Asked by: Lord Freyberg (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government, in respect of its guidance Creating the right framework to realise the benefits for patients and the NHS where data underpins innovation, which organisation or body will hold to account the boards of NHS organisations in ensuring that "any arrangements entered into by their organisation are fair, including recognising and safeguarding the value of the data that is shared and the resources which are generated as a result of the arrangement”.
Answered by Baroness Blackwood of North Oxford
As set out in the recently published guidance Creating the right framework to realise the benefits for patients and the NHS where data underpins innovation, the Centre of Expertise will offer support to those National Health Service organisations seeking to understand whether proposed data arrangements meet the requirements set out in the five guiding principles. The Centre of Expertise will sit in NHSX. The requirement that terms are agreed which are fair to both an NHS organisation and the wider NHS, is included to ensure, for example, that local NHS trusts consider arrangements which can provide benefits to the whole NHS, not just to an individual trust. This may include a NHS trust providing access to anonymised healthcare data for development of a healthcare product in return for access at a reduced cost to that product for the whole NHS, not just that particular trust. Fair terms should ensure that benefits returned to NHS organisations and the NHS as a whole are commensurate with the outputs that are generated by the data partner. The principles are intended to apply to all NHS organisations at the primary, secondary and tertiary care levels, including national NHS organisations. However, we will consider the inclusion of arm’s length bodies as part of the next phase of work in developing a full policy framework.
Asked by: Lord Freyberg (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government, in respect of its guidance Creating the right framework to realise the benefits for patients and the NHS where data underpins innovation, whether, in referring to NHS organisations, national NHS organisations, pertinent departments and arms-length bodies are required not to enter into “exclusive arrangements for raw data held by them”.
Answered by Baroness Blackwood of North Oxford
As set out in the recently published guidance Creating the right framework to realise the benefits for patients and the NHS where data underpins innovation, the Centre of Expertise will offer support to those National Health Service organisations seeking to understand whether proposed data arrangements meet the requirements set out in the five guiding principles. The Centre of Expertise will sit in NHSX. The requirement that terms are agreed which are fair to both an NHS organisation and the wider NHS, is included to ensure, for example, that local NHS trusts consider arrangements which can provide benefits to the whole NHS, not just to an individual trust. This may include a NHS trust providing access to anonymised healthcare data for development of a healthcare product in return for access at a reduced cost to that product for the whole NHS, not just that particular trust. Fair terms should ensure that benefits returned to NHS organisations and the NHS as a whole are commensurate with the outputs that are generated by the data partner. The principles are intended to apply to all NHS organisations at the primary, secondary and tertiary care levels, including national NHS organisations. However, we will consider the inclusion of arm’s length bodies as part of the next phase of work in developing a full policy framework.
Asked by: Lord Freyberg (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made of the amount of research and development funding required by organisations involved in (1) health research, and (2) data-driven health research, in the UK.
Answered by Baroness Blackwood of North Oxford
The Department’s National Institute for Health Research (NIHR) budget for 2019/20 is just over £1 billion and welcomes funding applications for research into any aspect of human health. The NIHR funds research projects, training and research infrastructure. Applications are subject to peer review and judged in open competition, with awards being made on the basis of the importance of the topic to patients and health and care services, value for money and scientific quality.
The NIHR also is a co-funder of Health Data Research UK who are committed to uniting the United Kingdom’s health data to enable discoveries and ensure that every health and care interaction and research endeavour will be enhanced by access to large scale data and advanced analytics. The NIHR also supports a number of initiatives to help researchers to access health data, samples and to identify participants for research.
The future of budgets outside of the NHS England resource settlement, including capital budgets for research and development, will be confirmed later this year at the Spending Review 2019.
Asked by: Lord Freyberg (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what plans they have to explore the scope to design a dedicated privacy shield confined to health and care data before negotiating a trade deal with the government of the United States after Brexit.
Answered by Baroness Blackwood of North Oxford
The Government has committed to maintaining a high level of data protection standards, which are set out in the Data Protection Act 2018.
These safeguards allow the public to have trust in how and why their data is used and it is important that we maintain them. Access and use of data should always be done lawfully, safely and securely. We reiterate that National Health Service data must always be held securely, with appropriate and strong privacy and cyber-security protections.
As the United Kingdom leaves the European Union we have made arrangements with the United States that will ensure that in both ‘deal’ and ‘no deal’ scenarios, transfers of personal data from the UK to US Privacy Shield participant organisations can continue to be made under the Privacy Shield Framework.
Asked by: Lord Freyberg (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what plans they have to design a new, improved data privacy shield that takes on board concerns about the current EU–United States Privacy Shield before negotiating a trade deal with the government of the United States after Brexit, so that it safeguards individuals as well as providing for the promotion of the UK’s life science and technology sectors.
Answered by Baroness Blackwood of North Oxford
The Government has committed to maintaining a high level of data protection standards, which are set out in the Data Protection Act 2018.
These safeguards allow the public to have trust in how and why their data is used and it is important that we maintain them. Access and use of data should always be done lawfully, safely and securely. We reiterate that National Health Service data must always be held securely, with appropriate and strong privacy and cyber-security protections.
As the United Kingdom leaves the European Union we have made arrangements with the United States that will ensure that in both ‘deal’ and ‘no deal’ scenarios, transfers of personal data from the UK to US Privacy Shield participant organisations can continue to be made under the Privacy Shield Framework.
Asked by: Lord Freyberg (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what plans they have, if any, to permit anonymised data (1) controlled, or (2) generated, by publicly funded health and care organisations in the UK to be shared for commercial purposes with businesses headquartered in non-EEA countries after Brexit.
Answered by Baroness Blackwood of North Oxford
Access to patient information for commercial purposes is not permitted, unless the patient has given their consent. The Government's principles governing data-sharing agreements entered into by National Health Service organisations, originally published in draft in December 2018 and reaffirmed in the policy framework update document published earlier this month, make clear that NHS data may only be accessed by third parties where there is an explicit aim to improve the health, welfare and/or care of patients in the NHS or the operation of the NHS, and that a fair share of the benefits from any agreements flow back to the NHS. We do not anticipate this will change when the United Kingdom leaves the European Union.
Asked by: Lord Freyberg (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government in which countries the NHS is permitted to host patient identifiable health data; and whether this includes the UK.
Answered by Baroness Manzoor
The National Health Service does not operate a data localisation policy. In January 2018 the Department, NHS England, NHS Digital and NHS Improvement published guidance for the NHS on offshoring patient data. A copy of NHS and social care data: off-shoring and the use of public cloud services is attached.
NHS and social care organisations are permitted to host patient identifiable data in countries that provide an adequate level of protection; within the United Kingdom, the European Economic Area, countries deemed by the European Commission to have adequate protections for the rights of data subjects, or in the United States where covered by Privacy Shield. There are no restrictions on where in the UK data may reside. For example, data from the NHS in England data may be hosted in Scotland, and vice versa.
The guidance makes clear that while there are no additional risks attached to hosting data offshore, local data controllers should adopt a risk based approach to decision making about offshoring data. This provides data controllers with the option of keeping data onshore when they feel it necessary to do so.
Asked by: Lord Freyberg (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government who owns the (1) information contained in patients’ health records, and (2) health records themselves; and who is responsible for (a) the use of information contained in patients’ health records, and (b) access to the health records themselves.
Answered by Lord O'Shaughnessy
The Data Protection Act 2018 gives effect to The General Data Protection Regulation (GDPR) introduced in May 2018. The GDPR provides rights in relation to the control of data, rather than referring to ownership.
The organisation that creates a health record is responsible for the use of information in the record and determines who has access to it and that any access is lawful. In addition, under the national data opt-out an individual has the right to opt out of their data being shared beyond their direct care, and under Article 21 of the GDPR, an individual has the right to object to the processing of their personal data under certain circumstances.
Every organisation is required by law to maintain the original medical record of patients and must safeguard it from loss, damage, alteration and unauthorised use. Every organisation handling personal data must comply with the GDPR when processing patients’ personal data and is accountable for its own compliance and risk management strategies and decisions.
Asked by: Lord Freyberg (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what economic modelling NHS England has carried out on the net budgetary impact of introducing a national molecular pathology service in cancer; what estimate they have made of the direct annual cost of such a service; whether they have considered switching off any legacy services to help fund its introduction; and if so, which.
Answered by Lord O'Shaughnessy
NHS England is developing a National Genomic Medicine service and this will bring together both existing clinical genetics services, and new genomic laboratory infrastructure to provide seamless service delivery for patients with rare and inherited disease and cancer. However, NHS England is not introducing a national molecular pathology service in cancer and therefore has not carried out economic modelling or an estimate of cost for such a service.
A key element of the Genomic Medicine Service is the National Genomic Test Directory which outlines the entire repertoire of genomic tests – from existing tests for single genes and molecular markers Whole Genomic Sequencing to Whole Genome Sequencing – that are available as part of the National Health Service clinical service. This includes cancer genomic tests.
As part of the NHS Genomic Medicine Service, a National Genomics Informatics System (NGIS) is being developed by Genomics England, on behalf of NHS England. When fully operational NGIS will enable NHS England to monitor the number of genomic tests being carried out across the country and benchmark activity.
Asked by: Lord Freyberg (Crossbench - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 27 November (HL11452), what was the average turnaround time from sample collection to clinical report for Genomic England's somatic whole genome sequencing for cancer patients in the last six months; what is the most clinically useful timeframe from sample collection to clinical report for such genome sequencing; and how many cancer patients in Genomic England's programme have died to date without receiving their clinical report.
Answered by Lord O'Shaughnessy
Following reengineering of tumour provision to fresh tissue supply and creating 300 pathways for tumour supply across the 13 NHS Genomic Medicine Centres (GMCs), Genomics England has continued to work with the National Health Service to improve throughput over the life of the programme.
Over the past six months, the average (median) turnaround time for cancer cases from enrolment to return of analysis was 39 working days. For fast-tracked and clinically urgent cases, this average over the last six months is 25 working days. By September 2018, Genomics England were returning samples at scale in 20 days or less demonstrating the improvements in the majority of cases received.
The most clinically useful timeframe depends on each individual patient’s clinical circumstances. As the 100,000 Genomes Project is a research programme, patients were all offered the NHS standard of care for their condition, in addition to Whole Genome Sequencing, so their therapy could proceed as rapidly as needed. During the 100,000 Genomes Project about half of the cancer cases in the Project contained actionable findings identifying a potential targeted therapy or clinical trial opportunity.
To date, 5,801 participants results have been returned to NHS GMCs (some participants have multiple reports). In total, 506 participants in the 100,000 Genomes Project, many of whom had advanced disease at the time of enrolment, died before Genomics England returned a whole genome analysis to the NHS. Of these, 176 were participants who died before their DNA samples were received by Genomics England. In many cases the deceased cancer participants became part of the Project via consent by a nominated representative, relative or friend because of the value for research to help others even though it was too late for the individual concerned.