Urgent review of SCR consent model recommended

Tags: CfH emergency GP HealthSpace Information iS NPfIT Scotland Security Spine Summary Care Record Wales

06 May 2008

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.”

Readers Comments

fair processing

06 May 08 11:55

"Consent to view" the SCR at the time of a consultation between a doctor and a patient is all very well but it does not remove the absolute requirement for informed consent prior to uploading of GP records. It is undeniably good practice but not a replacement for lawful consent to upload.

In order to satisfy the fair processing requirements of the 1st principle of the Data Protection Act, GPs must be absolutely confident that the CfH publicity campaign had indeed reached all their patients, that all their patients had seen, read and understood the leaflets, had understood that doing nothing would lead to their records being uploaded and, if the GP has not heard from them, had decided not to seek an appointment with the GP to ask any questions, and not to opt out. And that's all their patients - including the homeless, the travellers, those who cannot read or write, the blind, those for whom English is not their first language, those with learning disabilities, those moving from practice to practice....

Evidently - and predictably - from this report, GPs - the data controller - cannot be confident of this whatsoever.

Worth reading report in full!

06 May 08 13:16

Professor Greenhalgh and her team have IMO delivered an authoritative, frank and insightful report which has wider scope and implications than the above article's focus on consent (and even the Summary Care Record) implies.

http://preview.tinyurl.com/3jf6hk

Their intelligent and at times witheringly humorous document deserves the widest possible audience within the DoH, NHS, CfH and supplier communities. For many key players this will be uncomfortable reading.

and the real "opt out" rate?

cunpr@globalnet.co.uk

06 May 08 15:50

Your article takes CfH's oft quoted opt out rate of 0.8 or so %. This review highlights the fact that it is much much more. The 0.8% is the numbers who opt out as compared to the number of addresses printed on the letters in the mailing. It does not compare with numbers of patients who; received the letter, read it, understood it and then opted out. The report shows that 1 in 7 people attending places of urgent care delivery recollected receiving a letter about the SCR. So the real opt out rate may be as high as 7 times that quoted by CfH. This is an important observation thats easy to overlook.

a joy to read

06 May 08 19:14

Post 2 of this trail is absolutely right this report is one of the best and most informative i have ever read. Here are some quotes from it:

"our interpretation was that these people unconsciously sought to blame a host of problems on what they characterised, disparagingly, as the ‘other side’ – the government, CFH, the press, “the privacy fascists”, “single issue campaigners”, and so on. This mutual demonisation, to which some sectors of the press have contributed with a lamentable lack of criticality, has to a large extent overshadowed sensible debate."

"Polarised claims on both sides tend to be simplistic, entrenched, moralistic, and generate more heat than light"

Any chance we could have a debate in these postings that DIDN'T fall into this trap?

Still not getting it

stewart.smith@cd-tr.wales.nhs.uk

09 May 08 08:53

I despair sometimes. We have had DP law for 20 years and still can't get it right. I commend the Information Commissioner's "Privacy Impact Assessment" as a starting point

At last....

david.royal@nhs.net

12 May 08 09:15

Could not agree more with the comments of the report. I am a GP and also a techy who believes strongly in the role of IT and information sharing. I however have enormous concerns about the model of consent proposed and the safety of data under the current model. Whenever I raise questions or queries about this at PCT level I am dubbed a luddite, awkward and self-serving GP. When I speak to GPs about IT and the benefits of a shared record I am accussed of being unpractable and of endangering patients confidentiality. Perhaps a sensible debate will now take place.

Processing fairly

13 May 08 15:17

'In order to satisfy the fair processing requirements of the 1st principle of the Data Protection Act, GPs must be absolutely confident that the CfH publicity campaign had indeed reached all their patients, that all their patients had seen, read and understood the leaflets.... etc'

This is a rather Jesuitical interpretation of the DPA. If you look at the Act, particularly schedules 2 and 3, it is quite possible to defend the approach agreed by the Ministerial Taskforce and adopted by CfH. As with most laws, there is an element of interpretation, but I'm sure that if this were not the case, The Big Opt Out would have had their day in court by now.

Excellent Report

bob.curtis@glos.nhs.uk

13 May 08 15:55

I too thought this was an excellent and thoughtful report.

I am, I suppose, one of the Luddites in that I have written to my GP asking for my data not to be uploaded into the SCR. I support the "Big Opt-Out Campaign" in this regard. I agree with almost everything the report says about the benefits of an SCR and but I believe that the disbenefits of a big national database outweigh those benefits. I would be happy for my GP to share relevant clinical details with other NHS staff who are caring for me but I don't see why it has to be on a central database. After all, I had a working (well, almost) system demonstrated to me in my office by the NHSIA some years ago which linked a hospital to a patients summary record in a GP surgery. We could be there already with something workable that was based on patient consent, GP support and need to know.

Hey ho, only six weeks to go until my retirement!

Stand not upon the order of your going...

13 May 08 17:33

Bob, if it makes you feel any better, I remember talking to a GP 10 years ago (who himself was then on the verge of retirement) and he explained to me like this:

There's a bunch of people (both GPs and Patients) who regard a conversation a GP and a patient as being sacrosanct, like confession to a priest.

And then there's another bunch (both GPs and patients) who think the conversation is between a patient and the NHS, and who expect to pass on information when it makes sence to do so.

Not only are these groups never going to agree, they are never even going to be able to see that the other side has a point.

Sounds like you've managed to get it in the neck from both sides. Enjoy your retirement, I dare say its well earned

Fair processing

13 May 08 18:09

actually that advice is from the Medical Defence Union.

Whom GPs tend to listen to.

Medical defence

14 May 08 09:52

And presumably the MDU wouldn't be likely to take a particularly conservative view of this? One would have thought that if the people charged with applying the law (in this case ICO) agree to an approach, then this should be acceptable within the context that it was agreed. Unless people have other reasons for not wanting to do something of course...

Prof Greenhalgh's summary care independent full report

17 Jun 08 10:39

could someone correct the tinyurl link poster2put above as not valid not sure that www.ucl.ac.uk/openlearning/documents/scrie2008.pdf