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Towards Principles–Based Approaches to Governance of Health–Related Research Using Personal Data

Published online by Cambridge University Press:  20 January 2017

Graeme Laurie  and
Nayha Sethi
Graeme Laurie
Affiliation:
University of Edinburgh – School of Law
Nayha Sethi
Affiliation:
The Mason Institute, University of Edinburgh – School of Law
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Abstract

Technological advances in the quality, availability and linkage potential of health data for research make the need to develop robust and effective information governance mechanisms more pressing than ever before; they also lead us to question the utility of governance devices used hitherto such as consent and anonymisation. This article assesses and advocates a principles–based approach, contrasting this with traditional rule–based approaches, and proposes a model of principled proportionate governance. It is suggested that the approach not only serves as the basis for good governance in contemporary data linkage but also that it provides a platform to assess legal reforms such as the draft Data Protection Regulation.

Type
Articles
Information
European Journal of Risk Regulation , Volume 4 , Issue 1 , March 2013 , pp. 43 - 57
Copyright
Copyright © Cambridge University Press 2013

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References

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45 Section 55(A) Data Protection Act 1998.

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51 Proposal for a new Regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) Brussels, 25.1.2012 COM(2012) 11 final.

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53 In fact, proportionality is emerging as a key concept within the regulatory landscape and features in the proposal for a new EU Data Protection Regulation, supra note 46. Note mention of proportionality also appears in draft recitals 133 and 139 and also draft Article 22(4).

54 See draft Recitals 22, 53, 123, 125 and 126.

55 Pursuant to Article 290 TFEU.

56 The following publications offer examples of the research which SHIP has facilitated: Logue, Jennifer et al, “Do men develop type 2 diabetes at lower body mass indices than women?” 54 Diabetologia (2011), pp. 3003–3006; CrossRefGoogle ScholarPubMed Walker, Jeremy et al, “Effect of Socioeconomic Status on Mortality Among People with Type 2 Diabetes; A study from the Scottish Diabetes Research Network Epidemiology Group”, 34 Diabetes Care (2011), pp. 1127–1132.CrossRefGoogle ScholarPubMed

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