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 |
IA 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. |
IA 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. |
IA regulations |
Artificial intelligence |
|