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

ABSTRACT:

Background

The rapid proliferation of medical apps has transformed the health care landscape by giving patients and health care providers unprecedented access to personalized health information and services. However, concerns regarding the effectiveness and safety of medical apps have raised questions regarding the efficacy of randomized controlled trials (RCTs) in the evaluation of such apps and as a requirement for their regulation as mobile medical devices.

Objective

This study aims to address this issue by investigating alternative methods, apart from RCTs, for evaluating and regulating medical apps.

Methods

Using a qualitative approach, a focus group study with 46 international and multidisciplinary public health experts was conducted at the 17th World Congress o

SUBMITTER: Maaß L 

PROVIDER: S-EPMC11474120 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature