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NHS England has pulled the plug on the controversial Care.data project, after the national data guardian for health and care Fiona Caldicott asked the government to consider the future of the programme.
Health and life sciences minister George Freeman said in light of Caldicott’s review, “NHS England has taken the decision to close the Care.data programme.”
The programme, which aimed to extract anonymised patient data from GPs to a central database held by the Health and Social Care Information Centre (HSCIC), has been controversial since it first began.
In 2013, it was paused after accusations that the programme was being pushed through without explaining the implications for highly sensitive patient records.
This was followed by a disastrous education campaign, consisting of leaflets being posted through letterboxes that failed to include any information on the risks of the data being shared.
In February 2014, the programme was put on hold for six months following widespread criticism. It was due to start again that autumn, with 500 GP practices selected as pilot sites, but was put on hold yet again.
In June 2015, the programme began again, with four areas chosen as pathfinders to trial the project. However, the programme was again paused in September 2015, when health secretary Jeremy Hunt asked Caldicott to develop a model for consent and opt out.
Recommendations ‘go beyond’ Care.data
The review, which was published on 6 July 2016, recommends an eight-point consent model for patient data sharing, with separate opt-outs for patient data used for research and for data used for running the health service.
Although the review was not asked to look at Care.data in particular, the pathfinders have been “involved in shaping and testing the proposed consent/opt-out model,” the report said.
“What we’re recommending goes beyond what Care.data did because we’re going beyond the information that goes from GPs anywhere outside the practice for other purposes. We’re talking about the movement of data across the whole system in the patients’ and the public’s interest,” said Caldicott.
George Freeman said the government remains committed “to realising the benefits of sharing information”.
“Therefore, this work will now be taken forward by the National Information Board, in close collaboration with the primary care community, to retain public confidence and to drive better care for patients,” he said.
Eight-point consent model
In her report, Caldicott recommends that the proposals for an eight-point consent model now go out for a public consultation. She believes it is important to include both the public and professionals in the further development and uptake of the consent model.
The report was originally due to be published in February 2016, but was delayed to April before it was further held up due to the European Union (EU) referendum.
Speaking at a press briefing on 6 July 2016, Caldicott said the group looking into the new guidance have come up with a simple model, which gives people the option to opt out of any of their information being used “for purposes beyond care”.
“We made it slightly more complicated by saying it was worth putting to the public the choice of having two separate groups of information to opt out of – [those being] research and information used for running the health service,” she said.
“If you put all of the possible uses of data currently in the system together and asked people to opt in or out of that, it’s actually asking them to make a choice about a very big collection of information.
“[People] may want to have the possibility of saying, ‘Yes, I’d like my data to be used for the possibility of research, but I don’t want it to be used for running the health service’.”
Caldicott added that the benefits of data sharing and what it means needs to be communicated clearly to the public, as there’s a lot of confusion around how the data is used.
Read more about Care.data
- Tim Kelsey, the driving force behind the Care.data project to set up an NHS patient records database, has quit – but what does his departure mean for the troubled programme?
- Sharing healthcare data could deliver better care for patients, but people must be allowed to assess the benefits and risks themselves, says Caldicott.
The eight-point model, which explains to patients exactly what data is used for, is followed by four different options for asking the public about whether or not they wish to opt out of personal data being used for purposes other than direct care.
“The four options could be used to test whether or not the public would prefer a single opt-out, or two opt-outs distinguishing between using information about them to run services and using it for research,” said the review.
“In each case there are two variants: asking people to choose an information profile that accords with their preferences; or asking them to tick a box when they want to opt out,” the review said, adding that extensive testing would be needed “before asking people to make this important choice”.
The Department of Health has accepted the recommendations, and confirmed that a public consultation will take place.
Stronger data protection needed, says review
The review, which also looks at data security in the NHS, recommends that the government considers introducing stronger sanctions to protect anynomised data, including criminal penalties “for deliberate and negligent re-identification of individuals”.
“Whether people opt out or not, they should be reassured that their health and care information will only ever be used if the law allows and never for marketing or insurance, unless they consent separately to this,” the review said.
In response to the recommendations made by Caldicott, the Wellcome Trust is setting up an independent taskforce to develop a framework for “clear and transparent discussions with the public, patients and healthcare professionals about how data can be used to impove health”.
Jeremy Farrar, director of Wellcome, said: “We will only unlock the immense value of patient data if we have open and honest discussions about how and why data can be used for care and research, what’s allowed and not allowed, and how personal information is safeguarded.”