Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We There Yet? A Response to the Recent Commentaries

Document Type : Correspondence

Authors

1 Research Group Clinical Pharmacology and Clinical Pharmacy (KFAR), Centre for Pharmaceutical Research (CePhar), Vrije Universiteit Brussel (VUB), Brussels, Belgium

2 Medical Ethics Committee, Universitair Ziekenhuis Brussel, Brussels, Belgium

3 Gerontological Sciences (GERO), Vrije Universiteit Brussel (VUB), Brussels, Belgium

Abstract

Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We There Yet? A Response to the Recent Commentaries

Keywords

Full Text

In our viewpoint paper we outlined the United States’ and the European Union’s (EU’s) regulatory response on the rapidly changing digital health landscape with specific focus on the impact on clinical decision support (CDS) systems as a type of medical device software. Further challenges have been raised in subsequent commentaries.1-3 In this correspondence, we discuss some of the many remaining challenges, and provide further thoughts on the regulation of artificial intelligence (AI) in healthcare. ...(Read more...)

References

  1. Beckers R, Hoydonck PV. Impact of the regulatory framework on medical device software manufacturers: are the guidance documents supporting the practical implementation? Comment on "Clinical decision support and new regulatory frameworks for medical devices: are we ready for it? - A viewpoint paper.” Int J Health Policy Manag. 2023;12:7470. doi:34172/ijhpm.2023.7470
  2. McKee M, Wouters OJ. The challenges of regulating artificial intelligence in healthcare: Comment on "Clinical decision support and new regulatory frameworks for medical devices: are we ready for it? - A viewpoint paper.” Int J Health Policy Manag. 2023;12:7261. doi:34172/ijhpm.2022.7261
  3. Maresova P. Impact of regulatory changes on innovations in the medical device industry: Comment on "Clinical decision support and new regulatory frameworks for medical devices: are we ready for it? - A viewpoint paper.” Int J Health Policy Manag. 2023;12:7262. doi:34172/ijhpm.2022.7262
  4. Van Laere S, Muylle KM, Cornu P. Clinical decision support and new regulatory frameworks for medical devices: are we ready for it? - A viewpoint paper. Int J Health Policy Manag. 2022;11(12):3159-3163. doi:34172/ijhpm.2021.144
  5. European Commission. Single Market Compliance Space: List of Notified Bodies. https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notified-body-list?filter=legislationId:34,notificationStatusId:1. Accessed December 12, 2023.
  6. The Council of the European Communities. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Official Journal of the European Communities. 1993;L169:1-43.
  7. European Parliament and Council. Regulation (EU) 2017/745 (In Short: Medical Device Regulation (MDR)). 2023. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20230320. Accessed December 13, 2023.
  8. The European Parliament and the Council of the European Union. REGULATION (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Official Journal of the European Union. 2023;L80:24-29.
  9. Medical Device Coordination Group. MDCG 2023-2 List of Standard Fees. Medical Device Coordination Group Document; 2023.
  10. Lübbeke A, Smith JA, Prieto-Alhambra D, Carr AJ. The case for an academic discipline of medical device science. EFORT Open Rev. 2021;6(3):160-163. doi:1302/2058-5241.6.200094
  11. European Parliament and Council. Artificial Intelligence Act: Deal on Comprehensive Rules for Trustworthy AI. 2023. https://www.europarl.europa.eu/news/en/press-room/20231206IPR15699/artificial-intelligence-act-deal-on-comprehensive-rules-for-trustworthy-ai. Accessed December 11, 2023.
  12. European Commission. 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. 2021;2021/0106 (COD):107.

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History

  • Receive Date: 09 December 2023
  • Revise Date: 13 December 2023
  • Accept Date: 19 December 2023
  • First Publish Date: 19 December 2023

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