“Only by securing people’s confidence and support can we do all of the ambitious, innovative, life-changing things with data that are part of the system’s future vision for how health and care will be delivered”; this is according to the UK’s National Data Guardian (NDG), Dr Nicola Byrne, in her annual report 2021/22.
The report was published on 30 August 2022. It acknowledges the proliferation of “influential reviews, strategies and legislation” in the health data space during this period, and refers to an “uncertain and challenging” landscape.
The office of the NGD is a statutory appointment with a clear mission: to preserve trust in the confidentiality of health and care services, and to contribute to improved health outcomes through the “safe, appropriate and ethical use” of personal health and social data.
NDG involvement in health data strategy and initiatives
The report details the NDG’s involvement in a wide range of recent health data-related developments, through the prism of these objectives, including:
- Participation in the Goldacre report, including strong support for a move away from data dissemination towards trusted research environments (TREs), which featured strongly in the Goldacre recommendations (for more on the Goldacre review see our analysis here).
- Advising on the development of the recent “Data Saves Lives” government data strategy published in June;
- Responding to the MHRA’s consultation on the future regulation of medical devices, in particular with respect to the regulation of software and AI as a medical device, advocating for stronger safeguards for data protection, security and confidentiality (for more on the analysis of the MHRA’s consultation see here);
- Advising NHS England on plans to accelerate direct patient access to medical records (the NDG said it has as a long-standing priority” to remove barriers to individuals’ access to records);
- Collaboration with the Ada Lovelace Institute on its work on addressing digital inequalities (the same organisation which has been working with the NHS on its pilot efforts to strengthen algorithmovigilance, see further here);
- Working with the UK health security agency on public support aspects of its biosecurity efforts; and
- Working with NHS digital on opt out architecture in the context of clinical trials with a digital element.
Use of health data for commercial purposes relies on public trust
The NDG appears wary of the use of health and social data for commercial and other secondary purposes (i.e. outside a direct clinical care context). For example, the NDG was particularly concerned by a case study involving the sale of confidential data to a commercial third party “which did not respect patient privacy” in the context of its feedback to the MHRA as part of the medical devices regulation consultation.
In this report, the NDG emphasises the role of transparency in building public trust in data use. Its view is that the public should be able to “easily find information in an accessible format about who has been permitted access to their data and why, including where access is granted to commercial organisations”. According to the NDG, public support is only “conditional” when it comes to the involvement of commercial companies in data-driven innovation: the rationale for commercial involvement needs to be made clear and commercial organisations must demonstrate their trustworthiness, with “adequate safeguards against improper use” in place.
Overall, the NDG’s message is that “private profit should not outweigh the public benefit”, and one of the key priorities for the NDG in the year ahead includes plans to publish guidance for the UK health system on the meaning of “public benefit” when heath and care data is used for secondary purposes.
The NDG has also has set ambitious priorities to continue to advise, support and oversee the health and social care system in its use of confidential information as it enters a period of “significant legislative and operational structural change”, with a focus on public trust and safeguards. In particular, the NDG foresees significant involvement in the implementation of the government’s health data strategy, data protection legislation change and the implementation of secure data environments and TREs.
- The NDG has described involvement in a wide range of projects and an ambitious programme for the year ahead, and this report serves to illustrate the fast-paced and complex nature of recent and upcoming developments in the health data space as the UK government seeks to unlock rich NHS datasets.
- The balance between maintaining confidentiality and commercial interests inherent in this unlocking process will clearly not always be an easy one, especially as the UK government is likely to rely on commercial counterparties to help unlock its innovation and digitalisation plans.
- Forthcoming guidance on the meaning of “public benefit” in the context of when health data is used for secondary purposes may provide further insight into how these interests will be balanced.