Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It? - A Viewpoint Paper

Document Type : Viewpoint

Authors

1 Research Group of Biostatistics and Medical Informatics (BISI), Department of Public Health (GEWE), Vrije Universiteit Brussel, Brussel, Belgium

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

Highlights

 

Commentaries Published on this Paper

  •  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”

        Abstract | PDF

 

  •  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”

        Abstract | PDF

 

Keywords


Introduction 

Use of of Software as a Medical Device (SaMD) is continuously increasing. SaMD is defined by the International Medical Device Regulators Forum (IMDRF) as software intended to be used for medical purposes without being part of a hardware medical device.1 SaMD is software that can perform complex clinical tasks such as diagnosing medical conditions, suggesting treatments and informing clinical management.1...(Read more...)

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  2. S. Government Publishing Office. Public Law 114-255 - 114th Congress (in short: 21st Century Cures Act). 2016. https://www.govinfo.gov/app/details/PLAW-114publ255 [Last accessed: 22 Mar 2021].
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  8. US Food & Drug Administration. Clinical Decision Support Software. Draft Guidance for Industry and Food and Drug Administration Staff. 2019. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software [Last accessed: 22 Mar 2021].
  9. IMDRF SaMD Working Group. "Software as a Medical Device": Possible Framework for Risk Categorization and Corresponding Considerations. 2014. http://www.imdrf.org/docs/imdrf/ final/technical/imdrf-tech-140918-samd-framework-risk-categorization-141013.pdf [Last accessed: 22 Mar 2021].
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  11. Ancker JS, Edwards A, Nosal S, Hauser D, Mauer E, Kaushal R, et al. Effects of workload, work complexity, and repeated alerts on alert fatigue in a clinical decision support system. BMC Med Inform Decis Mak. 2017;17(1):36. https://doi.org/10.1186/s12911-017-0430-8
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Volume 11, Issue 12
December 2022
Pages 3159-3163
  • Receive Date: 24 March 2021
  • Revise Date: 15 October 2021
  • Accept Date: 17 October 2021
  • First Publish Date: 18 October 2021