Urgent review of SCR consent model recommended

The independent evaluation of the Summary Care Record has recommended an urgent review of its implied consent model and questioned whether a national system should be rejected in favour of a series of linked smaller systems.

The 138 page report on the SCR early adopter programme raises a series of issues to which it recommends that Connecting for Health pays urgent attention, including a review of the existing consent model.

In response Connecting for Health has promised that the SCR Advisory Group will urgently consider the report’s findings.

A statement from CfH adds: “The report provides a number of important learning points, particularly on the question of patient consent to use the Summary Care Record, and the need to retain a clear focus on the purpose and scope of the Summary Care Record as it is implemented.”

The evaluation team from University College London, led by Professor Trisha Greenhalgh questioned the continued use of the existing consent model which allows initial SCRs to be created on an implied consent basis after patients have been sent information about the SCR programme and their right to opt-out.

The report says its own investigation confirmed the findings of an early adopter practice which withdrew from the programme after conducting its own survey which concluded that patients remained ignorant of the basic issues despite receiving information. It said that in more than 100 interviews conducted with patients a high proportion did not recall having received information about the SCR or HealthSpace despite an extensive public information programme.

The report adds: “The fact that much of the individual resistance within GP practices has come not from IT-ignorant ‘laggards’ but from Caldicott Guardians who are generally the most information-literate members of staff and certainly the formal custodians of the practice’s data adds weight to the argument that the current consent model should be urgently reviewed.”

The evaluation team recommends that the SCR Programme Board and Advisory Group should look particularly at the ‘consent to view’ model which is used by both Scotland and Wales and means patients must give their explicit consent to view the record at each encounter.

The existing ‘hybrid’ consent model used by CfH means that after information on patients’ medication, allergies and adverse reactions has been uploaded on an informed consent basis, further information selected aspects of a patient’s medical history can be added in ‘phase 2’ with explicit consent.

The researchers reported: “There is a widespread desire from patients and staff for a simpler consent model.”

The BMA, which has consistently backed an explicit consent model for the SCR, welcomed the report. Dame Deidre Hine, chairman of the BMA’s working party on IT, said: “We support the recommendation to move to a ‘consent to view’ system which would meet much of the concern about informed consent expressed by doctors and gives patients appropriate control of their personal data. We hope that Connecting for Health will move quickly in responding to this guidance and we wish to continue to provide advice on how to achieve the necessary changes. However, we would strongly urge that until these changes are made there should be no further roll out of the scheme beyond the pilot sites already taking part.”

The evaluation team studied four of the six PCTs taking part in the early adopter programme, two of which had uploaded records to the Spine by the end of last month. It reported that by the end of April the SCR of 153,188 patients had been created and a total of 614,052 patients in four early adopter sites had been sent a letter informing them of the programme and their opportunity to opt-out. Of those 0.81% have actively opted out and 0.03% have asked for data on their SCR not to be shared.

The evaluation report raises a series of questions about several other key aspects of the SCR programme. It said there was some resentment among PCTs that CfH allegedly pushed forward on a tightly-managed and largely non-negotiable timetable for implementing the SCR despite the fact that not all software contractors had delivered key technologies to agreed schedule.

The report also states that although the technical security measures of the SCR appeared to meet high standards “there remain unresolved questions raised by experts about whether a series of linked smaller systems would be safer than a large single system and whether the plans for operational security will be fully enforceable in the busy environment of the NHS.”

The UCL team also criticised the SCR team within CfH for taking what it described as a narrow focus on implementing technology rather than a broader focus on socio-technical change. It recommended that the NPfIT National Programme Board

address this issue which it said posted a major risk to the success of NPfIT.

The report added: “A shift to a more socio-technical perspective would change the SCR programme considerably – for example, the SCR would no longer be seen as an end in itself (with ‘success’ measured in terms of number of records created and extent of use) but as a means to other ends (with ‘success’ being defined in terms of a range of locally relevant ends, for which the SCR would be provided as a resource).

Other recommendations include:

• Uncoupling HealthSpace from the SCR and instead focus initially on developing HealthSpace as a self-care resource in one or two chronic conditions. Uptake of HealthSpace was very low in the early adopter areas with only 0.12% of those invited to open an account completing the process.

• Tightening the definition of what the SCR should be used for to avoid the programme’s tendency to ‘scope creep’

• Shifting to a more flexible approach to change with a more negotiable framework of timescales and deliverables.

Commenting on the report Dr Gillian Braunold, clinical director of the SCR programme and HealthSpace, said: “"We set up the early adopter programme to ensure that problems, issues and practicalities of implementation were tested out in real life health care situations in a controlled and safe environment.

”The report offers the programme the foundations on which to base the necessary planning for improvement in design and implementation before national roll out. This will enable the ambition of enabling safer better care for patients in emergency and unscheduled care across England as quickly as possible.”