Making consent for electronic health and social care data research fit for purpose in the 21st century

There has been significant effort in linking different electronic datasets within healthcare and between health and social care,^1–6 both for research purposes and for clinical care. These electronic data are referred to as ‘routinely collected’ as they are collected during usual clinical practice, in contrast to ‘research’ data which are collected in a bespoke manner within the context of a research project. Such datasets (here referred to as routinely collected electronic health and social care data) are already used extensively in epidemiological research, to assess the impact of healthcare interventions in real-world practice, and to provide outcome measures in clinical trials.^7–9

In wider society, the actions of large personal data processors have brought public scrutiny on the use and misuse of personal data. Previous attempts at large-scale use of electronic health and social care data (eg, the national Electronic Health Record (EHR) in England) have been controversial in concept and problematic in execution, with consequent damage to public confidence in the ability of organisations to act as trustworthy stewards of personal data.^10–13 These negative experiences damage the relationship between individuals, their data and the research community.¹⁴ We argue for moving towards a model of consent and use based on respect for digital personhood, and review some of the technical and governance solutions that could enable this transition.