The care.data problem: what happens when you damage your patients’ trust?

There is no doubt that the majority of people are confused about the NHS’s “care.data” project. One only has to look to poll results on www.YouGov.co.uk to see that a staggering 67% of the public who voted did not receive the ‘Better information means better care’ pamphlet the NHS supposedly distributed last year. The title of the pamphlet is disinformative to say the least, and ironically so: better information does indeed mean better care, but the NHS certainly did not live up to “better information” when they failed to inform the public correctly.

We can see now that the government has breached the basic principle of informed consent, as set out by the Declaration of Helsinki, a research ethics document every clinician should be familiar with. The Declaration states clearly that the duty of a clinician is to protect the “life, health, privacy and dignity of the human subject” and that all subjects in any research program, therapeutic and nontherapeutic, must be volunteers. Consent is absolutely essential in therapeutic and nontherapeutic research. Information regarding the Declaration of Helsinki is laid out in The Oxford Textbook of Clinical Research Ethics (2008: 141-148) by Prof. Richard Ashcroft, who is an Advisor to the Tuke Institute on medical ethics. It appears that the care.data project, managed by the Department of Health, has ignored the Declaration of Helsinki’s basic principles of ethics. This is despite the fact that those basic principles of ethics and transparency were actually built into the framework and emphasised every step of the way, by the designer of the framework for protecting patients’ benefit in the project, the Tuke Institute’s very own Chairman, Dr. Rupert Whitaker.

Clearly, there is a massive communication loss between patients and the NHS on this project. Whilst having an enormous medical database presents promising research opportunities, it poses the risk of patients’ data being left for the likes of insurance companies to get their hands on. Patients’ privacy is protected only by pseudonyms, which does not guarantee that data can’t be traced back to individuals; predictive analytics makes it very easy to do this and anyone can buy the statistical software for it. Names, addresses and national insurance numbers are omitted from the database, but family history, vaccinations, diagnoses, mental health data, lab results are not. This data could be retrieved by those with malicious or commercial intent – who knows, but we do know that the NHS and Health and Social Care Information Centre (HSCIC) have acted too rashly.

On Monday 24th February, the HSCIC admitted giving the insurance industry the coded hospital records of millions of patients. This sparked calls for a substantial publicity campaign, to include national TV and radio. The question is, will this include patients themselves? Patients absolutely deserve the right to know about this, and all of us need to have the benefits, drawbacks and details communicated to us. Nothing and nobody should be left out. People deserve to know how the project works. The NHS and HSCIC acted without full consent — that’s what it comes down to; they used people’s data without the majority of the public knowing — I certainly did not know, and more importantly, I didn’t know I could opt out. I feel let down, and I’m sure I’m not alone in that. The trust of patients has been lost, and I am one of them.

Thankfully, the project has been put on hold for six months. This is down to the British Medical Association and the Information Commissioner’s Office, who accused health service officials of failing to properly communicate the public’s right to opt out of the £50m scheme. While data has already been sold, it’s not too late to regain the public’s trust and inform them of exactly what is going on. It’s true; the benefits are wide-ranging, but they too need to be carefully explained to the public, and then each individual person should enact their right to opt-out or opt-in. Communication is vital, and so is transparency when it concerns the patient’s protection. But this communication and transparency should be between patient and NHS, not a profit-making company.

Health-services should empower patients and hear our voices. We seem to have no control in this, apart from the poorly-communicated declaration that we can opt-out of the project. Where’s the patient control in this? We are not active participants in this project, as active participants of any given project are treated equally and communicated with as one of the team. I’ve visited my physician several times already this year, without once being told about care.data. Just how hard is it to hand over a leaflet? Or print on every prescription a notice about our right to opt-out? The NHS acted so quickly to sell our data, but not to tell us about it. Why? The public should not have been left in the dark about this, and there is no valid or technical reason why we have been. The Tuke Institute is already working on the issues that arise from the lack of patient participation, and there are already models for systemic participation in health-service delivery and governance. The solutions exist, the Department of Health just needs to listen and change its ways.

However, it’s great to see how many people are standing up for the rights of patients on this issue – it is absolutely fundamental that the patient voice and patients’ benefit come first and foremost. This is why the next six months should focus on informing the public as much as possible. It’s a pity that it is now supposedly going to happen after our data was sold. Ultimately, the answer to the question of what happens when you damage your patients’ trust is clear: you must work hard to regain it and show that you honestly do “care” about our data.

References:

Ashcroft R (2008) The Declaration of Helsinki pp. 141-148 in Emanuel E, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D: The Oxford Textbook of Clinical Research Ethics. Oxford University Press.

Whitaker R (2010) “A framework for public participation in a national system of medical research: Using public participation to protect the public’s interest”. Presentation on “The use of patient data: Exploring public participation in research” on behalf of the National Institute of Health Research’s Research Capability Programme, Department of Health, UK, at the PatientPartner NorthWestern European Regional Workshop, 12.11.09, Central Hall, Westminster, UK

Whitaker (2010) “Participative Medical Governance in the Delivery of Health-Effective Medical Services” http://www.tukeinstitute.org/publications/consultation-documents/1004-cd1

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