11 September 2012
A government-backed scheme will allow researchers unprecedented access to the health records of NHS patients.
The Clinical Practice Research Datalink (CPRD) aims to maximise the potential of this enormous NHS resource and increase participation in research studies by including patients’ anonymised medical data by default, unless they specifically opt out. Researchers will be charged for access (academics at half industry rates) and all work using the data must be made public.
Researchers who want to use the records will first have to apply to their local ethics committee, and then send their research plan to the Medicines and Healthcare Products Regulatory Agency (MHRA), which runs CPRD. If an independent scientific advisory committee approves the application the CPRD itself will then search the records and supply the results to the researchers.
Elaborate security precautions will be put in place to protect privacy: data will be anonymised and encrypted, and will only be accessible to those with security access codes that are re-generated every 30 seconds. In the event of a breach, researchers can be audited and their institution blocked. Nevertheless, some are concerned that these precautions may not be enough and that a search query for a combination of health conditions along with a geographical region could be enough to identify some individuals. Studies for which this is thought to be a risk will require explicit patient consent or for the Health Secretary to grant an exception, as in the case of a public health emergency.
The NHS constitution will need to be changed to allow presumed patient consent, and a consultation on this will take place in Autumn, accompanied by a review of patient record confidentiality led by Dame Fiona Caldicott.