISO/IEC","i":"iso-iec-42001","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO/IEC 42005 — ISO/IEC 42005 — AI system impact assessment","b":"Standard addressing impact assessment for artificial intelligence systems. ISO/IEC  International IEC 42005 IEC-42005 IEC42005","u":"/r/iso-iec-42005","k":"instrument · ISO/IEC","i":"iso-iec-42005","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO/IEC 5259 — ISO/IEC 5259 series — Data quality for analytics and machine learning","b":"Multi-part standard series addressing data quality for analytics and machine learning. ISO/IEC machine learning data quality International IEC 5259 IEC-5259 IEC5259","u":"/r/iso-iec-5259","k":"instrument · ISO/IEC","i":"iso-iec-5259","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISO/IEC SC 42 — ISO/IEC JTC 1/SC 42 work programme","b":"Published work programme of the ISO/IEC subcommittee responsible for artificial intelligence standards, listing projects and their stage codes. ISO/IEC  International SC 42 SC-42 SC42","u":"/r/iso-iec-sc42-programme","k":"instrument · ISO/IEC","i":"iso-iec-sc42-programme","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"GAMP AI Guide — ISPE GAMP Guide: Artificial Intelligence","b":"Industry guide published by ISPE addressing artificial intelligence within the GAMP framework. ISPE artificial intelligence International GAMP GAMP AI GAMP AI Guide","u":"/r/ispe-gamp-ai","k":"instrument · ISPE","i":"ispe-gamp-ai","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISPE GAMP RDI — ISPE GAMP Guide — Records and Data Integrity","b":"ISPE guidance in the GAMP family addressing records and data integrity, sold through the society's publications catalogue. International Society for Pharmaceutical Engineering  International ","u":"/r/ispe-gamp-rdi","k":"instrument · International Society for Pharmaceutical Engineering","i":"ispe-gamp-rdi","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"GAMP 5 2nd Ed — ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition)","b":"Industry guide published by ISPE addressing computerised systems in regulated environments. ISPE  International GAMP GAMP 5 GAMP 5 Second Edition GAMP5","u":"/r/ispe-gamp5-2e","k":"instrument · ISPE","i":"ispe-gamp5-2e","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"ISPE Pharma 4.0 — ISPE Pharma 4.0 programme outputs","b":"ISPE programme publishing guidance and outputs on digitalisation in regulated manufacturing. International Society for Pharmaceutical Engineering  International ","u":"/r/ispe-pharma-4-0","k":"instrument · International Society for Pharmaceutical Engineering","i":"ispe-pharma-4-0","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"MHRA AI Airlock — MHRA AI Airlock regulatory sandbox","b":"MHRA regulatory sandbox for artificial-intelligence-enabled medical devices. Medicines and Healthcare products Regulatory Agency  UK ","u":"/r/mhra-ai-airlock","k":"instrument · Medicines and Healthcare products Regulatory Agency","i":"mhra-ai-airlock","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"MHRA AI — MHRA publications on AI and software as a medical device","b":"MHRA publications addressing software and artificial intelligence as a medical device. Medicines and Healthcare products Regulatory Agency software UK ","u":"/r/mhra-ai","k":"instrument · Medicines and Healthcare products Regulatory Agency","i":"mhra-ai","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"MHRA data integrity — MHRA GxP Data Integrity Guidance and Definitions","b":"MHRA guidance on data integrity expectations across GxP, with definitions used by inspectors. Medicines and Healthcare products Regulatory Agency data integrity UK GxP Data Integrity Guidance MHRA GxP Data Integrity","u":"/r/mhra-data-integrity","k":"instrument · Medicines and Healthcare products Regulatory Agency","i":"mhra-data-integrity","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"NIST agent standards — NIST standards initiative on autonomous AI agents","b":"NIST programme of work addressing standards for autonomous artificial-intelligence agents. US National Institute of Standards and Technology  US ","u":"/r/nist-agent-standards","k":"instrument · US National Institute of Standards and Technology","i":"nist-agent-standards","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"NIST AI 600-1 — NIST AI 600-1 — Generative AI Profile","b":"NIST technical series publication issued as a companion profile to the AI Risk Management Framework, which is tracked separately as nist-ai-rmf. US National Institute of Standards and Technology  US ","u":"/r/nist-ai-600-1","k":"instrument · US National Institute of Standards and Technology","i":"nist-ai-600-1","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"NIST AI RMF Playbook — NIST AI RMF Playbook and crosswalks","b":"Companion resources to the NIST AI Risk Management Framework, including the playbook and crosswalks to other frameworks. US National Institute of Standards and Technology  US ","u":"/r/nist-ai-rmf-playbook","k":"instrument · US National Institute of Standards and Technology","i":"nist-ai-rmf-playbook","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"NIST AI RMF — NIST AI Risk Management Framework 1.0","b":"Voluntary framework describing functions for managing risks associated with artificial intelligence systems. US National Institute of Standards and Technology risk management International AI RMF AI RMF 1.0 NIST AI 100-1 NIST AI RMF","u":"/r/nist-ai-rmf","k":"instrument · US National Institute of Standards and Technology","i":"nist-ai-rmf","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"NIST CSF 2.0 — NIST Cybersecurity Framework 2.0","b":"NIST framework organising cybersecurity outcomes into functions, categories and subcategories. Referenced alongside NIST SP 800-82 in operational technology security work. US National Institute of Standards and Technology cybersecurity US CSF CSF 2.0 CSWP 29 NIST Cybersecurity Framework","u":"/r/nist-csf","k":"instrument · US National Institute of Standards and Technology","i":"nist-csf","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"NIST SP 800-82 — NIST SP 800-82 — Guide to Operational Technology Security","b":"NIST guidance on securing operational technology, including industrial control systems, referenced in work harmonising OT security practice. US National Institute of Standards and Technology security US 800-82 OT Security Guide SP 800-82 SP-800-82 SP800-82","u":"/r/nist-sp-800-82","k":"instrument · US National Institute of Standards and Technology","i":"nist-sp-800-82","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"NISTIR 8183 — NISTIR 8183 — Cybersecurity Framework Manufacturing Profile","b":"Document published by National Institute of Standards and Technology, sourced by the publisher's own page as read on 2026-08-12. National Institute of Standards and Technology  US NISTIR 8183 Cybersecurity Framework Manufacturing Profile","u":"/r/nistir-8183","k":"instrument · National Institute of Standards and Technology","i":"nistir-8183","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"NMPA portal — NMPA English portal — front page","b":"The English-language front page of China's National Medical Products Administration portal. A navigation page; no document is tracked here. National Medical Products Administration artificial intelligence China ","u":"/r/nmpa-ai","k":"instrument · National Medical Products Administration","i":"nmpa-ai","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"PDA TR 80 — PDA Technical Report No. 80 — Data Integrity Management System for Pharmaceutical Laboratories","b":"Technical report published by the Parenteral Drug Association and listed in the publisher's own catalogue of current publications. The text is sold through the PDA bookstore. Parenteral Drug Association data integrity International PDA TR 80 TR 80 TR-80 TR80","u":"/r/pda-tr-80","k":"instrument · Parenteral Drug Association","i":"pda-tr-80","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"PIC/S GMP Guide — PIC/S Guide to Good Manufacturing Practice","b":"GMP guide maintained by PIC/S and applied by participating inspectorates, including annexes on computerised systems and data integrity. Pharmaceutical Inspection Co-operation Scheme good manufacturing practice manufacturing International ","u":"/r/pic-s","k":"instrument · Pharmaceutical Inspection Co-operation Scheme","i":"pic-s","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"PIC/S Annex 11 — PIC/S GMP Guide, Annex 11 — Computerised Systems","b":"The PIC/S GMP guide annex on computerised systems, published and revised separately from the EU instrument of the same number. Pharmaceutical Inspection Co-operation Scheme computerised systems International Annex 11 PIC/S Annex 11","u":"/r/pics-annex-11","k":"instrument · Pharmaceutical Inspection Co-operation Scheme","i":"pics-annex-11","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"PIC/S PI 011 — PIC/S PI 011 — Good practices for computerised systems in regulated GxP environments","b":"PIC/S guidance document on good practices for computerised systems in regulated GxP environments, distributed from the scheme's publications index. Pharmaceutical Inspection Co-operation Scheme  International ","u":"/r/pics-pi-011","k":"instrument · Pharmaceutical Inspection Co-operation Scheme","i":"pics-pi-011","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"PIC/S PI 041 — PIC/S PI 041 — Good Practices for Data Management and Integrity","b":"PIC/S document addressing good practices for data management and integrity in regulated environments. Pharmaceutical Inspection Co-operation Scheme  International Good Practices for Data Management PI 041 PI-041 PI041 PIC/S PI 041","u":"/r/pics-pi041","k":"instrument · Pharmaceutical Inspection Co-operation Scheme","i":"pics-pi041","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"PMDA AI — PMDA publications on AI in medical products","b":"PMDA publications addressing artificial intelligence in medical products. Pharmaceuticals and Medical Devices Agency  Japan ","u":"/r/pmda-ai","k":"instrument · Pharmaceuticals and Medical Devices Agency","i":"pmda-ai","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"prEN 18229-1 — prEN 18229-1 — Trustworthiness framework for AI (Part 1)","b":"Draft European standard developed under CEN/CENELEC JTC 21 in support of the EU AI Act. CEN/CENELEC JTC 21 trustworthiness EU Part 1","u":"/r/pren-18229-1","k":"instrument · CEN/CENELEC JTC 21","i":"pren-18229-1","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"prEN 18229-2 — prEN 18229-2 — Trustworthiness framework for AI (Part 2)","b":"Draft European standard developed under CEN/CENELEC JTC 21 in support of the EU AI Act. CEN/CENELEC JTC 21 trustworthiness EU Part 2","u":"/r/pren-18229-2","k":"instrument · CEN/CENELEC JTC 21","i":"pren-18229-2","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"prEN 18281 — prEN 18281 — AI quality management","b":"Draft European standard developed under CEN/CENELEC JTC 21 in support of the EU AI Act. CEN/CENELEC JTC 21 quality management EU ","u":"/r/pren-18281","k":"instrument · CEN/CENELEC JTC 21","i":"pren-18281","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"prEN 18282 — prEN 18282 — AI conformity assessment","b":"Draft European standard developed under CEN/CENELEC JTC 21 in support of the EU AI Act. CEN/CENELEC JTC 21  EU ","u":"/r/pren-18282","k":"instrument · CEN/CENELEC JTC 21","i":"pren-18282","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Swissmedic — Swissmedic publications on medical device software","b":"Swissmedic publications addressing medical device software. Swissmedic software Switzerland ","u":"/r/swissmedic-ai","k":"instrument · Swissmedic","i":"swissmedic-ai","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"TGA SaMD — TGA regulation of software as a medical device","b":"TGA material addressing the regulation of software-based medical devices. Therapeutic Goods Administration software Australia ","u":"/r/tga-samd","k":"instrument · Therapeutic Goods Administration","i":"tga-samd","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"21 CFR Part 11 — 21 CFR Part 11 — Electronic Records; Electronic Signatures","b":"US regulation setting criteria under which electronic records and electronic signatures are considered trustworthy and reliable. US Food and Drug Administration electronic records electronic signatures US 21 CFR 11 21CFR11 Electronic Records; Electronic Signatures Part 11","u":"/r/us-21-cfr-part-11","k":"instrument · US Food and Drug Administration","i":"us-21-cfr-part-11","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"21 CFR Part 211 — 21 CFR Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals","b":"The US current good manufacturing practice regulations for finished pharmaceuticals, including provisions on automatic and electronic equipment, record retention and laboratory records. US Food and Drug Administration good manufacturing practice manufacturing US 21 CFR 211 cGMP for finished pharmaceuticals Part 211","u":"/r/us-21-cfr-part-211","k":"instrument · US Food and Drug Administration","i":"us-21-cfr-part-211","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"21 CFR Part 820 (QMSR) — 21 CFR Part 820 — Quality Management System Regulation","b":"US regulation setting out quality management system requirements for medical devices, codified in title 21 of the Code of Federal Regulations. US Food and Drug Administration  US ","u":"/r/us-21-cfr-part-820","k":"instrument · US Food and Drug Administration","i":"us-21-cfr-part-820","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"WHO AI health — WHO guidance on artificial intelligence for health","b":"WHO guidance addressing the ethics and governance of artificial intelligence for health. World Health Organization artificial intelligence International ","u":"/r/who-ai-health","k":"instrument · World Health Organization","i":"who-ai-health","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"WHO data management — WHO Annex 5 — Guidance on Good Data and Record Management Practices","b":"WHO guidance on good data and record management practices, published as an annex to a WHO Expert Committee technical report. World Health Organization  International Annex 5 Good Data and Record Management Practices WHO Annex 5","u":"/r/who-annex5-data-management","k":"instrument · World Health Organization","i":"who-annex5-data-management","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"WHO computerised systems — WHO guideline on computerised systems and data integrity","b":"WHO technical guidance addressing computerised systems and data integrity in pharmaceutical manufacture. World Health Organization data integrity computerised systems International ","u":"/r/who-computerised-systems","k":"instrument · World Health Organization","i":"who-computerised-systems","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"WHO data integrity guideline — WHO Annex 4 — Guideline on data integrity","b":"WHO guideline on data integrity, published as Annex 4 to WHO Technical Report Series No. 1033, the fifty-fifth report of the Expert Committee on Specifications for Pharmaceutical Preparations. World Health Organization data integrity International WHO TRS 1033 Annex 4 TRS 1033 Annex 4 WHO Annex 4","u":"/r/who-trs1033-annex4-data-integrity","k":"instrument · World Health Organization","i":"who-trs1033-annex4-data-integrity","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Sources that return HTTP 200 to a browser and a non-200 to an AI-agent user-agent: not measured","b":"Count of sources where the browser user-agent received HTTP 200 and the AI-agent user-agent did not, on the same URL, seconds apart. This archive sent an agent request to 0 of 132 probed sources: it no longer requests a host as an agent that host's robots.txt refuses, so an observed refusal can only come from a host that permits the agent and then declines it.","u":"/findings#ai-agent-blocks","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"8 source(s) name an AI agent in robots.txt and disallow it from the whole site","b":"Count of sources whose robots.txt carries a group naming an AI agent with `Disallow: /`. Read from the publisher's own file, identifying as this archive. No request is sent to a host that refuses the agent by name.","u":"/findings#ai-agent-declared-exclusions","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"11 of 11 declared API sources observed","b":"Count of declared API sources with at least one observation recorded. A source requiring a credential that is not configured is recorded as unobserved on every run rather than omitted, so the gap is visible in the series instead of resembling an empty result.","u":"/findings#api-sources","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Sources that return HTTP 200 to an AI-agent user-agent and a non-200 to a browser: not measured","b":"The inverse of the preceding finding, recorded from the same two probes, and bounded the same way: an agent request was sent to 0 of 132 probed sources.","u":"/findings#browser-blocked","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"56 of 110 recorded candidate(s) resolved by rule, 54 with no verdict recorded, 0 confirmed by analysis, 0 confirmed by a person","b":"Every change candidate staged or ruled on here, by stage. A candidate's LATEST verdict decides its stage: one carries a person's confirmation, a chair-ordered withdrawal, a discard and a machine decline, and counting receipts would publish a person-confirmed item this record no longer holds. Rule classes come from the receipts' own words, so the vocabulary is the store's, not a list held here.","u":"/findings#change-pipeline","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"3 of 6 recorded committees have a scope quoted from their charter","b":"Count of body records carrying a non-empty scope. Scope must be the charter's own words; a charter that cannot be retrieved yields no scope rather than a paraphrase.","u":"/findings#committee-scope-quoted","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"84 of the 132 sources probed for crawlability return the document to a standard HTTP client (132 instruments are tracked in total)","b":"Each source URL is requested twice: once with a desktop browser user-agent and once with an AI-agent user-agent. `yes` means at least one request returned HTTP 200 with 600 or more characters of extractable text. No judgment about the publisher is expressed or implied.","u":"/findings#crawlability","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Longest interval between a recorded status date and today: us-21-cfr-part-11, 10,666 days","b":"For each verified instrument, the number of days from the date the SOURCE states for its status to today. This measures the age of the regulatory fact, NOT how long this archive has observed it — the observation series is far younger and its length is reported separately. No weighting is applied.","u":"/findings#days-in-status","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"1 tracked document(s) changed, 10 of 152 observed record(s) not retrieved, 54 of 110 recorded candidate(s) with no verdict recorded","b":"The figures in the nightly sentence, re-derived here from the stores rather than read from the page. `changed` counts tracked rows whose DOCUMENT-class observation changed on the run's day carrying no decline receipt for it. `not_retrieved` counts records dated that night whose own error field is non-empty, the population the watcher prints. `pending_review` counts queue candidates with no…","u":"/findings#front-door","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"8 of 110 recorded candidate(s) are offered as a change","b":"Counted from state/triple-projection.json, which derives the three limbs for every file in state/revision-staging/. `offered` is every derivation agreeing; `waiting` is a limb that has not been measured yet; `withheld` is the remainder, each carrying its own reason.","u":"/findings#front-line","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"13 of 132 tracked instruments name a producing committee","b":"Count of distinct instrument ids appearing in the produces list of any body record, intersected with the tracked corpus. Counting only: a committee producing more tracked instruments is the count says how many instruments a committee produced and nothing further about the committee.","u":"/findings#instruments-per-committee","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"119 tracked instruments name no producing committee","b":"Count of tracked instruments not appearing in any body produces list. States a gap in this archive's committee coverage; it is not evidence that no committee produced the document.","u":"/findings#instruments-without-committee","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"0 source URL(s) retrievable at first observation and not at the last","b":"Count of instruments whose most recent observation was not a direct read and which had at least one earlier observation with fetch_method=direct. Three classes are counted and reported separately: refused (fetch_method=blocked), gone (HTTP 404 or 410) and other non-direct. Sources not retrievable from the first observation are not counted as rot.","u":"/findings#link-rot","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Median days in current status: 1099","b":"Median of (today − status_as_of) in days, over instruments with a verified status and a recorded status date.","u":"/findings#median-days-in-status","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"98 days of continuous observation across 150 observed sources (132 instruments tracked)","b":"Count of calendar days from the first recorded observation to today, inclusive. Every tracked instrument is fetched and hashed on every run, including runs where nothing changed. The observed-source count exceeds the tracked count because observation records for instruments since removed from scope are retained rather than deleted — the series is not broken by a scope decision.","u":"/findings#observation-days","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"26 provision(s) tracked at article or section level; 0 with an applicability date still in the future","b":"Count of records in the provisions collection, and of those whose recorded applicability_date is later than today. Applicability is recorded per provision because instruments phase in across years and a single instrument-level date would be wrong for most of their articles.","u":"/findings#provisions-tracked","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"19 status pack(s) wait and 0 can be pressed","b":"Counted from state/packs/_index.json: the queued and withheld entries the confirm queue reads. `keypress` counts those its accept gate would admit; `blocked_on_collector` counts those whose pack states no corroborating passage or no capture, which a keystroke cannot supply.","u":"/findings#queue-status-packs","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"24 register row(s), by state: 0 CONFIRMED-DERIVED · 11 NOT-CHANGED · 13 UNDETERMINED · 0 CONFIRMED-MODEL-READ · 0 WAITING · 0 BLOCKED","b":"Population: register-tier rows whose checked_by reads machine, a tier method and not an act on a date. Each takes one of six states from its published status. A known status re-run by its recorded extraction rule is CONFIRMED-DERIVED only for an admitted signal family, and none is admitted. For an unknown status, NOT-STATED is NOT-CHANGED; STATED and UNMAPPED are UNDETERMINED; UNREAD is WAITING.","u":"/findings#register-states","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"0 revisions recorded: the collection holds none","b":"Count of records in the revisions collection by `change_class`. A revision is recorded when the SHA-256 of an instrument's normalised text differs from the previous observation. Detection currently holds 110 candidate(s), 110 unconfirmed; candidates are proposals and are not counted here.","u":"/findings#revisions-by-class","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"21 of 132 probed sources publish no robots policy this archive can read","b":"Count of sources whose /robots.txt could not be retrieved, or returned a body that is not a robots file, when requested with this archive's own user-agent. A policy that cannot be confirmed is not a permission: no agent probe is sent to these hosts.","u":"/findings#robots-unreadable","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"0 silent revision(s): content changed with no declared version or date change","b":"Count of revisions where the normalised text hash changed and no version identifier or declared date differed between the two observations. Version identifiers are matched by pattern in the normalised text. Detection currently holds 110 candidate(s), 110 unconfirmed; candidates are proposals and are not counted here.","u":"/findings#silent-revisions","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"14 standard(s) tracked by lifecycle stage; 8 with a stage code other than unverified","b":"Count of instruments with at least one standards-progression record. Stage codes are published openly by ISO, CEN/CENELEC and ICH even where the standard's text is paywalled, so progression is observable without reproducing any restricted text.","u":"/findings#standards-progression","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"0 row(s) carry a publisher-stated status; 3 unknown row(s) of 13 on a host with a status surface have one stated","b":"Rows reading unknown, UNMAPPED or in the unresolved verification state. For each on a host whose status surface this record reads (the GOV.UK Content API, NIST CSRC publication pages, FDA guidance pages and listing, and surveyed page markup), the latest reading's status field is asked whether the publisher's word spells a status value, case aside. A stated value is written by a publisher-stated…","u":"/findings#status-by-statement","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Status across the tracked corpus: 74 unknown, 39 final, 13 in-force, 3 draft, 2 withdrawn, 1 superseded","b":"Count of instruments by the `status` field, as recorded after human verification against the primary source. Instruments never verified are counted as `unknown`.","u":"/findings#status-distribution","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"16 of 107 recorded status value(s) unresolved; 25 row(s) sit off the verification axis in the register tier","b":"The verification axis is the tracked corpus minus the register tier, which promises no person-verification and is stated separately rather than folded into a total. A row is unresolved when its status is unknown, it is not frozen, and it records no status basis; each such row states what its status-term rule found.","u":"/findings#status-verification","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"55 of 57 recorded tier-1 member(s) carry the assignment; 37 carry a verified status","b":"THE POPULATION IS THE RATIFIED RULE, NOT THE DECLARED LIST ALONE. Tier 1 = the declared list in sources/tier1-declared.yaml, union the approved canon in state/canon-candidates.json, union a documented exception in docs/referents/declarations.json. Derived through scripts/tier_identity.py: 37 declared, 40 in the approved canon, 2 documented exception(s); the three overlap, so the union is smaller…","u":"/findings#tier1-coverage","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"2 documented exception(s) to the tier-1 rule","b":"A row named in the declared tier-1 list that carries no `tier: 1` because it is not a document. Each is recorded in docs/referents/declarations.json with its reason rather than special-cased in code: a name special-cased in code is a name satisfying a condition it does not meet. The reasons, verbatim: ema-qig: declared tier 1 and carries no `tier: 1` row because it is a BODY…","u":"/findings#tier1-exceptions","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"every instrument assigned tier 1 is admitted by the ratified rule","b":"THE POPULATION IS THE RATIFIED RULE. Count of rows literally carrying `tier: 1` whose id is in neither the declared list, nor the approved canon, nor the documented exceptions. A non-zero here means the tier assignment and the rule disagree, and it is reported rather than reconciled silently. A zero means they agree — a measured zero, derived through scripts/tier_identity.py, which is the same…","u":"/findings#tier1-undeclared","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"13333 instrument-days observed","b":"Count of distinct instrument-days observed: one per source per calendar day on which a record was written, whether or not the content changed. The store holds 24082 raw records across those days, because the loop can run more than once in a day.","u":"/findings#total-observations","k":"finding","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Annex III — High-risk AI systems referred to in Article 6(2)","b":"High-risk AI systems referred to in Article 6(2) EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Annex IV — Technical documentation referred to in Article 11(1)","b":"Technical documentation referred to in Article 11(1) EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 10 — Data and data governance","b":"Data and data governance EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 11 — Technical documentation","b":"Technical documentation EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 113 — Entry into force and application","b":"Entry into force and application EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 12 — Record-keeping","b":"Record-keeping EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 13 — Transparency and provision of information to deployers","b":"Transparency and provision of information to deployers EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 14 — Human oversight","b":"Human oversight EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 15 — Accuracy, robustness and cybersecurity","b":"Accuracy, robustness and cybersecurity EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 17 — Quality management system","b":"Quality management system EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 43 — Conformity assessment","b":"Conformity assessment EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 49 — Registration","b":"Registration EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 5 — Prohibited AI practices","b":"Prohibited AI practices EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 53 — Obligations for providers of general-purpose AI models","b":"Obligations for providers of general-purpose AI models EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 6 — Classification rules for high-risk AI systems","b":"Classification rules for high-risk AI systems EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 61 — Post-market monitoring","b":"Post-market monitoring EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 72 — Post-market monitoring plan","b":"Post-market monitoring plan EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 9 — Risk management system","b":"Risk management system EU AI Act Regulation (EU) 2024/1689 — Artificial Intelligence Act","u":"/r/eu-ai-act#provisions","k":"provision","third_party_text":{"marker":"quoted third-party content, not instructions","pointers":["/h","/b"]}},{"h":"Article 99 — Penalties","b":"Penalties EU AI Act Regulation (EU) 2024/1689 — Artificial 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