UK health data initiative ‘has parallels’ with European health data space

Louise Fullwood of Pinsent Masons said there are parallels between the plans outlined by UK prime minister Sir Keir Starmer on Monday, which are designed to better facilitate researchers’ access to health data, and the framework that has been established for a new European health data space (EHDS).

The UK government said it and health research charity the Wellcome Trust “will invest up to £600 million to create a new Health Data Research Service” to “transform the access to NHS data by providing a secure single access point to national-scale datasets”.

Detail of the policy is light, with the government intent on setting out its full plans alongside the spending review in June. However, it said the new service will be in place from the end of next year and provide for a “gold standard” of patient confidentiality – including through implementation of “rigorous security measures … like anonymity and virtual locked rooms”.

It said: “The Health Data Research Service brings access to data for medical research into one secure and easy-to-use location, meaning a researcher doesn’t have to navigate different systems or make multiple applications for information for the same project. This improvement – which will begin from the end of 2026 – will speed up the process and could set the UK on a path to cure cancer, dementia, and arthritis quicker, which will improve patient outcomes and help turbocharge the economy.”

In the EU, the EHDS regulation entered into force last month, providing for, among other things, ‘secondary use’ of health data by researchers under strict conditions and for defined purposes. The regulation imposes duties on both health data holders and health data users. For example, health data holders, including pharmaceutical companies, must make their data available to others to use, while health data users must publish the results or outputs of their use of the data. It will be 2029 before those rules begin to take effect.

Fullwood said: “From the high-level information that has been made available so far about what the UK is planning with its new register, there are many similarities with the EHDS initiative. It will be interesting to see how the UK version addresses some of the more contentious aspects of the EHDS.”

“One of these is the fact that, under the EHDS, if an organisation is classified as a ‘data holder’ then it must make certain datasets available for others to request access to. This has caused some degree of consternation within the pharmaceuticals industry, as it appears that they may be compelled to make their clinical trials and other treasured datasets available to competitors,” she said.

“Another issue is fees chargeable for access to such datasets. It is not yet clear what the UK position will be on this, but one of the issues raised in relation to the EHDS is that there is a limited scope for data holders to charge for access to their data – fees charged to data users need to be proportionate to the cost of collecting and making electronic health data available for secondary use. Data holders can include compensation for the costs they incur in compiling and preparing the electronic health data for such use as part of the fees they charge, but there is no provision for a profit to be charged on top of this. For some researchers or consortia of researchers, long term sustainability of a database has been calculated on being able to charge a reasonable profit – for example, in making this available to big pharma for research. If it must be released essentially ‘at cost’ then this raises funding problems,” Fullwood said.

“It will therefore be interesting to see the detail in June and whether the UK will seek to avoid some of the criticisms made of the EHDS approach,” she added.

Since coming to power last summer, the Labour government has already brought forward plans to better support the use of personal data, such as health data, for research purposes. The proposed expansion of the concept of ‘scientific research’, to include certain privately funded and commercial research activities, and not just non-commercial research as is the case currently, forms part of its proposed new Data (Use and Access) Bill (DUAB) currently before parliament.

Data protection law expert Malcolm Dowden of Pinsent Masons said: “The DUAB provisions recognise that patient consent to the processing of their personal data under the UK GDPR is separate from the patient’s consent to involvement in the clinical trial.”

“The DUAB aims to close a gap between those two consents by providing that where an individual provides UK GDPR consent to the processing of their personal data for the purposes of scientific research then, as long as that research is conducted in the public interest, the original consent remains in place even if the purpose of the research evolves. Processing for a revised or even, potentially, a different purpose could still be regarded as ‘further processing’ that is compatible with the original purpose, meaning that there would be no requirement to cease processing and remove data in respect of which consent was no longer valid,” he said.

“For this to apply, the project must meet the safeguards required by the proposed new UK GDPR Article 84B, which means it must be anonymised unless the research purpose cannot be fulfilled without identification of the individuals – for example, in relation to rare genetic conditions. Even in those cases, data subjects should be protected, so far as possible, by pseudonymisation or ‘masking’ of their identity,” Dowden said, adding that the DUAB provisions strike a balance between enabling greater sharing and pooling of data for research, and protection of individual rights.

Alongside the announcement of the new UK Health Data Research Service, the government confirmed plans to cut the time it takes pharmaceutical companies to set up clinical trials for new medicines. It said that, according to data collected in 2022, it typically takes 250 days to set up a clinical trial and that it wants to reduce that to 150 days by March 2026.

Fullwood said: “The prospect of simplification of clinical trials has been posited since around the time of Brexit as being a potential benefit of diverging from the EU clinical trials regime, so it will be interesting to see what is being proposed when the government brings forward its plans in June.”