The Government has instructed NHS England to begin extracting identifiable patient data for research from GP records from today on an opt-in basis.
A legal direction issued yesterday, and coming into force today, said NHS England should establish a service to enable GP data to be ‘collected and disseminated’ for specific research studies that have been approved to access the information.
‘Explicit consent’ needs to be provided ‘by or on behalf of the participant to their data being shared with that study for health research’, the direction said.
A separate document explained that NHS England will collect data from GPs ‘via their GP system suppliers’ set out in the existing GP Data for Pandemic Planning and Research (GDPPR) data specification.
‘In order to minimise costs and reduce burden on GP Practices and their GP system suppliers, no new physical data collection by NHS England is therefore required,’ it said.
The Government argued that the ‘coded patient data held in the GP records is a rich source of information about health’ because ‘for some conditions it may be the only place where a diagnosis or risk factor is recorded’.
‘In other cases, it can complement other sources of healthcare data to give a more complete picture and avoid biases. However, many patients’ permissions for their GP record to be shared are unmet at the date of these Directions,’ it said.
‘Current studies must establish individual agreements with GP practices to access data held about their participants. This is burdensome for both research studies and GPs, who are not resourced to conduct the detailed review needed to ensure that requests from individual studies are appropriate.
‘To address these issues, the Secretary of State has therefore directed NHS England under the Directions to establish and operate an information system for the collection of certain information held in GP health records.’
Under the directions, NHS England will ‘operate a service’ to share this data with ‘Approved Research Studies’, for ‘certain patients’ where:
- explicit consent has been provided by or on behalf of the participant to their data being shared with that Approved Research Study for health research; or
- it is lawful (as described below) under the 2005 Act for the Approved Research Study to carry out the research on, or in relation to a participant who lacks capacity.
NHSE will need to issue a data provision notice to GP practices to set up the service.
For studies to become approved by the DHSC and NHSE, they have to meet certain access criteria, the document said.
The RCGP, which was consulted on the new service, said it understood GPs would not hold responsibility for the extracted data.
RCGP chair Professor Victoria Tzortziou Brown said: ‘The RCGP has long supported the sharing of data for appropriate research purposes, subject to the necessary safeguards to ensure data security and patient trust. In recent years, the College has sought to promote the sharing of GP patient records in cases such as these where patients have given their specific consent.
‘We understand that in issuing this Direction, the Secretary of State is relieving GPs of liability for this collection, and we are encouraged to see that DHSC and NHSE are taking careful steps to communicate this to practices and give them information about how the data will be collected and used.’
Last year, it was revealed that the Government intended to change the rules to allow GP patient data access beyond their previous ‘pandemic-only’ scope.
The BMA was also consulted on the new service.
Patients in scope of the collection
The Data Specification identifies, as being in scope, all patients currently registered with a GP or with a date of death on or after 1 November 2019 whose record contains certain coded information. For each patient, the following data will be collected:
• NHS Number
• Postcode
• Address
• Surname and forename
• Sex
• Ethnicity
• Date of birth
• Date of death.
Data will be collected for the associated SNOMED code(s) and date(s) for GP record entries
including:
• Diagnoses and findings
• Medications and other prescribed items
• Investigations, tests and results
• Treatments and outcomes
• Vaccinations and immunisations.
Type 1 Objections
Type 1 Objections are applied to data prior to collection by NHS England and those records are excluded from the Data Specification. Therefore, the data for those participants who have registered a Type 1 Objection with their GP will not be collected and will not be available to share with an Approved Research Study, even if explicit consent has been provided by or on behalf of those participants, for so long as a Type 1 Objection is in place.
Source: DHSC
A version of this story first appeared on our sister title Pulse.
