Doctors to vote on national patient record system consent

Concerns about consent are at the centre of a series of motions to be debated by doctors from across the UK next week, particularly the NPfIT’s plans to load all patient records in England onto NHS Care Record Service (NCRS) – the national system of patient records.  While many of the motions are broadly supportive of NPfIT plans, others reflect serious concerns about the practical and legal considerations involved, and the model of implied consent adopted.

Motions tabled by local LMCs include calls for “adequate patient consent procedures for data transfer and sharing”.  Another reads: “That conference has grave concerns regarding the confidentiality of centrally held electronic patient records and requires considerable reassurance from the government that access will be restricted to responsible clinicians on a need to know basis."

The national programme has elected for an implied model of patient consent, requiring patients to actively opt out of having their records visible on the national record system.  Even when patients have opted out of having their record visible on the National Care Record System (NCRS) the record will still be held on the system should they subsequently change their minds.

Responding to questions from E-Health Insider on the approach to consent adopted, the NPfIT said in a statement: “The national programme has taken advice from the Patient Advisory Board (PAB) and the National Clinical Advisory Board and has decided on an opt-out with a warning period approach."

In essence, members of the public will be assumed to have given their consent unless they specifically request that their medical records not be shared or made available across the spine.  This implied consent will be assumed to have been given if they have not responded by the end of an (as yet unspecified) public information campaign.

The NPfIT declined to give any details of when the public information campaign will begin or how long it will last, though such an exercise was first described as imminent in October 2003 at the launch of the PAB.

According to NPfIT, “There will be public information initiatives – local and national, in various formats, using various media throughout the implementation period."

Asked by EHI whether an English citizen could choose not only to not have their information shared but not held on NCRS at all, NPfIT stated: “No. A patient can opt out of their medical record being shared, so that it cannot be accessed. However, the data will be retained should they choose to opt back in."

Asked when the public information campaign will begin the NPfIT said: "Patients will be informed about the content and scope of the NHS Care Record and given a period of choice, prior to any data being accessible through the NHS Care Records Service.

“When NHS staff are uncertain that an individual has been effectively informed about the NHS Care Record and the choices available, they will be encouraged to check to make sure that this is the case. Those who do not want their records included will be able to opt out at any time after the choice period end, or indeed to opt back in again."

Asked whether the current architecture for NCRS had the flexibility for citizens to opt out entirely, if this proved necessary to obtain the backing of the medical profession, the national programme said: "The National Programme has adopted the consent model by means of ‘opt-out’ with a warning period following advice from the National Clinical Advisory Board and Patient Advisory Board. Naturally, the national programme will be keen to hear the views of the BMA’s local medical committees on the consent model we have adopted.

However, the basis of the recommendation on consent provided by the PAB is open to interpretation.  Dr Paul Cundy, chairman of the joint BMA and Royal College of GPs IT Committee, told E-Health Insider that the PAB’s guidance had been based on three main considerations: money; ethics; and patient choice.

The main piece of research on which the PAB is understood to have recommended an ‘opt-out’, implied consent model was the NHS Information Authority and Consumer Association’s 2002 research into patient consent, based on interviews with 2087 patients.

“96% said that they wanted some form of consent whether ‘one time’ or ‘consent by event’," said Dr Cundy.

The 2002 research found that while people were generally happy to share health information, they had serious reservations about sensitive details in their records and access to records for non-clinical staff.  It concluded that the NHS must publish a charter outlining how it will share health information, and stressed that service users must be given a chance to isolate and control access to the most sensitive details.