University of Edinburgh - Edinburgh Law School

University of Edinburgh School of Law Working Paper Series No 2011/26

Information Governance of Use of Health-Related Data in Medical Research in Scotland: Current Practices and Future Scenarios Graeme Laurie and Nayha Sethi Professor of Medical Jurisprudence and Research Fellow [email protected]

This text may be downloaded for personal research purposes only. Any additional reproduction for other purposes, whether in hard copy or electronically, requires the consent of the author(s). If cited or quoted, reference should be made to the name(s) of the author(s), the title, the number, and the working paper series © 2011 Graeme Laurie & Nayha Sethi Edinburgh School of Law Working Paper Series University of Edinburgh

Abstract This paper has been prepared as part of the governance work stream of the Scottish Health Informatics Programme (SHIP). It is intended as a platform for discussion and further elaboration with colleagues and those interested in issues surrounding the governance of secondary uses of health data for research. The main aims of the paper are two-fold. First, to offer an ethical, legal and social account of the current regulatory framework governing the use of person identifiable information (PII) for medical research in Scotland. It does so by both mapping out the legislation and key actors involved in governance, as well as illustrating how the framework is perceived to work in practice. A second aim of the report is to suggest a template to be used in the assessment of good governance. This template can be used both to evaluate current practices and to test any proposals for change in approaches to governance in Scotland and elsewhere with respect to uses of patient data for research purposes. It is anticipated that this template will be developed and refined with input from SHIP colleagues (particularly those at Information and Statistics Division (ISD) of NHS Scotland and those involved in the SHIP Systematic Review) as well as other stakeholders. This is the first in a series of papers in the governance stream of the SHIP programme, funded by the Wellcome Trust. Future papers will address the design challenges of a new system of information governance for health-related medical research in Scotland.

Keywords Information governance : governance: personal data; patient identifiable information; secondary uses of data; research; SHIP; health informatics; regulatory landscape

University of Edinburgh School of Law Working Paper No 2011/26

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