In April, a handful of primary care trusts (PCTs) in England will start the process of uploading the first electronic patient records onto the national NHS database, or "Spine".
This pilot, involving summary care records – initially containing information only about medications, allergies and adverse reactions – is the first stage of the government's ambitious project to deliver the NHS Care Records Service.
It follows extensive debate about the ethics, security and confidentiality of sharing sensitive health information electronically. The controversy, particularly over issues of patient consent, reached a crescendo in the national media in December 2006.
According to a campaign group, called TheBigOptOut, thousands of patients have been downloading a template letter from their website to send to their GPs, requesting that their notes are not uploaded to the NHS Spine.
The campaign was set up to protect patient confidentiality and to provide a focus for patient-led opposition to the Care Records Service. TheBigOptOut website (see Resources) highlights the concerns of patients such as practice manager Helen Wilkinson, one of the directors of the campaign, who spent two years getting her medical records removed from NHS databases after she discovered she had been mistakenly labelled as an alcoholic.
Nevertheless, in December 2006 the government announced that the summary care record pilot would go ahead, guided by the recommendations of a ministerial taskforce it had set up to look at the issues involved. The taskforce's report concluded that a summary care record would significantly improve the safety and efficiency of patient care.(1)
The group acknowledged that there were merits and concerns attached to both the explicit consent (opt in), strongly recommended by the British Medical Association (BMA), and implied consent (opt out) models.
A question of consent
The Department of Health (DH) has agreed that the process for creating summary care records will begin with a public information programme, explaining to patients that they will have a defined period of time to review their proposed summary record. They will be able to view their records on HealthSpace (the online health area for patients, see Resources) or obtain a printed copy from their GP. Patients will then be invited to correct or amend their record and either offer consent for their record to be shared or to opt out if they wish.
After a realistic period (yet to be defined), it will be assumed that those patients who have chosen not to view their summary care record will have given implied consent for it to be shared.
The taskforce noted that there may be people who do not want their summary care record to be shared or uploaded. Ways of resolving this situation will be considered by a new advisory group, which has been set up to oversee the future development of the summary care record.
The BMA, which is represented on this advisory group, says that NHS Connecting for Health (CfH) has defined an "opt out" as sharing. This means if a patient asks to opt out, their summary record will be uploaded onto the Spine, but it will not be visible. Patients can then request that a blank summary replaces the original upload. However, the initial upload will still be traceable in the audit trail. The BMA's view is that if a patient asks to opt out, no information should be uploaded.
Dr Paul Thornton, a Warwickshire GP and one of the coordinator's of TheBigOptOut campaign, argues that patients who request to opt out could, ironically, jeopardise their privacy: "It is very difficult for people who have sensitive information in their records to defend their entitlement to privacy without the paradoxical effect of drawing attention to themselves or having their information disseminated more widely," he says. "It is essential that the profession takes all necessary action, on behalf of our vulnerable patients, to defend the records from the powerful vested interests who are seeking access."
Health minister Lord Warner has pointed out that a veto was offered to people in Scotland before the NHS began uploading a similar "emergency care record", but only 250 out of six million patients asked for their details to be withheld.
BMA chairman, Mr James Johnson, says the report is a "good first step", but warns: "It is crucial to the success of the NHS Care Records Service that the anxieties of both patients and professionals are properly dealt with and that the wishes of patients are fully respected."
Scrutiny and the doubting
The government's plans to establish an electronic health records database were further endorsed by the Information Commissioner (the public information watchdog) in January this year. The Commissioner scrutinised the plans after receiving a number of enquiries from people who had seen articles in the media. He says he can see the potential benefits of electronic care records, but will be keeping a close eye on the accuracy of the information to be uploaded, the way people are informed about the changes and the systems that will be put in place to allow people to access their own information.(2)
Dr Gillian Braunold, CfH GP clinical lead, says that with consensus reached on some of these controversies, the way is now clear for the launch of the pilots. "This is a much more comfortable place to be in now. People who have been standing in front of the lorry are now falling over, but we still have a lot of work to do to ensure that we don't have too much blood on the road," she says.
She is confident that the experiences of the early adopter practices will highlight the practical issues involved in uploading patient data onto the spine, and will influence how everybody moves forward. Feedback will be obtained and listened to from everybody involved – patients, doctors, nurses and practice managers.
As the implementation of summary care records moves a step closer, Dr Braunold says practice managers should be starting to think of moving away from the idea that practices keep records only for their own business needs, and towards the concept that healthcare records belong to patients.
"Practice managers should be talking to patients, discussing how they feel about sharing records and showing them copies of their summary record and asking if they are accurate – they can print them out in the practice and give them to patients to take home.
"They must be ensuring that their data quality is good – up to now they may have been thinking about data quality for the QOF (Quality and Outcomes Framework) but not for other things. They should be looking hard at the Information Management and Technology (IM&T) directed enhanced service (DES), which provides the resources they will need."
The Royal College of GPs (RCGP) is drawing up guidelines on the standards required for the new summary records. A letter is going out soon from CfH to GPs, explaining patient consent issues and how to support those who want to opt out of sharing their records.
A new, open healthcare environment
Practice managers will also need to ensure that all staff in the practice have been properly trained to understand the controls built in to safeguard patients' records, and ensure they have all signed confidentiality agreements.
"It's not going to be as big a deal as the QOF, but it will involve a different culture of including patients in looking at their records and sharing information," says Dr Braunold. "People have not thought of patient involvement in this way before, and healthcare professionals are going to have to be much more open about what is in the records they make, knowing they are going to be shared.
"Practice managers will also need to be aware of improving security and be a lot smarter about electronic records, as they are now going to have a life beyond the surgery," she advises.
Practice workload implications
Dr Braunold predicts that the biggest challenge of the next decade for healthcare professionals and practice managers will be information governance. She explains that in the same way that clinical governance appeared to be a complex concept when it was first introduced, many people may now be nervous about information governance. "It's all about looking after the quality of information we have and sharing it – that is the challenge ahead for all of us."
Dr Thornton of TheBigOptOut believes the introduction of electronic records is potentially hazardous when it comes to the practice workload. He says: "The burden of seeking consent to broadcast information at every consultation is potentially onerous. The proposals were not thought through. If it was simply a matter of sharing relevant and necessary information with a limited number of identifiable people who are likely to need it, then shared records become viable."
However, Professor Mayur Lakhani, RCGP chairman and a member of the ministerial taskforce, says the latter's report was a pragmatic way forward and the consensus now is that everyone should be focusing on the benefits of the electronic record for patients. In his experience, most patients are in favour of sharing their records electronically.
The College will be keeping a close eye on concerns over patient consent, the quality and accuracy of data, and internet security.
"The key issue now is: how do we support patients and GPs?" says Professor Lakhani. He explains: "We need to look at how we can shape and influence the project, rather than taking extreme positions. It is a complex issue and not in any way straightforward. Even if a GP does not believe in sharing records, the rights and needs of patients are really important, and it's a tradition in general practice that we work with our patients. It would be paternalistic for a GP to say, 'I won't do this for you.'"
Dr Brian Fisher, a GP at the Wells Park Practice in Lewisham, London, has no doubt that the concept of giving patients access to their records is here to stay. He has been sharing records with patients for 20 years.
Dr Fisher is currently working with clinical software supplier EMIS on a programme that enables patients to see their records, either through a kiosk in the waiting room or online at home. Research has shown that, given the opportunity, 75% of patients will look at their records.(3)
"People have been almost universally excited about it – it is convenient, helps them better to understand what is going on and enables them to take part in shared decision making," he says.
Numerous studies conducted at Dr Fisher's surgery and other practices show that sharing records improves patient compliance with treatment, with patients suffering from long-term conditions accessing and benefiting from their records the most.(4,5)
"Our system is different because we are not organising it through the Spine, but I believe that most of the hue and cry about the Spine is ill-informed and unhelpful. Confidentiality is the least of the issues that patients we have spoken to are worried about. Our studies show that most people are more concerned about the accuracy of their records."(6)
Dr Fisher has been running a pilot, in conjunction with EMIS, for six months that allows patients full access to their records, which is currently being rolled out to another 100 practices. If successful, it will be extended to all practices
using EMIS software.(*)
Chris Cunliffe, practice manger at the Park Road Surgery, St Helens, says the scale of the entire national Care Records Service project appears to her to be "massive".
"I think if I saw the electronic patient record coming at me in one go I would resign. It isn't our main concern at the moment, although I can see it is sneaking up on us gradually through the policies and procedures we are having to put in place to comply with the IM&T DES," she says.
Her IM&T manager, Phil Matthews, says they are currently working hard to get everything in place. "Over the next year we will be working to improve the quality of the information on our system, conducting a training needs analysis of every member of staff and working through the various checklists of things we need to supply to the PCT. Even if the Spine did not go ahead, this would still be a very good exercise for the practice to do," he observes.
Mrs Cunliffe says the feeling among practice managers is that there has been a lot of talk and now the bigger picture about electronic records is beginning to emerge. She says: "Practice managers do have one thing in common – we may all complain about this for the first 10 minutes, but then we will just knuckle down and get on with it."
NHS Connecting for Health
NHS Care Records Service
*Any practices interested in becoming involved in this pilot can email Dr Fisher: firstname.lastname@example.org