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

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...)

  1. IMDRF SaMD Working Group. Software as a Medical Device (SaMD): Key Definitions. 2013. http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf [Last accessed: 22 Mar 2021].
  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].
  3. European Parliament and Council. Regulation (EU) 2017/745 (in short: Medical Device Regulation (MDR)). 2017. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX: 02017R074 5-201705052017 [Last accessed: 22 Mar 2021].
  4. European Union. Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions. 2020. http://data.europa.eu/eli/reg/2020/561/oj [Last accessed: 22 Mar 2021].
  5. Sutton RT, Pincock D, Baumgart DC, Sadowski DC, Fedorak RN, Kroeker KI. An overview of clinical decision support systems: benefits, risks, and strategies for success. NPJ Digit Med. 2020;3:17. https://doi.org/10.1038/s41746-020-0221-y
  6. Kracov DA, Pippins R, Habtemariam A, Gitterman A. FDA's 21st Century Cures Act Guidance Documents Clarify the Landscape for Digital Health Innovation. 2017. https://www.arnoldporter.com/en/perspectives/publications/2017/12/fdas-21st-century-cure-guidance-documents [Last accessed: 22 Mar 2021].
  7. Kent J. FDA Updates Draft Guidance on Clinical Decision Support Software. 2019. https://healthitanalytics.com/news/fda-updates-draft-guidance-on-clinical-decision-support-software [Last accessed: 22 Mar 2021].
  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].
  10. Carli D, Fahrni G, Bonnabry P, Lovis C. Quality of Decision Support in Computerized Provider Order Entry: Systematic Literature Review. JMIR medical informatics. 2018;6(1):e3. https://doi.org/10.2196/medinform.7170
  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
  12. Muylle KM, Gentens K, Dupont AG, Cornu P. Evaluation of an optimized context-aware clinical decision support system for drug-drug interaction screening. Int J Med Inform. 2021;148:104393. https://doi.org/10.1016/j.ijmedinf.2021.104393
  13. Evans B, Ossorio P. The Challenge of Regulating Clinical Decision Support Software After 21(st) Century Cures. Am J Law Med. 2018;44(2-3):237-51. https://doi.org/10.1177/ 0098858818789418
  14. Vasiljeva K, van Duren BH, Pandit H. Changing Device Regulations in the European Union: Impact on Research, Innovation and Clinical Practice. Indian J Orthop. 2020;54(2):123-9. https://doi.org/10.1007/s43465-019-00013-5
  15. European Commission. Medical Devices - Topics of Interest: Notified Body. 2017. https://ec.europa.eu/health/md_topics-interest/notified_bodies_en [Last accessed: 22 Mar 2021].
  16. no. Clinical Decision Support Software Regulatory landscape in Europe from May 26th 2020. 2020. https://bigmed.no/assets/Reports/clinical_decision_support_software.pdf2020 [Last accessed 22 Mar 2021]
  17. Reflection Paper on regulatory frameworks for digital health technologies in Europe. 2019. https://www.digitaleurope.org/wp/wp-content/uploads/2019/04/DIGITAL EUROPE-Reflection-on-regulatory-frameworks-for-digital-health-technologies-in-Europe-.pdf [Last accessed 22 Mar 2021]
  18. European Commission. Bodies - Regulation (EU) 2017/745 on medical devices. https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 [Last accessed: 22 Mar 2021].
  19. Medical Device Coordination Group (MDCG). Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. 2019. https://ec.europa.eu/docsroom/documents/37581/attachments/1/translations/en/renditions/native [Last accessed: 22 Mar 2021].
  20. US Food & Drug Administration. Product Classification. 2021. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm [Last accessed: 22 Mar 2021].

Articles in Press, Corrected Proof
Available Online from 18 October 2021
  • Receive Date: 24 March 2021
  • Revise Date: 15 October 2021
  • Accept Date: 17 October 2021