title: Data Safe Havens in health research and healthcare.
abstract: BACKGROUND
  The data that put the 'evidence' into 'evidence-based medicine' are central to developments in public health, primary and hospital care. A fundamental challenge is to site such data in repositories that can easily be accessed under appropriate technical and governance controls which are effectively audited and are viewed as trustworthy by diverse stakeholders. This demands socio-technical solutions that may easily become enmeshed in protracted debate and controversy as they encounter the norms, values, expectations and concerns of diverse stakeholders. In this context, the development of what are called 'Data Safe Havens' has been crucial. Unfortunately, the origins and evolution of the term have led to a range of different definitions being assumed by different groups. There is, however, an intuitively meaningful interpretation that is often assumed by those who have not previously encountered the term: a repository in which useful but potentially sensitive data may be kept securely under governance and informatics systems that are fit-for-purpose and appropriately tailored to the nature of the data being maintained, and may be accessed and utilized by legitimate users undertaking work and research contributing to biomedicine, health and/or to ongoing development of healthcare systems.
  
  
  RESULTS
  This review explores a fundamental question: 'what are the specific criteria that ought reasonably to be met by a data repository if it is to be seen as consistent with this interpretation and viewed as worthy of being accorded the status of 'Data Safe Haven' by key stakeholders'? We propose 12 such criteria.
  
  
  BACKGROUND
  paul.burton@bristol.ac.uk.
authors.affiliation: Data to Knowledge (D2K) Research Group, University of Bristol, Oakfield House, Oakfield Grove, Clifton, Bristol BS8 2BN, UK, Public Population Project in Genomics and Society (PG), Montreal, QC H3A 0G1, Canada.
authors.forename: Paul R
authors.initials: PR
authors.lastname: Burton
authors.affiliation: Data to Knowledge (D2K) Research Group, University of Bristol, Oakfield House, Oakfield Grove, Clifton, Bristol BS8 2BN, UK.
authors.forename: Madeleine J
authors.initials: MJ
authors.lastname: Murtagh
authors.affiliation: Data to Knowledge (D2K) Research Group, University of Bristol, Oakfield House, Oakfield Grove, Clifton, Bristol BS8 2BN, UK.
authors.forename: Andy
authors.initials: A
authors.lastname: Boyd
authors.affiliation: Department of Computer Science, University of Toronto, Sandford Fleming Building, Toronto, ON M5S 3G4, Canada.
authors.forename: James B
authors.initials: JB
authors.lastname: Williams
authors.affiliation: JK Mason Institute for Medicine, Life Sciences and the Law, School of Law, University of Edinburgh, Old College, South Bridge, Edinburgh EH8 9YL, UK.
authors.forename: Edward S
authors.initials: ES
authors.lastname: Dove
authors.affiliation: Public Population Project in Genomics and Society (PG), Montreal, QC H3A 0G1, Canada, Department of Health Sciences, University of Leicester, Adrian Building, University Road, Leicester LE1 7RH, UK.
authors.forename: Susan E
authors.initials: SE
authors.lastname: Wallace
authors.affiliation: Public Population Project in Genomics and Society (PG), Montreal, QC H3A 0G1, Canada.
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Tassé
authors.affiliation: School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa, Ottawa, ON K1H 8M5, Canada.
authors.forename: Julian
authors.initials: J
authors.lastname: Little
authors.affiliation: Center for Genetic Medicine and Surgery, Northwestern University, Rubloff Building, 750 N Lake Shore, Chicago, IL 60611, USA.
authors.forename: Rex L
authors.initials: RL
authors.lastname: Chisholm
authors.affiliation: Data to Knowledge (D2K) Research Group, University of Bristol, Oakfield House, Oakfield Grove, Clifton, Bristol BS8 2BN, UK.
authors.forename: Amadou
authors.initials: A
authors.lastname: Gaye
authors.affiliation: Department of Public Health and General Practice, Norwegian University of Science and Technology, Postboks 8905, 7401 Trondheim, Norway.
authors.forename: Kristian
authors.initials: K
authors.lastname: Hveem
authors.affiliation: Department of Health Sciences, University of Leicester, Adrian Building, University Road, Leicester LE1 7RH, UK.
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Brookes
authors.affiliation: C3 Collaborating for Health, 7-14 Great Dover Street, London SE1 4YR.
authors.forename: Pat
authors.initials: P
authors.lastname: Goodwin
authors.affiliation: MRC Medical Bioinformatics Centre, Leeds Institute of Health Sciences, University of Leeds, University of Leeds, Charles Thackrah Building,101 Clarendon Road, Leeds LS2 9LJ.
authors.forename: Jon
authors.initials: J
authors.lastname: Fistein
authors.affiliation: University of Cambridge, Wolfson College, Cambridge CB3 9BB, UK and.
authors.forename: Martin
authors.initials: M
authors.lastname: Bobrow
authors.affiliation: Public Population Project in Genomics and Society (PG), Montreal, QC H3A 0G1, Canada, Centre of Genomics and Policy, McGill University, Montreal, QC H3A 0G1, Canada.
authors.forename: Bartha M
authors.initials: BM
authors.lastname: Knoppers
mesh_terms: D022126:Access to Information; D035843:Biomedical Research; D003219:Confidentiality; D003695:Delivery of Health Care; D006801:Humans; D012106:Research