{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T16:44:31Z","timestamp":1760028271232,"version":"3.38.0"},"reference-count":106,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,2,5]],"date-time":"2025-02-05T00:00:00Z","timestamp":1738713600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2025,2,5]],"date-time":"2025-02-05T00:00:00Z","timestamp":1738713600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"funder":[{"DOI":"10.13039\/100005326","name":"Yale University","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005326","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Minds & Machines"],"DOI":"10.1007\/s11023-025-09710-7","type":"journal-article","created":{"date-parts":[[2025,2,5]],"date-time":"2025-02-05T20:44:01Z","timestamp":1738788241000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["An App a Day will (Probably Not) Keep the Doctor Away: An Evidence Audit of Health and Medical Apps Available on the Apple App Store"],"prefix":"10.1007","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5221-4770","authenticated-orcid":false,"given":"Jessica","family":"Morley","sequence":"first","affiliation":[]},{"given":"Joel","family":"Laitila","sequence":"additional","affiliation":[]},{"given":"Joseph S.","family":"Ross","sequence":"additional","affiliation":[]},{"given":"Joel","family":"Schamroth","sequence":"additional","affiliation":[]},{"given":"Joe","family":"Zhang","sequence":"additional","affiliation":[]},{"given":"Luciano","family":"Floridi","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2025,2,5]]},"reference":[{"key":"9710_CR1","doi-asserted-by":"publisher","first-page":"29","DOI":"10.1038\/s41746-024-01021-y","volume":"7","author":"M Aboy","year":"2024","unstructured":"Aboy, M., Crespo, C., & Stern, A. (2024). Beyond the 510(k): The regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA\u2019s De Novo pathway. NPJ Digital Medicine, 7, 29.","journal-title":"NPJ Digital Medicine"},{"key":"9710_CR2","doi-asserted-by":"publisher","first-page":"330","DOI":"10.1093\/jamia\/ocz175","volume":"27","author":"S Akbar","year":"2020","unstructured":"Akbar, S., Coiera, E., & Magrabi, F. (2020). Safety concerns with consumer-facing mobile health applications and their consequences: A scoping review. Journal of the American Medical Informatics Association, 27, 330\u2013340.","journal-title":"Journal of the American Medical Informatics Association"},{"key":"9710_CR3","doi-asserted-by":"publisher","first-page":"2042","DOI":"10.1177\/1460458219896492","volume":"26","author":"F Alqahtani","year":"2020","unstructured":"Alqahtani, F., & Orji, R. (2020). Insights from user reviews to improve mental health apps. Health Informatics Journal, 26, 2042\u20132066.","journal-title":"Health Informatics Journal"},{"key":"9710_CR4","unstructured":"Anthes, E. (2016). Pocket psychiatry: Mobile mental-health apps have exploded onto the market, but few have been thoroughly tested. Nature, 532."},{"key":"9710_CR5","doi-asserted-by":"publisher","unstructured":"Armstrong, S. (2015). Which app should I use? BMJ, h4597. https:\/\/doi.org\/10.1136\/bmj.h4597","DOI":"10.1136\/bmj.h4597"},{"key":"9710_CR6","doi-asserted-by":"crossref","unstructured":"Armstrong, S. (2016). What happens to data gathered by health and wellness apps? BMJ (Online), 353.","DOI":"10.1136\/bmj.i3406"},{"key":"9710_CR7","doi-asserted-by":"publisher","first-page":"283","DOI":"10.1038\/s42256-021-00331-0","volume":"3","author":"B Babic","year":"2021","unstructured":"Babic, B., Gerke, S., Evgeniou, T., & Cohen, I. G. (2021). Direct-to-consumer medical machine learning and artificial intelligence applications. Nature Machine Intelligence, 3, 283\u2013287.","journal-title":"Nature Machine Intelligence"},{"key":"9710_CR8","doi-asserted-by":"publisher","first-page":"1975","DOI":"10.1001\/jama.2018.14378","volume":"320","author":"DW Bates","year":"2018","unstructured":"Bates, D. W., Landman, A., & Levine, D. M. (2018). Health apps and health policy: What is needed? JAMA, 320, 1975\u20131976.","journal-title":"JAMA"},{"key":"9710_CR9","doi-asserted-by":"crossref","unstructured":"Batterham, P. J., Calear, A. L., O\u2019Dea, B., Larsen, M. E., Kavanagh, D. J., Titov, N., March, S., Hickie, I., Teesson, M., Dear, B. F., Reynolds, J., Lowinger, J., Thornton, L., & Gorman, P. (2019). Stakeholder perspectives on evidence for digital mental health interventions: Implications for accreditation systems. DIGITAL HEALTH, 5, 205520761987806","DOI":"10.1177\/2055207619878069"},{"key":"9710_CR10","doi-asserted-by":"publisher","DOI":"10.2196\/16741","volume":"8","author":"C Baxter","year":"2020","unstructured":"Baxter, C., Carroll, J.-A., Keogh, B., & Vandelanotte, C. (2020). Assessment of mobile health apps using built-in smartphone sensors for diagnosis and treatment: Systematic survey of apps listed in international curated health app libraries. JMIR mHealth and uHealth, 8, e16741.","journal-title":"JMIR mHealth and uHealth"},{"key":"9710_CR11","first-page":"e018280","volume":"7","author":"R Buechi","year":"2017","unstructured":"Buechi, R., Faes, L., Bachmann, L. M., Thiel, M. A., Bodmer, N. S., Schmid, M. K., Job, O., & Lienhard, K. R. (2017). Evidence assessing the diagnostic performance of medical smartphone apps: a systematic review and exploratory meta-analysis. British Medical Journal Open, 7, e018280.","journal-title":"British Medical Journal Open"},{"key":"9710_CR12","doi-asserted-by":"publisher","first-page":"90","DOI":"10.1136\/eb-2012-100885","volume":"18","author":"AWG Buijink","year":"2013","unstructured":"Buijink, A. W. G., Visser, B. J., & Marshall, L. (2013). Medical apps for smartphones: Lack of evidence undermines quality and safety. BMJ Evidence-Based Medicine, 18, 90\u201392.","journal-title":"BMJ Evidence-Based Medicine"},{"key":"9710_CR13","doi-asserted-by":"publisher","first-page":"305","DOI":"10.1097\/PRS.0b013e318219c171","volume":"128","author":"PB Burns","year":"2011","unstructured":"Burns, P. B., Rohrich, R. J., & Chung, K. C. (2011). The levels of evidence and their role in evidence-based medicine. Plastic and Reconstructive Surgery, 128, 305\u2013310.","journal-title":"Plastic and Reconstructive Surgery"},{"key":"9710_CR14","doi-asserted-by":"publisher","first-page":"12","DOI":"10.1038\/s41746-018-0021-9","volume":"1","author":"O Byambasuren","year":"2018","unstructured":"Byambasuren, O., Sanders, S., Beller, E., & Glasziou, P. (2018). Prescribable mHealth apps identified from an overview of systematic reviews. NPJ Digital Medicine, 1, 12.","journal-title":"NPJ Digital Medicine"},{"key":"9710_CR15","volume-title":"Systems architecture, global edition","author":"B Cameron","year":"2016","unstructured":"Cameron, B., Crawley, E., & Selva, D. (2016). Systems architecture, global edition. Pearson."},{"key":"9710_CR16","doi-asserted-by":"publisher","first-page":"186","DOI":"10.1108\/JSIT-07-2015-0061","volume":"18","author":"N Carroll","year":"2016","unstructured":"Carroll, N., & Richardson, I. (2016). Software-as-a-medical device: Demystifying connected health regulations. JSIT, 18, 186\u2013215.","journal-title":"JSIT"},{"key":"9710_CR17","unstructured":"Center for Devices and Radiological Health. (2023) How to determine if your product is a medical device. FDA."},{"key":"9710_CR18","doi-asserted-by":"publisher","first-page":"147","DOI":"10.1111\/jpm.12744","volume":"29","author":"AHY Chan","year":"2022","unstructured":"Chan, A. H. Y., & Honey, M. L. L. (2022). User perceptions of mobile digital apps for mental health: Acceptability and usability\u2014An integrative review. Journal of Psychiatric and Mental Health Nursing, 29, 147\u2013168.","journal-title":"Journal of Psychiatric and Mental Health Nursing"},{"key":"9710_CR19","doi-asserted-by":"publisher","first-page":"1038","DOI":"10.1089\/tmj.2015.0002","volume":"21","author":"S Chan","year":"2015","unstructured":"Chan, S., Torous, J., Hinton, L., & Yellowlees, P. (2015). Towards a framework for evaluating mobile mental health apps. Telemedicine and e-Health, 21, 1038\u20131041.","journal-title":"Telemedicine and e-Health"},{"key":"9710_CR20","doi-asserted-by":"crossref","unstructured":"Chandrashekar, P. (2018). Do mental health mobile apps work: evidence and recommendations for designing high-efficacy mental health mobile apps. Mhealth, 4.","DOI":"10.21037\/mhealth.2018.03.02"},{"key":"9710_CR21","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/1741-7015-12-29","volume":"12","author":"E Charani","year":"2014","unstructured":"Charani, E., Castro-S\u00e1nchez, E., Moore, L. S., & Holmes, A. (2014). Do smartphone applications in healthcare require a governance and legal framework? It depends on the application! BMC Medicine, 12, 1\u20133.","journal-title":"BMC Medicine"},{"key":"9710_CR22","doi-asserted-by":"publisher","first-page":"e163","DOI":"10.1016\/S2589-7500(20)30057-1","volume":"2","author":"AB Cohen","year":"2020","unstructured":"Cohen, A. B., Mathews, S. C., Dorsey, E. R., Bates, D. W., & Safavi, K. (2020). Direct-to-consumer digital health. The Lancet Digital Health, 2, e163\u2013e165.","journal-title":"The Lancet Digital Health"},{"key":"9710_CR23","doi-asserted-by":"publisher","first-page":"133","DOI":"10.1177\/1090198112452126","volume":"40","author":"LT Cowan","year":"2013","unstructured":"Cowan, L. T., Van Wagenen, S. A., Brown, B. A., Hedin, R. J., Seino-Stephan, Y., Hall, P. C., & West, J. H. (2013). Apps of steel: are exercise apps providing consumers with realistic expectations? A content analysis of exercise apps for presence of behavior change theory. Health Education & Behavior, 40, 133\u2013139.","journal-title":"Health Education & Behavior"},{"key":"9710_CR24","doi-asserted-by":"publisher","DOI":"10.1111\/eci.13072","volume":"49","author":"IA Cristea","year":"2019","unstructured":"Cristea, I. A., Cahan, E. M., & Ioannidis, J. P. A. (2019). Stealth research: Lack of peer-reviewed evidence from healthcare unicorns. Eur J Clin Investigation, 49, e13072.","journal-title":"Eur J Clin Investigation"},{"key":"9710_CR25","doi-asserted-by":"publisher","first-page":"e12333","DOI":"10.1111\/nin.12333","volume":"27","author":"RM Dawson","year":"2020","unstructured":"Dawson, R. M., Felder, T. M., Donevant, S. B., McDonnell, K. K., Card, E. B., King, C. C., & Heiney, S. P. (2020). What makes a good health \u2018app\u2019? Identifying the strengths and limitations of existing mobile application evaluation tools. Nursing Inquiry, 27, e12333.","journal-title":"Nursing Inquiry"},{"key":"9710_CR26","doi-asserted-by":"publisher","DOI":"10.2196\/37677","volume":"24","author":"S Day","year":"2022","unstructured":"Day, S., Shah, V., Kaganoff, S., Powelson, S., & Mathews, S. C. (2022). Assessing the clinical robustness of digital health startups: Cross-sectional observational analysis. Journal of Medical Internet Research, 24, e37677.","journal-title":"Journal of Medical Internet Research"},{"key":"9710_CR27","unstructured":"Digital Therapeutics Allianc. (2022). DTx Regulatory & reimbursement pathways. Infographic. https:\/\/dtxalliance.org\/wp-content\/uploads\/2022\/01\/US-Regulatory-and-Reimbursement-Pathways.pdf."},{"key":"9710_CR28","doi-asserted-by":"crossref","unstructured":"Ess\u00e9n, 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\u2019 approaches. npj Digital Medicine, 5.","DOI":"10.1038\/s41746-022-00573-1"},{"key":"9710_CR29","unstructured":"European Commission. (2016). Clinical evaluation: a guide for manufacturers and notified bodies under directives 93\/42 and 90\/385."},{"key":"9710_CR30","doi-asserted-by":"publisher","DOI":"10.2196\/jmir.6.3.e35","volume":"6","author":"G Eysenbach","year":"2004","unstructured":"Eysenbach, G. (2004). Tackling publication bias and selective reporting in health informatics research: Register your eHealth Trials in the International eHealth Studies Registry. Journal of Medical Internet Research, 6, e35.","journal-title":"Journal of Medical Internet Research"},{"key":"9710_CR31","unstructured":"FDA. (2019a). Step 3: Pathway to Approval. FDA."},{"key":"9710_CR32","unstructured":"FDA. (2019b) Step 4: FDA Device Review. FDA."},{"key":"9710_CR87","doi-asserted-by":"publisher","first-page":"303","DOI":"10.1007\/s11023-008-9113-7","volume":"18","author":"L Floridi","year":"2024","unstructured":"Floridi, L. (2008). The method of levels of abstraction. Minds and Machines, 18, 303\u2013329.","journal-title":"Minds and Machines"},{"key":"9710_CR106","doi-asserted-by":"publisher","first-page":"495","DOI":"10.1007\/s11023-017-9438-1","volume":"27","author":"L Floridi","year":"2024","unstructured":"Floridi, L. (2017). The logic of design as a conceptual logic of information. Minds & Machines, 27, 495\u2013519.","journal-title":"Minds and Machines"},{"key":"9710_CR33","doi-asserted-by":"publisher","first-page":"2263","DOI":"10.1016\/S0140-6736(18)32819-8","volume":"392","author":"H Fraser","year":"2018","unstructured":"Fraser, H., Coiera, E., & Wong, D. (2018). Safety of patient-facing digital symptom checkers. The Lancet, 392, 2263\u20132264.","journal-title":"The Lancet"},{"key":"9710_CR34","unstructured":"FTC (2022). Mobile health app interactive tool. Federal Trade Commission https:\/\/www.ftc.gov\/business-guidance\/resources\/mobile-health-apps-interactive-tool."},{"key":"9710_CR35","doi-asserted-by":"publisher","first-page":"14","DOI":"10.1038\/s41746-019-0212-z","volume":"3","author":"WJ Gordon","year":"2020","unstructured":"Gordon, W. J., Landman, A., Zhang, H., & Bates, D. W. (2020). Beyond validation: Getting health apps into clinical practice. Npj Digital Medicine, 3, 14.","journal-title":"Npj Digital Medicine"},{"key":"9710_CR36","doi-asserted-by":"publisher","DOI":"10.2196\/24824","volume":"22","author":"WJ Gordon","year":"2020","unstructured":"Gordon, W. J., & Mandl, K. D. (2020). The 21st century cures act: A competitive apps market and the risk of innovation blocking. Journal of Medical Internet Research, 22, e24824.","journal-title":"Journal of Medical Internet Research"},{"key":"9710_CR37","doi-asserted-by":"publisher","first-page":"493","DOI":"10.1038\/s41551-019-0426-z","volume":"3","author":"WJ Gordon","year":"2019","unstructured":"Gordon, W. J., & Stern, A. D. (2019). Challenges and opportunities in software-driven medical devices. Nature Biomedical Engineering, 3, 493\u2013497.","journal-title":"Nature Biomedical Engineering"},{"key":"9710_CR38","doi-asserted-by":"publisher","first-page":"2665","DOI":"10.1016\/S0140-6736(18)33129-5","volume":"392","author":"F Greaves","year":"2018","unstructured":"Greaves, F., Joshi, I., Campbell, M., Roberts, S., Patel, N., & Powell, J. (2018). What is an appropriate level of evidence for a digital health intervention? The Lancet, 392, 2665\u20132667.","journal-title":"The Lancet"},{"key":"9710_CR39","doi-asserted-by":"publisher","first-page":"1051","DOI":"10.1016\/j.amepre.2016.07.009","volume":"51","author":"QH Grundy","year":"2016","unstructured":"Grundy, Q. H., Wang, Z., & Bero, L. A. (2016). Challenges in assessing mobile health app quality. American Journal of Preventive Medicine, 51, 1051\u20131059.","journal-title":"American Journal of Preventive Medicine"},{"key":"9710_CR40","doi-asserted-by":"publisher","first-page":"110","DOI":"10.1038\/s41746-020-00314-2","volume":"3","author":"C Guo","year":"2020","unstructured":"Guo, C., Ashrafian, H., Ghafur, S., Fontana, G., Gardner, C., & Prime, M. (2020). Challenges for the evaluation of digital health solutions\u2014A call for innovative evidence generation approaches. NPJ Digital Medicine, 3, 110.","journal-title":"NPJ Digital Medicine"},{"key":"9710_CR41","unstructured":"Health, C. for D. and R. Classify Your Medical Device. FDA https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/classify-your-medical-device (2023)."},{"key":"9710_CR42","unstructured":"Health. Class I and Class II Device Exemptions. FDA (2023)."},{"key":"9710_CR43","doi-asserted-by":"publisher","first-page":"18","DOI":"10.1186\/s12910-018-0255-8","volume":"19","author":"A Ho","year":"2018","unstructured":"Ho, A., & Quick, O. (2018). Leaving patients to their own devices? Smart technology, safety and therapeutic relationships. BMC Medical Ethics, 19, 18.","journal-title":"BMC Medical Ethics"},{"key":"9710_CR44","doi-asserted-by":"publisher","first-page":"94","DOI":"10.3389\/fpsyt.2019.00094","volume":"10","author":"L Hoffman","year":"2019","unstructured":"Hoffman, L., Benedetto, E., Huang, H., Grossman, E., Kaluma, D., Mann, Z., & Torous, J. (2019). Augmenting mental health in primary care: A 1-year study of deploying smartphone apps in a multi-site primary care\/behavioral health integration program. Frontiers in Psychiatry, 10, 94.","journal-title":"Frontiers in Psychiatry"},{"key":"9710_CR45","doi-asserted-by":"crossref","unstructured":"Holl, F., & Hrynyschyn, R. (2023). How to evaluate health and medical apps in public health\u2014What are alternatives to randomized controlled trials? Population Medicine, 5.","DOI":"10.18332\/popmed\/165233"},{"key":"9710_CR46","doi-asserted-by":"publisher","first-page":"214","DOI":"10.1186\/s12916-015-0444-y","volume":"13","author":"K Huckvale","year":"2015","unstructured":"Huckvale, K., Prieto, J. T., Tilney, M., Benghozi, P.-J., & Car, J. (2015). Unaddressed privacy risks in accredited health and wellness apps: A cross-sectional systematic assessment. BMC Medicine, 13, 214.","journal-title":"BMC Medicine"},{"key":"9710_CR47","doi-asserted-by":"publisher","first-page":"e0154248","DOI":"10.1371\/journal.pone.0154248","volume":"11","author":"A Huguet","year":"2016","unstructured":"Huguet, A., Rao, S., McGrath, P. J., Wozney, L., Wheaton, M., Conrod, J., & Rozario, S. (2016). A systematic review of cognitive behavioral therapy and behavioral activation apps for depression. PLoS ONE, 11, e0154248.","journal-title":"PLoS ONE"},{"key":"9710_CR48","unstructured":"IMDRF Software as a Medical Device (SaMD) Working Group. (2014). \u2018Software as a medical device\u2019: Possible framework for risk categorization and corresponding considerations. https:\/\/www.imdrf.org\/sites\/default\/files\/docs\/imdrf\/final\/technical\/imdrf-tech-140918-samd-framework-risk-categorization-141013.pdf."},{"key":"9710_CR49","doi-asserted-by":"publisher","first-page":"4514","DOI":"10.2196\/45143","volume":"10","author":"C Jacob","year":"2023","unstructured":"Jacob, C., Lindeque, J., Klein, A., Ivory, C., Heuss, S., & Peter, M. K. (2023). Assessing the quality and impact of eHealth tools: Systematic literature review and narrative synthesis. JMIR Human Factors, 10, 4514.","journal-title":"JMIR Human Factors"},{"key":"9710_CR50","doi-asserted-by":"publisher","first-page":"e190","DOI":"10.2196\/mhealth.8758","volume":"5","author":"DE Jake-Schoffman","year":"2017","unstructured":"Jake-Schoffman, D. E., Silfee, V. J., Waring, M. E., Boudreaux, E. D., Sadasivam, R. S., Mullen, S. P., Carey, J. L., Hayes, R. B., Ding, E. Y., Bennett, G. G., & Pagoto, S. L. (2017). Methods for evaluating the content, usability, and efficacy of commercial mobile health apps. JMIR mHealth and uHealth, 5, e190.","journal-title":"JMIR mHealth and uHealth"},{"key":"9710_CR51","doi-asserted-by":"publisher","first-page":"S106","DOI":"10.1016\/j.pmrj.2017.02.018","volume":"9","author":"C-K Kao","year":"2017","unstructured":"Kao, C.-K., & Liebovitz, D. M. (2017). Consumer mobile health apps: Current state, barriers, and future directions. PM&R, 9, S106\u2013S115.","journal-title":"PM&R"},{"issue":"4","key":"9710_CR86","doi-asserted-by":"publisher","DOI":"10.1007\/s11023-024-09692-y","volume":"34","author":"K Karpathakis","year":"2024","unstructured":"Karpathakis, K., Morley, J. & Floridi, L. (2024). A justifiable investment in AI for healthcare: aligning ambition with reality. Minds and Machines, 34(4), 38. https:\/\/doi.org\/10.1007\/s11023-024-09692-y.","journal-title":"Minds and Machines"},{"key":"9710_CR52","doi-asserted-by":"publisher","first-page":"235","DOI":"10.1111\/bioe.12674","volume":"34","author":"TJ Kasperbauer","year":"2020","unstructured":"Kasperbauer, T. J., & Wright, D. E. (2020). Expanded FDA regulation of health and wellness apps. Bioethics, 34, 235\u2013241.","journal-title":"Bioethics"},{"key":"9710_CR53","doi-asserted-by":"publisher","first-page":"1538","DOI":"10.1177\/1460458219884195","volume":"26","author":"R Kenny","year":"2020","unstructured":"Kenny, R., Fitzgerald, A., Segurado, R., & Dooley, B. (2020). Is there an app for that? A cluster randomised controlled trial of a mobile app\u2013based mental health intervention. Health Informatics Journal, 26, 1538\u20131559.","journal-title":"Health Informatics Journal"},{"key":"9710_CR54","doi-asserted-by":"publisher","first-page":"1559","DOI":"10.1377\/hlthaff.2023.00384","volume":"42","author":"A Kumar","year":"2023","unstructured":"Kumar, A., Ross, J. S., Patel, N. A., Rathi, V., Redberg, R. F., & Dhruva, S. S. (2023). Studies of prescription digital therapeutics often lack rigor and inclusivity: Study examines prescription digital therapeutics standards. Health Affairs, 42, 1559\u20131567.","journal-title":"Health Affairs"},{"key":"9710_CR55","doi-asserted-by":"publisher","first-page":"228","DOI":"10.1016\/j.amepre.2013.03.017","volume":"45","author":"S Kumar","year":"2013","unstructured":"Kumar, S., Nilsen, W. J., Abernethy, A., Atienza, A., Patrick, K., Pavel, M., Riley, W. T., Shar, A., Spring, B., Spruijt-Metz, D., Hedeker, D., Honavar, V., Kravitz, R., Lefebvre, R. C., Mohr, D. C., Murphy, S. A., Quinn, C., Shusterman, V., & Swendeman, D. (2013). Mobile health technology evaluation. American Journal of Preventive Medicine, 45, 228\u2013236.","journal-title":"American Journal of Preventive Medicine"},{"key":"9710_CR56","doi-asserted-by":"publisher","first-page":"201","DOI":"10.1111\/acps.13306","volume":"144","author":"S Lagan","year":"2021","unstructured":"Lagan, S., D\u2019Mello, R., Vaidyam, A., Bilden, R., & Torous, J. (2021). Assessing mental health apps marketplaces with objective metrics from 29,190 data points from 278 apps. Acta Psychiatrica Scand, 144, 201\u2013210.","journal-title":"Acta Psychiatrica Scand"},{"key":"9710_CR57","doi-asserted-by":"publisher","first-page":"18","DOI":"10.1038\/s41746-019-0093-1","volume":"2","author":"ME Larsen","year":"2019","unstructured":"Larsen, M. E., Huckvale, K., Nicholas, J., Torous, J., Birrell, L., Li, E., & Reda, B. (2019). Using science to sell apps: Evaluation of mental health app store quality claims. Npj Digital Medicine, 2, 18.","journal-title":"Npj Digital Medicine"},{"key":"9710_CR58","doi-asserted-by":"publisher","DOI":"10.2196\/mhealth.6020","volume":"4","author":"ME Larsen","year":"2016","unstructured":"Larsen, M. E., Nicholas, J., & Christensen, H. (2016). Quantifying app store dynamics: Longitudinal tracking of mental health apps. JMIR mHealth and uHealth, 4, e6020.","journal-title":"JMIR mHealth and uHealth"},{"key":"9710_CR59","doi-asserted-by":"publisher","DOI":"10.2196\/17798","volume":"8","author":"N Lau","year":"2020","unstructured":"Lau, N., et al. (2020). Android and iPhone mobile apps for psychosocial wellness and stress management: Systematic search in app stores and literature review. JMIR mHealth and uHealth, 8, e17798.","journal-title":"JMIR mHealth and uHealth"},{"key":"9710_CR60","doi-asserted-by":"publisher","DOI":"10.2196\/29689","volume":"9","author":"N Lau","year":"2021","unstructured":"Lau, N., O\u2019Daffer, A., Yi-Frazier, J. P., & Rosenberg, A. R. (2021). Popular evidence-based commercial mental health apps: Analysis of engagement, functionality, aesthetics, and information quality. JMIR mHealth and uHealth, 9, e29689.","journal-title":"JMIR mHealth and uHealth"},{"key":"9710_CR61","doi-asserted-by":"publisher","first-page":"730","DOI":"10.7326\/M17-2715","volume":"168","author":"TT Lee","year":"2018","unstructured":"Lee, T. T., & Kesselheim, A. S. U. S. (2018). Food and drug administration precertification pilot program for digital health software: Weighing the benefits and risks. Annals of Internal Medicine, 168, 730\u2013732.","journal-title":"Annals of Internal Medicine"},{"key":"9710_CR62","doi-asserted-by":"publisher","first-page":"e58","DOI":"10.1016\/S2589-7500(19)30025-1","volume":"1","author":"S Leigh","year":"2019","unstructured":"Leigh, S., & Ashall-Payne, L. (2019). The role of health-care providers in mHealth adoption. The Lancet Digital Health, 1, e58\u2013e59.","journal-title":"The Lancet Digital Health"},{"key":"9710_CR63","doi-asserted-by":"publisher","first-page":"74","DOI":"10.1038\/s41746-020-0268-9","volume":"3","author":"DM Levine","year":"2020","unstructured":"Levine, D. M., Co, Z., Newmark, L. P., Groisser, A. R., Holmgren, A. J., Haas, J. S., & Bates, D. W. (2020). Design and testing of a mobile health application rating tool. NPJ Digital Medicine, 3, 74.","journal-title":"NPJ Digital Medicine"},{"key":"9710_CR64","doi-asserted-by":"crossref","unstructured":"Levy, J., & Romo-Avil\u00e9s, N. (2019). \u2018A good little tool to get to know yourself a bit better\u2019: A qualitative study on users\u2019 experiences of app-supported menstrual tracking in Europe. BMC Public Health, 19.","DOI":"10.1186\/s12889-019-7549-8"},{"key":"9710_CR65","doi-asserted-by":"publisher","DOI":"10.2196\/13057","volume":"8","author":"P Llorens-Vernet","year":"2020","unstructured":"Llorens-Vernet, P., & Mir\u00f3, J. (2020). Standards for mobile health\u2013related apps: Systematic review and development of a guide. JMIR mHealth and uHealth, 8, e13057.","journal-title":"JMIR mHealth and uHealth"},{"key":"9710_CR66","doi-asserted-by":"publisher","first-page":"128","DOI":"10.1016\/j.socscimed.2015.04.004","volume":"133","author":"D Lupton","year":"2015","unstructured":"Lupton, D., & Jutel, A. (2015). \u2018It\u2019s like having a physician in your pocket!\u2019A critical analysis of self-diagnosis smartphone apps. Social Science & Medicine, 133, 128\u2013135.","journal-title":"Social Science & Medicine"},{"key":"9710_CR67","doi-asserted-by":"publisher","first-page":"e100006","DOI":"10.1136\/bmjhci-2019-100006","volume":"26","author":"F Magrabi","year":"2019","unstructured":"Magrabi, F., Habli, I., Sujan, M., Wong, D., Thimbleby, H., Baker, M., & Coiera, E. (2019). Why is it so difficult to govern mobile apps in healthcare? BMJ Health & Care Informatics, 26, e100006.","journal-title":"BMJ Health & Care Informatics"},{"key":"9710_CR68","doi-asserted-by":"publisher","first-page":"38","DOI":"10.1038\/s41746-019-0111-3","volume":"2","author":"SC Mathews","year":"2019","unstructured":"Mathews, S. C., McShea, M. J., Hanley, C. L., Ravitz, A., Labrique, A. B., & Cohen, A. B. (2019). Digital health: a path to validation. NPJ Digital Medicine, 2, 38.","journal-title":"NPJ Digital Medicine"},{"key":"9710_CR69","unstructured":"May, L. C. (2023). Mind the gap(s) in mental health care. On the claimed and actual evidence-base of publicly available top-rated mHealth applications for depression: a scoping review."},{"key":"9710_CR70","doi-asserted-by":"publisher","first-page":"441","DOI":"10.3109\/03091902.2015.1088087","volume":"39","author":"AD McCarthy","year":"2015","unstructured":"McCarthy, A. D., & Lawford, P. V. (2015). Standalone medical device software: The evolving regulatory framework. Journal of Medical Engineering & Technology, 39, 441\u2013447.","journal-title":"Journal of Medical Engineering & Technology"},{"key":"9710_CR71","doi-asserted-by":"crossref","unstructured":"McCartney, M. (2013). How do we know whether medical apps work? BMJ, 346.","DOI":"10.1136\/bmj.f1811"},{"key":"9710_CR72","doi-asserted-by":"publisher","first-page":"22","DOI":"10.1177\/1357633X16673538","volume":"24","author":"FH McKay","year":"2018","unstructured":"McKay, F. H., Cheng, C., Wright, A., Shill, J., Stephens, H., & Uccellini, M. (2018). Evaluating mobile phone applications for health behaviour change: A systematic review. Journal of Telemedicine and Telecare, 24, 22\u201330.","journal-title":"Journal of Telemedicine and Telecare"},{"key":"9710_CR73","unstructured":"MHRA. (2022). Guidance: Medical device stand-alone software including apps (including IVDMDs). https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/1105233\/Medical_device_stand-alone_software_including_apps.pdf."},{"key":"9710_CR74","doi-asserted-by":"publisher","DOI":"10.2196\/17046","volume":"8","author":"M Milne-Ives","year":"2020","unstructured":"Milne-Ives, M., Lam, C., De Cock, C., Van Velthoven, M. H., & Meinert, E. (2020). Mobile apps for health behavior change in physical activity, diet, drug and alcohol use, and mental health: Systematic review. JMIR mHealth and uHealth, 8, e17046.","journal-title":"JMIR mHealth and uHealth"},{"key":"9710_CR75","doi-asserted-by":"publisher","first-page":"e166","DOI":"10.2196\/jmir.4391","volume":"17","author":"DC Mohr","year":"2015","unstructured":"Mohr, D. C., Schueller, S. M., Riley, W. T., Brown, C. H., Cuijpers, P., Duan, N., Kwasny, M. J., Stiles-Shields, C., & Cheung, K. (2015). Trials of intervention principles: Evaluation methods for evolving behavioral intervention technologies. Journal of Medical Internet Research, 17, e166.","journal-title":"Journal of Medical Internet Research"},{"key":"9710_CR76","doi-asserted-by":"publisher","first-page":"252","DOI":"10.1017\/S0266462320000288","volume":"36","author":"MR Moshi","year":"2020","unstructured":"Moshi, M. R., Tooher, R., & Merlin, T. (2020). Development of a health technology assessment module for evaluating mobile medical applications. International Journal of Technology Assessment in Health Care, 36, 252\u2013261.","journal-title":"International Journal of Technology Assessment in Health Care"},{"key":"9710_CR77","doi-asserted-by":"publisher","first-page":"313","DOI":"10.1007\/s11019-023-10146-y","volume":"26","author":"R M\u00fcller","year":"2023","unstructured":"M\u00fcller, R., Primc, N., & Kuhn, E. (2023). \u2018You have to put a lot of trust in me\u2019: Autonomy, trust, and trustworthiness in the context of mobile apps for mental health. Medicine, Health Care and Philosophy, 26, 313\u2013324.","journal-title":"Medicine, Health Care and Philosophy"},{"key":"9710_CR78","doi-asserted-by":"publisher","first-page":"1089","DOI":"10.1093\/jamia\/ocy050","volume":"25","author":"R Nouri","year":"2018","unstructured":"Nouri, R., Kalhori, S. R. N., Ghazisaeedi, M., Marchand, G., & Yasini, M. (2018). Criteria for assessing the quality of mHealth apps: a systematic review. Journal of the American Medical Informatics Association, 25, 1089\u20131098.","journal-title":"Journal of the American Medical Informatics Association"},{"key":"9710_CR79","doi-asserted-by":"publisher","DOI":"10.2196\/17457","volume":"22","author":"K Nwe","year":"2020","unstructured":"Nwe, K., Larsen, M. E., Nelissen, N., & Wong, D.C.-W. (2020). Medical mobile app classification using the national institute for health and care excellence evidence standards framework for digital health technologies: Interrater reliability study. Journal of Medical Internet Research, 22, e17457.","journal-title":"Journal of Medical Internet Research"},{"key":"9710_CR80","doi-asserted-by":"publisher","first-page":"13","DOI":"10.24989\/dp.v1i2.1816","volume":"1","author":"T O\u2019Rourke","year":"2020","unstructured":"O\u2019Rourke, T., Pryss, R., Schlee, W., & Probst, T. (2020). Development of a multidimensional app-quality assessment tool for health-related apps (AQUA). Digit Psychology, 1, 13\u201323.","journal-title":"Digit Psychology"},{"key":"9710_CR81","doi-asserted-by":"publisher","first-page":"e42415","DOI":"10.2196\/42415","volume":"11","author":"S Paganini","year":"2023","unstructured":"Paganini, S., Meier, E., Terhorst, Y., Wurst, R., Hohberg, V., Schultchen, D., Strahler, J., Wursthorn, M., Baumeister, H., & Messner, E. M. (2023). Stress management apps: Systematic search and multidimensional assessment of quality and characteristics. JMIR mHealth and uHealth, 11, e42415.","journal-title":"JMIR mHealth and uHealth"},{"key":"9710_CR82","doi-asserted-by":"publisher","first-page":"518","DOI":"10.1186\/s12905-023-02612-9","volume":"23","author":"D Paripoorani","year":"2023","unstructured":"Paripoorani, D., Gasteiger, N., Hawley-Hague, H., & Dowding, D. (2023). A systematic review of menopause apps with an emphasis on osteoporosis. BMC Women\u2019s Health, 23, 518.","journal-title":"BMC Women\u2019s Health"},{"key":"9710_CR83","doi-asserted-by":"publisher","first-page":"198","DOI":"10.1016\/j.ijlp.2019.04.002","volume":"64","author":"L Parker","year":"2019","unstructured":"Parker, L., Halter, V., Karliychuk, T., & Grundy, Q. (2019). How private is your mental health app data? An empirical study of mental health app privacy policies and practices. International Journal of Law and Psychiatry, 64, 198\u2013204.","journal-title":"International Journal of Law and Psychiatry"},{"key":"9710_CR84","doi-asserted-by":"publisher","DOI":"10.1136\/bmjgh-2017-000676","volume":"3","author":"D Peiris","year":"2018","unstructured":"Peiris, D., Miranda, J. J., & Mohr, D. C. (2018). Going beyond killer apps: Building a better mHealth evidence base. BMJ Global Health, 3, e000676.","journal-title":"BMJ Global Health"},{"key":"9710_CR85","doi-asserted-by":"publisher","DOI":"10.2196\/mhealth.5720","volume":"4","author":"Q Pham","year":"2016","unstructured":"Pham, Q., Wiljer, D., & Cafazzo, J. A. (2016). Beyond the randomized controlled trial: A review of alternatives in mHealth clinical trial methods. JMIR mHealth and uHealth, 4, e107.","journal-title":"JMIR mHealth and uHealth"},{"key":"9710_CR88","doi-asserted-by":"publisher","first-page":"8","DOI":"10.1038\/s41746-023-00754-6","volume":"6","author":"O Sadare","year":"2023","unstructured":"Sadare, O., Melvin, T., Harvey, H., Vollebregt, E., & Gilbert, S. (2023). Can Apple and Google continue as health app gatekeepers as well as distributors and developers? NPJ Digital Medicine, 6, 8.","journal-title":"NPJ Digital Medicine"},{"key":"9710_CR89","doi-asserted-by":"publisher","first-page":"115","DOI":"10.1377\/hlthaff.2018.05081","volume":"38","author":"K Safavi","year":"2019","unstructured":"Safavi, K., Mathews, S. C., Bates, D. W., Dorsey, E. R., & Cohen, A. B. (2019). Top-funded digital health companies and their impact on high-burden. High-cost conditions. Health Affairs, 38, 115\u2013123.","journal-title":"Health Affairs"},{"key":"9710_CR90","doi-asserted-by":"crossref","unstructured":"Schueller, S. M., Neary, M., O\u2019Loughlin, K., & Adkins, E. C. (2018). Discovery of and interest in health apps among those with mental health needs: Survey and focus group study. Journal of Medical Internet Research, 20.","DOI":"10.2196\/preprints.10141"},{"key":"9710_CR91","doi-asserted-by":"publisher","first-page":"62","DOI":"10.1071\/AH18064","volume":"44","author":"IA Scott","year":"2020","unstructured":"Scott, I. A., Scuffham, P., Gupta, D., Harch, T. M., Borchi, J., & Richards, B. (2020). Going digital: A narrative overview of the effects, quality and utility of mobile apps in chronic disease self-management. Australian Health Review, 44, 62.","journal-title":"Australian Health Review"},{"key":"9710_CR92","doi-asserted-by":"crossref","unstructured":"Sedhom, R., McShea, M. J., Cohen, A. B., Webster, J. A., & Mathews, S. C. (2021). Mobile app validation: a digital health scorecard approach. npj Digital Medicine, 4.","DOI":"10.1038\/s41746-021-00476-7"},{"key":"9710_CR93","doi-asserted-by":"publisher","first-page":"2293","DOI":"10.1056\/NEJMsb1609216","volume":"375","author":"RE Sherman","year":"2016","unstructured":"Sherman, R. E., Anderson, S. A., Dal Pan, G. J., Gray, G. W., Gross, T., Hunter, N. L., LaVange, L., Marinac-Dabic, D., Marks, P. W., Robb, M. A., Shuren, J., Temple, R., Woodcock, J., Yue, L. Q., & Califf, R. M. (2016). Real-world evidence\u2014What Is it and what can it tell us? New England Journal of Medicine, 375, 2293\u20132297.","journal-title":"New England Journal of Medicine"},{"key":"9710_CR94","doi-asserted-by":"publisher","first-page":"e27","DOI":"10.2196\/mhealth.3422","volume":"3","author":"SR Stoyanov","year":"2015","unstructured":"Stoyanov, S. R., Hides, L., Kavanagh, D. J., Zelenko, O., Tjondronegoro, D., & Mani, M. (2015). Mobile app rating scale: A new tool for assessing the quality of health mobile apps. JMIR mHealth and uHealth, 3, e27.","journal-title":"JMIR mHealth and uHealth"},{"key":"9710_CR95","unstructured":"The Medical Devices Regulations (2002). https:\/\/www.legislation.gov.uk\/uksi\/2002\/618\/regulation\/2\/made."},{"key":"9710_CR96","unstructured":"The Design Council & The Point People. (2020). System-shifting design: An emerging practice explored. https:\/\/www.designcouncil.org.uk\/fileadmin\/uploads\/dc\/Documents\/Systemic%2520Design%2520Report.pdf."},{"key":"9710_CR97","doi-asserted-by":"publisher","first-page":"97","DOI":"10.1002\/wps.20592","volume":"18","author":"J Torous","year":"2019","unstructured":"Torous, J., Andersson, G., Bertagnoli, A., Christensen, H., Cuijpers, P., Firth, J., Haim, A., Hsin, H., Hollis, C., Lewis, S., Mohr, D. C., Pratap, A., Roux, S., Sherrill, J., & Arean, P. A. (2019). Towards a consensus around standards for smartphone apps and digital mental health. World Psychiatry, 18, 97\u201398.","journal-title":"World Psychiatry"},{"key":"9710_CR98","doi-asserted-by":"publisher","first-page":"437","DOI":"10.1001\/jamapsychiatry.2017.0262","volume":"74","author":"J Torous","year":"2017","unstructured":"Torous, J., & Roberts, L. W. (2017). Needed innovation in digital health and smartphone applications for mental health: Transparency and trust. JAMA Psychiatry, 74, 437.","journal-title":"JAMA Psychiatry"},{"key":"9710_CR99","doi-asserted-by":"publisher","first-page":"205520761770134","DOI":"10.1177\/2055207617701342","volume":"3","author":"M van Velthoven","year":"2017","unstructured":"van Velthoven, M., & Powell, J. (2017). Do health apps need endorsement? Challenges for giving advice about which health apps are safe and effective to use. Digital Health, 3, 2055207617701342.","journal-title":"Digital Health"},{"key":"9710_CR100","volume":"8","author":"MH Van Velthoven","year":"2018","unstructured":"Van Velthoven, M. H., Smith, J., Wells, G., & Brindley, D. (2018b). Digital health app development standards: A systematic review protocol. British Medical Journal Open, 8, e022969.","journal-title":"British Medical Journal Open"},{"key":"9710_CR101","doi-asserted-by":"publisher","first-page":"54","DOI":"10.1016\/j.ijmedinf.2018.08.003","volume":"118","author":"MH Van Velthoven","year":"2018","unstructured":"Van Velthoven, M. H., Wyatt, J. C., Meinert, E., Brindley, D., & Wells, G. (2018a). How standards and user involvement can improve app quality: A lifecycle approach. International Journal of Medical Informatics, 118, 54\u201357.","journal-title":"International Journal of Medical Informatics"},{"key":"9710_CR102","volume-title":"Understanding computers and cognition: A new foundation for design","author":"T Winograd","year":"1986","unstructured":"Winograd, T., & Flores, F. (1986). Understanding computers and cognition: A new foundation for design. Ablex Pub. Corp."},{"key":"9710_CR103","doi-asserted-by":"publisher","first-page":"4","DOI":"10.1136\/ebmental-2018-300069","volume":"22","author":"H Wisniewski","year":"2019","unstructured":"Wisniewski, H., Liu, G., Henson, P., Vaidyam, A., Hajratalli, N. K., Onnela, J.-P., & Torous, J. (2019). Understanding the quality, effectiveness and attributes of top-rated smartphone health apps. Evidence Based Mental Health, 22, 4\u20139.","journal-title":"Evidence Based Mental Health"},{"key":"9710_CR104","doi-asserted-by":"publisher","DOI":"10.2196\/12390","volume":"21","author":"T Wykes","year":"2019","unstructured":"Wykes, T., & Schueller, S. (2019). Why reviewing apps is not enough: Transparency for trust (T4T) principles of responsible health app marketplaces. Journal of Medical Internet Research, 21, e12390.","journal-title":"Journal of Medical Internet Research"},{"key":"9710_CR105","doi-asserted-by":"publisher","DOI":"10.2196\/53262","volume":"12","author":"T Zhou","year":"2024","unstructured":"Zhou, T., Salman, D., & McGregor, A. (2024). mHealth Apps for the self-management of low back pain: Systematic search in app stores and content analysis. JMIR mHealth and uHealth, 12, e53262.","journal-title":"JMIR mHealth and uHealth"}],"container-title":["Minds and Machines"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11023-025-09710-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s11023-025-09710-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11023-025-09710-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,5]],"date-time":"2025-03-05T15:19:21Z","timestamp":1741187961000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s11023-025-09710-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,5]]},"references-count":106,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025,3]]}},"alternative-id":["9710"],"URL":"https:\/\/doi.org\/10.1007\/s11023-025-09710-7","relation":{},"ISSN":["1572-8641"],"issn-type":[{"type":"electronic","value":"1572-8641"}],"subject":[],"published":{"date-parts":[[2025,2,5]]},"assertion":[{"value":"14 August 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 January 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"5 February 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}}],"article-number":"11"}}