Scheibner J, Ienca M, Kechagia S, Troncoso-Pastoriza JR, Raisaro JL, Hubaux J-P, et al. Data protection and ethics requirements for multisite research with health data: a comparative examination of legislative governance frameworks and the role of data protection technologies. J Law Biosci. 2020;7.
Scheibner J, Raisaro JL, Troncoso-Pastoriza JR, Ienca M, Fellay J, Vayena E, et al. Revolutionizing medical data sharing using advanced privacy-enhancing technologies: technical, legal, and ethical synthesis. J Med Internet Res. 2021;23: e25120.
Edwards L, Veale M. Enslaving the algorithm: From a “Right to an Explanation” to a “Right to Better Decisions”? IEEE Secur Priv. 2018;16:46–54.
Conley E, Pocs M. GDPR Compliance challenges for interoperable health information exchanges (HIEs) and trustworthy research environments (TREs). Eur J Biomed Inform. 2018;14.
Quinn P, Quinn L. Big genetic data and its big data protection challenges. Comput Law Secur Rev. 2018;34:1000–18.
Brall C, Berlin C, Zwahlen M, Ormond KE, Egger M, Vayena E. Public willingness to participate in personalized health research and biobanking: a large-scale Swiss survey. PLoS ONE. 2021;16: e0249141.
Spindler G, Schmechel P. Personal data and encryption in the European General Data Protection Regulation. J Intellect Prop Inf Technol Electron Commer Law. 2016;:[i]-177.
Cramer R, Damgrd IB, Nielsen JB. Secure multiparty computation and secret sharing. 1st ed. New York: Cambridge University Press; 2015.
Chillotti I, Gama N, Georgieva M, Izabachène M. Faster Fully Homomorphic Encryption: Bootstrapping in Less Than 0.1 Seconds. In: Cheon JH, Takagi T, editors. Advances in Cryptology—ASIACRYPT 2016. Berlin, Heidelberg: Springer; 2016. p. 3–33.
Wiebe A, Schur N. Protection of trade secrets in a data-driven, networked environment – Is the update already out-dated? J Intellect Prop Law Pract. 2019;14:814–21.
Raisaro JL, Troncoso-Pastoriza JR, Misbach M, Sousa JS, Pradervand S, Missiaglia E, et al. MedCo: Enabling secure and privacy-preserving exploration of distributed clinical and genomic data. IEEE/ACM Trans Comput Biol Bioinform. 2018;:1–1.
Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010;10:67.
Day PF, Petherick E, Godson J, Owen J, Douglas G. A feasibility study to explore the governance processes required for linkage between dental epidemiological, and birth cohort, data in the U.K. Community Dent Health. 2018;35:201–3.
Haber S, Stornetta WS. How to time-stamp a digital document. In: Menezes AJ, Vanstone SA, editors. Advances in cryptology-CRYPTO’ 90. Springer: Berlin Heidelberg; 1991. p. 437–55.
Ølnes S, Ubacht J, Janssen M. Blockchain in government: benefits and implications of distributed ledger technology for information sharing. Gov Inf Q. 2017;34:355–64.
Herian R. The Politics of Blockchain. Law Crit. 2018;29:129–31.
Dwork C, Naor M. Pricing via processing or combatting junk mail. In: Brickell EF, editor. Advances in cryptology—CRYPTO’ 92. Springer: Berlin Heidelberg; 1993. p. 139–47.
Herian R. Blockchain and the (re)imagining of trusts jurisprudence. Strateg Change. 2017;26:453–60.
Azaria A, Ekblaw A, Vieira T, Lippman A. MedRec: Using blockchain for medical data access and permission management. In: 2016 2nd International Conference on Open and Big Data (OBD). 2016. p. 25–30.
Troncoso-Pastoriza JR, Raisaro JL, Gasser L, Ford B, Hubaux J-P. MedChain: accountable and auditable data sharing in distributed medical scenarios. 2019.
Casino F, Dasaklis TK, Patsakis C. A systematic literature review of blockchain-based applications: current status, classification and open issues. Telemat Inform. 2019;36:55–81.
Munn L, Hristova T, Magee L. Clouded data: privacy and the promise of encryption. Big Data Soc. 2019;6:2053951719848781.
Berberich M, Steiner M. Blockchain technology and the GDPR—How to reconcile privacy and distributed ledgers reports: Practitioner’s corner. Eur Data Prot Law Rev EDPL. 2016;2:422–6.
Bentzen HB, Castro R, Fears R, Griffin G, ter Meulen V, Ursin G. Remove obstacles to sharing health data with researchers outside of the European Union. Nat Med. 2021;27:1329–33.
Dove ES, The EU. General data protection regulation: implications for international scientific research in the digital era. J Law Med Ethics. 2018;46:1013–30.
Epstein C. Surveillance, privacy and the making of the modern subject: habeas what kind of corpus? Body Soc. 2016;22:28–57.
Metille S. Swiss information privacy law and the transborder flow of personal data. J Int Commer Law Technol. 2013;8:71–80.
Wagner J. The transfer of personal data to third countries under the GDPR: when does a recipient country provide an adequate level of protection? Int Data Priv Law. 2018;8:318–37.
Martani A, Egli P, Widmer M, Elger B. Data protection and biomedical research in Switzerland : setting the record straight. Swiss Med Wkly. 2020;150.
Naqib M. Update on the revision of the Swiss Federal Act on Data Protection. PwC. https://www.pwc.ch/en/insights/fs/swiss-federal-act-on-data-protection-revision.html. Accessed 24 Jan 2020.
Meier-Abt PJ, Lawrence AK, Selter L, Vayena E, Schwede T. The Swiss approach to precision medicine. Swiss Med Wkly. 2018. https://doi.org/10.3929/ethz-b-000274911.
Martani A, Geneviève LD, Pauli-Magnus C, McLennan S, Elger BS. Regulating the secondary use of data for research: arguments against genetic exceptionalism. Front Genet. 2019;10.
Driessen S, Gervasoni P. Research projects in human genetics in Switzerland: analysis of research protocols submitted to cantonal ethics committees in 2018. Swiss Med Wkly. 2021. https://doi.org/10.4414/smw.2021.20403.
Driessen S, Gervasoni P. Response to comment on: research projects in human genetics in Switzerland: analysis of research protocols submitted to Cantonal Ethics Commissions in 2018. Swiss Med Wkly. 2021. https://doi.org/10.4414/smw.2021.20518.
Hemminki E, Virtanen JI, Veerus P. Varying ethics rules in clinical research and routine patient care—Research ethics committee chairpersons’ views in Finland. Health Res Policy Syst. 2014;12:15.
Whiddett D, Hunter I, McDonald B, Norris T, Waldon J. Consent and widespread access to personal health information for the delivery of care: a large scale telephone survey of consumers’ attitudes using vignettes in New Zealand. BMJ Open. 2016;6: e011640.
Törrönen J. Using vignettes in qualitative interviews as clues, microcosms or provokers. Qual Res J. 2018;18:276–86.
Nicolini D. Articulating practice through the interview to the double. Manag Learn. 2009;40:195–212.
Schweikart SJ. Should immigration status information be considered protected health information? AMA J Ethics. 2019;21:32–7.
McCradden MD, Baba A, Saha A, Ahmad S, Boparai K, Fadaiefard P, et al. Ethical concerns around use of artificial intelligence in health care research from the perspective of patients with meningioma, caregivers and health care providers: a qualitative study. CMAJ Open. 2020;8:E90–5.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3:77–101.
Morse JM. Data were saturated …. Qual Health Res. 2015;25:587–8.
Guest G, Bunce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field Methods. 2006;18:59–82.
Ienca M, Scheibner J, Ferretti A, Gille F, Amann J, Sleigh J, et al. How the General Data Protection Regulation changes the rules for scientific research: Study. Report. ETH Zurich; 2019.
Ferretti A, Ienca M, Hurst S, Vayena E. Big data, biomedical research, and ethics review: new challenges for IRBs. Ethics Hum Res. 2020;42:17–28.
Voss WG, Castets-Renard C. Proposal for an international taxonomy on the various forms of the right to be forgotten: a study on the convergence of norms international & comparative technology law. Colo Technol Law J. 2015;14:281–344.
Francis B. General data protection regulation (GDPR) and data protection act 2018: What does this mean for clinicians? Arch Dis Child - Educ Pract. 2020;105:298–9.
Politou E, Alepis E, Patsakis C. Forgetting personal data and revoking consent under the GDPR: Challenges and proposed solutions. J Cybersecurity. 2018;4.
Martani A, Geneviève LD, Elger B, Wangmo T. “It’s not something you can take in your hands”. Swiss experts’ perspectives on health data ownership: an interview-based study. BMJ Open. 2021;11:e045717.
Gymrek M, McGuire AL, Golan D, Halperin E, Erlich Y. Identifying personal genomes by surname inference. Science. 2013;339:321–4.
Favaretto M, De Clercq E, Briel M, Elger BS. Working through ethics review of Big Data research projects: an investigation into the experiences of Swiss and American Researchers. J Empir Res Hum Res Ethics. 2020;15:339–54.
Gloy V, McLennan S, Rinderknecht M, Ley B, Meier B, Driessen S, et al. Uncertainties about the need for ethics approval in Switzerland: a mixed-methods study. Swiss Med Wkly. 2020. https://doi.org/10.4414/smw.2020.20318.
Coman Schmid D, Crameri K, Oesterle S, Rinn B, Sengstag T, Stockinger H. SPHN—The BioMedIT network: a secure it platform for research with sensitive human data. In: Digital personalized health and medicine. IOS Press; 2020. p. 1170–4.
Maurer J, Saccilotto R, Pauli-Magnus C. E-general consent: development and implementation of a nationwide harmonised interactive electronic general consent. Swiss Med Inform. 2018;34.
Pormeister K. Genetic data and the research exemption: is the GDPR going too far? Int Data Priv Law. 2017;7:137–46.
Carter P, Laurie GT, Dixon-Woods M. The social licence for research: why care. Data ran into trouble. J Med Ethics. 2015;41:404–9.
Ploug T, Holm S. Meta consent—A flexible solution to the problem of secondary use of health data. Bioethics. 2016;30:721–32.
Ploug T, Holm S. Eliciting meta consent for future secondary research use of health data using a smartphone application—A proof of concept study in the Danish population. BMC Med Ethics. 2017;18:51.
Proposal for a Regulation of the European Parliament and Of the Council on European data governance (Data Governance Act). 2020.
Chevrier R, Foufi V, Gaudet-Blavignac C, Robert A, Lovis C. Use and understanding of anonymization and de-identification in the biomedical literature: scoping review. J Med Internet Res. 2019;21: e13484.
van Veen E-B. Observational health research in Europe: understanding the General Data Protection Regulation and underlying debate. Eur J Cancer. 2018;104:70–80.
Article 29 Data Protection Working Party. Working Paper 259 Guidelines on Consent under Regulation 2016/679. 2017.
Shabani M. The Data Governance Act and the EU’s move towards facilitating data sharing. Mol Syst Biol. 2021;17: e10229.
Wirth C, Kolain M. Privacy by BlockChain Design: A BlockChain-enabled GDPR-compliant Approach for Handling Personal Data. In: Proceedings of 1st ERCIM Blockchain Workshop 2018. European Society for Socially Emebdded Technologies (EUSSET); 2018.