Guest Post: Paraskevas Vezyridis
Article: Dissenting from Care.data: An Analysis of Opt-out Forms
In our article, which is part of a wider project examining the technical, social and ethical challenges of big data in primary care, we simply wanted to explore how varied opt out forms can be when there is no standardised form available. We took as our case study opt out forms from care.data; the highly controversial (scrapped in July 2016) programme of work by NHS England and the Health and Social Care Information Centre (HSCIC) to extract and link (in one central database) healthcare information from GP practices and other NHS and social care services for all sorts of administrative and research purposes. This was an important research question for us since wordings, available options and even design layouts could influence the decision of patients whether to allow the sharing of their GP record for the care.data programme.
While it relies on the individual’s inertia (and often lack of awareness) an opt out is usually considered a more practical and valid approach to consent when compared to an opt in, particularly for low risk, population level studies where highly representative samples are required. For care.data, two types of opt outs were possible: data would either not be extracted from GP records and/or shared outside of the HSCIC in any identifiable form. However, there was no standardised opt out form released, like with the Summary Care Records (SCR). GPs had to come up with their own forms to register patients’ dissent. We searched websites of GP practices to retrieve around 100 unique forms. We did not examine the information provided on GP practices’ websites. While there are around 8,000 GP practices in England, we believe that our sample was big enough to study any evident variability and make a point about the need to standardise these forms so that everyone, from GPs to patients, is on the same page.
What was striking for us was that, while the majority of these forms provided patients with the 2 types of objection, there were some forms that provided only one option (opt out from care.data altogether). There was also variability in other information provided: who was responsible for this programme (HSCIC and NHS England), what was it about and it was important for the NHS and researchers, where patients could have found more information, how data was to be protected, who could had access to this data and whether the programme had any support, for example, by a healthcare professional association.
Interestingly, no more than a third of these forms mentioned other important information: care.data was not related to SCR, patients maintained their right to opt back in at any time, their relationship with their GP and the direct care they received was not to be affected and approved releases of identifiable information was possible. These, we believe, were very important information for patients even though they were not included in the final form. Moreover, the practice of including all NHS data sharing schemes in the same opt out form could have driven patients, who may only have been concerned about one data scheme, to opt out from every other scheme, affecting (unintentionally) their direct care in unpredictable ways.
As we were analysing these opt out forms, we could see how difficult it must have been for some patients to decide. Some forms appeared more sympathetic towards the programme while others emphasised more how sensitive and personal this data is. We believe that all the above point to a flawed design of the programme with regards to the opt out forms, especially when someone considers the size of the sensitive data this programme aspired to collect as well as its significance for NHS administrative and research purposes.
When hoping to create probably the biggest, most accurate and longitudinal database of complete patient journeys across a national health system of the size of England, it could never be good practice to leave to others, such GPs and patients, to figure out what these datasets might actually be used for and why they should not opt out. This was evident in this study when we noticed, for example, that the first form someone could download from Google to opt out can be found on the website of a civil liberties group campaigning for medical confidentiality.
Undoubtedly, there is a great challenge ahead for NHS England and NHS Digital. The National Data Guardian’s latest review of health and social data use and her recommendations on testing various consent and opt-out options is a great first step towards the standardisation of these forms. It will not be an easy task, but the public and professional discussions during this process may be future care.data’s only chance to produce something meaningful, understandable and, above all, respectful so that patients can autonomously exercise their informed decision.