Health research with big data: Time for systemic oversight

Journal of Law, Medicine and Ethics

Volumn 46, Issue 1, 2018, Pages 119-129

  Vayena, Effy ^a   Blasimme, Alessandro ^b  

^a UNIVERSITY OF MINNESOTA   (United States)

^b UNIVERSITY OF MILAN   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; INFORMED CONSENT; LEGAL SERVICE; MEDICAL RESEARCH; MONITORING; PIPELINE; PRIVACY; ACCESS TO INFORMATION; CONFIDENTIALITY; HUMAN; INFORMATION DISSEMINATION; LEGISLATION AND JURISPRUDENCE; UNITED STATES;

ACCESS TO INFORMATION; BIG DATA; BIOMEDICAL RESEARCH; CONFIDENTIALITY; HUMANS; INFORMATION DISSEMINATION; INFORMED CONSENT; UNITED STATES;

EID: 85049506876     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1177/1073110518766026     Document Type: Article

References (91)

1. F. S. Collins and H. Varmus, “A New Initiative on Precision Medicine,” New England Journal of Medicine 372, no. 9 (2015): 793-795
2. E. Elenko, L. Underwood, and D. Zohar, “Defining Digital Medicine,” Nature Biotechnology 33, no. 5 (2015): 456-461
3. S. Hawgood, I. G. Hook-Barnard, T. C. O’Brien, and K. R. Yamamoto, “Precision Medicine: Beyond the Inflection Point,” Science Translational Medicine 7, no. 300 (2015): 300ps17
4. A. Blasimme and E. Vayena, “‘Tailoredto-You’: Public Engagement and the Political Legitimation of Precision Medicine,” Perspectives in Biology and Medicine 59, no. 2 (2017): 172-188.
5. National Research Council, Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease (Washington, D.C.: National Academies Press, 2011).
6. A. Blasimme and E. Vayena, “Becoming Partners, Retaining Autonomy: Ethical Considerations on the Development of Precision Medicine,” BMC Medical Ethics 17, no. 1 (2016): 67.
7. J. S. Brownstein, C. C. Freifeld, and L. C. Madoff, “Digital Disease Detection — Harnessing the Web for Public Health Surveillance,” New England Journal of Medicine 360, no. 21 (2009): 2153-2157
8. M. Salathé et al., “Digital Epidemiology,” PLOS Computational Biology 8, no. 7 (2012): e1002616
9. E. Vayena, M. Salathé, L. C. Madoff, J. S. Brownstein, “Ethical Challenges of Big Data in Public Health,” PLoS Computational Biology 11, no. 2 (2015): e1003904, doi:10.1371/journal.pcbi.1003904
10. M. J. Khoury, M. F. Iademarco, and W. T. Riley, “Precision Public Health for the Era of Precision Medicine,” American Journal of Preventive Medicine 50, no. 3 (2016): 398-401
11. A. Flahault, A. Geissbuhler, I. Guessous, P. Guérin, I. Bolon, M. Salathé, and G. Escher, “Precision Global Health in the Digital Age,” Swiss Medical Weekly 147 (2017): w14423.
12. A. Blasimme, T. Haüserman, A. Adjekum, and E. Vayena, “Digital Health: Meeting the Ethical and Policy Challenges,” Swiss Medical Weekly (in press)
13. E. Underwood and D. Zohar, “Defining Digital Medicine,” Nature Biotechnology 33, no. 5 (2015): 456-461.
14. L. Floridi, ed., The Onlife Manifesto: Being Human in a Hyperconnected Era (New York: Springer, 2014): at 7.
15. World Health Organization, The Health Data Ecosystem and Big Data, available at (last visited January 24, 2018)
16. E. Vayena, J. Dzenowagis, J.S. Brownstein, and A. Sheikh, “Policy Implications of Big Data in the Health Sector,” Bulletin of the World Health Organization 96, no. 1 (2018): 66-68.
17. S. H. Jain, B. W. Powers, J. B. Hawkins, and J. S. Brownstein, “The Digital Phenotype,” Nature Biotechnology 33, no. 5 (2015): 462-463
18. E. Vayena and U. Gasser, “Strictly Biomedical? Sketching the Ethics of the Big Data Ecosystem in Biomedicine,” in B. D. Mittelstadt and L. Floridi, eds., The Ethics of Biomedical Big Data (Cham, Switzerland: Springer International Publishing, 2016): 17-39.
19. C. C. Freifeld, J. S. Brownstein, C. M. Menone, W. Bao, R. Filice, and T. Kass-Hout, “Digital Drug Safety Surveillance: Monitoring Pharmaceutical Products in Twitter,” Drug Safety 37, no. 5 (2014): 343-350.
20. D. O’Brien, J. Ulman, M. Altman, U. Gasser, M. Bar-Sinai, K. Nissim, S. Vadhan, M. J. Wocik, and A. Wood, “Integrating Approaches to Privacy Across the Research Lifecycle: When Is Information Purely Public?” Berkman Center Research Publication, Paper no. 2015-7 (2015), available at (last visited December 27, 2017).
21. Organisation for Economic Co-operation and Development, “Recommendation on Health Data Governance,” (2017), available at (last visited January 24, 2018).
22. I. G. Cohen, R. Amarasingham, A. Shah, B. Xie, and B. Lo, “The Legal And Ethical Concerns That Arise From Using Complex Predictive Analytics In Health Care,” Health Affairs 33, no. 7 (2014): 1139-1147
23. W. Nicholson Price II, “Black-Box Medicine,” Harvard Journal of Law & Technology 28, no. 2 (2015): 419-467.
24. Anonymous, “A Digital Revolution in Health Care Is Speeding up,” The Economist, March 2, 2017, available at (last visited January 24, 2018).
25. D. Nafus, ed., Quantified: Biosensing Technologies in Everyday Life (Cambridge, MA: MIT Press, 2016): at ix.
26. J. L. Roberts, S. Pereira, and A. L. McGuire, “Should You Profit from Your Genome?” Nature Biotechnology 35, no. 1 (2017): 18-20.
27. G. M. Weber, K. D. Mandl, and I. S. Kohane, “Finding the Missing Link for Big Biomedical Data,” JAMA 311, no. 24 (2014): 2479-2480.
28. E. Hafen, “Midata Cooperatives — Citizen-Controlled Use of Health Data Is a Prerequisite for Big Data Analysis, Economic Success and a Democratization of the Personal Data Economy,” Abstract presented at 9th European Congress on Tropical Medicine and International Health, September 6-10, 2015, Basel, Switzerland, in Tropical Medicine & International Health 20, Suppl. 1 (2015): 129.
29. E. Vayena, A. Mastroianni, and J. Kahn, “Caught in the Web: Informed Consent for Online Health Research,” Science Translational Medicine 5, no. 173 (2013): 173fs6.
30. E. C. Hayden, “A Broken Contract,” Nature 486, no. 7403 (2012): 312-314.
31. G. E. Henderson, “Is Informed Consent Broken?” American Journal of the Medical Sciences 342, no. 4 (2011): 267-272.
32. M. A. Sekeres and T. D. Gilligan, “Informed Patient? Don’t Bet On It,” New York Times, March 1, 2017, available at (last visited January 24, 2018).
33. B. A. Koenig, “Have We Asked Too Much of Consent?” Hastings Center Report 44, no. 4 (2014): 33-34.
34. The Precision Medicine Initiative Cohort Program-Building a Research Foundation for 21st Century Medicine, available at at 81 (last visited January 24, 2018).
35. B. S. Elger and A. L. Caplan, “Consent and Anonymization in Research Involving Biobanks: Differing Terms and Norms Present Serious Barriers to an International Framework,” EMBO Reports 7, no. 7 (2006): 661-666.
36. National Institutes of Health, Genomic Data Sharing Policy, NOT-OD-14-124 (August, 27, 2014), available at (last visited December 27, 2017).
37. A. Blasimme, C. Moret, S. A. Hurst, and E. Vayena, “Informed Consent and the Disclosure of Clinical Results to Research Participants,” American Journal of Bioethics 17, no. 7 (2017): 58-60.
38. C. Grady, L. Eckstein, B. Berkman, D. Brock, R. Cook-Deegan, S. M. Fullerton, H. Greely, M. G. Hansson, S. Hull, B. Lo, R. Pentz, L. Rodriguez, C. Weil, B. S. Wilfond, and D. Wendler, “Broad Consent for Research With Biological Samples: Workshop Conclusions,” American Journal of Bioethics 15, no. 9 (2015): 34-42.
39. D. Wendler and E. Emanuel, “The Debate over Research on Stored Biological Samples: What Do Sources Think?” Archives of Internal Medicine 162, no. 13 (2002): 1457-1462.
40. D. Wendler, “Broad versus Blanket Consent for Research with Human Biological Samples,” Hastings Center Report 43, no. 5 (2013): 3-4
41. T. Tomlinson, “Respecting Donors to Biobank Research,” Hastings Center Report 43, no. 1 (2013): 41-47.
42. J. E. Lunshof, R. Chadwick, D. B. Vorhaus, and G. M. Church, “From Genetic Privacy to Open Consent,” Nature Reviews Genetics 9, no. 5 (2008): 406-411.
43. V. Árnason, “Coding and Consent: Moral Challenges of the Database Project in Iceland,” Bioethics 18, no. 1 (2004): 27-49
44. B. Hofmann, “Broadening Consent — and Diluting Ethics?,” Journal of Medical Ethics 35, no. 2 (2009): 125-129
45. J. R. Karlsen, J. H. Solbakk, and S. Holm, “Ethical Endgames: Broad Consent for Narrow Interests Open Consent for Closed Minds,” Cambridge Quarterly of Healthcare Ethics 20, no. 4 (2011): 572-583.
46. G. Helgesson, “In Defense of Broad Consent,” Cambridge Quarterly of Healthcare Ethics 21, no. 1 (2012): 40-50.
47. Food and Drugs Administration, “Use of Electronic Informed Consent: Questions and Answers. Guidance for Institutional Review Boards, Investigators and Sponsors” available at (last visited January 24, 2018)
48. J. Kaye, E. A. Whitley, D. Lund, M. Morrison, H. Teare, and K. Melham, “Dynamic Consent: A Patient Interface for Twenty-First Century Research Networks,” European Journal of Human Genetics 23, no. 2 (2015): 141-146.
49. F. H. Cate and V. Mayer-Schönberger, “Notice and Consent in a World of Big Data,” International Data Privacy Law 3, no. 2 (2013): 67-73.
50. J. P. Kahn, E. Vayena, and A. C. Mastroianni, “Opinion: Learning as We Go: Lessons from the Publication of Facebook’s Social-Computing Research,” Proceedings of the National Academy of Sciences 111, no. 38 (2014): 13677-13679.
51. E. Vayena and A. Blasimme, “Biomedical Big Data: New Models of Control over Access, Use and Governance,” Journal of Bioethical Inquiry 14, no. 4 (2017): 1-13.
52. A. Blassime, A. Soulier, S. Julia, S. Leonard, and A. Cambon-Thomsen, “Disclosing Results to Genomic Research Participants: Differences That Matter,” American Journal of Bioethics 12, no. 10 (2012): 20-22
53. E. Vayena and J. Tasioulas, “Genetic Incidental Findings: Autonomy Regained?” Genetics in Medicine 15, no. 11 (2013): 868-870.
54. V. Anastasova, A. Blasimme, S. Julia, and A. Cambon-Thomsen, “Genomic Incidental Findings: Reducing the Burden to Be Fair,” American Journal of Bioethics 13, no. 2 (2013): 52-54.
55. T. Caulfield, R. E. G. Upshur, and A. Daar, “DNA Databanks and Consent: A Suggested Policy Option Involving an Authorization Model,” BMC Medical Ethics 4, no. 1 (2003): E1.
56. E. M. Bunnik, A. Cecile, J. W. Janssens, and M. H. N. Schermer, “A Tiered-Layered-Staged Model for Informed Consent in Personal Genome Testing,” European Journal of Human Genetics 21, no. 6 (2013): 596-601.
57. A. L. McGuire and L. M. Beskow, “Informed Consent in Genomics and Genetic Research,” Annual Review of Genomics and Human Genetics 11 (2010): 361-381.
58. J. Kaye, E. A. Whitley, D. Lund, M. Morrison, H. Teare, and K. Melham, “Dynamic Consent: A Patient Interface for Twenty-First Century Research Networks,” European Journal of Human Genetics 23, no. 2 (2015): 141-146
59. I. Budin-Ljøsne, H. J. A. Teare, J. Kaye, S. Beck, H. B. Bentzen, L. Caenazzo, C. Collett, F. D. Abramo, H. Felzmann, T. Finlay, M. K. Javaid, E. Jones, V. Katic, A. Simpson, and D. Mascalzoni, “Dynamic Consent: A Potential Solution to Some of the Challenges of Modern Biomedical Research,” BMC Medical Ethics 18, no. 1 (2017): 4
60. K. H. Jones, G. Laurie, L. Stevens, C. Dobbs, D. V. Ford, and N. Lea, “The Other Side of the Coin: Harm due to the Non-Use of Health-Related Data,” International Journal of Medical Informatics 97, no. 1 (2017): 43-51.
61. J. Sugarman, “Examining Provisions Related to Consent in the Revised Common Rule,” American Journal of Bioethics 17, no. 7 (2017): 22-26. 50.
62. J. N. Rosenau, “Governance in the Twenty-First Century,” Global Governance 1, no. 1 (1995): 13-43.
63. P. Macnaghten, M. B. Kearnes, and B. Wynne, “Nanotechnology, Governance, and Public Deliberation: What Role for the Social Sciences?” Science Communication 27, no. 2 (2005): 268-291.
64. G. Laurie, “Reflexive Governance in Biobanking: On the Value of Policy Led Approaches and the Need to Recognise the Limits of Law,” Human Genetics 130, no. 3 (2011): 347-356.
65. J. Polonetsky, O. Tene, and J. Jerome, “Benefit-Risk Analysis for Big Data Projects,” Future of Privacy Forum (September, 2014), available at (last visited August 18, 2017).
66. F. Pasquale, The Black Box Society: The Secret Algorithms That Control Money and Information (Cambridge: Harvard University Press, 2015): at 51
67. P. M. Macnaghten, M. B. Kearnes, and B. Wynne, “Nanotechnology, Governance, and Public Deliberation,” Science Communication 27, no. 2 (2005): 268-291.
68. J.-P. Voß and B. Bornemann, “The Politics of Reflexive Governance: Challenges for Designing Adaptive Management and Transition Management,” Ecology and Society 16, no. 2 (2011): 9.
69. C. M. Hendriks and J. Grin, “Contextualizing Reflexive Governance: The Politics of Dutch Transitions to Sustainability,” Journal of Environmental Policy & Planning 9, no. 3 (2007): 333-350.
70. D. Collingridge, The Social Control of Technology (New York: St. Martin’s Press, 1980): at 47.
71. R. A. W. Rhodes, “The New Governance: Governing without Government,” Political Studies 44, no. 4 (1996): 652-667
72. J. Scott and D. M. Trubek, “Mind the Gap: Law and New Approaches to Governance in the European Union,” European Law Journal 8, no. 1 (2002): 1-18.
73. P. Macnaghten, M. B. Kearnes, and B. Wynne, “Nanotechnology, Governance and Public Deliberation: What Role for the Social Sciences?” Science Communication 27, no. 2 (2005): 268-291.
74. G. Ramachandran, S. M. Wolf, J. Paradise, J. Kuzma, R. Hall, E. Kokkoli, and L. Fatehi, “Recommendations for Oversight of Nanobiotechnology: Dynamic Oversight for Complex and Convergent Technology,” Journal of Nanoparticle Research 13, no. 4 (2011): 1345-1371.
75. A. Rip, J. Schot, and T. J. Misa, “Constructive Technology Assessment: A New Paradigm for Managing Technology in Society”, in A. Rip, J. Schot, and T. J. Misa (eds.), Managing Technology in Society. The Approach of Constructive Technology Assessment (New York: Pinter Publishers, 1995): 1-14
76. D. H. Guston and D. Sarewitz, “Real-Time Technology Assessment,” Technology in Society 24, nos. 1-2 (2002): 93-109
77. J. Grin and H. van de Graaf, “Technology Assessment as Learning,” Science, Technology & Human Values 21, no. 1 (1996): 72-99
78. A. Genus, “Rethinking Constructive Technology Assessment as Democratic, Reflective, Discourse,” Technological Forecasting and Social Change 73, no. 1 (2006): 13-26.
79. J. Stilgoe, R. Owen, and P. Macnaghten, “Developing a Framework for Responsible Innovation,” Research Policy 42, no. 9 (2013): 1568-1580.
80. K. C. O’Doherty, M. M. Burgess, K. Edwards, R. P. Gallagher, A. K. Hawkins, J. Kaye, V. McCaffrey, and D. E. Winckoff, “From Consent to Institutions: Designing Adaptive Governance for Genomic Biobanks,” Social Science & Medicine 73, no. 3 (2011): 367-374.
81. S. B. Garrett, D. Dohan, and B. A. Koenig, “Linking Broad Consent to Biobank Governance: Support From a Deliberative Public Engagement in California,” American Journal of Bioethics 15, no. 9 (2015): 56-57
82. E. Vayena, R. Brownsword, S. J. Edwards, B. Greshake, J. P. Kahn, N. Ladher, J. Montgomery, D. O’Connor, M. P. Richards, A. Rid, M. Sheehan, P Wicks, and J Tasioulas, “Research Led by Participants: A New Social Contract for a New Kind of Research,” Journal of Medical Ethics 42, no. 4 (2016): 216-219.
83. B. J. Evans, “Barbarians at the Gate: Consumer-Driven Health Data Commons and the Transformation of Citizen Science,” American Journal of Law & Medicine 42, no. 4 (2016): 651-658
84. B. J. Evans, “Power to the People: Data Citizens in the Age of Precision Medicine,” Vanderbilt Journal of Entertainment & Technology Law 19, no. 2 (2017): 243-265.
85. M. G. Hansson, J. Dillner, C. R. Bartram, J. A. Carlson, and G. Helgesson, “Should Donors Be Allowed to Give Broad Consent to Future Biobank Research?” The Lancet Oncology 7, no. 3 (2006): 266-269.
86. M. Shabani, B. M. Knoppers, and P. Borry, “From the Principles of Genomic Data Sharing to the Practices of Data Access Committees,” EMBO Molecular Medicine 7, no. 5 (2015): 507-509.
87. C. Grady, L. Eckstein, B. Berkman, D. Brock, R. Cook-Deegan, S. M. Fullerton, H. Greely, et al., “Broad Consent for Research With Biological Samples: Workshop Conclusions,” American Journal of Bioethics 15, no. 9 (2015): 34-42.
88. European General Data Protection Regulation, available at (last visited January 24, 2018).
89. Swiss Federal Department of Justice and Police “Den Datenschutz verbessern und den Wirtschaftsstandort stärken” available at (last visited January 24, 2018).
90. KPMG, “EU General Data Protection Regulation Ratified,” (2016), available at (last visited January 24, 2018).
91. E. Vayena, U. Gasser, A. Wood, D. R. O’Brien, and M. Altman, “Elements of a New Ethical Framework for Big Data Research,” Washington & Lee Law Review 72, no. 3 (2016): 420-441, available at (last visited January 24, 2018).