The use of health data in the research and development of new medicines, therapies and services is essential to the health and wellbeing of society. Controllers and custodians of data play a significant role in enabling this research whilst safeguarding the data. As gatekeepers, they are responsible for ensuring that access is only granted to appropriately qualified individuals, in secure settings, and for purposes with a clear legal and ethical basis that serves the public interest.
The COVID-19 pandemic has demonstrated the power of access to health data and raised public awareness. Whilst few can deny the value and impact health data has had, the accelerated response has raised questions on the use of sensitive data, the safe guards in place to protect privacy and prevent security breaches, as well as the involvement and interest of commercial entities.
A data use register (also known as a data release register or list of approved projects) offers the public a clear record of how data is being used, by whom and most importantly, for what purpose. Currently, many data use registers are difficult to access, inconsistent in content and form and in some cases, not available to the public.
In July 2021, with proposed recommendations for a data use register standard, which went out for public consultation via an online survey. This report discusses the results from the survey, exploring the community’s support for the standard and gathering perspectives on both the drivers and barriers to successful implementation of the recommendations. Sixty respondents completed the survey (Fig.1). In addition, focus groups were held with patient and public involvement panels, capturing a further 54 responses.
Fig.1. Sixty responses were received from a widespread of the community.
The high level of interest and input from lay representatives highlights the need for transparency and potential for increased public advocacy in data use.
The significance of accessibility and need for “active promotion” of data use registers was an important theme across the feedback:
“The public and patients need to know that data use registers are there. We may not want to find or use them, but we need to know they are there.“ – Lay representative
How can we make the process easier?
The vast majority of respondents (98%) indicated their support for Recommendation 1 (Fig.2), highlighting that the first key step to transparency is for data custodians to publish a register of any clinical or non-clinical research studies, projects and requests that have been approved for data use under their custodianship.
A preliminary analysis of data custodians practice on publishing data use registers highlighted that not all data use registers are publicly available. So, a practical immediate step would be for the Alliance to drive publication of data use registers, including information about who is accessing data and for what purpose.
Recommendation 2 highlighted the importance of populating data use registers in near real time or shortly after a data access request has been approved. The potential benefit of a more diversified research landscape through the provision of “real time” information was recognised by the majority of respondents. By providing researchers with a timely and accurate view of past and present research projects and data uses, we could reduce duplication, whilst also encouraging funders to increase investment in underserved areas of research. However, the practical limitations of this recommendation were also noted. As a transition to real-time data is heavily dependent on the automation of data access management systems, it was acknowledged that not all organisations would be in a position to move on with real time updates of data use registers.
“Implementing a truly real-time solution may be costly, and not the best use of limited NHS resource. There needs to be a balance.” – Lay representative
Likewise, the majority of respondents (84%) appreciated the potential for improved accessibility by the availability of data use registers in both human-readable and machine -readable formats (Recommendation 3). But as the majority of current data use registers are exclusively in web-based formats, implementing such a standard may prove difficult.
NHS Digital’s recent transition from a machine-readable register to a more interactive and user-friendly Power BI dashboard, is a great example of how data custodians can improve accessibility for the general public through a friendly interface, without losing the analytical advantages of a CSV file.
Recommendation 4 of the Green Paper proposes a consistency of format and content that is based on the Five Safes framework, ensuring that information around Safe People, Safe Projects, Safe Data, Safe Settings and Safe Outputs is captured. Whilst, alignment to the Five Safes framework was well supported (Fig.3) and praised as a “useful way of conceptualising information security “, providing an attainable minimum standard by identifying the “key mandatory elements” was also noted as necessary for the long-term adoption and sustainability of data use registers.
In view of this, we would suggest that a minimum dataset should be comprised of at least organisation name,, dataset name, approval date and TRE location. This would be a first step to transparency and offer a foundation that can be developed over time.
Closing the loop on impact through links to research outputs
Demonstrating the impact of data used for research and innovation was recognised by all sections of the community as an essential final element in the data access ‘life cycle’, with 98% of respondents supportive of Recommendation 5. Patient endorsement and advocacy of health data usage through better communication of research outputs was a benefit obvious to most, with a reminder that “negative findings can be just as valuable as positive findings”. However, respondents also acknowledged that the link to research outputs is not currently implemented in a consistent and effective manner.
The challenge of capturing the outputs for non-academic data users were also highlighted by lay representatives, as the outputs of research will not always be in the form of a publication, but rather insights into improved therapies or policy changes. Therefore, transparency about all research outputs produced through the use of health data is crucial.
Linking data uses to research outputs is also an ambitious target and requires the joint effort of data custodians, funders and researchers to develop an interconnected ‘ecosystem’ to ensure the long-term sustainability of this process. In addition, a better understanding of existing reporting platforms, data sharing repositories and a more effective use of acknowledgements and Digital Object Identifiers could help increase transparency of how data is used and what the impact of that data use is.
Data use registers provide a great opportunity to establish and drive best practice in this important area.
Ensuring adoption through continued patient and public involvement
Data custodians and controllers responsible for the collection, storage and sharing of data have a moral, ethical and in some instances legal obligation to publish a register of approved research studies, projects and other data uses.
Establishing a standard will provide a consistent framework to support this ambition, but it may take time before this translates into adoption. Data custodians are at different stages in this journey, as shown by our recent analysis on the current state of data use registers. However, through the drive and leadership of the Alliance, there is great potential for this to become a priority for all data custodians moving forward.
Finally, continued patient and public involvement and engagement is critical. Although the benefits of using health data are clear to most people, there are still concerns. The recent discussions around NHS Digital’s plans for a General Practice Data for Research and Planning database has shown that data custodians and controllers cannot underestimate the value of appropriately communicating and involving patients in decisions about the use of their data.
“Make sure we, the public, as individuals and as interest groups, are involved at every stage of the process.” – Lay representative
The community responses through this survey will be incorporated into a White Paper with final recommendations for the standards for Data Use Registers by UK data custodians.
This White Paper will be reviewed the UK Health Data Research Alliance board on 20 October 2021 and published subsequently.