Putting patients in control of data from electronic health records

Research using data from electronic health records offers great potential in healthcare, but patients must be informed about how their data are to be used and for what purpose

Many areas of healthcare use electronic health records to document and store clinical data for direct patient care, however there is a growing interest in how consented patient data can be used for clinical research and improving patient outcomes.

Several approaches can be used to get consent for identifiable data being shared for purposes other than patient care. Organisations have tended to favour an opt-out model, believing that an opt-in approach based on active consent would be unfeasible or lead to a low participation rate. In both models, if not enough patients opt-in or too many patients opt-out, it could be argued that the data are no longer useful or generalisable.

Patients must be informed of the intended uses and benefits of sharing their data for research to raise public confidence in data sharing and to avoid patients opting out. Here, we describe our experience of an opt-in approach for sharing electronic health record data and national and global approaches to consent for sharing health data in research.

Using electronic health records

Electronic health records can provide comprehensive data on medical history, prescriptions, and service use for large populations. They have an advantage over research databases in that there is no interviewer or patient recall bias. Linking electronic primary care data to secondary care service records also allows researchers to assess disease progression and use of healthcare resources.

In England, primary care has used computerised record keeping since 2000 and general practices use one of several, nationally available electronic record systems. However, they are not generally used for research and there is no standardisation between systems.

Across the UK, national datasets such as the Clinical Practice Research Datalink use primary care records for clinical research, but these are not linked to other electronic health records and are not suitable for use to monitor a clinical study because they are not updated in real time.

Inconsistencies between different sources of electronic health record data can make sharing difficult. In the UK, primary and secondary care providers use different coding schemes and terminology for classifying diseases and these must be cross mapped, although coding for long term conditions has become more robust since the introduction of the Quality and Outcomes Framework in 2004. In addition, certain data important for clinical research, such as disease severity, are not well coded in electronic health records.

In Europe, Sweden and the Netherlands are leading the way. Sweden has a national health record that can be accessed by healthcare providers across the country as well as by patients and their nominated family or carers. Consent for data sharing is on an opt-out basis, and patients can request information from their provider on how their details are used.

Salford integrated record

Ten years ago, Salford, a borough of Greater Manchester, UK, relied on many disease specific registers to identify and manage patients across the district, resulting in much duplication of effort for those with comorbidity. In 2007, the Salford Integrated Record (SIR) was established with real time electronic links between primary and secondary care. The SIR linked these sources with patients’ prescription information, capturing data on everyone accessing health services in Salford.

Key to the success of the project was informing patients about how their data would be used—that is, predominantly to allow local clinicians access to their information for better healthcare. All patients were sent an information letter and asked if they wanted to opt out. Fewer than 500 of 230 000 patients chose to opt out (<0.2%). SIR then became an integral part of primary and secondary care.

In 2008, the NorthWestEHealth (NWEH) group was established to use SIR data for research. The group brought together computer scientists, clinicians, researchers, statisticians, epidemiologists, and project managers to develop methods and a governance framework to extract patient healthcare data for use in real world research studies. The Salford lung studies (SLS) are one example of the integrated record being used for research.

Acceptability

Experience from the SIR project suggests that the opt-out approach is acceptable across Salford for facilitating clinical care. The transparent opt-in approach used in the lung studies informs patients about the purpose for which their data are to be used and who will have access to their data. Trial participants did not object to their information being held by a trusted third party for research purposes and supported anonymised data extracts being sent to the study sponsor.

This suggests that patients throughout the UK might be willing to provide informed consent to data sharing and give consent for specific use of their medical information if the government restricts access to health related organisations.

The Salford experience also provides evidence that local data for local use is acceptable to patients and health providers. This approach is consistent with the recently revised Caldicott principles and may be more acceptable to patients than NHS Digital holding all data centrally. Patients’ views were considered when designing SLS, and many expressed their pleasure at being able to take part in clinical research.

In the Greater Manchester area, as part of the devolution of the health and social care budget to the city, the devolved Health and Social Care Partnership is already developing and rolling out DataWell, a platform that will be used to enable health data to be shared between healthcare providers. This could enable the SIR/SLS technologies to be extended to the entire local Greater Manchester population (2.9 million).

The main barriers to the opt-in approach were the time and staff required to explain the terms of data usage to patients. Although it took time to help patients understand how their data would be used, in general they were reassured by these explanations. The most common questions asked by patients were who would be able to see their data and if they would be used for their clinical care; in this case, the data were only used for the study.

Rationalising an opt-in approach

An opt-in approach to data sharing aims to provide an ethical resource to support clinical research that ultimately benefits patients, clinicians, and payers.

Patient consent for data sharing allows the linkage of datasets, which is more difficult to achieve with anonymised data. Under an opt-in approach patients should be informed before their data are accessed. The system should also allow for varying levels of data sharing with different stakeholders (eg, for clinical care, for research, for clinical commissioning, or with pharmaceutical or healthcare providers), ideally with patients being informed of who has been provided with their data, for what purpose, and what the outcomes of the research were, to alleviate concerns over misuse of personal data. Patients should be able to amend their opt-in choices at any time, allowing them control of how their data are used.

The static, one-off approach used in SLS is not a perfect model. Ideally, patients would be able to review their consent and opt-out at any time. Additionally, the single level of consent in SLS made all sections of patients’ electronic records accessible. A more refined system that allows patients to select who can access their records, and the level of access for each person, would be an improvement.

In light of the NHS strategy to allow patients access to their medical records online, the NHS has been in discussions about developing a simple, secure portal. Parallel incorporation of an opt-in choice for different levels of data sharing, and enabling users to update their permission settings (akin to updating cookie preferences for website access), would add extra value for patients, clinicians, and payers. Development of individual “health accounts” could allow patients to access their data and approve or amend their use by certain organisations at any time. Such developments must be underpinned throughout by effective and transparent communication with patients to build trust.

The full BMJ article can be read here

Key messages

• Data from electronic health records cannot be used for research without patient consent
• Opt-in methods for consent have been avoided because of fears about low participation
• Experience in Salford suggests patients will opt in to data sharing if properly informed