NHS Connecting for Health, the agency that manages the National Health Service’s information technology programme, has launched a 12-week public consultation on secondary uses of patient data.
These include research purposes as well as managing and planning care in the NHS. The public consultation will be complemented by a series of workshops across England addressing the issues raised.
Sharing patient information can help to improve the well-being of the population through medical research, disease surveillance, screening, needs assessment and preventative activities, Connecting for Health said. Although the NHS has always used patient information for planning and research, the advent of new technology through the NHS Care Records Service offers fresh opportunities for the electronic collection of clinical and patient data.
The consultation, which is being run by Tribal Consulting on behalf of NHS Connecting for Health, explains the perceived benefits of secondary data use as well as the “legal safeguards and practical steps available to meet ethical and confidentiality obligations”. Among the questions put to the general public and healthcare professionals are:
– Who should have access to patient data?
– For what additional or secondary uses should patient data be used other than for direct care?
– What process should govern access when individual patients can or cannot be identified?
– Who should control and manage access to the information?
– What consent options and safeguards should there be for patients?
– What concerns do people have about secondary uses and how can they best be addressed?
Professor Sir Alex Markham, Professor of Medicine at the University of Leeds and chair of the Research Capability Programme, which is taking forward the recommendations of a report on research simulations issued by the UK Clinical Research Collaboration’s (UKCRC) Research and Development Advisory Group to NHS Connecting for Health in June 2007, said it was “vitally important that patients and the public understand how their health information might be useful and feel confident that their confidentiality will be protected”.
“Our conversations with patients suggest that the vast majority of them are willing to participate in medical research,” he added. “It is essential that those who do not wish to do so have their wishes fully respected.”
Properly managed use of electronic patient data under the national IT programme for the NHS would have “enormous” benefits for all types of clinical, public health and health services research, as well as for many aspects of patient care, the UKCRC concluded in last year’s report.
But it also highlighted a number of key data, regulatory and governance issues that needed to be tackled before this potential could be released. There was also a public relations battle to be won, the UKCRN noted, calling for “formal recognition that research is a core, not secondary, component of the development of the NHS Care Records” and a communications strategy to convince stakeholders of the dual benefits of using electronic patient records (EPR) for both research and clinical care.
Can the SUS deliver?
The pharmaceutical industry has set great store by the National Programme for IT, seeing potential access to some 52 million EPRs as a unique selling proposition that could help to restore the UK as a hub of clinical research and check the drift of clinical trials to lower-cost markets such as India or China.
However, industry has been sceptical about the ability of the programme’s Secondary Uses Service (SUS) to deliver on these goals. The SUS was established by Connecting for Health to provide pseudonymised, patient-based data and information through the NHS Care Records Service (CRS) for management and clinical purposes other than direct patient care.
Industry’s concerns were borne out by the findings of the research simulation (one of four in total) conducted by the UKCRC to explore the capability of the NHS CRS infrastructure to support clinical trials.
The simulation team, which included representatives of GlaxoSmithKline, Johnson & Johnson and the Medicines and Healthcare products Regulatory Agency, said it did not “expect a solution solely based on SUS to be the best way forward, but that hybrid approaches should be explored and pursued”.
