NHS Patient Data

Leading the Parliamentary debate on the use of patient data.

George Freeman (Mid Norfolk) (Con): It is a pleasure to serve under your chairmanship, Mr Bayley. I thank the Backbench Business Committee for supporting me in applying for this debate, and those hon. Members who have found the time, on a day when attendance here in Parliament is not compulsory, to join me in supporting this important agenda, which is incredibly timely given the recent debate and coverage in the media about concerns over care.data and the wider issues that it raises. I thank the Select Committee on Health for its hearing earlier this week and its support for this debate.

It is no exaggeration to say that the use of patient data is one of the most important subjects being debated in this Parliament, because the use of such data is central to numerous important quiet revolutions. The first is discovering and preventing another Mid-Staffordshire NHS Trust, possibly the biggest institutional failure in public services in recent decades. It is also key to planning the health and care of an ageing society, the costs of which are one of the key drivers of the health budget element of the structural deficit that promises to hold this country in debt.

Data are key to evidence-based policy making and the modernisation of 21st-century NHS services to tackle the chronic gap in health productivity. They are key to tackling the growing medicines deficit, which is causing the NHS and the UK to fall ever lower in the league tables for access to new medicines. They are key to helping unlock the UK’s ability not just to tackle that but to turn it on its head by becoming a global hub of the new model of patient-centred drug discovery sweeping the globe. Finally, they are crucial to generating huge new revenues for the national health service and potentially massive savings in the drugs budget by making the UK the best place in the world to design the new generation of 21st-century targeted and personalised medicines, which are replacing the old one-size-fits-all model of drug design—the old big pharma blockbuster model—which is failing.

The Francis report highlighted a major crisis in the NHS and was a massive wake-up call for all of us. Let us remember that thousands of patients suffered unnecessarily as the result of a massive systemic failure of health care delivery that was deliberately and shockingly ignored by health professionals, who ignored whistleblowers. It was not identified by any management data at the time, because although we were recording it, we were not using it. The use of outcomes data to measure outcomes and performance is utterly core to the successful delivery of modern services across our society. The biggest crisis in this debate is not our over-exploitation of NHS data but our shameful failure to allow transparent performance management in the NHS and care sectors earlier.

As we have seen these last few weeks, issues involving the use of patient data can arouse a storm of controversy and highly charged emotional and partisan debate, including a hugely visceral set of conspiracy fears based on the idea of big government allowing their friends in big business to exploit our data for narrow commercial interests and the incompetence of Governments to manage data securely. This debate is fuelled by and, at worst, worsening a profound collapse of trust generally in Government and big business, which is becoming something of a defining zeitgeist of our times. Pro and anti campaigners have come out in force to proclaim the merits of their relative positions.

Sir Peter Bottomley (Worthing West) (Con): Although it was not directly about data, the last time this happened was during the scandalous media coverage of the measles, mumps and rubella vaccine scares. It took 12 years or so to find out eventually that the arguments against the vaccine had been absolutely bogus from the beginning. I say to my hon. Friend, because I may not be able to make a speech, that some of the campaigning organisations, including SumOfUs and 38 Degrees, have stirred up trouble when they should have been backing responsible use of NHS data for the benefit of all of us.

George Freeman: My hon. Friend makes a powerful point. I will acknowledge later the veracity of some of the points raised, but he is right that some irresponsible fears have been raised, which do nothing but damage public health. The MMR debacle is a good example of why we need to use those data and why we need very high rates of opt-in so that they can be used in that way.

Unsurprisingly, due to that debacle, many now ask whether there is a future for this quiet revolution in the use of patient data to deliver the benefits outlined above. After all the controversy and public backlash, where can the hope of a data-led NHS go? Is public trust now so low that the Arab spring of health outcomes and transparency is over? I suggest that it is not, and that the Government and NHS England’s decision to delay the care.data initiative in order to give more time for a wider public discourse provides a platform for rebuilding public trust and confidence. I will make some specific suggestions for the Government to consider that I think would go a long way towards achieving that.

I will begin by sketching out the revolution that I believe is currently under way in 21st-century medicine and how data are central to driving it. I will then show how the ten-minute rule Bill that I have introduced on patient rights over patient data, and the “Patients4Data” campaign that I helped to found, some of whose members are here in the gallery, are articulating the benefits of patient data. I will then summarise and address the understandable concerns of many patient data opponents, which have been aired in the past few weeks. We must carry public trust and confidence; how can we put measures in place to combat those concerns? Finally, I will set out how I believe the scheme can be saved and how we can ensure that patient data can be used to deliver the benefits that we all want in a way that carries public trust.

Fundamentally, I suggest, this debate on data is a small but important test for our politics. Will we let some of the greatest advances in modern medicine and the chance of a truly 21st-century model of health care elude us and get lost in a muddled partisan debate that generates more heat than light, or let failures of health care delivery like those in Mid-Staffordshire be compounded by failures of parliamentary and political process? Or will we rise above it to recognise the reasonable objections raised by opponents, address them with the studied calm that an issue of this importance demands and find a workable solution on a truly cross-party basis?

I hope that this debate will play a part in helping us take the latter course and show this House at its best, with politicians coming together to find answers in the interests of the British people, patients and the NHS, as well as the care professionals who rely on us to get it right. As they have a duty of care to the patients of this country, so we as elected representatives have a duty of care to the democratic process and to them as citizens. The transformational impact of data is too important to get lost in a debate dominated by petty factionalism and party rivalry. This serious issue demands serious answers, which this debate will help to provide.

I mentioned a quiet revolution in modern medicine. I suggest that slowly but surely, 21st-century health is changing from something done to us by government when government has thought that we needed it to something that modern citizens do for ourselves. It is a revolution ultimately driven by data in three profound ways—a quiet revolution in transparency of outcomes across the NHS; in research and how medicines are developed; and in empowerment of patients to take more responsibility for their own health care.

On transparency, we saw—most traumatically in the Francis report, although it is working across other areas of health care—that our constituents increasingly want to understand and see that their patient journey through the health system and, crucially, the care system is properly tracked. To share a personal example, I have power of attorney for my elderly mother, who was hospitalised last summer. When she came out of hospital, as thousands of our constituents do every day, she was suffering and in pain, and not getting the care that she needed. I wanted to be able to log on quickly to see what her diagnosis was, what she had been prescribed by way of pain relief and which of the mountain of expensive multicoloured pills she had been prescribed over the previous weeks and months she should have been taking that afternoon. I wanted to be able to ask the right questions of the system and the people in it when she was unable to do so for herself. Why could she not simply have given me her login password so that I, with power of attorney, could log on with her NHS number to her care record and see at a glance live information on her condition?

I have given a small example, but it is one that the younger generation in particular now expect in the delivery of public services. They want and expect data and easy online access to drive accountability. The genie is somewhat out of the bottle in terms of public interest in the power of data and online access to drive both transparency of outcomes and patient empowerment. The frightening truth is that we are currently in a dark age in some areas of our health service. The Government have sought to tackle that through the care.data initiative, and we should welcome that. The issue is how we tackle that in a way that commands public trust and confidence.

Despite all the technological advances of the last century, we are still unable to say how many people receive chemotherapy in the NHS each year, or how many prescriptions are issued. For all we know, there could be another Harold Shipman—God forbid—operating in a GP practice somewhere in Britain; or, more likely, a GP surgery or social care unit that is operating well below acceptable standards. We—the patients, taxpayers and citizens of this country—have a right to know, and to expect that MPs are asking the right questions and using our position in Government and privileged access to that vast data set to ensure that we are asking those questions and demanding the answers.

The horror stories from Mid Staffs were brought to light only by the power of outcomes data. Patients were dying unnecessarily. People were drinking water from flower vases. We now know that whistleblowers were ignored. It was only through the power of data that the scandal was uncovered. After all, data do not lie. If, as the Secretary of State said, sunlight is the best disinfectant, open data provide the light we need to stop the sort of abuses that were going on in places such as Mid Staffs and Winterbourne View.

The second and perhaps most groundbreaking application of data is in research. The truth is that the traditional model of medicines development on which we and the NHS have relied for almost 50 years, in which the pharmaceutical industry goes away for us and spends hundreds of millions—increasingly, billions—and comes back with a perfect drug claiming to suit everyone, is a model that neither we nor the NHS can afford any longer.

Having had a career in biomedical research, my experience is that over the past 10 to 15 years this country has quietly come to lead in the appliance of patient data sets in particular disease areas to drive and accelerate the development of modern medicines. That has had extraordinary benefits for NHS patients. I declare an interest in that I spent the last seven years of my career in biomedical science and research helping to create partnerships in the NHS between NHS clinician scientists, research charities, industry and university scientists, in order to try to accelerate the process by which modern medicines are discovered and developed.

The truth is that the more we learn about genetics, genomics, patients and disease, the more we know that someone else’s disease will probably be different from mine. Our susceptibility to it will be different, as will our response to different drugs. The revolution in research data offers an extraordinary opportunity for the NHS to be the place in the world where we develop and design 21st-century medicines targeted at the patients who need them, and generate extraordinary opportunities for NHS patients and clinicians. Instead of being a country that can no longer afford a spiralling drug bill and that, through inevitable rationing, becomes an ever less attractive place to develop and launch new drugs—accelerating our crisis in access to medicines—we could become the best territory in the world in which to do patient-centred drug design, and thus get the fastest access to the latest medicines. That would be a huge prize for our country.

I shall give an example that brings that opportunity to life. The last project that I worked on before coming to Parliament was at King’s college here in London, with Professor Simon Lovestone, the head of research at the college’s academic health science centre and the professor of psychiatry. The project was funded by the NHS National Institute for Health Research and looked at the catchment population of the South London and Maudsley NHS mental health trust—250,000 patients suffering from a range of mental health ailments. Members will be aware that there is no magic bullet drug in mental health; there is a huge cocktail of some very difficult drugs, with often hugely traumatic experiences and side effects for patients. It is an unsatisfactory area of modern health care in which we are still failing a large number of patients, despite the best efforts of those seeking to care for them.

The system that was put in place, funded by the NIHR, created an anonymised data set of the 250,000 patients, which allows researchers to look across that cohort at relationships between medicines and outcomes and between disease diagnosis and MRI scans. It shines a light on which drugs are working for which patients and starts to allow us to improve treatments, target the right drugs to the right patients, and begin to understand the complex interplay of genetic, lifestyle and pharmaceutical factors shaping disease, as well as giving possible opportunities for breakthroughs in diagnosis and treatment.

Interestingly, in the context of the anonymisation debate, crucial to the success of the NIHR-funded system is the ability to trace and analyse GPs’ notes in a long sequence of diagnoses for an individual patient, and to understand the interaction of a number of different factors in that patient’s life in predicting particular patterns of predisposition and response to drugs. In discussing anonymity, pseudo-anonymisation and total anonymisation, we must therefore be careful to ensure that we support a system that allows the right people to use the right data in the right way in order to drive health benefits.

We must also distinguish the use of data for research from the publication of data. We have discovered from the story this week in TheDaily Telegraph about a secondary analysis of data by insurance companies that those data were originally published by a think-tank. We must therefore be careful to put in place an appropriate system so that, for core research within the NHS, the necessary freedoms to look at individual patient and non-anonymised data are protected, but we have a cascade of protections leading out so that published data are absolutely safeguarded against de-anonymisation.

Damian Hinds (East Hampshire) (Con): I congratulate my hon. Friend very warmly on securing such a timely and important debate. The protections that he is talking about are fundamental to a lot of people with strong views on this issue. By what mechanism does he envisage data sets becoming available? Who would be in charge of the protection? Do we make large data sets available? Would there be some sort of automated system to find breaks in the data? My question, essentially, is: what are the mechanisms to reassure people?

George Freeman: My hon. Friend has put his finger on it. I will come in due course to some detailed ideas, but his question merits an “in principle” response. It was proposed in the initial version of care.data to use one or two advisory boards within NHS England. Their memberships are not particularly accountable or transparent, and nor are their criteria, although they are no doubt staffed by laudable and well-meaning public professionals. My hon. Friend’s question shines a light on the issue—what is the basis on which different sorts of data are being released, for what purpose and to whom?

Later on I will suggest that we ought to be putting such advisory bodies and the framework for data release on a statutory footing, with protections to help to secure public trust and confidence. We must also ensure that Parliament can look—annually, biannually, or whatever might be appropriate—at ensuring for itself, and for the benefit of our constituents, that the system is working as intended. My hon. Friend’s key point is that if we are to maintain public trust and confidence in a system based on opt-out—that is essential for the data set to be maintained at the level of scale and competence required for its function—we must earn the right to win over public support for opt-out. If we do not put in place the right protections, we will not earn that right, and we will risk large numbers of patients opting out. If that happens, we would have been better off putting in place protections that we would have preferred not to be necessary, but were, in order to secure public confidence.

To return to the system in the South London and Maudsley NHS mental health trust that was established by Simon Lovestone, it creates extraordinary opportunities for us here in London—and Britain more generally—to lead in the field of developing treatments for a whole range of mental health ailments, from Alzheimer’s to a range of other psychiatric conditions that cause so much pain and suffering. They also cause vast secondary costs to our health economy.

The third and most important reason this quiet revolution of NHS data is so important is in what I call empowerment. If health care is to move from being something that Government do to us to something that we increasingly, as modern health care citizens, take responsibility for, we need to be empowered to engage in that health care economy. We need to be enabled to take more responsibility for our own health, our own health outcomes and our own predispositions to disease, and enabled to embrace an active role as health citizens able to use the system to drive the search for new treatments and cures; and we need to be given the tools to play a more active role in shaping our own health care destinies.

Twentieth-century medicine has essentially been passive: we wait until we get a condition and then we get what we are given. I believe 21st-century health care will be all about empowering a new generation of health care citizens to be proactive, taking an active interest and role in preventing disease, and helping to engage as patients in research and in treatment as patient support networks. The revolution in social media and the internet is already playing a profound role in allowing that to happen, making Britain the home of some extraordinary work that is being driven by our medical research charities in bringing patients together to support research, and also to support treatment, care and networks. It is connecting British patients, particularly in the field of rare diseases, with global networks and communities of patients.

We are seeing extraordinary things happening with patient groups raising money; philanthropic funding; companies being formed; and joint venture vehicles being formed by patient groups wanting to go and find the cure to their disease, often going back to interrogate old data from yesterday’s drugs, or failed drugs, to discover whether they might have worked for particular patient catchments and cohorts. That revolution is all to the good. It is something that we need to be encouraging and building into the system.

Ask any clinician and they will tell you the same thing. It is very striking that when patients first get a serious diagnosis, they quickly become overnight advocates of the power of the internet, online support and patient data, and the ability to plug into research, online information and patient networks. It can be very challenging, particularly when patients are hungry for information, to stumble into and across the wrong source—unhelpful sources of information—and GPs often find themselves having to correct their patients and put them back on track, but I do not think that that is a reason to say that the revolution is wrong or bad. It is a reason to make sure that we make it easier for patients to plug into the right sources of information.

When we talk to patients, the sources that they naturally trust are the NHS, the National Institute for Health Research—the NHS’s own research base—and the great charities whose philanthropic and disease commitment is unquestioned. We ought to be thinking about creating a framework for patients to access online to make it easier for our patients to plug into those trusted sources of information.

I spoke recently to Cancer Research UK, which is in the process of developing a patient portal. It will sit on the Cancer Research UK website as a portal to help cancer patients access clinical trials. It will recruit through the trials, through the Cancer Research UK charity. It also has a major technology transfer arm and is developing and supporting the development of new medicines—in many cases, medicines on which the industry simply does not see enough of a return to develop, because they are often targeting quite rare and specialist cancers. This is the revolution of medicines discovery that we need to be encouraging, and it is utterly based on patients engaging and supporting each other, and driving philanthropic and joint venture and mixed models of medicines, discovery and development. All that is down to data. Without those data, we are powerless to see neglect in our health care system; to help to save lives through research; or to gain further control of our own health care through this revolution of empowerment.

Fundamentally, we need to remember that we are talking about an evolutionary process. This quiet revolution did not start last month with the care.data leaflet job. The Health and Social Care Information Centre is not a sudden change sprung upon the public. We have been collecting health data in this country for more than 25 years. The UK and the NHS have been slowly leading the world in this field, but, for a range of reasons, we have not yet told the public the story. No wonder they are confused.

We started collecting basic health data 25 years ago. Most recently, out-patient data were added in 2003. A and E data were added in 2008. Crucially, the previous Government did not feel it was necessary to give anybody the chance to opt out. That is a decision that was taken, I am sure, in good faith at the time. I think it is a sign of how public attitudes are changing that the Government announcing they are giving people the right to opt out has triggered a massive backlash and public debate about on what basis there is any assumption that there is an automatic opt-in. It is a sign of how public attitudes are changing and that public trust in Government to always act in the best interests of its citizens is lower than it was.

Sir Peter Bottomley: We must pay tribute to the media in helping us on all this. They are not always helpful. When Dr Foster information on hospital experiences is aggregated and published, everyone is pleased because they can see what is good, what is better and what should be stopped, but when it starts spreading to GPs, people suddenly start thinking it is all a frightful shock. It took the BBC, I fear to say, six days to wake up to the benefits and the common currency of the use of anonymised medical data for the benefit of us all.

George Freeman: My hon. Friend again makes a very important point. Such debates are difficult. Whenever science and complex science are being debated, there is a danger that the easy, controversial and headline-grabbing arguments will dominate. I will not throw stones from Parliament and bemoan the lack of qualified scientists in the media. The truth is that we have a lack of well-informed science dialogue in our public discourse. There are excellent journalists in the debate. They do us a favour by understanding and promoting sensible and high-quality public debate, but my hon. Friend is absolutely right that we have seen—he has mentioned MMR—cases in which well-intended public policy has been distorted by a badly handled media debate—that is true across different parts of the biosciences.

In agriculture, we have seen similar debates around GM. The proper debate about the benefits is not had because the level of public discourse does not allow us even to acknowledge what they are—we stay at an emotional level. Somehow, Parliament needs to find the ability to have those conversations. We are extraordinarily well equipped in this country compared with Europe. We are the only country that has a chief scientific officer in every Department, and that has a cabinet of chief scientists that meet weekly to advise the Government as a whole as well as their individual Ministers. Only three other nations in Europe have a system of chief scientific officers. Britain has an opportunity to lead as we grapple with a lot of higher science and technology in the 21st century.

The HSCIC in its new form will allow better use of information to join up care, but it comes as part of an evolution of health care data, not a revolution launched with care.data this year. It is no good having a £3.8 billion integration fund for better provision of services unless we have the right information, and unless we can join up intelligence to understand what really good care looks like. The truth is that this is part of a much bigger picture, with medicine and health care being transformed by an explosion of new technologies around the world. I contend we are living through a biomedical revolution every bit as profound as the agricultural and industrial revolutions that came before. Extraordinary new diagnostics, devices and drugs are being developed that will transform health care.

I want to share one example, which I recently came across in hosting the “Silicon Valley comes to the UK” med-tech event in Cambridge before Christmas. Interestingly, I met a Brit based in California who, after a successful first career in Hollywood special effects, decided that he wanted to put something back and do something rather more meaningful. As a child, he was obsessed—that was his word—by the “Star Wars” movies. He ended up developing a helmet that reads the neurological signals in the brain and, using algorithms and software, converts those into basic speech.

Having developed the first prototype, he trialled it on a cerebral palsy patient, a young man with an acute palsy who was unable to communicate. His mother had, like mothers do when children are diagnosed or suffer in that way, spent 21 years caring for her son. When they put the helmet on, to establish some communication protocols, he said to the mother, “I am now going to ask a series of simple questions that you will know the answer to and I want to establish whether your son is hearing and answering me correctly.” He proceeded to ask yes/no questions, including, “Do you like coffee?” and “Do you like tea?” The answers, translated by the algorithm, came up on the screen, “Yes” and “No”. He asked the boy’s mother, “Are these answers correct?” She said, “They are 100% correct.” He then asked, after a long pause, “Do you love your mother?” What came up on the screen was, “Yes. Yes. Yes. Yes.” After 21 years of not having any communication from her son with cerebral palsy, for the first time she heard that her son loved her. That was achieved by the most extraordinary combination of algorithmic, diagnostic and Hollywood-derived technologies.

In health care, we are seeing an extraordinary convergence of technologies across different fields, which are genuinely transforming what will be possible in the 21st century. Data and information sit right at the heart of it. We have a duty to try to tell the public what could be possible if we allowed this revolution to be unlocked.

The UK is pioneering a new model of patient-centred biomedical research. Across the world, the life science industry is radically reconstituting itself around what everybody is coming to recognise as the most important asset of all in modern biomedicine: the ability to work with clinicians and their patients, with biopsies, and with patient records and data, to design a new generation of targeted and personalised medicines, diagnostics and devices. That model of targeted medicine unlocks the biggest prize of all: a new model of reimbursement, where, instead of our officials sitting in smoke-filled rooms every five years to negotiate prices for one-size-fits-all blockbuster drugs with the pharmaceutical industry, which neither we nor they, increasingly, can afford, we get to be the country getting drugs at reduced prices, reflecting the value we have delivered through our NHS infrastructure. That is why the Prime Minister’s leadership in grasping this opportunity, through the life science strategy, matters so much, building on the legacy—I should pay tribute to it—of the previous Government.

Long-term thinking and cross-party unity of purpose is essential if we are going to unlock that value for the UK.

Of particular note are the launch in 2011 of the life science strategy, the catalyst fund, the patent box, the NHS open data initiatives, the “Innovation, Health And Wealth” reforms, and now the £100 million Genomics England project, in which the UK is making a bold leap into leading the world in genomics medicine, and for the first time sequencing the genome of 100,000 NHS patients and combining that at scale with its phenotypic hospital outcome data. With that, we will have not just partial bits of genetic information, but the entire genome. That will allow us to be the first place in the world that starts to identify certain things, saying, for example, “Interestingly, 98% of patients who don’t respond to that drug have this tiny genetic variation that we never spotted before.” That holds the promise of opening up a whole new world of medical research based here in the UK.

Ultimately, linking clinical and genomic data and using the power of modern computing provides the opportunity to turn the NHS from a major driver of our structural deficit into a major driver of growth in life sciences and a catalyst for public service innovation, reform, and patient and citizen empowerment. This agenda really matters.

The most inspiring examples of this tectonic shift in health care are, of course, the stories of the individuals whose lives have been saved by this data revolution. They include a man called Graham Hampson Silk, whose life was saved by the revolution in research-based medicine. Ten years ago, he was given three years to live. Yes, Members heard me correctly: Graham was supposed to die seven years ago. His life has been saved by the team of clinicians and NHS staff at Birmingham Royal infirmary and the Institute of Translational Medicine, led by the inspiring Professor Charlie Craddock. He found a drug in development in the USA and, to do that, he personally led a fund-raising effort on behalf of his patient, highlighting again the way in which philanthropy and charitable work, embedded in our NHS as part of a mixed economy working with industry, is increasingly vital to the development of new medicines. Charlie raised the money through local fundraising to fund a trial for Graham and is now pioneering personalised cancer treatment here in the NHS, with NHS patients and their data, so that every patient in that unit becomes a research patient, helping prevent the next generation from suffering unnecessarily.

It was because Graham’s story and many thousands like it that I agreed to co-found with him the Patients4Data campaign this year, to highlight the life-saving effects of patient data. Patients4Data exists to make the case for how the medical revolution can and will transform, and is transforming, our lives. Our contention is that, if we do not embrace this data revolution, there is a clear and present risk of the UK—far from leading in this world of personalised medicine and winning in the global race for investment; and far from the NHS pioneering new models of health care, productivity and patient empowerment—becoming a backwater, talking the talk but not walking the walk.

Specifically on data, in a few years’ time it will be unimaginable to think of health records and patient monitoring as it is today, with paper records, cardboard boxes, partial digitisation, fragmentation across hospitals and community care a black hole. How many patients—our constituents—realise that what data integration there is in our health service currently depends on the humble treasury tag, that little green piece of string with two bits of metal at either end that holds together different cards and pieces of paper, particularly in our hospital system? On those treasury tags rely our 21st century system of medicine. It simply is not good enough.

That will be as unimaginable in health care as it was in the world of banking before electronic and telephone banking empowered millions of banking consumers to take more responsibility for their finances. I am old enough to remember when the first online bank was launched. I remember being worried that I could not really trust them with my money; worrying that the number on the screen might not actually resemble the amount of money in my bank account; and worrying that my money would leak and be lost, along with my financial data. I need not have worried, because that revolution in online banking has transformed banking and personal finance and has driven an extraordinary revolution in the UK in personal financial services. It has driven huge benefits for customers and citizens, with huge savings and a huge new market in online financial services. It is now taken for granted. The same revolution is happening and will happen in health care.

The Patients4Data movement and the Patient Data Bill, in respect of patient rights, which we have sponsored, have already secured extraordinary support from a wide range of key opinion leaders in this field: those who have seen what is coming and want the UK to be at the forefront, leading the charge. Those opinion leaders include more than 75 medical research charities, leading professor clinicians on the front line of UK research medicine, the NHS national director for patients and information and the Ethical Medicines Industry Group, which is not big pharma but small, emerging companies that are pioneering the new treatments and diagnostics that are all too often locked out by our current system of NHS innovation rationing.

Patient data are part of a wider story that will transform how we think about health and save hundreds of thousands of lives along the way. As with any revolution, there are new concerns, which I will now address. As the past few weeks have shown, many people have legitimate worries about the use and integration of GP and hospital data. Who has access to those data? Might your drink problem, sexually transmitted disease or confidential discussions with your GP be revealed? I am not talking about you, Mr Bayley, but about a hypothetical constituent. Will there be a free-for-all for insurance companies or others that want to use the data for malign rather than benign purposes? Major objections have been raised by a number of organisations. MedConfidential has raised problems with the opt-out, and public ignorance of the scheme, the leaflet campaign and the communications. On the opt-out, medConfidential says:

“Where patients have objected to the flow of their personal confidential data from the general practice record, the HSCIC will receive clinical data without any identifiers attached (i.e. anonymised data)…This is not what any reasonable person would understand by opt out—if you opt out, no information from your medical record should leave your GP practice.”

A number of other concerns have been raised that merit attention.

Big Brother Watch has set out a number of concerns on the levels of public information, data extraction, the governance framework and sanctions, which merit consideration. On public information, Big Brother Watch flags the failure to ensure that the public are properly informed before any data are uploaded. It also highlights the conflation of various issues on the uses of data within care.data, from drug research to commissioning, monitoring of performance and treatment success. On data extraction, Big Brother Watch flags the lack of clarity on which data would be extracted for those who do or do not opt out, and the framework for the governance of that extraction. There are concerns about the ability of NHS England to establish a proper governance framework that commands public confidence. Big Brother Watch also raises the issue of appropriate sanctions for data protection infringements. The British Medical Association and the Royal College of General Practitioners have raised a number of concerns about communications.

I do not believe that those concerns equally merit Government attention, but some of them definitely do. I am interested to hear the Minister’s thoughts on how those issues will be addressed in the next six months. The major complaints are these: why cannot we have an easier opt-out? Everyone who understands the issue wants to see very low opt-out rates, but the price we pay for ensuring low opt-out rates is introducing a series of protections that cement public support for being opted in, as it were, unless they actively opt out.

There is a major concern about the governance, the lack of a code of practice, the lack of clarity on the basis on which the advisory councils work, the criteria that the advisory councils are using and what will constitute inappropriate release or use of data. There is also concern on the statutory basis of the advisory councils. Given how strongly we now know the public feel about that, should we not be thinking about ensuring that we put those advisory councils on a proper footing, so that they are accountable in some way to the people whom they are there to serve through Parliament?

Questions have been raised about the possibility of releasing not the raw data but a cleaned summary format, which is not straightforward. As I have highlighted, there are some areas in which the raw data are essential for the purposes of research but would not be appropriate for any wider publication. Some have asked whether we could have more transparency on the different fields of data. The truth is that the summary care data contains a patient’s name, postcode, blood group and date of birth—the basic data—down through their detailed diagnosis and treatment history. Different levels of sensitivity and confidentiality are inherent in that cascade before we even consider genomic data. A number of people have raised interesting issues on whether we should have different levels of consent and different stages of release for those different fields.

A number of people have asked whether we could have more transparency on the data being used, by whom and for what purpose. There are questions about the sanctions for inappropriate release and use of data. A number of people have pointed out that the current fines represent small change to big industry, and we need to ensure that we have appropriate sanctions that are an effective deterrent. What deters big industry will probably need to be different from what deters academics or a medical research charity of limited means from making a mistake.

There are interesting questions on appropriate parliamentary governance and oversight and on how we in Parliament, with a duty of care to our constituents, will be able to monitor the system. Even those who support my Bill and campaign have raised concerns that they want me to raise today. My hon. Friend the Member for Cambridge (Dr Huppert) has flagged reservations about the ability for people not to share their data if they wish. He particularly flagged the danger of patient-doctor confidentiality being breached and undermined by the release of data and the risk that patients would no longer want to talk to their doctor for fear that that confidentiality may be compromised. Other Members have raised questions about the scrutiny of the process, public awareness and the ability to unwind the process so that the Government can retrieve the situation if it is shown that data security cannot be assured. The Select Committee on Health has raised concerns, too.

Unless those issues are directly addressed, there is a huge danger that we will not win public trust and that we will lose the benefits of patient data altogether. To avoid that, we need to show how the revolution benefits us as patients and is designed in the interests of patients above all else. We need an opt-out system, but we have to earn public trust to allow it; we cannot just take that trust for granted.

We need to put the system within a framework of patient rights. Patients should have a framework and an architecture to access the data for themselves. We should encourage patients to take responsibility for their outcomes, their health and their data. If we do that, we will find much more public support for this important initiative. First, we should be clear about some of the basic facts relating to some of the debate in the past few months. For example, despite newspaper reports of the old story of data being released to an insurance company, which happened years ago, under the Government’s proposals it will be illegal to make data available for any type of marketing or the administration of any type of insurance.

We need to make it very clear that the experience of other European nations shows the importance of having an opt-out system. In Austria, which has an opt-out system, the consent rate is 99.98%. In Germany, which has a similar culture, economy and demographic situation to Austria’s but has an opt-in system, the consent rate is currently running at 12%. That has profound consequences for Germany’s public health planning and ability to unlock all the benefits that I described earlier.

To make the scheme worth while, the evidence shows that opting out is the only viable system. Low opt-in rates render the data patchy and partial, and they would hugely undermine the ability to spot the next Harold Shipman or Mid Staffs. Do we really want our constituents to be operating in a health system excluded from comprehensive outcome transparency? I do not want my constituents to be subject to that, but many of the objections listed above are valid. To address those problems, we need to set out clear measures to regain public trust in the power of patient data to save lives.

We must put the patient first and highlight the security of their data, because the data are theirs. The current mess is not sustainable, and we need a way to rebuild public confidence. How do we do that? I will conclude by saying that there is a clear way to address that question. I want to suggest five simple things that we could do to turn the current uncertainty into a genuine success, taking patients with us and addressing the concerns expressed. Some are contained in my Bill; others will require additional legislation.

First, we should establish a new charter of patient rights, as set out in my Bill, with the principles that the data are patients’ data and that there is a duty of care from NHS England, the Government and social care providers to patients. I well appreciate that it is difficult and something of a cul-de-sac to enshrine a legal definition of ownership in legislation, but a series of rights, responsibilities and obligations flow from the principle of it being patient data, and we should enshrine that in statute.

The charter of patient rights would enshrine what rights patients have and put the conversation on data back to where it should be. It should not be about which mandarin in Whitehall has access to patient data, but how patients can access their data and use them to discover and drive a new world of health care. My Bill sets out measures to make the data available, using the NHS number as a unique identifier, abolishing charges and letting patients access their data quickly.

Secondly, we need to enshrine a new duty of care on NHS and social care providers to collect data properly, using the NHS number to ensure that we foster a culture of open data and transparency across the health system. My Bill sets out why that should be a contractual obligation, created through a new clause in the contracts of GPs and clinicians. There should also be a new duty of responsibility on NHS and care institutions to ensure that they are properly collecting and recording data in a way that patients and GPs can access through an integrated pathway record.

Thirdly, we must put the data release advisory bodies on a proper statutory footing so that the public can have confidence that those bodies have proper oversight and governance arrangements. We must set out more clearly the different protections for different fields of data. There is a big difference between the use of summary care data and the use of genetic or detailed diagnosis data, and we need to acknowledge and consider different levels of consent.

Technology is changing what is possible. Sophisticated automated online consent systems are being developed—by great British software companies, as it happens. Those systems could help provide patients with that subtlety of consent framework. That concern is inherent in some of the concerns expressed in the past few weeks. Others have asked whether the Secretary of State should be required appropriately to sign off on different levels of data, but equally one does not want him to spend too much of his time signing off on individual data release. We need a framework that the public can have real trust in.

Fourthly, we need to think about having some sort of annual parliamentary reporting on the use of the data and a review of the outcomes and insights that the data are generating.

Finally, we need a tougher statutory framework, with real criminal sanctions for data breaches. That would reassure the public. Campaigners are right to suggest that fines are of little real deterrence to some. To give the public ultimate reassurance about the safety of their data, we must look again at the punishments that can be handed out for data breaches. There is simply no way we can ever win the argument on protecting the public’s data unless there are clear penalties.

The six-month delay in the roll-out of care.data is a valuable opportunity to address a number of widespread concerns. Ultimately, we must assure the public that their data will be used only to save lives and improve our collective health. Rather than focus on who has access to data, we should focus on how the data are used, and we can do that through a combination of those five new steps.

Most of all, I call for the Minister to take this opportunity to set up a proper formal working party of interested parties to address these issues, to show how fears can be addressed and to report back on a workable solution that could command the confidence of those concerned. We need to do that now. If we enact some of the described measures, and possibly others, and set up such a working group, we can use that six-month delay to get into a position where, when the care.data is relaunched in October, we have not just dealt with some of the concerns, but built a profound sense of public, patient and GP support for the process and the benefits that will flow from the use of these data. While there are always risks to any endeavour, the debate does not, as it has in the past few weeks, have to be characterised by a stale and overly polarised insistence on security on the one hand and data use on the other.

We have to explore the issues, break them down and tackle them. There is no security for the patient unable to live another 20 years because the data system is incomplete. In short, this is a make or break moment for the NHS and for public health in the UK. Will we embrace the new world of 21st-century health care, or do we want to let those advances be lost in the muddle of fear and reassurances that the public do not trust? We need to take robust action now to deal with the criticisms at hand. By doing so, we can make use of the truly world-leading reservoirs of data that the NHS has, for the benefit of us all.

While the economic argument is compelling, there is much more to the issue than projections about structural deficits and the cost of ageing. It is about one simple question: who wants to be better for longer? With the right safeguards in place, I know that there is only one real answer to that question, which is that we all want to be better for longer and we want to live in a society that is using every means at its disposal through the uniquely valuable institution of the NHS to make that moral, social, political and economic crusade a reality.

In conclusion, this debate and process can be a moment—not just here today at 2.26 pm, but this year—for our politics to demonstrate itself at its best. It can be a coming together of interests, with Parliament and politicians listening to the debate, taking the best arguments and working together in a non-partisan way to deliver a long-term benefit for the nation. The Francis report demonstrated the tragedies of the past and the dangers of an overly polarised debate. The future can be different. It is up to all of us in the House to try and make it so.

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Publications


George Freeman: New technology can save the NHS

21st September 2015 There is a truth in our society that we can no longer ignore. With a rapidly ageing population, the UK faces a new demographic reality. | ConservativeHome



George Freeman: How technology will transform care and debate about our NHS

18th January 2015 The technological revolutions which have transformed so much of our economy and society are about to transform healthcare. | ConservativeHome


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