(2 days, 17 hours ago)
Lords Chamber
Lord Tarassenko (CB)
My Lords, I shall also speak to Amendments 171 and 289, all in my name and that of the noble Baroness, Lady Kidron, who I thank for her support. I remind the Committee of my interests: I hold an honorary contract with Oxford University Hospitals NHS Foundation Trust, which is in the process of being renewed, and I am a director of LIO Health, a UK company which contracts with mental health NHS trusts.
The NHS holds health data no other country can match, namely longitudinal records for the whole population of England: primary care data, electronic patient records—EPRs—in hospitals and patient outcomes in multiple national registries. The single patient record, SPR, has the potential to bring primary care and secondary care records together for the first time and, in time, to link them to outcome data. That is a national asset of extraordinary value, not only for direct care but for research that will improve patient outcomes. It provides a unique opportunity for the UK companies that could build the systems which hold and process the SPR data.
The Government have told us that the SPR will indeed be delivered through contracts with multiple suppliers, with no single supplier dominating. Those contracts will be awarded over the next two years. These amendments ask a simple question: which companies are likely to win these contracts? Today, the US company Epic supplies the EPR in close to 20 NHS acute trusts. This year alone, four trusts in Somerset and Dorset have signed a £222 million 10-year contract with Epic, and Lewisham and Greenwich a £52 million contract. In general practice, EMIS, a company founded in Leeds, was sold to United Health in 2023 for £1.2 billion, and then on to another American company, a private equity firm, TPG, this year, so a large share of our GP records now sits with a US-owned supplier.
UK capability, although patchy, is still there. TPP, still UK-owned, supplies SystmOne across general practice and community services. Nervecentre, a British company founded in 2010, now has some 15 trusts committed to its cloud-native EPR, including a 10-year, £53-million contract with Liverpool University Hospitals, signed this spring. As I said at Second Reading, Kynos, a FTSE-250 company, won the contract in open competition to build UK Biobank’s output-checking system. UK companies can win and do win when procurement gives them a fair chance.
The contracts awarded for the single patient record in the next two years will typically run for 10 years and will define the health software market until the mid-2030s, the end of the NHS 10-year plan. If UK companies do not win a significant proportion of these contracts, the gap between US and UK suppliers will not stay where it is now. It will widen with every contract award, as revenue, engineering talent and know-how about NHS data build up on one side of the Atlantic. In 10 years’ time, that gap will be insurmountable. We will have lost the ability to build and support the core digital infrastructure of our own health service, and we will not get it back; the window to act is now.
Amendment 53 makes sure that UK jurisdiction and UK capability are taken into account when they matter: at the point of contract award. It requires the Secretary of State to take three matters into account when setting award criteria under Section 23 of the Procurement Act 2023 and when weighing value for money under Section 12(1)(a) for contracts for the single patient record and for national systems handling NHS patient data: first, the extent to which the data control and support of the system will remain within UK jurisdiction; secondly, the risk to the security and resilience of the NHS where they do not, including the risk that access to NHS patient data could be compelled under the law of another country, the US CLOUD Act being the obvious example; and, thirdly, consistent with our international obligations, the contribution the contract makes to building and maintaining UK capability.
Value for money is not simply the lowest price of a contract term. It must include the cost of dependency, the cost of exit and the value of the capability we keep. For larger contracts where data control or support will not remain entirely in the UK, the Secretary of State must consult the National Cyber Security Centre, patient representatives and NHS trade unions, and lay a Statement before Parliament explaining the award and whether domestic alternatives will be developed. Every year, the Secretary of State must report the number and total value of the contracts and the proportion awarded to UK suppliers, defined as UK companies with no foreign parent.
Amendment 53 deals with individual contracts and Amendment 171 provides a strategy. It requires the Secretary of State within 12 months of Royal Assent to publish an NHS digital sovereignty strategy. That strategy must cover four topics: first, treating NHS patient data as a sovereign data asset, including where it is stored and from where it may be accessed; secondly, assessing the risks across hardware, software, supply chains, and procurement, including reliance on foreign technology; thirdly, building domestic capability, including options to prioritise UK technologies; and, finally, research access to pseudonymised data in a way that keeps public trust. A sovereign data asset held in the UK under UK control with the benefits flowing back to the NHS is the best guarantee of that trust.
For research access, the NHS digital sovereignty strategy must set out the hierarchy: UK universities, medical research charities and the NHS itself, including the NIHR, will come first; UK suppliers second; and everyone else third. The strategy must also address how the NHS will share in the value created, with returns reinvested in the health service. Data must be accessed only within a trusted research environment in the UK, with outputs checked before release. Amendment 289 would bring both new clauses into force on Royal Assent, when the 12-month clock for the strategy would start, and the procurement duty in Amendment 53 would apply to the SPR contracts now being prepared.
All the amendments in this group share one concern: who controls the digital foundations of the NHS? I look forward to hearing from the noble Lords who have tabled them.
I support Amendment 277, from the noble Baroness, Lady Neville-Rolfe, which would require the Secretary of State to report on how NHS procurement supports patient care, value for money, resilient supply chains and economic activity in the UK. I also support Amendment 160, from the noble Lord, Lord Clement-Jones, which would require the Secretary of State to establish through regulations a governance framework for NHS IT and data contracts.
Several amendments in this group are concerned specifically with the Palantir contract for the NHS federated data platform. After the Secretary of State’s appearance in front of the Commons Health and Social Care Committee last week, when she refused to be drawn on whether the Palantir contract would be extended, I look forward to hearing what the Minister might have to say about the topic. I have two questions that I hope the Minister will answer in full. First, how will the value-for-money assessment of the SPR contracts take account of UK jurisdiction and resilience? Secondly, will the Government commit to publishing an NHS digital sovereignty strategy, whether or not they accept the wording of Amendment 171? After all, last week the Secretary of State said:
“We want … sovereignty. That has to include sovereignty for UK data”.
This country has world-class health data science and a health tech sector that should be given the opportunity to grow. The single patient record contracts are the biggest opportunity that the sector will see in the next 10 years. We must not spend the next decade buying back our own capability at a premium. I beg to move.
My Lords, it is a pleasure to follow the noble Lord, Lord Tarassenko. I will speak to Amendments 144, 147, 158 to 160, and 172E in my name, and I give our strong support to Amendment 53 on the digital sovereignty package, spoken to so convincingly by the noble Lord, Lord Tarassenko. We are very much singing from the same hymn sheet on these Benches.
I was unable to take part at Second Reading, but, over the years, as the noble Lord, Lord Kamall, will know from his time as a Minister, I have taken a strong interest in the access to, use and destination of NHS data for all purposes. Digital technology and data analytics hold transformative potential for our NHS, but technology is as effective only as the governance that underpins it, and health data platforms can succeed only if they command absolute public and clinical trust. If the NHS hands over its core data architecture to closed, proprietary vendors without retaining public ownership of software connectors or enforcing open API standards or clear parliamentary oversight, we risk locking our health service into perpetual vendor dependency.
In speaking to these amendments, I am building directly on the outstanding work of my Liberal Democrat colleagues in the Commons. I pay tribute to my honourable friend Martin Wrigley, who led the charge on vendor lock-in; my honourable friend Helen Morgan, who tabled a new clause on a sovereign health data trust; and my honourable friend Dr Danny Chambers, who tabled a new clause establishing the framework for an NHS digital sovereignty strategy.
On these Benches, we believe three principles should apply: NHS patient data is a sovereign public asset, exactly in the way that the noble Lord, Lord Tarassenko, described; data infrastructure must adhere to open, FAIR—findable, accessible, interoperable and reuseable—standards; and commercial suppliers must operate under strict public benefit conditions, with the NHS retaining full legal ownership of software interfaces and data pipelines.
(1 year, 6 months ago)
Lords Chamber
Lord Tarassenko (CB)
My Lords, I am authorised to speak on Motion 43A, as someone with regular day-to-day experience of scientific research. Since I started my PhD in 1981, I have had the privilege of spending more than half my working life doing scientific research in the UK—the last 20 years working with very sensitive patient data. Most of that research has been carried out in an academic setting, but some of it has been in collaboration with medtech, AI and pharmaceutical companies.
This research has required me to become familiar with many three-letter and four-letter acronyms. Noble Lords will know about DBS, but they might not know about RSO, TRO, HRA, LREC, MREC, CAG, and IRAS, to name just a few. I have spent hundreds of hours working with clinical colleagues to fill in integrated research application system—IRAS—forms. IRAS is used to apply for Health Research Authority—HRA—approval for research projects involving the NHS, social care or the criminal justice system. I have appeared before not only medical research ethics committees, or MRECs, which test whether a research protocol is scientifically valid and ethical, but local research ethics committees, or LRECs, which consider the suitability of individual researchers and local issues.
I was involved in a research project which reused data acquired from patients on a Covid isolation ward during the first two waves of the pandemic. That research project sought to understand how nurses interpreted continuous data from the clinical-grade wearables we used to monitor these high-risk patients during Covid. It took our research team more than 18 months to obtain the relevant permissions to reuse the data for our proposed analysis. Our application was reviewed by the Confidentiality Advisory Group—CAG—which provides independent expert advice on the use of confidential patient information without consent for research and non-research purposes. CAG already considers whether accessing the confidential data is justified by the public interest. Its advice is then used by the HRA and the Secretary of State for Health and Social Care to decide whether to grant access to the confidential data.
The existing provisions in this country to allow access to data for research purposes are stringent, and it is entirely right that they should be. The UK is respected the world over for the checks and balances of its research governance. The relevant safeguards already exist in the current legislation. Adding a further public interest test will only increase the amount of bureaucracy that will inevitably be introduced by the research services offices, or RSOs, and the translational research offices, or TROs, of our universities, which are very good at doing this.
The extra burden will fall on the researchers themselves, and some researchers may decide to concentrate their available time and energy elsewhere. This amendment, I am afraid, will have the unintended consequence of having a negative impact on research in this country, so I cannot support it.
My Lords, an onlooker might be forgiven for not perceiving a common theme in this group of amendments, but I thank the Minister for his introduction and the noble Viscounts for introducing their amendments so clearly.
I acknowledge that Motion 32A and Amendments 32B and 32C and Motion 52A and Amendments 52B and 52C from the noble Viscount, Lord Camrose, are considerably less prescriptive than the Spencer amendment in the House of Commons to introduce new Clause 21, which seemed to require public authorities to comb through every record to rectify data, went significantly further than the findings of the Supreme Court judgment, and potentially failed to account for the privacy afforded to GRC holders under the Gender Recognition Act. However, the Liberal Democrats will abstain from votes on the noble Viscount’s amendments for several key reasons.
Our primary reason is the need to allow time for the EHRC’s guidance to be finalised. I thought the Minister made his case there. The EHRC is currently updating its code of practice, as we have heard, to reflect the implications of the Supreme Court judgment on the meaning of sex in the Equality Act, with the aim of providing it to the Government by the end of June. This guidance, as I understand it, is intended specifically to support service providers, public bodies and others in understanding their duties under the Equality Act and putting them into practice in the light of the judgment. The EHRC is undertaking a public consultation to understand how the practical implications can best be reflected. These amendments, in our view, are an attempt to jump the gun on, second-guess or at the least pre-empt the EHRC’s code of practice.
On these Benches, we believe that any necessary changes or clarifications regarding data standards should be informed by the official guidance and implemented consistently in a coherent and workable manner. We should allow time for the EHRC’s guidance to be finalised, ensuring that any necessary changes or clarifications regarding data standards are informed by its advice and implemented consistently across public authorities in a coherent and workable manner. We have concerns about workability and clarity. Although the amendments proposed by the noble Viscount, Lord Camrose, are less prescriptive than previous similar proposals in the Commons tabled by Dr Spencer, we have concerns about their practical implementation. Questions arise about how public authorities would reliably ascertain biological sex if someone has a gender recognition certificate and has updated their birth certificate. I have long supported same-sex wards in the NHS, but I do not believe that these amendments are helpful in pursuing clarity following the Supreme Court judgment. We heard what the Minister had to say about passports.
I welcome the clarity provided by the Supreme Court judgment, but there are clearly implications, both practical and legal, to be worked out, such as those mentioned by the noble Viscount, Lord Hailsham. I thought he put his finger on many of those issues. I trust that the EHRC will deliver the right result. I agree that data needs to be accurate, and I welcome the Sullivan report, as did my noble friend. In summary, we will be abstaining. We believe that the EHRC process needs to conclude and provide comprehensive guidance, while also reflecting concerns about the workability and appropriateness of specific legislative interventions on data standards at this time.
I move on to Amendment 43B, tabled by the noble Viscount, Lord Colville. This amendment may not reinstate the precise wording
“conducted in the public interest”
that we previously inserted in this House, but it would introduce safeguards that seek to address the same fundamental concerns articulated during our debate on Report. It does two important things.
First, it provides a definition of “scientific research”, clarifying it as
“creative and systematic work undertaken in order to increase the stock of knowledge”.
This directly addresses the concerns raised on Report that the line between product development and scientific research is often blurred, with developers sometimes positing efforts to increase model capabilities or study risks as scientific research. Having a clear definition helps to distinguish genuine research from purely commercial activity cloaked as such.
Secondly, and critically, Amendment 43B would require:
“To meet the reasonableness test”
already present in the Bill,
“the activity being described as scientific research must be conducted according to appropriate ethical, legal and professional frameworks, obligations and standards”.
This requirement seeks to embed within the reasonableness test the principles that underpinned our arguments for the public interest requirement on Report and is the same as the amendment put forward by the chair of the Science, Innovation and Technology Select Committee, Chi Onwurah MP, which ties the definition to the definition in the OECD’s Frascati Manual: Guidelines for Collecting and Reporting Data on Research and Experimental Development:
“creative and systematic work undertaken in order to increase the stock of knowledge—including knowledge of humankind, culture and society—and to devise new applications of available knowledge”.
The Frascati framework is used worldwide by Governments, universities and research institutions to report R&D statistics, inform science policy and underpin R&D tax credit regimes, and it serves as a common language and reference point for international comparisons and policy decisions related to scientific research and innovation. These frameworks, obligations and standards are important because they serve the very purposes we previously identified for the public interest test: ensuring societal benefit, building public trust, preventing misuse for commercial ends, addressing harmful applications, and alignment with standards.
Amendment 43B in the name of the noble Viscount, Lord Colville, is a thoughtful and necessary counter-proposal. It is Parliament’s opportunity to insist that the principles of public benefit, trust and responsible conduct, rooted in established frameworks, must remain central to the definition of scientific research that benefits from data re-use exceptions.
I heard what the noble Lord, Lord Winston, had to say in his very powerful speech, but I cannot see how the amendment from the noble Viscount, Lord Colville, cuts across all the things that he wants to see in the outcomes of research.