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

Keywords


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...)

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