LONDON — The British government is considering plans to sell health data to private firms without patient consent, weeks after a public outcry over privacy forced it to scrap a similar scheme.

Buried in new guidelines on how to handle patient data, and barely mentioned by the Department of Health, is a recommendation that all patient data be collected from U.K. family doctors and stored centrally.

It also says that "in due course, the opt-out should not apply" — meaning that patients would no longer be given the choice to prevent their information being stored and sold. The fear for health and privacy campaigners is that the data could be sold on to private firms, including consultancies that help pharmaceutical companies penetrate the market.

The government has been here before. Last month a scheme called care.data — under which primary care data would have been collected and shared in order to assess care standards — was dropped after two independent reviews raised alarm over poor consent and awareness campaigns and a lack of transparency about what would be shared and with whom.

It appears the once-dead idea has been revived.

“This is basically a move back to February 2013, when we first learned of care.data and when no opt-out was to be available,” said Neil Bhatia, a doctor and campaigner for transparency and data privacy.

Campaigners say they recognize these benefits, but the lack of transparency troubles them.

Campaigners warn the new proposal goes further as it would allow all primary care records to be harvested and stored in one database run by NHS Digital, formerly the Health and Social Care Information Center. It would override the wishes of 1.2 million people who have requested that their family doctor does not pass on their health records, according to campaign group medConfidential.

“The Department of Health believes it alone can decide to ignore what you have told your doctor,” according to the pro-transparency group’s blog.

The work would be carried out by NHS Digital, which provides health data and IT systems and is partially funded by the government.

Bhatia said the government’s proposal would give “carte blanche for NHS Digital … to do what they like with our private confidential information, as there will be no truly independent oversight over what information is disseminated, or to whom.”

The government says nothing has been signed off yet; consultation on the project remains open until September 7. It also says any information used would be “de-identified” and that data sharing would only be in patients’ best interests.

“We have a strong legal framework to make sure NHS Digital only shares personal information where there is a clear health or care purpose,” a Department of Health spokesperson said. “This means data will only ever be used to deliver real benefits for people and puts beyond any doubt that data can be shared for commercial insurance or other solely commercial purposes.”

After the consultation period closes, Health Secretary Jeremy Hunt will have to respond with a final proposal.

He could choose to push ahead with the existing plan or make changes to give patients more control over who can see their data and what it can be used for.

Alternatively, these issues could be tackled in a new Digital Economy Bill — which would please campaigners — that has just begun its passage through parliament and should be wrapped up next year.

The U.K. is not alone in stumbling through the minefield that is balancing health data protection with the benefits of correctly harnessed data. Last year, Dutch Health Minister Edith Schippers announced controversial plans to use doctors as informants in disability fraud cases. This bill would fall foul of the EU's new General Data Protection Regulation, which took effect in May but will not be implemented for another two years.

In the U.K. the effect of these new EU rules is unclear because of Brexit. The U.K. is unlikely to leave the EU before the implementation deadline. If Britain did take up the EU rules, patients would have greater protection than the existing proposal over how their data would be used.

Private access

A review of care.data by Dame Fiona Caldicott, the National Data Guardian for Health and Care, suggested a more comprehensive system of opt-outs for patients, one that would let them differentiate between allowing data to be used for medical research purposes and being given to private companies.

But advocates argue the new proposal makes it easy for private companies to access the data since they simply need to state it would be in the interests of the NHS or patients.

“Once you have asked patients to consent, the ball passes back to the requester’s court to find a loophole in the cause,” said Phil Booth, co-founder and coordinator of campaign group medConfidential.

Anonymous hospital data has been collated and analyzed by organizations since the late 1990s. This data cannot be used for marketing purposes but it can be used to aid a drug maker gain market access with a product.

“How is that any different? It’s not,” said Booth.

In the first three months of the year, more than 800 requests for hospital health care data from NHS Digital were approved. The majority were from public bodies and universities, but among them were numerous private firms including Walsh Harvey Ltd, Beacon Consulting and Compufile System Ltd.

Walsh Harvey helps pharma and medical devices companies penetrate the health care market with new products; Beacon Consulting, also known as Meditrends Ltd, provides “specialist pharmaceutical consultancy”; and Compufile provides “business intelligence and data management solutions for the financial, healthcare and pharmaceutical industries,” according to their websites.

Digitizing health care

Both the government and campaigners agree digitization can bring huge benefits to patients and health systems, if harnessed correctly.

“If we are to achieve our ambition to deliver the safest, most efficient healthcare possible for NHS patients, we must make the most of this digital information revolution,” said George Freeman last month. He was the life sciences minister until Prime Minister Theresa May’s cabinet reshuffle.

Campaigners say they recognize the benefits of patient records analysis, but the lack of transparency troubles them.

Health records are becoming increasingly useful as scientists learn more about human biology. Each individual has different genetic characteristics, which means, for example, not everyone with breast cancer will respond to the same treatment.

Subsequently, therapies are becoming more stratified to treat patients with certain genetic forms of a disease and increasingly targeted to the individual patient.

Patient records enable researchers to find out, for example, which therapies worked well in some patients but not others. They can also help identify which patients would most likely benefit from new treatments, and save costs from the blanket treatment of all patients with the same disease.

Campaigners say they recognize these benefits, but the lack of transparency troubles them.

Under the former care.data scheme the government was criticized for its weak awareness campaign. It involved putting a poster in every family doctor's waiting room, which the information commissioner said fell below fair standards. An unaddressed leaflet drop followed. But households that had opted out from junk mail never received it. A poll afterwards found only 30 percent of members of the public were aware of the proposed scheme to share their health records.

In addition, the government claimed the data from family doctors would be as secure as that from hospitals, but an exposé revealed insurance firms had been given access to the hospital data which resulted in the care.data scheme being temporarily halted for an inquiry.

Now advocates fear the situation is repeating itself.

“At the moment this is all done in secret: You can see it online but it’s not hugely transparent,” Booth said.

The medConfidential group wants the government to legislate to solve the ongoing transparency and consent problems, caused in part, they say, by the lack of strong leadership in the Department of Health.

Former Life Sciences Minister Freeman was leading the health data package. But his position was axed by Prime Minister May in the government shuffle. His duties have now been spread among ministers in the health and business departments, but advocates argue such an important issue should be addressed by the health secretary.

The Digital Economy Bill going through parliament could be an opportunity to legitimize the process for health care records, campaigners say.

Campaigners want a system that gives every patient access to the names of organizations approved to see their data. This full transparency would build trust between patients, their doctors and the government, they say, and give patients the choice of who to share their data with.

The Digital Economy Bill going through parliament could be an opportunity to legitimize the process for health care records, they say.

Campaign group SumOfUs is taking another approach — calling on the government to scrap once and for all any proposals to sell patient records to private companies. It has launched a petition that so far has more than 63,000 signatures.

“Jeremy Hunt and the prime minister should listen to the overwhelming majority of Britons who oppose this exchange and permanently scrap plans to sell access to our private medical data,” said Martin Caldwell, SumOfUs senior campaigner.