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This paper is in the following e-collection/theme issue:

Mobile Health (mhealth) (3781) Ethics, Privacy, and Legal Issues (691) E-Health Policy and Health Systems Innovation (396) Policy (77) eHealth Infrastructures (453) Regulatory Issues and Medical Device Certification (11) Ethical, Legal, and Social Implications of Public Health Informatics (23)

Published on in Vol 26 (2024)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/54814, first published .
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Challenges and Alternatives to Evaluation Methods and Regulation Approaches for Medical Apps as Mobile Medical Devices: International and Multidisciplinary Focus Group Discussion

Challenges and Alternatives to Evaluation Methods and Regulation Approaches for Medical Apps as Mobile Medical Devices: International and Multidisciplinary Focus Group Discussion

Authors of this article:

Laura Maaß1, 2, 3 Author Orcid Image ;   Robert Hrynyschyn2, 4 Author Orcid Image ;   Martin Lange5 Author Orcid Image ;   Alexandra Löwe5 Author Orcid Image ;   Kathrin Burdenski6 Author Orcid Image ;   Kaley Butten7 Author Orcid Image ;   Sebastian Vorberg8, 9 Author Orcid Image ;   Mariam Hachem10, 11 Author Orcid Image ;   Aldo Gorga12 Author Orcid Image ;   Vittorio Grieco13 Author Orcid Image ;   Vincenzo Restivo14 Author Orcid Image ;   Giuseppe Vella15 Author Orcid Image ;   Marlien Varnfield7 Author Orcid Image ;   Felix Holl2, 16 Author Orcid Image
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Journals

  1. Memon K, Yahya N, Yusoff M, Remli R, Mustapha A, Hashim H, Ali S, Siddiqui S. Edge Computing for AI-Based Brain MRI Applications: A Critical Evaluation of Real-Time Classification and Segmentation. Sensors 2024;24(21):7091 View
  2. Ankolekar A. Beyond Waiting: How Patients Are Reshaping Digital Health. Journal of Medical Internet Research 2025;27:e89205 View
  3. Gehder S, Brückner S, Gilbert S, Goeldner M. A scoping review on using real-world data to evaluate the effectiveness of mHealth applications. npj Digital Medicine 2026;9(1) View

Books/Policy Documents

  1. Lange M, Schaller A. Fehlzeiten-Report 2025. View
  2. Yadav S, Kapat K. Medical Devices in Modern Healthcare. View
  3. Saukkonen A, Härkönen H, Syrjälä J, Vanhanen M, Laukka E, Torkki P, Talman K, Yesmean M, Jansson M. Digital Health and Wireless Solutions: Towards Trustworthy and Person-Centric Digital Health. View