Chair of Bioethics

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Responsible Digital Health Innovation

Digital health promises to profoundly transform medicine. At the same time, however, it raises conspicuous ethical and regulatory issues. Our project aims to identify what regulatory and governance approaches can enable responsible, yet effective digital health innovation.  

Given the complexity and fast-paced dynamics of digital health innovation, this project extensively employs participatory research methodologies. To date, we have involved well over 70 senior stakeholders including regulatory bodies, big pharmaceutical and technology companies, start-ups, and patient representatives. Through an interactive co-creation approach we have collaboratively defined the core impediments to responsible digital health and developed solution-oriented models. We further investigate how technological uncertainty can be addressed through regulation.

The project’s core deliverable is to define key requirements for regulatory and governance tools and processes that will culminate in a regulatory roadmap for Switzerland. The project is funded by the external page Swiss National Science Foundation's external page NRP 77 grant.
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Balancing AI Innovation and Equitable Health Benefits with Professor Effy Vayena

Peer-reviewed publications

Vayena, E. (2024). Machina non deus: being in charge of AI. The Lancet, 403(10427), 606-607.

Sleigh, J., Hubbs, S., Blasimme, A., & Vayena, E. (2024). Can digital tools foster ethical deliberation? Humanities and Social Sciences Communications, 11(1), 1-10.

Shaw, J., Ali, J., Atuire, C. A., Cheah, P. Y., Español, A. G., Gichoya, J. W., . . . Paolotti, D. (2024). Research ethics and artificial intelligence for global health: perspectives from the global forum on bioethics in research. BMC medical ethics, 25(1), 46.

Ormond, K. E., Bavamian, S., Becherer, C., Currat, C., Joerger, F., Geiger, T. R., . . . Vayena, E. (2024). What are the bottlenecks to health data sharing in Switzerland? An interview study. Swiss medical weekly, 154(1).

Landers, C., Ormond, K. E., Blasimme, A., Brall, C., & Vayena, E. (2024). Talking ethics early in health data public private partnerships. Journal of Business Ethics, 190(3), 649-659. external page https://doi.org/10.1007/s10551-023-05425-w

Landers, C., Blasimme, A., & Vayena, E. (2024). Sync fast and solve things—best practices for responsible digital health. NPJ digital medicine, 7(1), 113. external page https://doi.org/10.1038/s41746-024-01105-9

Kijewski, S., Ronchi, E., & Vayena, E. (2024). International organisations and the global governance of AI in health. In Research Handbook on Health, AI and the Law (pp. 255-272): Edward Elgar Publishing.

Goldberg, C. B., Adams, L., Blumenthal, D., Brennan, P. F., Brown, N., Butte, A. J., . . . Drazen, J. (2024). To do no harm—and the most good—with AI in health care. In (Vol. 1, pp. AIp2400036): Massachusetts Medical Society.

Ferretti, A., Adjei, K. K., Ali, J., Atuire, C., Ayuk, B. T., Banougnin, B. H., . . . Juma, D. O. (2024). Digital tools for youth health promotion: principles, policies and practices in sub-Saharan Africa. Health promotion international, 39(2), daae030.

Canali, S., Ferretti, A., Schiaffonati, V., & Blasimme, A. (2024). Wearable Technologies for Healthy Ageing: Prospects, Challenges, and Ethical Considerations. The Journal of Frailty & Aging, 13(2), 149-156. external page https://doi.org/10.14283/jfa.2024.19

Andreoletti, M., Haller, L., Vayena, E., & Blasimme, A. (2024). Mapping the ethical landscape of digital biomarkers: A scoping review. PLOS Digital Health, 3(5), e0000519.

Vayena, E., Blasimme, A., & Sugarman, J. (2023). Decentralised clinical trials: ethical opportunities and challenges. The Lancet Digital Health, 5(6), e390-e394. external page https://doi.org/10.1016/S2589-7500(23)00052-3

Nittas, V., Daniore, P., Landers, C., Gille, F., Amann, J., Hubbs, S., . . . Blasimme, A. (2023). Beyond high hopes: A scoping review of the 2019–2021 scientific discourse on machine learning in medical imaging. PLOS Digital Health, 2(1), e0000189. external page https://doi.org/10.1371/journal.pdig.0000189

Minssen, T., Vayena, E., & Cohen, I. G. (2023). The challenges for regulating medical use of ChatGPT and other large language models. Jama.

Landers, C., Wies, B., & Ienca, M. (2023). Ethical considerations of digital therapeutics for mental health. In Digital Therapeutics for Mental Health and Addiction (pp. 205-217): Elsevier.

Landers, C., Vayena, E., Amann, J., & Blasimme, A. (2023). Stuck in translation: Stakeholder perspectives on impediments to responsible digital health. Frontiers in Digital Health, 5, 1069410. external page https://doi.org/10.3389/fdgth.2023.1069410

Ferretti, A., Vayena, E., & Blasimme, A. (2023). Unlock digital health promotion in LMICs to benefit the youth. PLOS Digital Health, 2(8), e0000315.

Amann, J., Vayena, E., Ormond, K. E., Frey, D., Madai, V. I., & Blasimme, A. (2023) Expectations and attitudes towards medical artificial intelligence: A qualitative study in the field of stroke. Plos one, 18(1), e0279088. external page https://doi.org/10.1371/journal.pone.0279088

Scheibner, J., Ienca, M., & Vayena, E. (2022). Health data privacy through homomorphic encryption and distributed ledger computing: an ethical-legal qualitative expert assessment study. BMC medical ethics, 23(1), 121.

Ienca, M., Fins, J. J., Jox, R. J., Jotterand, F., Voeneky, S., Andorno, R., . . . Chneiweiss, H. (2022). Towards a governance framework for brain data. Neuroethics, 15(2), 20.

Hutler, B., Blasimme, A., Gur-Arie, R., Ali, J., Barnhill, A., Hood, A., . . . Vayena, E. (2022). Assessing the Governance of Digital Contact Tracing in Response to COVID-19: Results of a Multi-National Study. Journal of Law, Medicine & Ethics, 50(4), 791-804. external page https://doi.org/10.1017/jme.2023.20

Ferretti, A., & Vayena, E. (2022). In the shadow of privacy: overlooked ethical concerns in COVID-19 digital epidemiology. Epidemics, 41, 100652.

Brall, C., Berlin, C., Zwahlen, M., Vayena, E., Egger, M., & Ormond, K. E. (2022). Public preferences towards data management and governance in Swiss biobanks: results from a nationwide survey. BMJ Open, 12(8), e060844.

Blasimme, A. (2022). Machine Learning in Paediatrics and the Childs's Right to An Open Future. Available at SSRN 4295917.

Wies, B., Landers, C., & Ienca, M. (2021). Digital mental health for young people: a scoping review of ethical promises and challenges. Frontiers in Digital Health, 3, 697072. external page https://pubmed.ncbi.nlm.nih.gov/34713173/

Vayena, E., & Blasimme, A. (2021). Towards Adaptive Governance in Big Data Health Research: Implementing Regulatory Principles. The Cambridge Handbook of Health Research Regulation, 257-265.

Sleigh, J., & Vayena, E. (2021). Public engagement with health data governance: the role of visuality. Humanities and Social Sciences Communications, 8(1), 1-12.

Ferretti, A., Ienca, M., Sheehan, M., Blasimme, A., Dove, E. S., Farsides, B., . . . Kleist, P. (2021). Ethics review of big data research: What should stay and what should be reformed? BMC medical ethics, 22(1), 51.

Blasimme, A., Ferretti, A., & Vayena, E. (2021). Digital contact tracing against COVID-19 in Europe: current features and ongoing developments. Frontiers in Digital Health, 3, 660823.

Gasser, U., Ienca, M., Scheibner, J., Sleigh, J., & Vayena, E. (2020). Digital tools against COVID-19: taxonomy, ethical challenges, and navigation aid. The Lancet Digital Health, 2(8), e425-e434.

Amann, J., Blasimme, A., Vayena, E., Frey, D., Madai, V. I., & Consortium, P. Q. (2020). Explainability for artificial intelligence in healthcare: a multidisciplinary perspective. BMC Medical Informatics and Decision Making, 20, 1-9.

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Self-organised

  • Innovative regulation for digital healthcare, Switzerland, Online, 31.03.2021
  • The Science and Technology Options Assessment (STOA) Committee, European Parliament, Belgium,
    Brussels, 11.02.2022
     

Active Participation

  • International conference on ‘Conceptual and methodological aspects of biomedical research, Czech
    Republic, Prague, 29.10.2020
  • AAAS Annual meeting, United States of America, Online, 11.02.2021
  • Lider Lab – Scuola Superiore Sant’Anna di Pisa, Italy, Pisa, 15.02.2021
  • World Health Summit 2020, Germany, Berlin, 25.10.2020
  • 15th Berlin Debate / Robert Bosch Stiftung, Germany, Berlin, 07.11.2020
  • Virtual High-Level Conference Digital Health 2020 – EU on the Move, Switzerland, Online, 11.11.2020
  • 2nd Global Health Forum (WHO), Switzerland, Geneva, 02.06.2021
  • ZHAW/CLAIRE event: Digital Tools against Covid-19, Switzerland, Zurich, 15.06.2021
  • SCTO Symposium, Switzerland, Lugano, 15.06.2022
  • 6th VPH Summer School, Spain, Barcelona, 27.05.2022
  • P2M Rouen International Symposium, France, Rouen, 24.03.2022
  • WHO / Privacy International panel discussion on use of AI in diagnosis and risk-based diagnosis,
    Switzerland, Geneva, 07.12.2021
  • European Biobanking Week – EBW2021 – BBMRI-ERIC, Austria, Graz, 08.11.2021
  • Symposium on Responsible Research and Innovation, Italy, Rome, 07.05.2020
  • AI and industry class 2022, France, Paris, 04.03.2022
  • Linkedin Live, Switzerland, Zurich, 28.06.2022
  • RRI in/under Urgency: Workshop 2022 in Athens , Greece, Athens, 03.06.2022
  • Digital Public Health Tools in a pandemic: lessons for responsible innovation during a crisis,
    Switzerland, zurich, 12.05.2022
  • Delphi Economic Forum, Switzerland, Davos, 07.06.2022
  • European IA Alliance, Belgium / European AI week 2022, Belgium, Brussels, 14.03.2022
  • OECD: Expert Workshop on Data Ethics: Balancing Ethical and Innovative Uses of Data (online), France,
    Paris, 09.12.2021
  • NIH/RDMLA and Harvard Countway Library: Workshop on Data Ethics in Health Sciences (Exploring
    Ethical Considerations of Health Sciences Research Data) , United States of America, Boston, 09.08.2022
  • The Responsible AI Forum (TRAIF), Germany, Munchen, 06.12.2021
  • Intelligent Health Amsterdam 2021, online, Netherlands, Amsterdam, 12.10.2021
  • ITU: AI for good discovery, Switzerland, Geneva, 15.09.2021
  • ZHAW/CLAIRE event: Digital Tools against Covid-19, Switzerland, Winterthur, 15.06.2021
  • 2nd Global Health Forum (WHO), Switzerland, Geneva, 02.06.2021
  • Delphi Economic Forum VI, Switzerland, Davos, 14.05.2021
  • 15th Berlin Debate / Robert Bosch Stiftung, Germany, Berlin, 07.11.2020
  • World Health Summit 2020, Switzerland, Geneva, 25.10.2020
  • Annual Research Ethics Seminar, South Africa, Stellenbosch University, 26.10.2022
  • 2050: What the Future Holds for Bioethical Issues in Biomedical Research, Israel, Jerusalem,
    14.11.2022
  • AI in Life Sciences – Regulating Risk, Liability and Innovation, Switzerland, Webinar, 17.11.2022
  • Global Forum for Bioethicsm , South Africa, Capetown, 30.11.2022
  • Life Sciences College/Digital Health App’ero (organized by Sidley), Belgium, Brussel, 08.02.2023
  • Berman Institute of Bioethics/Unversiti Malaya, Switzerland, online, 13.02.2023
  • Journée thematique: “Data analysis and artificial intelligence approaches for biomedical research,
    France, École de l’Inserm Liliane Bettencourt Paris, 18.03.2023
  • Harvard Bioethics Fellowship Event, Switzerland, online, 24.03.2023
  • Reatch Podcast , Switzerland, Zurich, 09.05.2023
  • Governance of medical AI and genomics conference, Hongkong, Hongkong University, 10.05.2023
  • CeBIL symposium, Denmark, University of Copenhagen, 14.06.2023
  • Nostos Conference on Mental Health, Greece, Stavros Niarchos Foundation (SNF) Athens, 22.06.2023
  • Kantonale Ethikkommission, Switzerland, Kantonale Ethikkommission Zürich , 27.06.2023
  • AI4H Summer school, France, Paris, 03.07.2023
  • FutureHealth Conference Basel, Switzerland, Basel, 21.03.2024
  • World Minds Annual Event, Switzerland, Zürich, 14.03.2024
  • Samueli Initiative for Responsible AI in Medicine, Israel, Tel Aviv, 12.03.2024
  • Hellenic Society of Infectious Diseases, Greece, Athens, 08.03.2024
  • Raisina Dialogue, India, New Delhi, 22.02.2024
  • UK Embassy Round Table , Switzerland, Bern, 08.02.2024
  • Global Forum for Bioethics, Malaysia, Kuala Lumpur, 22.01.2024
  • Hellenic Society for Hand Surgery and Plastic Surgery, Greece, Athens, 23.11.2023
  • RAISE Meeting, Harvard Medical School, United States of America, Cambridge, MA, 31.10.2023
  • WHO Symposium on the Future of Health Systems in a Digital Era in the European Region, Portugal,
    Porto, 04.09.2023
  • Goethe Talk, Germany, Online Seminar, 17.06.2023
     

Knowledge transfer events

  • Liveupdate 4.0 (Swissmedic), Switzerland, Online, 28.06.2021
  • Basel DayOne - data scenario building - stakeholder workstream, Switzerland, Online, 01.03.2021
  • AI and Digital Health, Switzerland, Basel, 06.06.2024
  • Frontiers in drug discovery and development (ECPM), Switzerland, Basel, 08.02.2024
     

Public communication

  • A bioethicist and a professor of medicine on regulating AI in health care, The Economist, 2023

Digital Health Innovation Roadmap for Policymakers

This roadmap presents governance principles and concrete actions for decision-makers to promote responsible digital health innovation in Switzerland. Governance principles are action guides; they indicate what needs to be done to achieve desirable governance goals.

Read the roadmap

The website of the Roadmap
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