The future of care.data hangs in the balance. In the last week, rival proposals from government and by critics, have offered parliament radically different diagnoses – and cures – for the malaise now afflicting the scheme. In the end, though, the question remains: is this all too little, too late? Can care.data recover from here?
First up was a government narrative that differed little from what we have been hearing over the last few months. According to Dr Daniel Poulter, MP, Parliamentary Under Secretary of State at the Department of Health, the issue was mostly one of public re-assurance. Government had already put in place far greater safeguards over patient data than had existed previously. He blamed poor communication.
However, as part of the process of re-establishing public confidence he was putting forward three amendments to the Care Bill: re-stating the duty to respect and promote the privacy of patients; locking the HSCIC into disseminating information only where this would be for “the provision of health care or adult social care”; and requiring the HSCIC to “have regard to any advice given to it by the committee appointed by the Health Research Authority under paragraph 8(1) of Schedule 7 to the Care Act 2014”. This is the Confidentiality Advisory Group.
Would this be enough to silence the doubters? Probably not.
According to medConfidential, who have now joined forces with Professor Allison Pollock and former neuroscientist Lord David Owen to put forward an amendment of their own, the first safeguard - on privacy - already exists under Article 8 of the Human Rights Act. The second would exclude legitimate research uses, while still allowing data to be released for commercial purposes. Worse, it would place on a statutory basis the very abuses it claims to address.
Finally, the introduction of the Confidentiality Advisory Group into the mix provides little re-assurance unless accompanied by independent oversight and full transparency on every release of individual-level patient data.
medConfidential’s scepticism is unsurprising, given the disdain in which senior NHS England and HSCIC staff appear to hold the views of advisory groups. Earlier this year HSCIC rejected an Independent Advisory Group view that provision of data to insurance companies was lawful – while refusing to explain the legal basis for their own views.
NHS England’s chief data officer Geraint Lewis got himself in hot water for tweeting to the effect that an information governance assessment written by the IAG had “no official status”.
An alternative amendment has been put forward designed to make parliamentary oversight of the HSCIC explicit. The amendment (NC35), proposed by Barbara Keeley, MP, would tie any future decisions on use of data to the “super-affirmative resolution procedure”.
This would require the Secretary of State to lay before parliament any new proposals for data use, some 60 days before they took effect. During this period, parliament might question and, potentially, reject proposals.
Speaking in favour, Barbara Keeley said: “there is a need to ensure that Parliament retains oversight of the HSCIC. The amendment would ensure that the main powers and duties […] that relate to the functions of the HSCIC are all made subject to the super-affirmative resolution. That would be needed until we felt more comfortable and our concerns had been allayed.”
She added: “it is vital that the relationship of trust between a patient and a doctor is not lost. To ensure that that does not happen, patients must feel that their personal information that they disclose to a doctor will remain confidential. I do not think that people have that confidence at the moment, and much needs to happen to make sure that they will”.
Ms Keeley has a point. Many of the most trenchant critics of care.data - including Ben Goldacre and Professor Pollock - support its broad aims. They are not so much opposed to the project, as horrified by the inept way in which it has been implemented.
All the same, can trust really be regained by piling yet more regulatory fine print on the detail that already exists? As Mr Poulter put it, dismissing Ms Keeley’s amendment: “she has not read the 2012 Act properly, because I have just outlined the section 245 powers that the Secretary of State has. That is parliamentary oversight in anyone’s terms”.
He probably meant section 254 (section 245 actually refers to powers in respect of NICE). But this is a not entirely unreasonable point. While the Health and Social Care Act 2012 placed NHS England – and care.data – at arm’s length from parliamentary control, the Secretary of State remained there as backstop.
The larger question remained: how far back – and what level of rule-bending was he prepared to put a stop to. Transparency, as MedConfidential’s amendment makes explicit, would help.
In the end the issue is public trust. The problem for the current administration is that the public, having grown used to tales of data abuse. We no longer trust Ministers to interpret safeguards – such as patient data only to be used to benefit patients – in the way that we would interpret this.
Against such a climate, it is not just the fine print that matters, but the language of public pronouncements and the perceptions created.
It therefore matters that Dr Poulter has twice in two weeks got the Law wrong, while rudely dismissing critics for their ignorance.
It matters, too, that on a range of issues, from use of free text information to information about conditions such HIV/AIDS, sexually transmitted infections, termination of pregnancy, and domestic abuse, the best that he could come up with was: “clear safeguards and reassurances have been established on those issues, and I hope that reassures my hon. Friend further”.
It is currently unclear whether parliamentary protocol will allow the amendment to be debated and voted on when the Bill returns to the Lords for consideration of amendments passed in the Commons.
However Lord David Owen tabled the amendment at the end of last week in the Lords and it is possible that in that place, where party whips hold rather less sway, it may yet prevail.