{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T18:41:13Z","timestamp":1792780873718,"version":"4.5.0"},"reference-count":53,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Particip Med"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec sec-type=\"background\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Health apps, which comprise medical and wellness apps, hold potential to improve prevention, diagnosis, treatment, and management of disease. Yet, recommendation and prescription rates by health care professionals (HCPs) are low. Trusted standardized health app quality reports providing the information HCPs need to recommend or prescribe a specific app for an individual patient and guidelines from medical societies are considered crucial to enable this digital transformation of medicine. The CEN-ISO 82304\u20102 (hereinafter \u201c82304\u20102\u201d) Technical Specification, an initiative of the European Commission, includes a research-based health app quality assessment framework comprising 81 quality requirements. Results of 82304\u20102 app assessments are summarized in an intuitive \u201chealth app quality label.\u201d The 82304\u20102 quality label\u2019s potential to increase HCP willingness to recommend health apps was recently confirmed. To adequately enable decision-making and thus app recommendations, 82304\u20102 proposes a more detailed \u201chealth app quality report\u201d to complement the 82304\u20102 quality label.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"objective\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study aimed to design the 82304\u20102 health app quality report that satisfies the information needs of individual HCPs in decision-making on an individual health app for an individual patient.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"methods\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A participatory design approach was applied. In an 18-month process of participatory prototyping with 9 HCPs with digital health expertise, the 82304\u20102 quality report was iteratively designed. A convenience sample of 31 HCPs indicated the priority 82304\u20102 quality requirements they considered useful in decision-making on recommending an app, and thus needed detailed quality information. Final feedback meetings with the 9 HCPs and 8 medical societies were used to finalize the 82304\u20102 quality report design. Web-based questions in these meetings, feedback from the Dutch Patient Federation, and a comparative content analysis and the Health Education Materials Assessment Tool were used to evolve to and evaluate the final 82304\u20102 quality report design.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"results\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In total, 37% (30\/81) of the 82304\u20102 quality requirements were prioritized by &gt;50% of the HCPs. The final 82304\u20102 quality report design provides detailed information for 90% (27\/30) of the prioritized quality requirements. The reporting detail for 2 quality requirements requires more research. The final feedback meetings, the Patient Federation feedback, comparative content analysis, and Health Education Materials Assessment Tool provide indicative proof of the usefulness and usability of the quality report design.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"conclusions\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>We succeeded in our aim to design the 82304\u20102 health app quality report and found promising potential for its distinctive usefulness for HCPs and patients in recommending and considering a health app, respectively, and for medical societies in creating guidance. Further efforts are needed to test its effectiveness, fine-tune multistakeholder and intercontinental usefulness and usability, support medical societies in providing guidance and potentially training on recommending health apps, and advance from the current design to a scalable fully functional version of the quality report and associated open access database.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2196\/86473","type":"journal-article","created":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T14:30:08Z","timestamp":1787581808000},"page":"e86473-e86473","source":"Crossref","is-referenced-by-count":0,"title":["Developing a Health App Quality Report for CEN-ISO\/TS 82304-2 to Satisfy Health Care Professionals\u2019 Information Needs on the Quality of Health Apps: Participatory Design Study"],"prefix":"10.2196","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3824-648X","authenticated-orcid":false,"given":"Petra","family":"Hoogendoorn","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8657-8476","authenticated-orcid":false,"given":"Antanas","family":"Montvila","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3305-8834","authenticated-orcid":false,"given":"Kristina","family":"Ziuteliene","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9958-4330","authenticated-orcid":false,"given":"Paulius Algirdas","family":"Povilonis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4930-1982","authenticated-orcid":false,"given":"Mar\u00eda","family":"Villalobos-Quesada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8607-9199","authenticated-orcid":false,"given":"Niels H","family":"Chavannes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4120-5048","authenticated-orcid":false,"given":"Maaike","family":"Kleinsmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6645-9437","authenticated-orcid":false,"given":"Jochen","family":"Klucken","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,10,23]]},"reference":[{"key":"R1","unstructured":"ISO\/TS 82304-2:2021 health software part 2: health and wellness apps\u2013quality and reliability. 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Handbook of Ethics, Values, and Technological Design. Springer; 2015:41-66. [doi: 10.1007\/978-94-007-6970-0_33]","DOI":"10.1007\/978-94-007-6970-0_33"},{"issue":"8","key":"R31","doi-asserted-by":"publisher","first-page":"1193","DOI":"10.1177\/1357633X241262820","article-title":"Participatory design in telehealth research: practical case examples","volume":"31","author":"Clemensen","journal-title":"J Telemed Telecare"},{"issue":"03","key":"R32","doi-asserted-by":"publisher","first-page":"255","DOI":"10.1142\/S1363919608001996","article-title":"Participatory innovation","volume":"12","author":"Buur","journal-title":"Int J Innov Mgt"},{"issue":"4","key":"R33","doi-asserted-by":"publisher","DOI":"10.2196\/13780","article-title":"Generative participatory design methodology to develop electronic health interventions: systematic literature review","volume":"22","author":"Vandekerckhove","journal-title":"J Med Internet Res"},{"key":"R34","unstructured":"European Product Registry for Energy Labelling. European Commission. URL: https:\/\/eprel.ec.europa.eu\/screen\/home [Accessed 10-09-2026]"},{"key":"R35","unstructured":"Digi-HTA assessment library. Oulu University Hospital. URL: https:\/\/fincchta.fi\/en\/digi-hta-eng\/arvioinnit-eng\/ [Accessed 30-09-2026]"},{"key":"R36","unstructured":"Summary of product characteristics. European Medicines Agency (EMA). URL: https:\/\/www.ema.europa.eu\/en\/glossary-terms\/summary-product-characteristics [Accessed 10-09-2026]"},{"key":"R37","unstructured":"Therappx. AppGuide. URL: https:\/\/appguide.ca [Accessed 10-09-2026]"},{"key":"R38","unstructured":"EUDAMED\u2014European Database on Medical Devices. European Commission. URL: https:\/\/ec.europa.eu\/tools\/eudamed\/#\/screen\/home [Accessed 10-09-2026]"},{"key":"R39","unstructured":"Welcome to the international HTA database. International Network of Agencies for Health Technology Assessment (INAHTA). URL: https:\/\/database.inahta.org [Accessed 10-09-2026]"},{"key":"R40","unstructured":"Understanding the energy label. European Commission. URL: https:\/\/energy-efficient-products.ec.europa.eu\/ecodesign-and-energy-label\/understanding-energy-label_en [Accessed 10-09-2026]"},{"key":"R41","unstructured":"Sant\u00e9 publique France. Nutri-Score. URL: https:\/\/www.santepubliquefrance.fr\/nutrition-et-activite-physique\/nutri-score [Accessed 14-09-2026]"},{"key":"R42","unstructured":"The Over-the-Counter Drug Facts Label. United States Food and Drug Administration (US FDA). URL: https:\/\/www.fda.gov\/drugs\/understanding-over-counter-medicines\/over-counter-drug-facts-label [Accessed 4-10-2026]"},{"key":"R43","doi-asserted-by":"crossref","unstructured":"Bos-de Vos M . A framework for designing for divergent values. Digital Research Society; 2020. [doi: 10.21606\/drs.2020.374]","DOI":"10.21606\/drs.2020.374"},{"issue":"1","key":"R44","first-page":"65","volume":"14","author":"Kleinsmann","journal-title":"Int J Design"},{"key":"R45","doi-asserted-by":"publisher","DOI":"10.1016\/j.destud.2021.101073","article-title":"Participation in design research","volume":"78","author":"van Oorschot","journal-title":"Design Studies"},{"key":"R46","unstructured":"Health education materials assessment tool. National Library of Medicine. URL: https:\/\/medlineplus.gov\/pdf\/health-education-materials-assessment-tool.pdf [Accessed 10-09-2026]"},{"issue":"2","key":"R47","doi-asserted-by":"publisher","DOI":"10.1136\/bmjgh-2019-002248","article-title":"Improving the reporting of health research involving design: a proposed guideline","volume":"5","author":"Bazzano","journal-title":"BMJ Glob Health"},{"key":"R48","doi-asserted-by":"publisher","DOI":"10.3389\/fdgth.2023.1217479","article-title":"Covering digital health applications in the public insurance system: how to foster innovation in patient care while mitigating financial risks-evidence from Germany","volume":"5","author":"Groene","journal-title":"Front Digit Health"},{"key":"R49","unstructured":"Use apps to take charge of your health this winter. Vodafone. URL: https:\/\/www.vodafone.co.uk\/newscentre\/smart-living\/lifestyle\/use-apps-to-take-charge-of-your-health-this-winter [Accessed 10-09-2026]"},{"key":"R50","unstructured":"Vodafone and Teladoc Health launch health-e: an all-in-one online health service. Vodafone Ziggo. 2023. URL: https:\/\/www.vodafoneziggo.nl\/en\/nieuws\/vodafone-and-teladoc-health-launch-health-e-an-all-in-one-online-health-service [Accessed 10-09-2026]"},{"key":"R51","unstructured":"Biscotti L . New recipe for supermarkets: marrying health, tech, and profits. Forbes; URL: https:\/\/www.forbes.com\/sites\/louisbiscotti\/2023\/08\/23\/supermarkets-new-recipe-marrying-health-tech-and-profits [Accessed 10-09-2026]"},{"key":"R52","unstructured":"Deutsche Gesellschaft f\u00fcr Digitale Medizin. 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