Health app policy: international comparison of nine countries' approaches
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...
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sg-ntu-dr.10356-1643382023-03-05T16:53:21Z Health app policy: international comparison of nine countries' approaches Essén, Anna Stern, Ariel D. Haase, Christoffer Bjerre Car, Josip Greaves, Felix Paparova, Dragana Vandeput, Steven Wehrens, Rik Bates, David W. Lee Kong Chian School of Medicine (LKCMedicine) Centre for Population Health Sciences Science::Medicine Healthcare Systems International Comparison 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. Published version Open access funding provided by Stockholm School of Economics. 2023-01-17T01:59:15Z 2023-01-17T01:59:15Z 2022 Journal Article 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). https://dx.doi.org/10.1038/s41746-022-00573-1 2398-6352 https://hdl.handle.net/10356/164338 10.1038/s41746-022-00573-1 35304561 2-s2.0-85126735096 1 5 en NPJ Digital Medicine © 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 http://creativecommons.org/licenses/by/4.0/. application/pdf |
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Science::Medicine Healthcare Systems International Comparison Essén, Anna Stern, Ariel D. Haase, Christoffer Bjerre Car, Josip Greaves, Felix Paparova, Dragana Vandeput, Steven Wehrens, Rik Bates, David W. Health app policy: international comparison of nine countries' approaches |
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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. |
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Lee Kong Chian School of Medicine (LKCMedicine) |
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Lee Kong Chian School of Medicine (LKCMedicine) Essén, Anna Stern, Ariel D. Haase, Christoffer Bjerre Car, Josip Greaves, Felix Paparova, Dragana Vandeput, Steven Wehrens, Rik Bates, David W. |
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Article |
author |
Essén, Anna Stern, Ariel D. Haase, Christoffer Bjerre Car, Josip Greaves, Felix Paparova, Dragana Vandeput, Steven Wehrens, Rik Bates, David W. |
author_sort |
Essén, Anna |
title |
Health app policy: international comparison of nine countries' approaches |
title_short |
Health app policy: international comparison of nine countries' approaches |
title_full |
Health app policy: international comparison of nine countries' approaches |
title_fullStr |
Health app policy: international comparison of nine countries' approaches |
title_full_unstemmed |
Health app policy: international comparison of nine countries' approaches |
title_sort |
health app policy: international comparison of nine countries' approaches |
publishDate |
2023 |
url |
https://hdl.handle.net/10356/164338 |
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1759854258180587520 |