Health app policy: international comparison of nine countries’ approaches
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 f...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2022-03-01
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| Series: | npj Digital Medicine |
| Online Access: | https://doi.org/10.1038/s41746-022-00573-1 |
| _version_ | 1797643032704581632 |
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| author | Anna Essén Ariel D. Stern Christoffer Bjerre Haase Josip Car Felix Greaves Dragana Paparova Steven Vandeput Rik Wehrens David W. Bates |
| author_facet | Anna Essén Ariel D. Stern Christoffer Bjerre Haase Josip Car Felix Greaves Dragana Paparova Steven Vandeput Rik Wehrens David W. Bates |
| author_sort | Anna Essén |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T14:08:48Z |
| format | Article |
| id | doaj.art-047490c3647a4b2bacc1b3988173dd84 |
| institution | Directory Open Access Journal |
| issn | 2398-6352 |
| language | English |
| last_indexed | 2024-03-11T14:08:48Z |
| publishDate | 2022-03-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Digital Medicine |
| spelling | doaj.art-047490c3647a4b2bacc1b3988173dd842023-11-02T00:37:40ZengNature Portfolionpj Digital Medicine2398-63522022-03-015111010.1038/s41746-022-00573-1Health app policy: international comparison of nine countries’ approachesAnna Essén0Ariel D. Stern1Christoffer Bjerre Haase2Josip Car3Felix Greaves4Dragana Paparova5Steven Vandeput6Rik Wehrens7David W. Bates8House of Innovation, Stockholm School of EconomicsHarvard Business School, Harvard UniversityDepartment of Public Health, University of CopenhagenCentre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological UniversityDepartment of Primary Care and Public Health, Imperial College LondonDepartment of Information Systems, Centre for e-Health and Centre for Digital Transformation, University of AgderbeMedTech VZWSchool of Health Policy and Management, Erasmus UniversityHarvard Medical School and Harvard T. H. Chan School of Public Health, Harvard UniversityAbstract 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.https://doi.org/10.1038/s41746-022-00573-1 |
| spellingShingle | Anna Essén Ariel D. Stern Christoffer Bjerre Haase Josip Car Felix Greaves Dragana Paparova Steven Vandeput Rik Wehrens David W. Bates Health app policy: international comparison of nine countries’ approaches npj Digital Medicine |
| title | 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_short | Health app policy: international comparison of nine countries’ approaches |
| title_sort | health app policy international comparison of nine countries approaches |
| url | https://doi.org/10.1038/s41746-022-00573-1 |
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