Putting patients in control of data from electronic health recordsBMJ 2018; 360 doi: https://doi.org/10.1136/bmj.j5554 (Published 02 January 2018) Cite this as: BMJ 2018;360:j5554
- John P New, clinical professor of diabetes and endocrinology1 2,
- David Leather, global medical affairs and study lead33,
- Nawar Diar Bakerly, respiratory physician1 2,
- John McCrae, chief technology officer1,
- J Martin Gibson, clinical professor of diabetes and endocrinology1 2
- 1Salford Royal NHS Foundation Trust, Salford, UK
- 2Manchester Academic Health Science Centre, University of Manchester, Manchester, UK
- 3GSK Respiratory Centre of Excellence, GlaxoSmithKline UK, Uxbridge, UK
- Correspondence to: J P New
Many areas of healthcare use electronic health records to document and store clinical data,1 and there is much interest in using this information for clinical research. However, such use is outside clinical care and requires patient consent if the data are identifiable.
Several approaches can be used to get consent for identifiable data being shared for purposes other than personal care. Organisations have tended to favour an opt-out model, believing that an opt-in approach based on active consent would be unfeasible or lead to a low participation rate. In both models, if not enough patients opt in or too many patients opt out, it could be argued that the data are no longer useful or generalisable.
NHS England’s care.data programme, designed to provide access to health and social care information from different settings, was abandoned, partly because it failed to provide clear information about how data would be used and win the confidence of patients and healthcare professionals.23 Patients must be informed of the intended uses and benefits of sharing their data for research to raise public confidence in data sharing and to avoid patients opting out. Here, we describe our experience of an opt-in approach for sharing electronic health record data and discuss it in the context of national and global approaches to consent for sharing health data in research.
Using electronic health records
Electronic health records can provide comprehensive data on medical history, prescriptions, and service use for large populations. They have an advantage over research databases in that there is no interviewer or patient recall bias (eg, adherence to medication can be estimated by …