{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T16:04:22Z","timestamp":1783008262281,"version":"3.54.5"},"reference-count":28,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,3,18]],"date-time":"2022-03-18T00:00:00Z","timestamp":1647561600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,3,18]],"date-time":"2022-03-18T00:00:00Z","timestamp":1647561600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["npj Digit. Med."],"abstract":"<jats:title>Abstract<\/jats:title><jats:p>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.<\/jats:p>","DOI":"10.1038\/s41746-022-00573-1","type":"journal-article","created":{"date-parts":[[2022,3,18]],"date-time":"2022-03-18T11:12:04Z","timestamp":1647601924000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":128,"title":["Health app policy: international comparison of nine countries\u2019 approaches"],"prefix":"10.1038","volume":"5","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3566-8409","authenticated-orcid":false,"given":"Anna","family":"Ess\u00e9n","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3586-1041","authenticated-orcid":false,"given":"Ariel D.","family":"Stern","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3895-518X","authenticated-orcid":false,"given":"Christoffer Bjerre","family":"Haase","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8969-371X","authenticated-orcid":false,"given":"Josip","family":"Car","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felix","family":"Greaves","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dragana","family":"Paparova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Vandeput","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rik","family":"Wehrens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6268-1540","authenticated-orcid":false,"given":"David W.","family":"Bates","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,3,18]]},"reference":[{"key":"573_CR1","volume-title":"The Paradox of Choice: Why More is Less","author":"B Schwartz","year":"2004","unstructured":"Schwartz, B. 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Consumer mobile health apps: current state, barriers, and future directions. PM R. 9, S106\u2013S115 (2017).","journal-title":"PM R."},{"key":"573_CR5","unstructured":"Gordon, W., Chopra, A., & Landman, A. Patient-led data sharing: a new paradigm for electronic health data. N. Engl. J. Med. Catalyst. https:\/\/catalyst.nejm.org\/patient-led-health-data-paradigm\/ (2018)."},{"key":"573_CR6","unstructured":"Stern, A. D., Matthies, H., Hagen, J., Br\u00f6nneke, J. B., & Debattin, J. F. Want to see the future of digital health tools? Look to Germany. Harv. Bus. Rev. https:\/\/hbr.org\/2020\/12\/want-to-see-the-future-of-digital-health-tools-look-to-germany (2020)."},{"key":"573_CR7","volume-title":"Mobile Applications to Support Contact Tracing in the EU\u2019s Fight against COVID-19","author":"European Committee for Standardization.","year":"2020","unstructured":"European Committee for Standardization. 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Martin, S.) 197\u2013225 (Kluwer, The Hague, 1994).","DOI":"10.1007\/978-94-015-8368-8_10"}],"container-title":["npj Digital Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41746-022-00573-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41746-022-00573-1","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41746-022-00573-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,11,25]],"date-time":"2022-11-25T07:39:10Z","timestamp":1669361950000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41746-022-00573-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3,18]]},"references-count":28,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2022,12]]}},"alternative-id":["573"],"URL":"https:\/\/doi.org\/10.1038\/s41746-022-00573-1","relation":{},"ISSN":["2398-6352"],"issn-type":[{"value":"2398-6352","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,3,18]]},"assertion":[{"value":"28 September 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 February 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 March 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"During the period when this manuscript was written A.D.S was a part-time employee of the Health Innovation Hub (HIH) of the German Federal Ministry of Health. Her contributions to this manuscript were informed by her work with the HIH, but her involvement in this project was uncompensated. F.G. is employed by the National Insitute for Health and Care Excellence (NICE) and Imperial College London. His contributions to this manuscript were informed by his work at NICE, but his involvement in this project was uncompensated. D.W.B. reports grants and personal fees from EarlySense, personal fees from CDI Negev, equity from ValeraHealth, equity from Clew, equity from MDClone, personal fees and equity from AESOP, personal fees and equity from Feelbetter, and grants from IBM Watson Health, outside the submitted work. The remaining authors declare no competing interests.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"31"}}