Abstract
This chapter examines the challenges of the revised opt-out system and the secondary use of health data in England. The analysis of this data could be valuable for science and medical treatment as well as for the discovery of new drugs. For this reason, the UK government established the “care.data program” in 2013. The aim of the project was to build a central nationwide database for research and policy planning. However, the processing of personal data was planned without proper public engagement. Research has suggested that IT companies—such as in the Google DeepMind deal case—had access to sensitive data and failed to comply with data protection law. Since May 2018, the government has launched the “national data opt-out” (ND opt-out) system with the hope of regaining public trust. Nevertheless, there is no evidence of significant changes in the ND opt-out, compared to the previous opt-out system. Neither in the use of secondary data, nor in the choices that patients can make. The only notorious difference seems to be in the way that these options are communicated and framed to the patients. Most importantly, according to the new ND opt-out, the type-1 opt-out option—which is the only choice that truly stops data from being shared outside direct care—will be removed in 2020. According to the Behavioral Law and Economics literature (Nudge Theory), default rules—such as the revised opt-out system in England—are very powerful, because people tend to stick to the default choices made readily available to them. The crucial question analyzed in this chapter is whether it is desirable for the UK government to stop promoting the type-1 opt-outs, and whether this could be seen as a kind of “hard paternalism.”
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Notes
- 1.
Deloitte (2016), p. 3.
- 2.
- 3.
See Digital NHS UK. Available at: https://digital.nhs.uk/national-data-opt-out. Accessed 10 June 2019.
- 4.
- 5.
Safran et al. (2007), pp. 1–9.
- 6.
Given the importance of this new field of law, the Government of the United Kingdom Cabinet Office established the “Behavioral Insight Team” (BIT)—unofficially known as the “Nudge Unit.” The BIT was originally a governmental organization set up to apply insights from behavioral economics to improve public policy and services. Recently, the BIT became a limited company and it is co-owned by the government. Since the BIT was spun off as a social purpose company, it has given birth to a global movement that now spans 153 countries. See, The Behavioral Insight Team. Available at: https://www.bi.team. Accessed 10 June 2019.
- 7.
- 8.
See English Collins Dictionary (Nudge).
- 9.
Corrales and Kousiouris (2017), p. 161.
- 10.
Corrales and Jurčys (2016), p. 533.
- 11.
Corrales and Jurčys (2016), p. 533.
- 12.
Thaler and Sunstein (2009), p. 6.
- 13.
Coggon et al. (2017), p. 177.
- 14.
See Nudging in the Cafeteria (2008). Available at: https://nudges.wordpress.com/2008/04/17/nudging-in-the-cafeteria/. Accessed 10 June 2019.
- 15.
Willis (2015).
- 16.
Thaler and Sunstein (2009) p. 6.
- 17.
Businessballs.com. Nudge theory. Available at: https://www.businessballs.com/improving-workplace-performance/nudge-theory/. Accessed 10 June 2019.
- 18.
Corrales and Kousiouris (2017), pp. 165–166.
- 19.
See, e.g., generally, Jamson (2013), p. 298.
- 20.
Thaler and Sunstein (2009), p. 3.
- 21.
Sunstein (2014), pp. 1–30, 179.
- 22.
- 23.
Ben-Porath (2010), p. 11.
- 24.
Heshmat (2015), p. 243.
- 25.
Corrales et al. (2019), p. 197.
- 26.
Detels and Gulliford (2015), p. 782.
- 27.
- 28.
Leitzel (2015), p. 137.
- 29.
Shafir (ed) (2013), p. 496.
- 30.
Corrales et al. (2019), p. 197.
- 31.
- 32.
Darzi (2017).
- 33.
Piel et al. (2018), pp. 594–600.
- 34.
NHS factsheets for health and care staff, Factsheet 1B—Types of data used and legal protection in place (2018), p. 1. Available at: https://digital.nhs.uk/services/national-data-opt-out-programme/guidance-for-health-and-care-staff. Accessed 10 June 2019.
- 35.
Mészáros and Ho (2019), p. 13.
- 36.
Lee et al. (2012), pp. 38–44.
- 37.
For more information behind the NHS plans for the secondary use of health data, before the creation of care.data program, see Department of Health (2006); see also Department of Health (2015).
- 38.
- 39.
Vezyridis and Timmons (2017), p. 2.
- 40.
The National Data Guardian (NDG) advises and challenges the health and care system in the UK to help ensure that citizens’ confidential information is safeguarded securely and used properly. Available at: https://www.gov.uk/government/organisations/national-data-guardian/about. Accessed 10 June 2019.
- 41.
National Data Guardian for Health and Care (2016), pp. 1–56.
- 42.
National Data Guardian for Health and Care (2016), pp. 6–9.
- 43.
Department of Health and Social Care (2016).
- 44.
- 45.
The ICO has ruled the Royal Free NHS Foundation Trust failed to comply with the Data Protection Act when it provided patient details to Google DeepMind. Available at: https://ico.org.uk/about-the-ico/news-and-events/news-and-blogs/2017/07/royal-free-google-deepmind-trial-failed-to-comply-with-data-protection-law/. Accessed 10 June 2019.
- 46.
- 47.
See Streams. Available at: https://deepmind.com/applied/deepmind-health/working-partners/how-were-helping-today/. Accessed 10 June 2019.
- 48.
McGoogan (2017).
- 49.
NHS (National Health Service) Digital is an executive non-departmental public body of the Department of Health in the UK. The NHS Digital is the national provider of information, data and IT systems for commissioners, analysts and clinicians in health and social care. Available at: https://www.gov.uk/government/organisations/nhs-digital/about. Accessed 10 June 2019.
- 50.
NHS Digital: Opting out of sharing your confidential patient information. Available at: https://digital.nhs.uk/about-nhs-digital/our-work/keeping-patient-data-safe/how-we-look-after-your-health-and-care-information/your-information-choices/opting-out-of-sharing-your-confidential-patient-information. Accessed 15 June 2019.
“Type 1 opt-out: medical records held at your GP practice: You can also tell your GP practice if you do not want your confidential patient information held in your GP medical record to be used for purposes other than your individual care. This is commonly called a type 1 opt-out. This opt-out request can only be recorded by your GP practice.”
- 51.
NHS Digital, Opting out of sharing your confidential patient information. Available at:
https://digital.nhs.uk/about-nhs-digital/our-work/keeping-patient-data-safe/how-we-look-after-your-health-and-care-information/your-information-choices/opting-out-of-sharing-your-confidential-patient-information. Accessed 10 June 2019.
- 52.
NHS Digital, About the national data opt-out. Available at: https://digital.nhs.uk/services/national-data-opt-out-programme. Accessed 10 June 2019.
- 53.
Article 29 Working Party, Opinion 05/2014 on Anonymisation Techniques (2014), p. 3.
- 54.
Regulation (EU) 2016/679 of the European Parliament of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) [hereinafter “GDPR”]. Recital 26: anonymous information, namely information which does not relate to an identified or identifiable natural person or to personal data rendered anonymous in such a manner that the data subject is not or no longer identifiable.
- 55.
Article 4 (5) of the GDPR: “pseudonymisation” means the processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organizational measures to ensure that the personal data are not attributed to an identified or identifiable natural person.
- 56.
Article 29 Working Party, “Opinion 05/2014 on Anonymization Techniques” (WP216, 10 April 2014), p. 20.
- 57.
National Data Guardian (2013), p. 128. “A clinical, social or public health activity concerned with the prevention, investigation and treatment of illness and the alleviation of suffering of individuals. It includes supporting individuals’ ability to function and improve their participation in life and society. It includes the assurance of safe and high-quality care and treatment through local audit, the management of untoward or adverse incidents, person satisfaction including measurement of outcomes undertaken by one or more registered and regulated health or social care professionals and their team with whom the individual has a legitimate relationship for their care.”
- 58.
NHS (2018) Your Data Matters to the NHS, p. 1. Available at: https://digital.nhs.uk/services/national-data-opt-out-programme/supporting-patients-information-and-resources. Accessed 25 May 2019.
- 59.
Powles and Hodson (2017), pp. 351–367.
- 60.
The ICO has ruled the Royal Free NHS Foundation Trust failed to comply with the Data Protection Act when it provided patient details to Google DeepMind. Available at: https://ico.org.uk/about-the-ico/news-and-events/news-and-blogs/2017/07/royal-free-google-deepmind-trial-failed-to-comply-with-data-protection-law/. Accessed 10 June 2019.
- 61.
NHS (2018) Your Data Matters to the NHS, p. 2. Available at: https://digital.nhs.uk/services/national-data-opt-out-programme/supporting-patients-information-and-resources. Accessed 25 May 2019.
- 62.
NHS (2018) Your Data Matters to the NHS, p. 2. Available at: https://digital.nhs.uk/services/national-data-opt-out-programme/supporting-patients-information-and-resources. Accessed 25 May 2019.
- 63.
Meskó et al. (2018), pp. 1–4.
- 64.
NHS, When your choice does not apply. Available at: https://www.nhs.uk/your-nhs-data-matters/where-your-choice-does-not-apply/. Accessed 10 June 2019.
- 65.
NHS (2018) Your Data Matters to the NHS, p. 2. Available at: https://digital.nhs.uk/services/national-data-opt-out-programme/supporting-patients-information-and-resources. Accessed 10 June 2019.
- 66.
NHS (2018) Your Data Matters to the NHS, p. 2. Available at: https://digital.nhs.uk/services/national-data-opt-out-programme/supporting-patients-information-and-resources. Accessed 10 June 2019.
- 67.
McDonald and Cranor (2009), pp. 543–568.
- 68.
Solove (2013), pp. 1880–1903.
- 69.
NHS (2018) A guide to the national data opt-out for carers. Available at: https://digital.nhs.uk/services/national-data-opt-out-programme/supporting-patients-information-and-resources. Accessed 11 May 2019.
- 70.
Understanding Patient Data, Frequently Asked Questions. Available at: https://understandingpatientdata.org.uk/what-you-need-know. Accessed 23 June 2019.
- 71.
NHS (2018) A guide to the national data opt-out for carers, p. 1. “If you think the person you care for is happy for their information to be shared you don’t need to do anything further.” “If you think that the person you care for would wish to register a national data opt-out, or you are satisfied that registering a national data opt-out is in that person’s best interest then follow step 3.”
- 72.
NHS Digital, statistics on the volumes of national data opt-outs. Available at: https://digital.nhs.uk/data-and-information/publications/statistical/national-data-opt-out. Accessed 12 June 2019.
- 73.
NHS Digital, statistics on the volumes of national data opt-outs, March 2019. Available at:
https://digital.nhs.uk/data-and-information/publications/statistical/national-data-opt-out/march-2019/ndop-mar19. Accessed 12 June 2019.
- 74.
Type 1 opt-outs have been reported as instances (i.e., number of times the opt-out code occurs within GP records, which may include the same patient recorded at more than one practice), therefore the NHS Digital could not de-duplicate this information.
- 75.
NHS Digital, statistics on the volumes of national data opt-outs, March 2018. Available at:
https://digital.nhs.uk/data-and-information/publications/statistical/care-information-choices/mi-care-information-choices-england-march-2018. Accessed 16 May 2019.
- 76.
Mill (1859).
- 77.
Corrales and Jurčys (2016), p. 534.
- 78.
Corrales and Jurčys (2016), p. 534.
- 79.
Corrales and Jurčys (2016), p. 534.
- 80.
Bishop (2009), p. 296.
- 81.
- 82.
See, e.g., generally, Jackson (2006), pp. 68–69.
- 83.
Sunstein (2014), pp. 63–99.
- 84.
Corrales and Jurčys (2016), pp. 534–535.
- 85.
Corrales and Jurčys (2016), pp. 534–535.
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Acknowledgements
This research is supported by a Novo Nordisk Foundation grant for a scientifically independent Collaborative Research Program in Biomedical Innovation Law (grant agreement number NNF17SA0027784) and the Multidisciplinary Health Cloud Research Program: Technology Development and the Application of Big Health Data. Academia Sinica, Taipei, Taiwan.
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Meszaros, J., Ho, Ch., Corrales Compagnucci, M. (2020). Nudging Consent and the New Opt-Out System to the Processing of Health Data in England. In: Corrales Compagnucci, M., Forgó, N., Kono, T., Teramoto, S., Vermeulen, E.P.M. (eds) Legal Tech and the New Sharing Economy. Perspectives in Law, Business and Innovation. Springer, Singapore. https://doi.org/10.1007/978-981-15-1350-3_5
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