The pilot phase of the controversial care.data programme will be subject to scrutiny from an independent panel led by Dame Fiona Caldicott, NHS England has revealed.
The commissioning board’s director of patients and information, Tim Kelsey, gave an update on the care.data programme to a parliamentary health committee hearing on the handling of NHS patient data yesterday.
Public controversy around the programme forced NHS England to delay the project, which aims to expand the Hospital Episode Statistics, link HES to GP and other datasets, and make the information available to researchers and others.
The project was due to start GP extractions last autumn, but this was pushed back to March this year, before being delayed a further six months, following a row over whether patients were well enough informed to opt-out if they wanted to, and who would have access to data.
Kelsey told the committee that NHS England has held about 120 community events since February to discuss concerns with civil liberties organisations and patient groups, on top of “numerous meetings” with the British Medical Association and Royal College of General Practitioners.
“We’ve been listening and I’m not afraid to say we’re learning a lot… We have heard a consistent series of concerns that we need to address.”
Kelsey said the pilot phase will be subject to independent scrutiny, with the independent Information Governance Oversight Panel agreeing to work with NHS England on the selection of the pilot practices and evaluation of the process.
The panel, chaired by Dame Fiona, was established by health secretary Jeremy Hunt to help implement recommendations from the second Caldicott review of information governance and “advise, challenge and report on the state of information governance” across the health system.
Chief medical officer Dr Sally Davies will also be involved with the pilot phase, while the final decision on the next step in the programme will be made by the care.data programme board.
“There are a number of key voices that will need to be in agreement that we’ve established a suitable standard of information,” Kelsey said.
He added that the Health and Social Care Information Centre is working on a proposal for a data lab within the centre, to function as a “sealed environment” where organisations can view the data gathered as part of the programme.
Kelsey said organisations will be “encouraged and in some cases mandated” to use the data lab, while there will be "significant downsides" for organisations who choose to view the data outside the centre – including a “one strike and you’re out” policy for any data breaches.
Kelsey said the first data extractions for the pilot practices are likely to begin in late October or early November.
However, he said the pilots will not begin until a number of “preconditions” are met, including the release of the HSCIC’s code of practice its data lab proposal, and government regulations for the Care Act outlining restrictions on data use for commercial benefit. “There are no artificial deadlines here – it is important that we get this right.”
Kelsey said NHS England will also publish a “road map” outlining how it will offer people the chance to make a case for the inclusion of new data codes in the pilot phase, such as for musculoskeletal conditions and sensitive information.
Last week, the BMA’s annual representative meeting voted for care.data to proceed on an opt-in, rather than an opt-out, basis. But Kelsey reiterated his belief that an opt-out is the most appropriate approach to make sure the data can be used to greatest effect.
“The evidence is really clear that people who need health care most receive it least… in order to plan services most effectively for greatest need, we need to have as much data as possible.”
He said NHS England is still discussing whether it will send letters to patients in the pilot phase informing them of their participation, while it wants to ensure that the public is made aware of the benefits of the programme.
“We want people to know how the data sharing has benefited other people, it’s important that they can see how the data is used and to what benefit,” Kelsey said.