Sync fast and solve things-best practices for responsible digital health
Open accessPublished version of a preprint
Abstract
Digital health innovation is expected to transform healthcare, but it also generates ethical and societal concerns, such as privacy risks, and biases that can compound existing health inequalities. While such concerns are widely recognized, existing regulatory principles, oversight methods and ethical frameworks seem out of sync with digital health innovation. New governance and innovation best practices are thus needed to bring such principles to bear with the reality of business, innovation, and regulation. To grant practical insight into best practices for responsible digital health innovation, we conducted a qualitative study based on an interactive engagement methodology. We engaged key stakeholders ( n = 46) operating at the translational frontier of digital health. This approach allowed us to identify three clusters of governance and innovation best practices in digital health innovation: i) inclusive co-creation, ii) responsive regulation, and iii) value-driven innovation. Our study shows that realizing responsible digital health requires diverse stakeholders’ commitment to adapt innovation and regulation practices, embracing co-creation as the default modus operandi for digital health development. We describe these collaborative practices and show how they can ensure that innovation is neither slowed by overregulation, nor leads to unethical outcomes.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The collaboration with end users throughout the platform development process likely contributed to users reporting high usefulness and acceptable usability.
“Our collaboration with end users throughout the platform development process [31,33] likely contributed to users reporting high usefulness and acceptable usability, as this co-creation approach has been recognized as essential for successful digital health technology development [36,37].”
From Caregiver experiences of an integrative patient-centered digital health application for pediatric type 1 diabetes care: Findings from a pilot clinical trial (2025) · cites this paper as [36]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
The global landscape of AI ethics guidelines
Jobin, A., Ienca, M., & Vayena, E. (2019) · Nature Machine Intelligence · doi:10.1038/s42256-019-0088-2 · Cited by 6,220 · see citing works
Self-citationREVIEW OF COMMUNITY-BASED RESEARCH: Assessing Partnership Approaches to Improve Public Health
Israel, B. A., Schulz, A. J., Parker, E. A., & Becker, A. B. (1998) · Annual Review of Public Health · doi:10.1146/annurev.publhealth.19.1.173 · Cited by 5,893 · see citing works
Machine learning in medicine: Addressing ethical challenges
Vayena, E., Blasimme, A., & Cohen, I. G. (2018) · PLOS Medicine · doi:10.1371/journal.pmed.1002689 · Cited by 912 · see citing works
Self-citationArtificial Intelligence, Values, and Alignment
Gabriel, I. (2020) · Minds and Machines · doi:10.1007/s11023-020-09539-2 · Cited by 896 · cited 1× · see citing works
“Iason Gabriel,aphilosopheratleadingAIcompanyDeepMind,emphasizedthe importanceofinvolvinglaypublicsinvaluealignmenttolegitimately identifyethicalprinciples 29 .”
Morley, J., Floridi, L., Kinsey, L., & Elhalal, A. (2020) · Science and Engineering Ethics · doi:10.1007/s11948-019-00165-5 · Cited by 882 · cited 1× · see citing works
“Technical solutions to further responsible digital health innovation have also emerged 13 .”
BackgroundBalazs, C. L., & Morello-Frosch, R. A. (2013) · Environmental Justice · doi:10.1089/env.2012.0017 · Cited by 480 · see citing works
Beyond validation: getting health apps into clinical practice
Gordon, W. J., Landman, A., Zhang, H., & Bates, D. W. (2020) · npj Digital Medicine · doi:10.1038/s41746-019-0212-z · Cited by 322 · see citing works
Nebeker, C., Torous, J., & Bartlett Ellis, R. J. (2019) · BMC Medicine · doi:10.1186/s12916-019-1377-7 · Cited by 241 · see citing works
Responsible AI for Digital Health: a Synthesis and a Research Agenda
Trocin, C., Mikalef, P., Papamitsiou, Z., & Conboy, K. (2023) · Information Systems Frontiers · doi:10.1007/s10796-021-10146-4 · Cited by 205 · see citing works
Digital health: meeting the ethical and policy challenges
Vayena, E., Haeusermann, T., Adjekum, A., & Blasimme, A. (2018) · Swiss Medical Weekly · doi:10.4414/smw.2018.14571 · Cited by 189 · see citing works
Self-citationMartin, K. E. (2019) · MIS Quarterly Executive · doi:10.17705/2msqe.00012 · Cited by 140 · see citing works
Health app policy: international comparison of nine countries’ approaches
Essén, A., Stern, A. D., Haase, C. B., Car, J., Greaves, F., Paparova, D., Vandeput, S., Wehrens, R., & Bates, D. W. (2022) · npj Digital Medicine · doi:10.1038/s41746-022-00573-1 · Cited by 131 · see citing works
“We the Scientists”: a Human Right to Citizen Science
Vayena, E., & Tasioulas, J. (2015) · Philosophy & Technology · doi:10.1007/s13347-015-0204-0 · Cited by 115 · see citing works
Self-citationBetween Openness and Privacy in Genomics
Vayena, E., & Gasser, U. (2016) · PLoS Medicine · doi:10.1371/journal.pmed.1001937 · Cited by 113 · see citing works
Self-citationThe Current State of Industrial Practice in Artificial Intelligence Ethics
Vakkuri, V., Kemell, K., Kultanen, J., & Abrahamsson, P. (2020) · IEEE Software · doi:10.1109/ms.2020.2985621 · Cited by 98 · see citing works
Research led by participants: a new social contract for a new kind of research
Vayena, E., Brownsword, R., Edwards, S., Tzovaras, B. G., Kahn, J. P., Ladher, N., Montgomery, J., O'Connor, D., O’Neill, O., RICHARDS, M. P. M., et al. (2015) · Journal of Medical Ethics · doi:10.1136/medethics-2015-102663 · Cited by 92 · see citing works
Self-citationFive Crucial Challenges in Digital Health
Cummins, N., & Schuller, B. W. (2020) · Frontiers in Digital Health · doi:10.3389/fdgth.2020.536203 · Cited by 84 · see citing works
Regulatory sandboxes in artificial intelligence
OECD (2023) · OECD digital economy papers · doi:10.1787/8f80a0e6-en · Cited by 84 · see citing works
Might, M., & Wilsey, M. (2014) · Genetics in Medicine · doi:10.1038/gim.2014.23 · Cited by 84 · see citing works
Regulatory considerations to keep pace with innovation in digital health products
Torous, J. B., Stern, A. D., & Bourgeois, F. T. (2022) · npj Digital Medicine · doi:10.1038/s41746-022-00668-9 · Cited by 83 · see citing works
Venture Capital and Corporate Social Responsibility
Cheng, C., Chu, Y., Deng, Z., & Huang, B. (2020) · Journal of Corporate Finance · doi:10.1016/j.jcorpfin.2022.102208 · Cited by 71 · see citing works
The regulatory gap in digital health and alternative pathways to bridge it
Iqbal, J. D., & Biller‐Andorno, N. (2022) · Health Policy and Technology · doi:10.1016/j.hlpt.2022.100663 · Cited by 67 · see citing works
Principles to Practices for Responsible AI: Closing the GapPreprint
Schiff, D. S., Rakova, B., Ayesh, A., Fanti, A., & Lennon, M. (2020) · arXiv (Cornell University) · doi:10.48550/arxiv.2006.04707 · Cited by 65 · see citing works
Ruotsalainen, P. S., & Blobel, B. G. M. E. (2020) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph17093006 · Cited by 64 · see citing works
The End of an Era: from Self-Regulation to Hard Law for the Digital Industry
Floridi, L. (2021) · Philosophy & Technology · doi:10.1007/s13347-021-00493-0 · Cited by 58 · see citing works
Alakent, E., Goktan, M. S., & Khoury, T. A. (2020) · Journal of Business Venturing · doi:10.1016/j.jbusvent.2020.106005 · Cited by 57 · see citing works
Responsible for Responsibility? A Study of Digital E-health Startups
Oftedal, E. M., Foss, L., & Яковлева, Т. В. (2019) · Sustainability · doi:10.3390/su11195433 · Cited by 45 · see citing works
The ECOUTER methodology for stakeholder engagement in translational research
Murtagh, M. J., Minion, J. T., Turner, A. J., Wilson, B., Blell, M. T., Ochieng, C., Murtagh, B., Roberts, S. J., Butters, O. W., & Burton, P. R. (2017) · BMC Medical Ethics · doi:10.1186/s12910-017-0167-z · Cited by 38 · see citing works
Stuck in translation: Stakeholder perspectives on impediments to responsible digital health
Landers, C., Vayena, E., Amann, J., & Blasimme, A. (2023) · Frontiers in Digital Health · doi:10.3389/fdgth.2023.1069410 · Cited by 38 · see citing works
Self-citationDo venture capital firms promote corporate social responsibility?
Jiu-jin, L., Xu, C., Fung, H., & Chan, K. C. (2020) · International Review of Economics & Finance · doi:10.1016/j.iref.2020.10.012 · Cited by 36 · see citing works
Marketplace and Literature Review of Spanish Language Mental Health Apps
Muñoz, A. O., Camacho, E., & Torous, J. B. (2021) · Frontiers in Digital Health · doi:10.3389/fdgth.2021.615366 · Cited by 36 · see citing works
Nebeker, C., Gholami, M., Kareem, D., & Kim, E. (2021) · Frontiers in Digital Health · doi:10.3389/fdgth.2021.690901 · Cited by 32 · see citing works
Experimental Regulations and Regulatory Sandboxes – Law Without Order?
Ranchordás, S. (2021) · Law and Method · doi:10.5553/rem/.000064 · Cited by 24 · see citing works
Artificial intelligence in European medicines regulation
Hines, P. A., Herold, R., Pinheiro, L., Frias, Z., & Arlett, P. (2023) · Nature Reviews Drug Discovery · doi:10.1038/d41573-022-00190-3 · Cited by 24 · see citing works
Roossien, C. C., de Jong, M., Bonvanie, A. M., & Maeckelberghe, E. L. M. (2021) · Frontiers in Digital Health · doi:10.3389/fdgth.2021.644539 · Cited by 18 · see citing works
Editorial: Responsible Digital Health
Ahmadpour, N., Ludden, G., Peters, D., & Vold, K. (2022) · Frontiers in Digital Health · doi:10.3389/fdgth.2021.841477 · Cited by 15 · see citing works
Does venture capital improve corporate social responsibility performance?
Luo, R., Zhao, B., Han, C., & Wang, S. (2023) · International Review of Economics & Finance · doi:10.1016/j.iref.2023.07.070 · Cited by 15 · see citing works
The AI field needs translational Ethical AI research
Borg, J. S. (2022) · AI Magazine · doi:10.1002/aaai.12062 · Cited by 15 · see citing works
Medical artificial intelligence is as much social as it is technological
Carusi, A., Winter, P., Armstrong, I. J., Ciravegna, F., Kiely, D. G., Lawrie, A., Lu, H., Sabroe, I., & Swift, A. J. (2023) · Nature Machine Intelligence · doi:10.1038/s42256-022-00603-3 · Cited by 13 · see citing works
From General Principles to Procedural Values: Responsible Digital Health Meets Public Health Ethics
Nyrup, R. (2021) · Frontiers in Digital Health · doi:10.3389/fdgth.2021.690417 · Cited by 12 · see citing works
Talking Ethics Early in Health Data Public Private Partnerships
Landers, C., Ormond, K. E., Blasimme, A., Brall, C., & Vayena, E. (2023) · Journal of Business Ethics · doi:10.1007/s10551-023-05425-w · Cited by 12 · see citing works
Self-citationEthical considerations of digital therapeutics for mental health
Landers, C., Wies, B., & Ienca, M. (2022) · Elsevier eBooks · doi:10.1016/b978-0-323-90045-4.00007-1 · Cited by 7 · see citing works
Self-citationThe Ten Principles of Socially Responsible Digital Health Design
Tsekleves, E., & Cooper, R. (2021) · doi:10.5151/ead2021-181 · Cited by 2 · see citing works
Ethics By Design: An organizational approach to responsible use of technology
Bullard, N., Guszcza, J., Lim, D., Ratté, E., Skeet, A. G., Sverdlova, I., & White, L. (2022) · Scholar Commons (Santa Clara University) · Cited by 2 · see citing works
Flagged first, then by citations
Research works printed but not linked: 3
- [34]US Food and Drug Administration. Software Precertification Program: regulatory framework for conducting the pilot program within current authorities. https://www.nature.com/articles/s41746-020-00370-8 (2019).
- [50]Tsekleves, E. & Cooper, R. In Proc.14th International Conference of the European Academy of Design, Safe Harbours for Design Research. 326–337 (2022).
- [54]Landers C Vayena E Amann J Blasimme A Stuck in translation: stakeholder perspectives on impediments to responsible digital health Front. Digit. Health 2023 5 1069410 10.3389/fdgth.2023.1069410 36815171 PMC9939685 · DOI
Cited by
Sorted by citations
An umbrella review on how digital health intervention co-design is conducted and described
Kilfoy, A., Hsu, T. C., Stockton-Powdrell, C., Whelan, P., Chu, C. H., & Jibb, L. (2024) · npj Digital Medicine · doi:10.1038/s41746-024-01385-1 · Cited by 98 · see citing works
Moylan, K., & Doherty, K. (2025) · Journal of Medical Internet Research · doi:10.2196/67114 · Cited by 46 · see citing works
A scoping review of ethical aspects of public-private partnerships in digital health
Bak, M., Horbach, D., Buyx, A., & McLennan, S. (2025) · npj Digital Medicine · doi:10.1038/s41746-025-01515-3 · Cited by 30 · see citing works
The case for inclusive co-creation in digital health innovation
Nickel, G. C., Wang, S., Kwong, J. C. C., & Kvedar, J. C. (2024) · npj Digital Medicine · doi:10.1038/s41746-024-01256-9 · Cited by 17 · see citing works
Threat to trust: A systematic review on Internet of medical things security
Shammar, E. A., Cui, X., Zahary, A. T., Alsamhi, S. H., & Al‐qaness, M. A. A. (2025) · Journal of Parallel and Distributed Computing · doi:10.1016/j.jpdc.2025.105172 · Cited by 15 · see citing works
What makes clinical machine learning fair? A practical ethics framework
Hoche, M., Mineeva, O., Rätsch, G., Vayena, E., & Blasimme, A. (2025) · PLOS Digital Health · doi:10.1371/journal.pdig.0000728 · Cited by 13 · see citing works
Self-citationLewerenz, S., Moen, A., & Martins, H. (2025) · International Journal of Medical Informatics · doi:10.1016/j.ijmedinf.2025.105794 · Cited by 12 · see citing works
Fostering inclusive co-creation in digital health
Blasimme, A., Landers, C., & Vayena, E. (2025) · npj Digital Medicine · doi:10.1038/s41746-025-01724-w · Cited by 10 · see citing works
Self-citationLukkien, D., Nap, H. H., ter Stal, M., Boon, W., Peine, A., Minkman, M. M. N., & Moors, E. H. M. (2024) · Journal of Responsible Technology · doi:10.1016/j.jrt.2024.100091 · Cited by 9 · see citing works
Sekalala, S. R., & Lake, S. J. (2025) · Oxford Open Digital Health · doi:10.1093/oodh/oqaf010 · Cited by 5 · see citing works
Operationalizing AI ethics in medicine—a co-creation workshop study
López-Ramos, L. M., Pluktaite, G., Bui, C. K. T., Amann, J., Haven, T. L., & Madai, V. I. (2025) · BMC Medical Ethics · doi:10.1186/s12910-025-01317-y · Cited by 4 · see citing works
Schultz, M. A., Kim, H. J., Chou, F., Flores, S. L., & Fangonil‐Gagalang, E. (2025) · Nursing Administration Quarterly · doi:10.1097/naq.0000000000000721 · Cited by 4 · see citing works
Kourounis, G., Gilbert, S., Knight, S. R., Leal, A., Scully, J. L., Loupy, A., Martin, D., Preka, E., Primc, N., Seoane, F., et al. (2026) · Transplant International · doi:10.3389/ti.2026.16316 · Cited by 4 · see citing works
Zahlan, A., Soh, P. H., & Clarysse, B. (2026) · npj Digital Medicine · doi:10.1038/s41746-026-02595-5 · Cited by 2 · see citing works
Ensuring the clinical impact of medical artificial intelligence
Andreoletti, M., Senkalfa, B., Vayena, E., & Blasimme, A. (2026) · The Lancet Digital Health · doi:10.1016/j.landig.2026.101030 · Cited by 2 · see citing works
Self-citationGovernance and Ethics in the Use of Artificial Intelligence in Health
da Costa, P. G., Machado, A. D. B., Willerding, I. A. V., & Lápolli, É. M. (2025) · IGI Global eBooks · doi:10.4018/979-8-3693-7630-0.ch015 · Cited by 2 · see citing works
Amed, S., Pinkney, S., Abdulhussein, F. S., Virani, A., Zachariuk, C., Tamana, S. K., Muralidharan, S., Görges, M., Barrett, B., van Rooij, T., et al. (2025) · PLOS Digital Health · doi:10.1371/journal.pdig.0000861 · Cited by 1 · see citing works
“Our collaboration with end users throughout the platform development process [31,33] likely contributed to users reporting high usefulness and acceptable usability, as this co-creation approach has been recognized as essential for successful digital health technology development [36,37].”
Wallraf, S., Dierks, M., Wöhlke, S., John, C., & Lander, J. (2025) · Frontiers in Digital Health · doi:10.3389/fdgth.2025.1591981 · Cited by 1 · see citing works
Art breaks obesity’s health information silos
Zhang, L., Zhang, J., & Yang, S. (2025) · Trends in Endocrinology and Metabolism · doi:10.1016/j.tem.2025.10.002 · Cited by 1 · see citing works
Braune, K., Schaaf, T., Balzer, F., Bershtein, D. I., Broderick, A., Çelik, P., Flügge, T. V., Kim, K. K., Lahmann, N., Lindeman, D. A., et al. (2026) · Ageing Research Reviews · doi:10.1016/j.arr.2026.103217 · Cited by 1 · see citing works
‘Smart’ or ‘intelligent’ household products as low-cost diagnostic tools in global health
Monikandan, D., Singh, A., Citartan, M., Peralam, P., Parmarthi, S., Roy, S., & Mani, N. K. (2026) · TrAC Trends in Analytical Chemistry · doi:10.1016/j.trac.2026.119102 · Cited by 1 · see citing works
Sofia, N., Hapisah, Aprilea, N. A., Rusmilawaty, R., Yuniarti, & Zakiah (2025) · Jurnal Teknokes · doi:10.35882/jteknokes.v18i4.127
de Groot, P., Fadaei, S., Luime, J. J., Wagenaar, W., Vis, M., Kok, M. R., Bos, W. H., & Tchetverikov, I. (2025) · EULAR Rheumatology Open · doi:10.1016/j.ero.2025.11.021
Sarwono, A. P., & Santiago, F. (2025) · Jurnal Greenation Sosial dan Politik · doi:10.38035/jgsp.v3i2.360
Digital Twins in Translational Research and Health Care: An Anthropological Perspective
Wagner, J. K. (2026) · Ethics & Human Research · doi:10.1002/eahr.70022
Ferlito, B., & Mertes, H. (2026) · Asian Bioethics Review · doi:10.1007/s41649-025-00395-9
Sekalala, S. R., Lake, S. J., Mbaka, P., Nyotu, R., Muhoza, E., Samow, A., & Mbate, F. (2026) · Health Research Policy and Systems · doi:10.1186/s12961-026-01488-z
AI nanomedicine: a new paradigm for precision cancer diagnosis and therapy
Fu, Y., Wu, C., Feng, W., & Chen, Y. (2026) · Chinese Science Bulletin (Chinese Version) · doi:10.1360/csb-2026-0391
Egher, C., van Hees, S., & Boon, W. (2026) · Journal of Responsible Innovation · doi:10.1080/23299460.2026.2657119
Wibowo, W., Halimah, N. S., Rohman, T., Rahmawati, M., & Prayoga, D. F. (2026) · IGI Global eBooks · doi:10.4018/979-8-3373-7026-2.ch012
Zhang, S., Zhang, J., Li, P., Zuo, M., & Feng, L. (2026) · Information · doi:10.3390/info17070649
Li, J., & Wang, L. (2026) · doi:10.2196/preprints.106850
Denecke, K., Massicot, N., Salminen, P. T., Isomursu, M., & Rivera-Romero, O. (2026) · doi:10.2196/preprints.106951
Захаров, С. (2026) · Актуальні питання у сучасній науці · doi:10.52058/2786-6300-2026-6(48)-322-337
Michael, O. S., Sunday, O., Raimi, O., Owolabi, R. O., & Wegbom, A. I. (2026) · World Journal of Public Health · doi:10.11648/j.wjph.20261103.13
Pele, A., Fernández, J. V., Ortega, F., Mulholland, C., & Dias, C. B. (2026) · AI and Ethics · doi:10.1007/s43681-026-01290-1
AI Use in Dementia Care Requires Engagement with Patient and Caregiver Perspectives
Friend, J., Black, V., & Chiong, W. (2026) · The American Journal of Bioethics · doi:10.1080/15265161.2026.2715910
Smet, W. D., Dam, L. V., & Janssens, P. (2026) · International Journal of Social and Psychological Aspects of Healthcare · doi:10.51847/rypziper4h
- Authors
- Landers, C., Blasimme, A., & Vayena, E.
- Affiliations
- ETH Zurich (CH)
- Corresponding author
- Vayena, Effy
- Venue
- npj Digital Medicine
- Published
- 2024-05-04
- Volume
- 7
- Issue
- 1
- Pages
- 113-113
- ISSN
- 2398-6352 (ISSN-L)
- PMC
- PMC11069566
- OpenAlex
- W4396637476
- Cited by
- 35
- References
- 44
- Citations by year
- 2026: 18 · 2025: 14 · 2024: 3
- FWCI
- 3.27
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- npj Digital Medicine (publishedVersion, cc-by)
- Research Square (acceptedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Repository for Publications and Research Data (ETH Zurich) (submittedVersion, cc-by)
- ETH Zürich Research Collection
- Funders
- Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (NRP77: 407740_187356)
- Topics
- Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Social Sciences › Safety Research › Ethics and Social Impacts of AI
- Keywords
- digital health innovation, governance, responsive regulation, stakeholder engagement, health disparities, privacy risks, algorithmic bias, ethics of digital health, overregulation
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
