Synthèses documentaires Intelligence artificielle

4 Mar 2025 | Intelligence artificielle

Retrouvez les documents à propos de l'intelligence artificielle
Union Européenne

Zone

 Date de publication ou de dernière mise à jour Organisme source Texte Application au secteur DM Mots clés
EU  2025 Comission  européenne Guidelines on prohibited artificial intelligence (AI) practices, as defined by the AI Act   IA, pratiques interdites 
Suisse 2025 Confédération Suisse Overview and Switzerland’s regulatory approach    IA, règlementaion
EU  2025 EU, experts indépendants Second draft General-purpose AI code of practice   IA,règlementation, projet
France 2024 AFNOR   SPEC 2213 – Garantie Humaine des Systèmes fondés sur l’intelligence Artificielle en santé   IA, garantie humaine
EU 2024 Parlement européen/Conseil 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.   IA, règlementation,IA Act
EU 2024 Comission européenne  Artificial Intelligence – Questions and Answers    IA, réponse
EU 2024 EMA Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle x IA,cycle de vie du produit, médicaments
EU 2024 Comission européenne  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   application de la règlementation IA
EU 2024 Team NB  Position paper – DM integrating an AI system x DM intégrant de l’IA
EU  2024 GMED AI Act, what are the requirements and deadlines for DM? x règlementation IA, exigences, dates limites
EU 2023 Comission européenne  AI Watch. Artificial Intelligence Standardization Landscape Update   IA, standardisation
EU 2023 BSI Recent Advancements in AI – Implications for medical device technology and certification x IA, dispositif médical, certification
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 x IA, health application 
EU 2023 BSI White paper on ethical and trustworthy artificial intelligence    IA, confiance, éthique
EU 2023 Parlement européen  What ThinkTanks are Thinking : Artificial Intelligence   IA, règlementation, opinions
EU 2023 Medtech Europe MedTech Europe signs joint healthcare statement highlighting how the AI Act can give citizens the confidence to embrace AI-enabled medical technologies  x IA, règlementation, fiable
EU 2023 European Union Agency for Cybersecurity (ENISA) Multilayer Framework for Good Cybersecurity Practices for AI   IA, cybersécurité
EU 2023 European Union Agency for Cybersecurity (ENISA) Cybersecurity and privacy in AI – Medical imaging diagnosis   IA, cybersécurité, imagerie de diagnostic médical
Germany 2023 Association for Electrical, Electronic & Information Technologies (VBE) /German Society for Biomedical Engineering (DGBMT) Market access of continuous learning AI systems in medicine x IA, accès au marché
EU 2023 Comission européenne  JRC : Cybersecurity of Artificial Intelligence in the AI Act   IA,  cybersécurité
UE 2023 Parlement européen/Conseil 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   IA,  harmonisation, proposition
France 2023 CNIL CNIL : premières guidelines sur le développement systèmes d’intelligence artificielle    IA, développement 
France 2022 AFNOR Feuille de route  stratégique pour la normalisation de l’intelligence artificielle   IA, standardisation
France 2022 CNIL IA comment être en conformité avec le RGPD   IA, RGPD, compliance
France 2022 CNIL Glossaire de l’intelligence artificielle    IA, définition
France 2022 CNIIL Quelques ressources utiles et accessibles à tous pour comprendre l’intelligence artificielle   IA, définition, source
France 2022 CNIL Intelligence artificielle, de quoi parle-t-on ?    IA, définition 
France 2022 CNIL Guide d’auto-évaluation pour les systèmes d’intelligence artificielle (IA)   IA,auto-évaluation
France 2022 Laboratoire d’innovation Numérique de la CNIL (LINC) Sécurité des systèmes d’IA   IA, securité
EU 2022 Comission européenne  Glossary of human-centric artificial intelligence   IA, définition, source
EU 2022 Parlement européen Artificial intelligence in healthcare: Applications, risks, and ethical and societal impacts x IA, soins médicaux, éthique, risque, impact
EU 2022 COCIR Joint statement in support of the new legislative framework and the AI Act   IA, règlementation 
France 2022 Comité consultatif national d’Ethique / Comité National Pilote d’Ethique du Numérique  Avis commun CCNE/CNPEN Diagnostic médical et intelligence artificielle : enjeux éthiques x IA, diagnostic, éthique
EU 2022 Team NB  Position Paper on the designation of notified bodies under the upcoming Artificial Intelligence Act   IA, règlementation, organisme notifié
EU 2022 Comission européenne  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)   IA, règlementation, proposition
EU 2021 Comission européenne  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   IA, règlementation, harmonisation
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 x IA, éthique, soins médicaux
EU 2021 The Lancet Digital  Health Muehlematter, U. J., Daniore, P., & Vokinger, K. N Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20): a comparative analysis. x IA, règlementation, dispositif médical , US/Europe
EU 2021 Comission européenne  AI Watch. Defining Artificial Intelligence 2.0   IA, définition
EU 2021 Medtech Europe Medtech Europe response to the open public consultation on the Proposal for an Artificial Intelligence Act (COM/2021/206)   IA, règlementation
EU 2021 Comission européenne  Study on eHealth, Interoperability of Health Data and Artificial Intelligence for Health and Care in the European Union x IA, santé, interopérabilité
EU 2021 TUV SUD Artificial Intelligence in medical devices – verifying and validating AI-based medical devices x IA, exigences règlementaires, écart
Netherlands 2021 Gouvernement des Pays-Bas Legal Analysis – European legislative proposal draft AI act and MDR/IVDR x IA, règlementation
France 2021 Laboratoire Nationnal de Métrologie et d’Essais (LNE) Référentiel de certification intelligence artificielle   IA, confiance,  conformité
EU 2021 Comission européenne  New rules for Artificial Intelligence – Questions and Answers   IA, règlementation, réponse
France 2021 LégiFrance Law n°2021-1017 of 2 August 2021 on bioethics introducing article L4001-3 of the Public Health Code   Bioéthique
EU 2020 High-Level Expert Group on Artificial Intelligence (AI HLEG) The assessment List for Trustworthy Artificial Intelligence (ALTAI)    IA, auto-évaluation, digne de confiance 
EU 2020 Comission européenne  White Paper on Artificial Intelligence: a European approach to excellence and trust   IA, digne de confiance, UE
EU 2020 Comission européenne  Artificial Intelligence in Medicine and Healthcare: applications, availability and societal impact x IA, soins médicaux, médecine personnalisée
EU 2020 COCIR Artificial Intelligence in EU medical device legislation  x IA, règlementation, modification
France 2020 HAS  Grille descriptive des fonctionnalités des dispositifs médicaux embarquant un système avec apprentissage automatique (intelligence artificielle) x IA, dispositif medical, fonction, remboursement
Germany 2020 DIN DIN SPEC 92001-2:2020 – Life cycle Processes and Quality Requirements – Part 2: Robustness    IA, cycle de vie, robustesse
EU 2019 Comission européenne  Ethical guidelines for trustworthy AI   IA, confiance, legal, éthique, robuste
EU 2019 Pharmalex  White Paper – Software, artificial intelligence and medical devices – what’s up? x IA, règlementation
EU 2019 BS I/ MHRA / AAMI The emergence of artificial intelligence and machine learning algorithms in healthcare: recommendations to support governance and regulation x IA, règlementation, soins médicaux
Germany 2019 DIN DIN SPEC 92001-1:2019 – Life cycle processes and quality requirements – Part1:Quality Metamodel  x IA, qualité, cycle de vie 
EU 2018 Comission européenne  Questions and Answers: coordinated plan for Artificial Intelligence « made in Europe »   IA, plan, Europe
UE  2016 Intersoft consulting  Regulation (EU) 2016/679 on General Data Protective Regulation   données, protection, circulation, 
Royaume-Uni
Zone Date de publication ou de dernière mise à jour Organisme source Texte Application au secteur DM Mots clés
UK 2022 Regulatory Horizons Council (RHC) Independent report – Regulatory Horinzons Council: The regulation of Artificial Intelligence as a medical device x IA, règlementation
UK 2023 National Health Service ( NHS) Understanding regulations of AI and digital technology in health and social care x IA, technologies numériques, règlementation
UK 2023 MHRA Software and Artificial Intelligence (AI) as a medical device x IA, logiciel
UK 2022 MHRA Guidance – Software and AI as a Medical Device Change Programme – Roadmap x IA, logiciel
UK 2024 MHRA Impact of AI on the regulation  of medical products  x IA, règlementation, impact
UK 2024 MHRA AI Airlock to address challenges for regulating medical devices that use Artificial Intelligence x IA, projet pilote, bac à sable, Air lock
UK 2024 MHRA Update – Guidance – Software and artificial intelligence (AI) as a medical device x IA, dispositif médical
UK 2024 MHRA Guidance – AI Airlock pilot cohort x IA, projet pilote, bac à sable, Air lock
Etats-Unis
Zone Date de publication ou de dernière mise à jour Organisme source Texte Application au secteur DM Mots clés
US 2021 FDA Artificial Intelligence and Machine Learning in Software as a Medical Device x IA, apprentissage automatique, logiciel
US 2021 FDA Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan x IA, apprentissage automatique, logiciel, plan d’action
US 2021 FDA Good Machine Learning Practice for Medical Device Development: Guiding Principles x apprentissage automatique
US 2019 FDA 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 x IA, règlementation, discussion
US 2019 Xavier Health’s Artificial Intelligence Summi White Paper : Perspectives and Best Practices for Artificial Intelligence and Continuously Learning Systems in Healthcare x IA, soins médicaux, meilleures pratiques
US 2022 Association for the Advancement of Medical Instrumentation (AAMI) CR34971:2022 Guidance on the Application of ISO 14971 to Artifical intelligence and Machine learning  IA, apprentissage automatique
US 2020 American International Standrards Institute (ANSI)/ Consumer Technology Association (CTA) 2089.1-2020 Definitions/Characteristics of Artificial Intelligence In Health Care  IA, soins médicaux
US 2023 National Institute of Standards and Technology (NIST) The language of trustworthy AI: An in-depth glossary of terms IA, définition
US 2023 Journal of the American Medical Informatics Association More than algorithms: an analysis of safety events involving ML-enabled medical devices reported to the FDA x IA, apprentissage automatique, sécutité, rapport
US 2023 FDA Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principle x PCCP, IA
US 2024 FDA  Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan x IA, logiciel, plan d’action
US 2024 FDA FDA, Santé Canada et MHRA : Nouveaux principes directeurs pour les DM contenant de l’IA x IA, principes directeurs
US 2024 FDA Methods and Tools for Effective Postmarket Monitoring of Artificial Intelligence (AI)-Enabled Medical Devices x IA, surveillance post-commercialisation
US 2024 FDA Artificial Intelligence Program: Research on AI/ML-Based Medical Devices x IA, apprentissage automatique
US 2024 FDA Addressing the Limitations of Medical Data in AI IA, limites, données
US 2024 FDA Evaluation Methods for Artificial Intelligence (AI)-Enabled Medical Devices: Performance Assessment and Uncertainty Quantification x IA, apprentissage automatique  performance, évaluation
US 2024 FDA Performance Evaluation Methods for Evolving Artificial Intelligence (AI)-Enabled Medical Devices x IA, apprentissage automatique  performance, évaluation
US 2024 FDA Regulatory Evaluation of New Artificial Intelligence (AI) Uses for Improving and Automating Medical Practices x IA, règlementation, évaluation
US 2024 FDA Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions – Draft Guidance x IA, soumission marketing, PCCP
US 2025 FDA Draft Guidance : Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations IA, cycle de vie, soumission marketing
Canada
Zone Date de publication ou de dernière mise à jour Organisme source Texte Application au secteur DM Mots clés
Canada 2018 Université de Montréal Déclaration de Montréal sur l’IA responsable   IA, responsabilité, risque, éthique
Canada 2020 Collège Royal des médecins et chirurgiens du Canada Intelligence artificielle (IA) et nouvelles technologies numériques   IA, logiciel
Canada 2022 Santé Cananda Plan prospectif de la réglementation 2022-2024 : Voie d’accès aux produits thérapeutiques de pointe pour les instruments médicaux à apprentissage machine adaptatif x IA, avancées, règlementation, plan 
Canada 2023 Santé Cananda Draft Guidance : Pre-market guidance for machine learning-enabled medical devices x IA, pré-commercialisation, proposition, apprentissage automatique 
Canada 2025 Santé Cananda Pre-market guidance for machine learning-enabled medical devices – Fev 2025 x IA, pré-commercialisation, apprentissage automatique 
Australie
Zone Date de publication ou de dernière mise à jour Organisme source Texte Application au secteur DM Mots clés
Australia 2024 TGA TGA AUSTRALIA: Consultation on Clarifying and Strengthening Regulation of Artificial Intelligence (AI) in Therapeutic Goods Legislation – September 2024 x IA, règlementation, opinions
Japon
Zone Date de publication ou de dernière mise à jour Organisme source Texte Application au secteur DM Mots clés
Japan 2021 Japan Association for the Advancement of Medical Equipment (JAAME) Policies to promote development of AI-based medical devices in Japan x IA, promotion
Japan 2022 PMDA 1st subcommittee on software as a medical device utilizing AI and machine learning x IA, apprentissage automatique, logiciel
Japan 2023 PMDA / Science Board PMDA – Report on AI-enabled programmed medical devices x IA, biais, challenges, discussion
Brésil
Zone Date de publication ou de dernière mise à jour Organisme source Texte Application au secteur DM Mots clés
           
International
Zone Date de publication ou de dernière mise à jour Organisme source Texte Application au secteur DM Mots clés
Int  2025 IMDRF Good Machine Learning Practice for Medical Device Development: Guiding Principles x IA, développement 
Int  2024 IMDRF Good machine learning practice for medical device development: Guiding principles x IA, apprentissage automatique,  développement
Int  2024 IEC Standards suitable to be used for the development of AI/ML standards in the medical area – sept 2024 x IA, développement 
Int  2023 ISO/IEC ISO/IEC 23894:2023 Information technology – Artificial intelligence – Guidance on risk management   IA, gestion du risque 
Int  2023 ISO/IEC ISO/IEC 23894:2023 Information technology – Artificial intelligence – Guidance on risk management   IA, gestion du risque 
Int  2023 ISO/IEC ISO/IEC 42001:2023 Information technology – Artificial intelligence – Management system   IA, system de gestion de risque 
Int  2023 International Telecommunication Union (ITU) 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 x IA, santé
Int  2023 Association for the Advancement of Medical Instrumentation (AAMI)/BSI 34971:2023; Application of ISO 14971 to machine learning in artificial intelligence – Guide   IA, apprentissage automatique, gestion de risque
Int  2022 ISO/IEC ISO/IEC 22989:2022 Information technology – Artificial Intelligence – Artificial intelligence concepts and terminology    IA, concept, définition
Int  2022 ISO/IEC ISO/IEC 23053:2022 Framework for Artificial Intelligence Systems Using Machine Learning (ML)    IA, apprentissage automatique
Int  2022 ISO/IEC ISO/IEC TR 24368:2022 Information technology – Artificial intelligence – Overview of ethical and societal concerns    IA, éthique, société
Int  2022 ISO/IEC ISO/IEC 27001:2022 Information security, cybersecurity and privacy protection – Information security management systems – Requirements    Ia, cybersécurité
Int  2022 ISO/IEC ISO/IEC 38507:2022 – Information technology – Governance of IT – Governance implications of the use of artificial intelligence by organizations    IA, IT
Int  2022 IMDRF Machine Learning-enabled Medical Devices: Key Terms and Definitions x IA, apprentissage automatique, définition
Int  2022 60 Leaders 60 thought leaders answer 17questions about artificial intelligence    questions, réponses
Int  2022 npj Digital Medicine volume AI in the hands of imperfect users   IA, utilisation
Int  2021 ISO/IEC ISO/IEC TR 24027:2021 Information technology – Artifical intelligence (AI) – Bias in AI systems and AI aided decision making    IA, decision, biais
Int  2021 ISO/IEC ISO/IEC TR 24029-1:2021Artificial Intelligence (AI) – Assessment of the ribustness of neural netwworks – part 1:Overview    IA, robustesse
Int  2021 ISO/IEC ISO/IEC TR 24030:2021 Information technology – Artificial intelligence – Use cases   IA, cas
Int  2021 ISO/IEC ISO/TR 24291:2021 Health Informatics – Applications of Machine Learning Technologies in Imaging  x apprentissage automatique, imagerie
Int  2021 ISO/IEC ISO/IEC TR 24372:2021 Information technology – Artificial intelligence – Overview of computational approaches for AI systems    IA, approche informatique 
Int  2021 WHO Ethics and governance of artificial intelligence for health x IA, éthique, soins médicaux 
Int  2021 WHO Generating evidence for artificial intelligence based medical devices: a framework for training validation and evaluation x IA, validation, évidence, évaluation
Int  2020 ISO/IEC ISO/IEC TR 24028:2020 Information technology – Artifical intelligence – Overview of trustworthiness in artificial intelligence    IA, confiance, vue d’ensemble 
Int  2020 ISO/IEC ISO/IEC TR 20547-1:2020 Information technology – Big data reference architecture – Part 1: Framework and application process    IA, règlementation, données 
Int  2020 ISO/IEC ISO/IEC 20547-3:2020 Information technology – Big data reference architecture – Part 3: Reference architecture    IA, données
Int  2020 ISO/IEC ISO/IEC TR 29119-11:2020 Software and systems engineering – Software testing – Part 11 : Guidelines on the testing of AI-based systems   IA, test
Int  2020 npj Digital Medicine volume The need for a system view to regulate artificial intelligence/machine learning-based software as medical device x IA, règlementation, apprentissage automatique 
Int  2018 ISO/IEC TR 20547-2:2018 Information technology – Big data reference architecture – Part 2 : Use cases and derived requirements    Ia, exigences
Int  2018 ISO/IEC TR 20547-5:2018 Information technology – Big data reference architecture – Part 5: Standards roadmap    IA, feuille de route, standard