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Title: Health app policy: international comparison of nine countries' approaches
Authors: Essén, Anna
Stern, Ariel D.
Haase, Christoffer Bjerre
Car, Josip
Greaves, Felix
Paparova, Dragana
Vandeput, Steven
Wehrens, Rik
Bates, David W.
Keywords: Science::Medicine
Issue Date: 2022
Source: Essén, A., Stern, A. D., Haase, C. B., Car, J., Greaves, F., Paparova, D., Vandeput, S., Wehrens, R. & Bates, D. W. (2022). Health app policy: international comparison of nine countries' approaches. NPJ Digital Medicine, 5(1).
Journal: NPJ Digital Medicine 
Abstract: An abundant and growing supply of digital health applications (apps) exists in the commercial tech-sector, which can be bewildering for clinicians, patients, and payers. A growing challenge for the health care system is therefore to facilitate the identification of safe and effective apps for health care practitioners and patients to generate the most health benefit as well as guide payer coverage decisions. Nearly all developed countries are attempting to define policy frameworks to improve decision-making, patient care, and health outcomes in this context. This study compares the national policy approaches currently in development/use for health apps in nine countries. We used secondary data, combined with a detailed review of policy and regulatory documents, and interviews with key individuals and experts in the field of digital health policy to collect data about implemented and planned policies and initiatives. We found that most approaches aim for centralized pipelines for health app approvals, although some countries are adding decentralized elements. While the countries studied are taking diverse paths, there is nevertheless broad, international convergence in terms of requirements in the areas of transparency, health content, interoperability, and privacy and security. The sheer number of apps on the market in most countries represents a challenge for clinicians and patients. Our analyses of the relevant policies identified challenges in areas such as reimbursement, safety, and privacy and suggest that more regulatory work is needed in the areas of operationalization, implementation and international transferability of approvals. Cross-national efforts are needed around regulation and for countries to realize the benefits of these technologies.
ISSN: 2398-6352
DOI: 10.1038/s41746-022-00573-1
Schools: Lee Kong Chian School of Medicine (LKCMedicine) 
Research Centres: Centre for Population Health Sciences 
Rights: © The Author(s) 2022. Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit
Fulltext Permission: open
Fulltext Availability: With Fulltext
Appears in Collections:LKCMedicine Journal Articles

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