Medical Writing Artificial intelligence and Digital Health What medical writers need to know about regulatory approval of mobile health and digital healthcare devices
front-coverpng

Volume 28, Issue 4 - Artificial intelligence and Digital Health

What medical writers need to know about regulatory approval of mobile health and digital healthcare devices

Abstract

The rapid growth of mobile health (mHealth) led to the development of internationally harmonised guidance for software as a medical device (SaMD) by the International Medical Device Regulators Forum (IMDRF), covering definitions, risk classification, quality management, and clinical evaluation. The EU Medical Devices Regulation (MDR), applicable from May 26, 2020, onwards, specifically addresses SaMDs and adopted aspects of IMDRF guidance. In particular, Rule 11 of the MDR will have significant implications, as many products so far not classified as medical devices or as class I, may be considered class IIa, IIb, or III medical devices. The entry of technology firms into the medical device field will further drive mHealth and the incorporation of novel technologies into SaMD. This article aims to provide the relevant regulatory background information for medical writers who are requested to support the preparation of the regulatory and clinical documentation for SaMD required for MDR compliance.

Download the full article

References

  1. eHealth: Digital health and care. 2019 [cited 2019 Sept 25]. Available from: Available from: https://ec.europa.eu/health/ehealth/ overview_en
  2. IMS Institute for Healthcare Informatics. Patient adoption of mHealth. Use, evidence and remaining barriers to mainstream acceptance. USA. 2015.
  3. Research2Guidance. mHealth app economics 2017. Current status and future trends in mobile jealth. Berlin. 2017.
  4. US Food & Drug Administration. Draft guidance for industry and Food and Drug Administration staff – mobile medical applications. Washington DC,. 2011.
  5. IMDRF Software as a Medical Device (SaMD) Working Group. Software as a medical device (SaMD): Key definitions. 2013.
  6. IMDRF Software as a Medical Device (SaMD) Working Group. “Software as a medical device”: Possible framework for risk categorization and corresponding considerations. 2014.
  7. IMDRF Software as a Medical Device (SaMD) Working Group. Software as a medical device (SaMD): Application of quality management system. 2015.
  8. IMDRF Software as a Medical Device (SaMD) Working Group. Software as a medical device (SaMD): Clinical evaluation. 2017.
  9. European Union, Regulation (EU) 2017/745 on Medical Devices. Official Journal of the European Union. 2017;L117
  10. Guidance on Qualification and Classi - fication of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. 2019. Medical Device Coordination Group (MDCG) as an author [cited 2019 Dec 6]. Available from: Available from: https://ec.europa.eu/ docsroom/documents/37581?locale=en
  11. App Store Review Guidelines. 2019 [cited 2019 Sept 25]. Available from: Available from: https://developer.apple.com/app-store/ review/guidelines/
  12. European Commission. Guidance document medical devices – scope, field of application, definition – qualification and classification of stand alone software – MEDDEV 2.1/6. 2016.
  13. European Union, Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (GDPR). Official Journal of the European Union. 2016; L119: p. 1-88.
  14. US Food & Drug Administration. Proposed regulatory framework for modifications to artificial intelligence/ machine learning (AI/ML)-based software as a medical device (SaMD) – discussion paper and request for feedback. Washington DC. 2019.
  15. Project Baseline by verily. 2019 [cited 2019 Sept 25]. Available from: Available from: https://www.projectbaseline.com/
  16. ResearchKit and CareKit. 2019 [cited 2019 Sept 25]. Available from: Available from: https://www.apple.com/lae/researchkit/

Search

Articles

Table of Contents
Artificial intelligence and digital health
President's Message
EMWA News
Medical writing in the era of artificial intelligence
Blockchain in healthcare, research, and scientific publishing
Embracing a new friendship: Artificial intelligence and medical writers
Drug development and medical writing in the digital world
Intelligent use of artificial intelligence for systematic reviews of medical devices
What medical writers need to know about regulatory approval of mobile health and digital healthcare devices
Digitalisation in long-term care: An issue for medical writers?
An introduction to medical affairs for medical writers
A primer on anonymisation
Sound, microphone, action: Podcasts for medical writers
Regulatory Matters
News from the EMA
Lingua Franca and Beyond
In the Bookstores
Getting Your Foot in the Door
Medical Devices
Veterinary Medical Writing
Teaching Medical Writing
Journal Watch
Medical Communications and Writing for Patients
Good Writing Practice
Out on Our Own
Upcoming issues of Medical Writing

Member Login

Links

The Write Stuff Archive Contact Instructions for Authors Feature Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief:

Co-Editor:

Managing Editor

show all +

Associate Editors:

Section Editors:

Ad-hoc Editors:

  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

Editor Emeritus: