Insurance companies will not be able to buy patient medical records through the controversial NHS data scheme, the Health Secretary has announced.
Jeremy Hunt is to legislate on the care data programme to appease some of the concerns that have been raised about the scheme.
Mr Hunt plans to provide "rock-solid" assurance to patients that confidential information will not be sold for commercial insurance purposes, the Department of Health said.
He is to put a raft of measures in place including a statutory requirement that any patient's opt-out will be respected and legislation that will prevent the Health and Social Care Information Centre (HSCIC) - the body which will control the data - from sharing personal information where there is "not a clear health or care benefit for people".
A Department of Health spokeswoman said that this "puts beyond any doubt that the HSCIC cannot release identifiable, or potentially identifiable, patient data for commercial insurance or other purely commercial purposes."
The HSCIC will also be bound by new laws to protect patient confidentiality when anonymised data is released. And any researchers who wish to access identifiable data must demonstrate "an ethical reason to do so".
He will also give an expert body which advises on releasing identifiable patient data statutory footing.
"The principles around this programme, which will bring real benefits to patients, are fundamentally right, and we completely support them," a source close to the Health Secretary said.
"But, alongside a new campaign from NHS England to explain the programme to the public and GPs, we also need to ensure that robust legislation is in place to address their concerns."
The care.data programme was pushed back until the autumn after NHS England, the body behind the scheme, bowed to enormous pressure from patient and medical groups including the Royal College of GPs and the British Medical Association (BMA).
Patients, doctors and other professional organisations, raised concerns that they had not been given enough time to learn about the project.
NHS England has said it will work with patients and professional groups to promote awareness of the scheme.
The idea behind the programme is to link data from GP records with information from hospitals to give an idea of what happens to patients at all stages of the NHS.
The data that will be extracted from GP systems includes information on family history, vaccinations, referrals for treatment, diagnoses and information about prescriptions.
It will also include biological values such as a patient's blood pressure, body mass index and cholesterol levels. Personal confidential data will also be taken, such as date of birth, postcode, NHS number and gender. The written notes a GP makes during a consultation will not be extracted.
The data will be held by the HSCIC and anonymised by officials there. Fully anonymised data will be made available publicly to anyone outside the NHS.
Data considered to be potentially identifiable - for example where a patient in a small town has a rare disease - will only be released to approved organisations for the specific purpose of benefiting the health and social care system.
Many including a large number of medical research organisations have backed the scheme, saying it will alert the NHS when standards drop, help create a better understanding of what happens to people, especially those with long-term conditions, who are cared for away from hospital, and provide information needed to assist and support research into new medicines, prevention and treatment of disease.
Professor Sir Simon Wessely, King's College London's Institute of Psychiatry, and President-Elect of the Royal College of Psychiatrists, said: "It is excellent to see that NHS-E is indeed responding swiftly to the concerns that have been expressed in many quarters. Many will particularly welcome the strengthening of the sanctions for corporate misuse.
"But it is perhaps more important that there is no headlong rush towards a 'quick fix' here, and I hope that NHS-E will take as long as is necessary to ensure that the new arrangements are not just 'fit for purpose' but are widely seen and acknowledged as such."
Liam Smeeth, Professor of Clinical Epidemiology, London School of Hygiene and Tropical Medicine, said: "These look like sensible proposals that are really a welcome tightening up of procedures. My hope is they will reassure the public that their confidential data will only be used responsibly and that they will not be able to be identified from it.
"The benefits to the NHS and the health of the population of England of being able to use these data are huge. The new explicit legislation will, I hope, mean people do not feel the need to opt out but will allow their data to go forward and be used for the good of all."
Professor Peter Weissberg, Director of Research, British Heart Foundation, said: "The British Heart Foundation welcomes what appears a genuine attempt by government to rectify some of the issues that have emerged over the past couple of weeks.
"What this appears to do is to enshrine the underlying principles of who controls the data and who has access to it (or perhaps more importantly, who doesn't) in law, which is what the data watch community was asking for. Hopefully, this will provide the reassurance over data handling that some patients were concerned about.
"However, as ever, the devil will be in the detail and there is always a risk that rushed legislation can sometimes backfire. We will need to see exactly what the proposed legislation looks like before we can give it our full backing."
John Parkinson, Director of the Clinical Practice Research Datalink, said: "The use of anonymised health record data to improve the delivery of care based upon up to date clinical guidelines and the flow of new and powerful treatments cannot be off anyone's list of important tasks. Neither can doing it in a way that ensures there is trust in the system.
"This all means maximum use of the anonymised data under very tight control, noting that some of the researchers do work for pharma companies and are required to ensure that medicines in everyday use have the right balance of benefit to risk.
"The NHS is unique, based upon a number of important factors, in being able to provide anonymised data, for what are reasons of excellent Public Health. It also needs to be at the forefront of data stewardship, trust and motive. These moves are part of that process that build upon the already large contribution of the use of data in the interest of public health that has been on going without detriment to privacy for many years."
Professor Nigel Mathers, Honorary Secretary of the Royal College of GPs, said: "We are very grateful to the Government for listening to the concerns of GPs and for meeting the assurances sought by the RCGP in order to ensure that patients' data is protected.
"Care.data is a vitally important project that has the capacity to bring enormous health benefits to patients up and down the country.
"However it was critical the Government was able to give the assurances the profession has been seeking, as without them the whole enterprise was at risk of sinking without trace due to a crisis of confidence among GPs and patients."
"What is now needed is a stepped-up publicity campaign to raise awareness of care.data and the safeguards that will exist, so that people are able to make an informed decision about whether to exercise their right to opt out."