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15 - Health Research, eHealth, and Learning Healthcare Systems

Key Approaches, Shortcomings, and Design Issues in Data Governance

from Part IV - Balancing Regulation, Innovation and Ethics

Published online by Cambridge University Press:  08 September 2022

Marcelo Corrales Compagnucci
Affiliation:
University of Copenhagen
Michael Lowery Wilson
Affiliation:
University of Turku, Finland
Mark Fenwick
Affiliation:
Kyushu University, Japan
Nikolaus Forgó
Affiliation:
Universität Wien, Austria
Till Bärnighausen
Affiliation:
Universität Heidelberg
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Summary

The pressure to collect more health data and use that data more effectively is mounting as healthcare systems face greater challenges. However, the risks of increasing health data collection and making our health data work harder are myriad. Given that ‘good outcomes’ in relation to health data usage will be context specific and temporally contingent, the emphasis here is on fit-for-purpose instruments and good practice, acknowledging that health data usage is mediated not only through law, but also through governance structures around data resources themselves. This chapter therefore reviews the Canadian health data ecosystem, examining its federal and provincial legislative elements (with an emphasis on Nova Scotia). It then critiques that ecosystem, bearing in mind the needs of learning healthcare systems. In doing so, it highlights four ecosystem shortcomings, which are grounded in no small part on the perceived competition between private and public interests, and the poor alignment between contemporary data uses and traditional protections associated with autonomy (consent) and privacy (anonymisation). Finally, it offers some key considerations for ecosystem design, addressing specifically social license to operate and the value foundation of both legislation and repository governance instruments.

Type
Chapter
Information
AI in eHealth
Human Autonomy, Data Governance and Privacy in Healthcare
, pp. 423 - 450
Publisher: Cambridge University Press
Print publication year: 2022

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References

Academy of Medical Sciences, Exploring a New Social Contract for Medical Innovation (Academy of Medical Sciences 2015).Google Scholar
Aitken, M, Porteous, C and others, ‘Who Benefits and How? Public Expectations of Public Benefits from Data-Intensive Health Research’ (2018) 5 Big Data & Society 112.Google Scholar
Aitken, M, Porteous, C and Tully, M and others, ‘Consensus Statement on Public Involvement and Engagement with Data Intensive Health Research’ (2019) 4 International Journal of Population Data Science 6.Google Scholar
Allen, J, Adams, C and Flack, F, ‘The Role of Data Custodians in Establishing and Maintaining Social License for Health Research’ (2019) Bioethics Online.CrossRefGoogle Scholar
Barua, B, Hasan, H and Timmermans, I, Comparing Performance of Universal Health Care Countries, 2017 (Fraser Institute 2017).Google Scholar
Bennett, C, Parsons, C and Molnar, A, ‘Forgetting, Non-Forgetting and Quasi Forgetting in Social Networking: Canadian Policy and Corporate Practice’ in Gutwirth, S, Leenes, R and De Hert, P (eds), Reloading Data Protection: Multidisciplinary Insights and Contemporary Challenges (Springer 2014) 41.Google Scholar
Brownsword, R, ‘The Cult of Consent: Fixation and Fallacy’ (2004) 15 King’s Law Journal 223.Google Scholar
Callahan, E, Hazarian, S and others, ‘Eliminating LGBTIQQ Health Disparities: The Associated Roles of Electronic Health Records and Institutional Culture’ (2014) 44 Hastings Center Report S48.CrossRefGoogle ScholarPubMed
Carter, P, Laurie, G and Dixon-Woods, M, ‘The Social License for Research: Why Care.Data Ran into Trouble’ (2015) 41 Journal of Medical Ethics 404.Google Scholar
Cate, F, Cullen, P and Mayer-Schönberger, V, ‘Data Protection Principles for the 21st Century: Revising the 1980 OECD Guidelines’ 2014, www.oii.ox.ac.uk/archive/downloads/publications/Data_Protection_Principles_for_the_21st_Century.pdf, accessed 28 July 2021.Google Scholar
Cohen, I, ‘Is There a Duty to Share Healthcare Data?’ in Cohen, I, Fernandez Lynch, H and others (eds), Big Data, Health Law and Bioethics (Cambridge University Press 2018) 209–22.Google Scholar
Cohen, J, ‘Examined Lives: Informational Privacy and the Subject as Object’ (2000) 52 Stanford Law Review 1373.Google Scholar
Colbert, Y, ‘More Than 2,500 Privacy Breaches at NS Health Authority in Recent Years, Report Says’ CBC News, 22 May 2019, www.cbc.ca/news/canada/nova-scotia/privacy-breaches-nsha-privacy-comissioner-1.5138360?cmp=rss, accessed 28 July 2021.Google Scholar
Commission on the Future of Health Care in Canada, Building on Values: The Future of Health Care in Canada (Queen’s Printer 2002).Google Scholar
Contreras, J, ‘Genetic Property’ (2016) 105 The Georgetown Law Journal 1.Google Scholar
Contreras, J and Nordfalk, F, ‘Liability (and) Rules for Health Information’ (2019) 29 Health Matrix 1.Google Scholar
Council of Canadian Academies, Honesty, Accountability and Trust: Fostering Research Integrity in Canada (Council of Canadian Academies 2010).Google Scholar
Crawford, K and Calo, R, ‘There Is a Blind Spot in AI Research’ (2016) 538 Nature News 311.Google Scholar
Dixon-Woods, M and Ashcroft, R, ‘Regulation and the Social Licence for Medical Research’ (2008) 11 Medicine, Health Care and Philosophy 381.Google Scholar
Dove, E and Garattini, C, ‘Expert Perspectives on Ethics Review of International Data-Intensive Research: Working Towards Mutual Recognition’ (2018) 14 Research Ethics 1.CrossRefGoogle Scholar
Egan, R, Stockley, D and others, ‘Research Ethics Board (REB) Members’ Preparation for, and Perceived Knowledge of Research Ethics’ (2016) 14 Journal of Academic Ethics 191.CrossRefGoogle Scholar
EU High-Level Expert Group on Artificial Intelligence, Ethics Guidelines for Trustworthy AI (2019), https://ec.europa.eu/digital-single-market/en/news/ethics-guidelines-trustworthy-ai, accessed 28 July 2021.Google Scholar
Evans, B, ‘Barbarians at the Gate: Consumer-Driven Health Data Commons and the Transformation of Citizen Science’ (2016) 42 American Journal of Law & Medicine 651.Google Scholar
First Nations Information Governance Centre, Ownership, Control, Access and Possession (OCAP™): The Path to First Nations Information Governance (2014).Google Scholar
Ford, E, Boyd, A and others, ‘Our Data, Our Society, Our Health: A Vision for Inclusive and Transparent Health Data Science in the UK and Beyond’ (2019) 3 Learn Health Systems 10191.Google Scholar
Gough, C, Cunningham, R and Mander, S, ‘Understanding Key Elements in Establishing a Social License for CCS: An Empirical Approach’ (2018) 68 The International Journal of Greenhouse Gas Control 16.Google Scholar
Hall, M, ‘Property, Privacy and the Pursuit of Interconnected Electronic Health Records’ (2010) 95 Iowa Law Review 631.Google Scholar
Hall, M, and Schulman, K, ‘Ownership of Medical Information’ (2009) 301 JAMA 1282.Google Scholar
Harmon, S, ‘Semantic, Pedantic or Paradigm Shift? Recruitment, Retention and Property in Modern Population Biobanking’ (2008) 16 European Journal of Health Law 27.Google Scholar
Harmon, S, ‘Solidarity: A (New) Ethic for Global Health Policy’ (2006) 14 Health Care Analysis 215.Google Scholar
Harmon, S and McMahon, A, ‘Banking (on) the Brain: From Consent to Authorisation and the Transformative Potential of Solidarity’ (2014) 22 Medical Law Review 572.Google Scholar
Heitmueller, A, Henderson, S and others, ‘Developing Public Policy to Advance the Use of Big Data in Health Care’ (2014) 33 Health Affairs 1523.Google Scholar
Henriksen-Bulmer, J and Jeary, S, ‘Re-Identification Attacks – A Systematic Literature Review’ (2016) 36 The International Journal of Information Management 1184.Google Scholar
Herder, M, ‘When Everyone Is an Orphan: Against Adopting a U.S.-Styled Orphan Drug Policy in Canada’ (2013) 20 Responsibility in Research 227.Google ScholarPubMed
Howe, N, Giles, E and others, ‘Systematic Review of Participants’ Attitudes Towards Data Sharing: A Thematic Synthesis’ (2018) 23 Journal of Health Services Research and Policy 123.CrossRefGoogle ScholarPubMed
Kaplan, B, ‘How Should Health Data Be Used?’ (2016) 25 Cambridge Quarterly of Healthcare Ethics 312.Google Scholar
Kass, N, ‘The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight’ (2013) 43 Hastings Center Reports S4.Google Scholar
King, M, ‘An Overall Approach to Health Care for Indigenous Peoples’ (2009) 56 Pediatric Clinics 1239.Google ScholarPubMed
Knoppers, B, Dove, E and others, ‘A Human Rights Approach to an International Code of Conduct for Genomic and Clinical Data Sharing’ (2014) 133 Human Genetics 895.Google Scholar
Kotecha, J, Manca, D, and others, ‘Ethics and Privacy Issues of a Practice-based Surveillance System: Need for a National-level Institutional Research Ethics Board and Consent Standards’ (2011) 57 Canadian Family Physician 1165.Google Scholar
Kukutai, T and Taylor, J (eds), Indigenous Data Sovereignty: Toward an Agenda (ANU Press 2016).CrossRefGoogle Scholar
McLeod, C and Sherwin, S, ‘Relational Autonomy, Self-Trust, and Health Care for Patients Who Are Oppressed’ (2000) 345 Philosophy Publications 259.Google Scholar
Mayer-Schonberger, V, Delete: The Virtue of Forgetting in the Digital Age (Princeton University Press 2009).Google Scholar
Mayor, F, ‘Preface’ in Proceedings of the First Session of the IBC (UNESCO 1994).Google Scholar
Moffat, K, Lacey, J and others, ‘The Social License to Operate: A Critical Review’ (2016) 89 Forestry 477.Google Scholar
Morley, J and Floridi, L, ‘NHS AI Lab: Why We Need to Be Ethically Mindful About AI for Healthcare’ (2019) SSRN 3445421, http://dx.doi.org/10.2139/ssrn.3445421.Google Scholar
NHS Digital, Data Insights and Statistics: Information and Technology for Better Health and Care (2018).Google Scholar
OECD, Guidelines on the Protection of Privacy and Transborder Flows of Personal Data (2013), www.oecd.org/sti/ieconomy/privacy.htm, accessed 28 July 2021Google Scholar
Page, S and Nyeboer, J, ‘Improving the Process of Research Ethics Review’ (2017) 2 Research Integrity and Peer Review 14.Google Scholar
Panel on Research Ethics, ‘TCPS2 Tutorial Course on Research Ethics (CORE)’, www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/, accessed 28 July 2021.Google Scholar
Paul, C, Sanson-Fisher, R and others, ‘Being Sorry Is Not Enough: The Sorry State of the Evidence Base for Improving the Health of Indigenous Populations’ (2010) 38 American Journal of Preventive Medicine 566.Google Scholar
PCC, ‘Appearance Before the Standing Committee on Access to Information, Privacy and Ethics (ETHI) Before the International Grand Committee on Big Data, Privacy and Democracy’, 28 May 2019, www.priv.gc.ca/en/opc-actions-and-decisions/advice-to-parliament/2019/parl_20190528/, accessed 28 July 2021.Google Scholar
PCC, ‘Guidance on Inappropriate Data Practices: Interpretation and Application of s 5(3) PIPEDA’ 2018, www.priv.gc.ca/en/privacy-topics/collecting-personal-information/consent/gd_53_201805/, accessed 28 July 2021.Google Scholar
Price, W, ‘Black-Box Medicine’ (2016) 28 The Harvard Journal of Law & Technology 419.Google Scholar
Price, W and Cohen, I, ‘Privacy in the Age of Medical Big Data’ (2019) 25 Nature Medicine 37.Google Scholar
Purtova, N, ‘Do Property Rights in Personal Data Make Sense After the Big Data Turn?’ (2017) 10 Journal of Law & Economic Regulation 208.Google Scholar
Radin, M, ‘Market-Inalienability’ (1987) 100 Harvard Law Review 1849.Google Scholar
Ramon, S and Mohr, A, ‘A Social License for Science: Capturing the Public of Co-Constructing Research?’ (2014) 28 Social Epistemology 258.Google Scholar
Reading, J and Nowgesic, E, ‘Improving the Health of Future Generations: The Canadian Institutes of Health Research Institute of Aboriginal Peoples’ Health’ (2002) 92 American Journal of Public Health 1396Google Scholar
Roberts, J, ‘Progressive Genetic Ownership’ (2018) 93 Notre Dame Law Review 1105.Google Scholar
Rodwin, M, ‘The Case for Public Ownership of Patient Data’ (2009) 302 JAMA 86.Google Scholar
Rothstein, M, ‘Ethical Issues in Big Data Health Research’ (2015) 43 Journal of Law, Medicine & Ethics 425.Google Scholar
Royal Commission on Aboriginal Peoples, Report of the Royal Commission on Aboriginal Peoples: Gathering Strength (1997).Google Scholar
Rumbold, J and Pierscionek, B, ‘Why Patients Shouldn’t “Own” Their Medical Records’ (2016) 34 Nature Biotechnology 586.Google Scholar
Scassa, T, ‘As Our Economy Becomes More Data Driven, Canadians Need a National Data Strategy that Encourages Innovation and Provides Security and Privacy’, Policy Options, 15 January 2019.Google Scholar
Schwartz, P, ‘Property, Privacy, and Personal Data’ (2004) 117 Harvard Law Review 2056.Google Scholar
Skopek, J, ‘Big Data’s Epistemology and Its Implications for Precision Medicine and Privacy’ in Cohen, I, Fernandez Lynch, H and others (eds), Big Data, Health Law and Bioethics (Cambridge University Press 2018).Google Scholar
Spector-Bagdady, K, DeVries, R and others, ‘Encouraging Participation and Transparency in Biobank Research’ (2018) 37 Health Affairs 1313.Google Scholar
Stahl, B and Wright, D, ‘Ethics and Privacy in AI and Big Data: Implementing Responsible Research and Innovation’ (2018) 16 IEEE Security and Privacy 26.Google Scholar
Terry, N, ‘Protecting Patient Privacy in the Age of Big Data’ (2012) 81 UMKC Law Review 385.Google Scholar
Thaler, R, ‘Show Us the Data (It’s Ours, After All)’ New York Times, 23 April 2011, www.nytimes.com/2011/04/24/business/24view.html?_r=1&partner=rss&emc=rssGoogle Scholar
Townend, D, ‘Conclusion: Harmonisation in Genomic and Health Data Sharing for Research: An Impossible Dream?’ (2018) 137 Human Genetics 657.Google Scholar
Townend, D, ‘Privacy, Politeness and the Boundary Between Theory and Practice in Ethical Rationalism’ in Capps, P and Pattinson, S (eds), Ethical Rationalism and the Law (Hart Publishing 2017) 171–90.Google Scholar

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