Documentary Synthesis Artificial Intelligence

2 Dec 2024 | Artificial intelligence

Documentary Synthesis Artificial Intelligence
European Union

 

Area

 Publication or last update date Text Theme Scope nexialist synthesis
EU 2016 Regulation (EU) 2016/679 on General Data Protective Regulation Data management Artificial intelligence Link
EU 2018 European Commission : Questions and Answers: coordinated plan for Artificial Intelligence “made in Europe” AI regulation Artificial intelligence
EU 2019 European Commission : Lignes directrices en matière d’éthique pour une IA digne de confiance Ethics Artificial intelligence
EU 2019 Pharmalex : White Paper – Software, artificial intelligence and medical devices – what’s up? AI regulation in healthcare Medical devices
EU 2019 BSI/MHRA/AAMI : The emergence of artificial intelligence and machine learning algorithms in healthcare: recommendations to support governance and regulation AI regulation in healthcare Healthcare
Germany 2019 DIN SPEC 92001-1:2019 – Life cycle processes and quality requirements – Part1:Quality Metamodel  Artificial intelligence Artificial intelligence
EU 2020 ALTAI : The assessment List for Trustworthy Artificial Intelligence (ALTAI)  Trustworthy AI Artificial intelligence
EU 2020 European Commission : White Paper on Artificial Intelligence: a European approach to excellence and trust AI regulation Artificial intelligence
EU 2020 JRC : Artificial Intelligence in Medicine and Healthcare: applications, availability and societal impact AI in healthcare Healthcare
EU 2020 COCIR : Artificial Intelligence in EU medical device legislation  AI regulation in healthcare Medical devices Link
EU 2020 BSI/AAMI : Machine learning AI in medical devices – Adapting Regulatory frameworks and standards to ensure safety and performance AI regulation in healthcare Medical devices
France 2020 HAS : Grille descriptive des fonctionnalités des dispositifs médicaux embarquant un système avec apprentissage automatique (intelligence artificielle) Reimbursment of medical devices with AI Medical devices
Germany 2020 DIN SPEC 92001-2:2020 – Life cycle Processes and Quality Requirements – Part 2: Robustness  Artificial intelligence Artificial intelligence
EU 2021 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS AI regulation Artificial intelligence Link
France 2021 Philippe Besse, Aurèle Besse-Patin, Céline Castets-Renard. Implications juridiques et éthiques des algorithmes d’intelligence artificielle dans le domaine de la santé. Statistique et Société, 2021. ⟨hal-02424285v2⟩ AI regulation in healthcare Healthcare
EU 2021 Muehlematter, U. J., Daniore, P., & Vokinger, K. N. (2021). Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20): a comparative analysis. The Lancet. Digital health, 3(3), e195–e203. https://doi.org/10.1016/S2589-7500(20)30292-2 AI regulation and medical devices Medical devices
EU 2021 JRC : AI Watch. Defining Artificial Intelligence 2.0 Definitions of AI Artificial intelligence
EU 2021 Medtech Europe response to the open public consultation on the Proposal for an Artificial Intelligence Act (COM/2021/206) AI regulation Artificial intelligence Link
EU 2021 European Commission : Study on eHealth, Interoperability of Health Data and Artificial Intelligence for Health and Care in the European Union AI regulation in healthcare Healthcare
EU 2021 TUV SUD : Artificial Intelligence in medical devices – verifying and validating AI-based medical devices Verification and validation of AI-medical device Medical devices
Netherlands 2021 Legal Analysis – European legislative proposal draft AI act and MDR/IVDR AI regulation and medical devices Medical devices Link
France 2021 LNE : Référentiel de certification intelligence artificielle Evaluation and certification of AI Artificial intelligence
EU 2021 European Commission : New rules for Artificial Intelligence – Questions and Answers AI regulation Artificial intelligence Link
France 2022 AFNOR : Feuille de route  stratégique pour la normalisation de l’intelligence artificielle AI standardization Artificial intelligence
France 2022 CNIL : IA comment être en conformité avec le RGPD GDPR and AI Artificial intelligence
France 2022 CNIL : Glossaire de l’intelligence artificielle  Definitions of AI Artificial intelligence
France 2022 CNIL : Quelques ressources utiles et accessibles à tous pour comprendre l’intelligence artificielle Definitions of AI Artificial intelligence
France 2022 CNIL : Intelligence artificielle, de quoi parle-t-on ?  Definitions of AI Artificial intelligence
France 2022 CNIL : Guide d’auto-évaluation pour les systèmes d’intelligence artificielle (IA) AI evaluation Artificial intelligence
France 2022 Laboratoire d’innovation numérique de la CNIL : Sécurité des systèmes d’IA Security of AI Artificial intelligence
EU 2022 JRC : Glossary of human-centric artificial intelligence Definitions of AI Artificial intelligence
EU 2022 Artificial intelligence in healthcare: Applications, risks, and ethical and societal impacts AI regulation in healthcare Healthcare
EU 2022 COCIR : Joint statement in support of the new legislative framework and the AI Act AI regulation in healthcare Healthcare Link
UK 2022 Independent report – Regulatory Horinzons Council: The regulation of Artificial Intelligence as a medical device AI regulation and medical devices Medical devices
France 2022 Avis commun CCNE/CNPEN Diagnostic médical et intelligence artificielle : enjeux éthiques Ethical AI in healthcare Healthcare
EU 2022 Team NB : Position Paper on the designation of notified bodies under the upcoming Artificial Intelligence Act Notified bodies Artificial intelligence Link
EU 2022 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on adapting non-contractual civil liability rules to artificial intelligence (AI Liability Directive) Liability rules to AI Artificial intelligence Link
EU 2022 Proposal for a Regulation of the European Parliament and of the Council laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending certain Union legislative acts – General approach (6 December 2022) AI regulation Artificial intelligence
EU 2022 MedTech Europe’s reaction to the EU Council’s General Approach on the AI Act Articulation between MD/IVD regulations and AI Act Medical devices
EU 2023 JRC : AI Watch. Artificial Intelligence Standardisation Landscape Update AI standardization Artificial intelligence
EU BSI : Recent Advancements in AI – Implications for medical device technology and certification AI regulation in healthcare Healthcare
France 2021 Law n°2021-1017 of 2 August 2021 on bioethics introducing article L4001-3 of the Public Health Code AI and ethics Healthcare Link
UK 2023 NHS: Understanding regulations of AI and digital technology in health and social care AI applicable regulation and guidance Artificial intelligence
UK 2023 MHRA: Software and Artificial Intelligence (AI) as a medical device AI regulation Artificial intelligence
UK 2022 Guidance – Software and AI as a Medical Device Change Programme – Roadmap Specific IA/DM regulation programme Medical devices
France 2023 Société française de radiologie et d’imagerie médicale – Communiqué de presse : Intelligence artificielle et garantie humaine IA un outil à utiliser avec raison Human warranty Healthcare
EU 2023 BSI – White paper on ethical and trustworthy artificial intelligence  Ethical and trustworthy AI Healthcare
EU 2023 UE Parlement – What ThinkTanks are Thinking : Artificial Intelligence – Juin 2023 UE Parliament on AI Artificial intelligence
EU 2023 UE – MedTech Europe signs joint healthcare statement highlighting how the AI Act can give citizens the confidence to embrace AI-enabled medical technologies – Juin 2023 Trustworthy AI Healthcare
EU 2023 ENISA – Multilayer Framework for Good Cybersecurity Practices for AI AI cybersecurity Artificial intelligence
EU 2023 ENISA – Cybersecurity and privacy in AI – Medical imaging diagnosis AI cybersecurity Artificial intelligence
Germany 2023 VDE DGBMT – Market access of continuous learning AI systems in medicine Continuous learning of AI systems Healthcare
EU 2023 JRC : Cybersecurity of Artificial Intelligence in the AI Act AI cybersecurity Artificial intelligence
UE 2023 Proposal for a Regulation of the European Parliament and of the Council laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending certain Union legislative acts AI system Artificial intelligence
France 2023 CNIL : premières guidelines sur le développement systèmes d’intelligence artificielle  AI regulations Intelligence artificielle
UK 2024 Mise en œuvre des principes du livre blanc sur l’IA : la MHRA définit sa stratégie pour l’IA dans le domaine des produits médicaux – Avril 2024. AI regulations Medical product
France 2024 AFNOR SPEC 2213 – Garantie Humaine des Systèmes fondés sur l’intelligence Artificielle en santé – mai 2024 Human warranty Artificial intelligence
UK 2024 MHRA launches AI Airlock to address challenges for regulating medical devices that use Artificial Intelligence – May 2024
 IA regulations AI as a medical device
UK 2024 update Guidance Software and artificial intelligence (AI) as a medical device – May 2024 software and artificial intelligence Medical devices
EU 2024 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act)Text with EEA relevance. AI regulations Artificial intelligence
EU 2024 European Commission : Artificial Intelligence – Questions and Answers – Août 2024 AI regulations Products containing  AI
EU 2024 EMA – Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle – sept 2024 AI regulations AI and medicinal products
EU 2024 European Commission – Draft implementing regulation laying down detailed rules for the application of the AI Regulation as regards the creation of an independent scientific panel of experts in the field of artificial intelligence IA regulations  Artificial intelligence
International

 

Area

 Publication or last update date Text Theme Scope nexialist synthesis
2020 The need for a system view to regulate artificial intelligence/machine learning-based software as medical device AI regulation in healthcare Medical devices
2022 Kostick-Quenet, K.M., Gerke, S. AI in the hands of imperfect users. npj Digit. Med. 5, 197 (2022). https://doi.org/10.1038/s41746-022-00737-z AI bias in healthcare Healthcare
IMDRF 2022 Machine Learning-enabled Medical Devices: Key Terms and Definitions Definitions of AI Medical devices
WHO 2021 Ethics and governance of artificial intelligence for health Ethics and governance of AI Healthcare Link
2021 Generating evidence for artificial intelligence based medical devices: a framework for training validation and evaluation Evaluation of medical devices incorporating AI Medical devices
ISO 2020 ISO/IEC TR 24028:2020 Information technology – Artifical intelligence – Overview of trustworthiness in artificial intelligence  Artificial intelligence Artificial intelligence
2021 ISO/IEC TR 24027:2021 Information technology – Artifical intelligence (AI) – Bias in AI systems and AI aided decision making  Artificial intelligence Artificial intelligence
2022 ISO/IEC 38507:2022 – Information technology – Governance of IT – Governance implications of the use of artificial intelligence by organizations  Artificial intelligence Artificial intelligence
2022 ISO/IEC 22989:2022 Information technology – Artificial Intelligence – Artificial intelligence concepts and terminology  Artificial intelligence Artificial intelligence
2021 ISO/IEC TR 24372:2021 Information technology – Artificial intelligence – Overview of computational approaches for AI systems  Artificial intelligence Artificial intelligence
2020 ISO/IEC TR 29119-11:2020 Software and systems engineering – Software testing – Part 11 : Guidelines on the testing of AI-based systems Artificial intelligence Artificial intelligence
2022 ISO/IEC 23053:2022 Framework for Artificial Intelligence Systems Using Machine Learning (ML)  Artificial intelligence Artificial intelligence
2023 ISO/IEC 23894:2023 Information technology – Artificial intelligence – Guidance on risk management Risk management Artificial intelligence
2021 ISO/IEC TR 24029-1:2021Artificial Intelligence (AI) – Assessment of the ribustness of neural netwworks – part 1:Overview  Artificial intelligence Artificial intelligence
2022 ISO/IEC TR 24368:2022 Information technology – Artificial intelligence – Overview of ethical and societal concerns Ethical and societal concerns Artificial intelligence
2021 ISO/TR 24291:2021 Health Informatics – Applications of Machine Learning Technologies in Imaging Artificial intelligence in healthcare Healthcare
2020 ISO/IEC TR 20547-1:2020 Information technology – Big data reference architecture – Part 1: Framework and application process  Big data Artificial intelligence
2018 ISO/IEC TR 20547-2:2018 Information technology – Big data reference architecture – Part 2 : Use cases and derived requirements Big data Artificial intelligence
2020 ISO/IEC 20547-3:2020 Information technology – Big data reference architecture – Part 3: Reference architecture Big data Artificial intelligence
2018 ISO/IEC TR 20547-5:2018 Information technology – Big data reference architecture – Part 5: Standards roadmap  Big data Artificial intelligence
2022 ISO/IEC 27001:2022 Information security, cybersecurity and privacy protection – Information security management systems – Requirements  Information security management system Artificial intelligence
International Telecommunication Union (ITU) 2023 Focus Group on Artificial Intelligence for Health – FG-IA4H DEL 2.2 : Good Practices for health applications of machine learning: Considerations for manufacturers and regulators Good practices related to AI and health Healthcare
AAMI 2023 BS/AAMI 34971:2023; Application of ISO 14971 to machine learning in artificial intelligence – Guide Risk management Artificial intelligence
ISO/IEC 2023 La norme ISO/IEC 23894:2023 relative à la gestion des risques appliquée à l’intelligence artificielle Risk management Artificial intelligence
ISO/IEC 2023 ISO/IEC 42001:2023 Information security management system Artificial intelligence
MDRF 2024 Good machine learning practice for medical device development: Guiding principles Good Machine Learning Practice (GMLP) for the development of medical devices incorporating artificial intelligence. Artificial intelligence
IEC 2024  IEC – Standards suitable to be used for the development of AI/ML standards in the medical area – sept 2024 IA regulations  Artificial intelligence
MDSAP US
Publication or last update date Text Theme Scope
2021 Page web : Artificial Intelligence and Machine Learning in Software as a Medical Device AI regulation and medical devices Medical devices
2021 Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan AI regulation and medical devices Medical devices
2021 Good Machine Learning Practice for Medical Device Development: Guiding Principles AI regulation and medical devices Medical devices
2019 Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback AI regulation and medical devices Medical devices
2019 Xavier University – White Paper : Perspectives and Best Practices for Artificial Intelligence and Continuously Learning Systems in Healthcare Building and AI for healthcare use Healthcare
2023 Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions – Draft Guidance Predetermined change control plan for AI/ML-enabled device software functions Medical devices
2022 AAMI CR34971:2022 Guidance on the Application of ISO 14971 to Artifical intelligence and Machine learning  Risk management Medical devices
2020 ANSI/CTA-2089.1-2020 Definitions/Characteristics of Artificial Intelligence In Health Care  Artificial Intelligence Healthcare
2023 NIST: The language of trustworthy AI: An in-depth glossary of terms Trustworthy AI Artificial intelligence
2023 David Lyell, Ying Wang, Enrico Coiera, Farah Magrabi, More than algorithms: an analysis of safety events involving ML-enabled medical devices reported to the FDA, Journal of the American Medical Informatics Association, 2023;, ocad065, https://doi.org/10.1093/jamia/ocad065 Safety events involving machine learning medical devices in the USA Medical devices
2023 Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principle machine learning medical devices medical devices
2024  Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan – Mars 2024 machine learning medical devices Medical devices
2024 FDA, Santé Canada et MHRA : Nouveaux principes directeurs pour les DM contenant de l’IA – Juin 2024. machine learning medical devices Medical devices
2024 Methods and Tools for Effective Postmarket Monitoring of Artificial Intelligence (AI)-Enabled Medical Devices  post-marketing surveillance Medical devices
2024 Artificial Intelligence Program: Research on AI/ML-Based Medical Devices Regulation and integration of AI/ML in medical device Regulatory Research
2024 Addressing the Limitations of Medical Data in AI Synthetic Data in Medical AI AI Applications
2024 Evaluation Methods for Artificial Intelligence (AI)-Enabled Medical Devices: Performance Assessment and Uncertainty Quantification Performance Evaluation Tool Development
2024 Performance Evaluation Methods for Evolving Artificial Intelligence (AI)-Enabled Medical Devices Regulatory AI Assessment Regulatory Guidance
2024 Regulatory Evaluation of New Artificial Intelligence (AI) Uses for Improving and Automating Medical Practices Evaluating New AI Applications Medical devices
MDSAP outside US

 

Country

 Publication or last update date Text Theme Scope
Brazil 2022 ANVISA – Preguntas & Respostas
Regularização de software como dispositivo médico (Software as a Medical Device – SaMD)		 Software-based medical devices regulation (with or without AI) Software
Japan 2022 1st subcommittee on software as a medical device utilizing AI and machine learning AI regulation and medical devices Medical devices
2021 Policies to promote development of AI-based medical devices in Japan AI regulation and medical devices Medical devices
2023 PMDA – Report on AI-enabled programmed medical devices Scientific report on the use of IA in MD Medical devices
Canada 2023 Draft Guidance : Pre-market guidance for machine learning-enabled medical devices Market submission of AI based MDs Medical devices
2022 Plan prospectif de la réglementation 2022-2024 : Voie d’accès aux produits thérapeutiques de pointe pour les instruments médicaux à apprentissage machine adaptatif AI regulation and medical devices Medical devices
2020 Collège Royal des médecins et chirurgiens du Canada : Intelligence artificielle (IA) et nouvelles technologies numériques AI and new technologies Artificial intelligence
2018 Déclaration de Montréal sur l’IA responsable AI liability Artificial intelligence
Australie 2024 TGA AUSTRALIE : Consultation sur la clarification et le renforcement de la réglementation de l’intelligence artificielle (IA) dans la législation sur les produits thérapeutiques – septembre 2024. Réglementation IA  Intelligence artificielle 
Asia

 

Country

 Publication or last update date Text Theme Scope
South Korea 2022 Guidance on the Review and Approval of Artificial Intelligence(AI)-based Medical Devices Review and approval of medical devices incorporating AI Medical devices
2019 Guidance for evaluation of the clinical efficacy of a medical device employing AI Clinical effectiveness of medical devices incorporating AI Medical devices
Corée et chine 2021 International Software Testing Qualifications Board
China 2021 Guiding principles for the classification and definition of artificial intelligence medical software products Classification of medical devices incorporating AI Medical devices
2021 GB/T 40691-2021 Artifical Intelligence — Affective Computing User Interface Model Artificial Intelligence Artificial Intelligence
2022 GB/T41867-2022 Information Technology — Artificial Intelligence –Terminology Artificial Intelligence Artificial Intelligence
2006 GB/T 5271.31-2006 Information Technology–Vocabulary–Part 31:Artifical Intelligence–Machine Learning Artificial Intelligence Artificial Intelligence
2006 GB/T 5271.29-2006 Information Technology–Vocabulary–Part 29:Artificial Intelligence–Speech Recognition And Synthesis Artificial Intelligence Artificial Intelligence

2021

NMPA Finalizes Artificial Intelligence (AI) Software Classification Guideline

 

 Artificial Intelligence Artificial Intelligence
2022 GB/T 42018-2022 Information Technology — Artifical Intelligence — Platform Computing Resource Specification Artificial Intelligence Artificial Intelligence
Singapor 2022 Regulatory Guidelines for Software Medical Devices – A Lifecycle Approach AI regulation and medical devices Medical devices
Saoudi Arabia 2023 Guidance for artificial intelligence and machine learning (AI/ML)-Enabled Medical Devices (MDS-G010) AI regulation and medical devices Medical devices
Taïwan Guidance for industry to Register Artificial Intelligence-Machine Learning-Based Software as Medical Device Approval of medical devices incorporating AI Medical devices