What's all the fuss about?

Patient consent is currently seen as the most controversial topic in the development and implementation by the NHS of universal, shared electronic health records. At least, that is how the medical profession and their legal advisers seem to view the situation. However, as a patient representative on the Care Record Development Board, it seems to me that the finer points of the opt-in or opt-out argument may be lost on even the most well informed patients.

Differences for patients

From the patient perspective, relatively few factors will ultimately matter in the process of establishing the NHS care record service. Topping patients' list will be the benefits gained from the end result, the overall security of identifiable patient information, and the basic practicalities of how long it all takes. The question is how opting in and opting out will affect the patient in those key areas.

Under the opt-in position, once I have given my informed consent to opt in, I will have a shared care record. The care record guarantee sets out the duties and responsibilities of the NHS in relation to the integrity and security of that record, together with my rights and obligations as a patient. If I refuse to give my consent, my medical records will still exist in electronic format, but access to medical data that identifies me will be restricted to the health professional that created the specific record. Regardless of my current state of health, the level of sensitivity I may have to existing medical information about me, and the time constraints of my local general practice, I will need to visit my local surgery and follow the opt-in consent process.

Under the opt-out version I will have a shared care record unless I choose to opt out. The care record guarantee operates to define NHS duties and responsibilities and patient rights and obligations, exactly as in the opt-in situation. If I opt out, my medical records will still exist in electronic format but the sharing of that data will be restricted, as it would be if I did not opt in. I will not need to trouble myself or my general practitioner unless I have specific concerns about the content of my health records and the sharing of that information.

It is easy to spot that the end results of opting out and opting in look remarkably similar from the patient's perspective. The care record and its benefits are the same; the ultimate security and safeguards are the same. It is difficult to imagine why most patients would vote for or support the opt-in model. They are more likely to wonder what all the fuss is about and to choose the more practical opt-out process. What ailing patient is going to appreciate a longer delay in gaining a surgery appointment because their general practitioner is snowed under in obtaining the opt-in consent for the care records of otherwise healthy patients? What unfortunate visitor to accident and emergency will be pleased to know that their basic medical history is not available because their general practice has not started the opt-in consent consultation process?

Who needs opting in?

Clearly, some patients with a sensitive medical history will have legitimate concerns. These are the people who will want to consult with the relevant health professional, to consider opting out, and to be advised of the possible consequences of such a decision. Another special group is public figures and celebrities. The risk of unscrupulous media organisations attempting to access the records of interesting people will exist, regardless of the consent model and of the personal consent decision. Although it is a risk, it affects a relatively small group, and several layers of access controls, audit processes, and further safeguards on even the demographic data of public figures are envisaged to mitigate that risk.

Although these two groups of patients could benefit from the more conservative opt-in consent model, they represent a tiny minority of the patient population in England. Anecdotal evidence suggests the majority of patients are likely to prefer to have the NHS care record service established sooner rather than later and to leave the medical professionals free to spend time on those who have serious concerns about their medical information or their privacy.

Is opting in for doctors or patients?

So we could conclude that the current debate is not really patient centric after all. Although the genuine desire to act in the patient's best interest is undoubtedly part of this debate, perhaps the leaning towards the more conservative opt-in approach is fuelled by the difficulties that the medical profession has with the NHS care record. There is disquiet about the transformation it would bring. Some doctors have difficulty with the change in perceived ownership of medical records that results from creating a shared resource used by all concerned with the process of health care.

The concern that poor quality data uploaded to the NHS spine could compromise patient care or even jeopardise patient safety is valid but is not part of the consent debate. Whether consent is express (opt in) or implied (opt out), all patients are consenting to is the disclosure of their data. Opting in should not imply that the patient is validating the data in the shared health record or somehow becomes responsible for the quality of the data. The care record guarantee makes it clear that it is the duty of the NHS to “maintain full and accurate records of the care we provide to you.”¹

So does the advantage of opting in for a minority of patients with sensitive histories stack up against the disadvantage imposed on the majority if a flawed implementation process results in delays and frustration for patients and hard pressed practitioners? Certainly, an effective public information campaign is vital to fulfil the ethical and legal requirements for informed consent. But surely patients have a right to expect the NHS to positively harness technology, to reform the way it uses information, and hence to improve services and the quality of patient care? It would be unfortunate if an over-riding emphasis on the NHS's role as guardian of patient confidentiality resulted in an unworkable operating model for the implementation of the care record.