Much of our national security cooperation with our European partners takes place outside EU structures and so is not dependent on our membership. We continue to work intensively with operational partners to ensure that we are ready for any eventuality.

If the Clinical Trials Regulation comes into force during the Implementation Period, as it is currently expected to in March 2020, it will apply to the United Kingdom. The Withdrawal Agreement and Implementation Bill will give effect to the implementation period in domestic law and will allow regulations to continue to apply in the UK for this time-limited period.

If this opportunity does not come to pass, we will give priority to taking the steps necessary to bring into UK law, without delay, all relevant parts of the European Union regulation that are within the UK’s control, so that those planning clinical research can do so with certainty.

The two key elements of the Regulation that are outside of the UK’s control, and this guarantee does not therefore cover, are the use of a shared central IT portal and database and participation in the single assessment model, both of which require a negotiated UK/EU agreement regarding UK involvement post-Brexit. We cannot pre-empt these negotiations, nor can we disadvantage the UK’s position in these negotiations by giving any further guarantees at this time.

Regardless of the outcome of a Brexit deal and the application date of the Regulation, the UK is committed to offering a competitive service for clinical trial assessment. This covers regulatory approval from the Medicines and Health products Regulatory Agency (MHRA) as well as services from the Health Research Authority, ethics services, the National Institute for Health Research and the National Health Service. The current regulatory approval legislation will stay in place until such time as any changes are needed so there will be no interruption in UK clinical trials approval.

In the event that the UK is not part of the EU shared central IT portal and database and therefore trials to be run wholly or in part in the UK are not submitted through the EU portal, it will still be perfectly possible for sponsors to run multistate trials involving the UK. Sponsors would have to apply to the MHRA as well as to the EU concerned states. However, MHRA would take every effort to ensure that a parallel submission to the MHRA was as streamlined and efficient as possible and that we were able to match or better the European timeline for assessment. MHRA and UK ethics committees are already internationally recognised for their robust yet timely assessment of trial applications and the UK is currently one of the most competitive Member States for timelines.

NHS Digital’s data recently published written evidence before the health select committee.

The report can be found here - http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument/health-committee/memorandum-of-understanding-on-datasharing-between-nhs-digital-and-the-home-office/written/76672.html

The department collects data that allows people undertaking apprenticeships to declare a mental health problem through the Individualised Learner Record.

We will be conducting a survey in early 2018 with 15,000 people currently undertaking further education or an apprenticeship, which will ask whether they have a physical or mental health condition.

Integrated care records are being developed across the National Health Service with the programme of work being undertaken under the Personalised Health and Care 2020 programme of work.

Camden’s strategy has been to maximise value (health outcomes per pound spent) across the system. This has focused on developing an integrated model of care through employing technological advances, of which Camden Integrated Digital Record is a key enabler.

The Improving Access to Psychological Therapies dataset does not currently make the distinction between sexuality and gender identity. The dataset has two fields that may be of relevance to this question:

Sexual orientation, which is the current sexual orientation of a person and has the following valid codes:

Gender, which is the current gender of a person. Note that the classification is phenotypical rather than genotypical; i.e. it does not provide codes for medical or scientific purposes. It has the following valid codes:

For all data collected by the National Health Service there is a standards approval process. This is managed by the Standardisation Committee for Care Information (SCCI), a subgroup of the National Information Board. All mental health data standards are approved via this process and result in an Information Standards Notice being issued which mandates Electronic Patient Record System suppliers and providers of NHS funded services to collect and submit the data.

The Mental Health Services Data Set reference is SCCI0011 (http://www.hscic.gov.uk/isce/publication/SCCI0011). It should be noted that this standard relates to the specification for data flowing from NHS-funded care providers to the Health and Social Care Information Centre for secondary use purposes. The standard has been designed so that it includes only data which can be derived from local clinical records and only data items which need to be directly collected. It also supports the principle that data is collected once and used many times.

In relation to data quality, the Department and NHS England successfully worked with Improving Access to Psychological Therapies providers to ensure consistent data quality. We will take a similar approach as we continue developing the new mental health dataset and would expect the five-year data plan which will inform future data collections on mental health to consider data quality.

The Health and Social Care Information Centre (HSCIC) is responsible for the Mental Health Services Data Set which is a patient level, output based, secondary uses dataset which will deliver robust comprehensive, nationally consistent and comparable person based information for children, young people and adults who are in contact with mental health services.

Data submission is mandatory for all instances of care including from independent providers that are wholly or partially funded by the National Health Service.

The Department is also working with the HSCIC and other health system partners to improve data submissions from independent providers.

Information is not collected centrally on how many clinical commissioning groups collect prevalence and standardised mortality data on autistic people as part of their joint strategic needs assessments.

The National Health Service is taking action to reduce premature death among people with autism and a learning disability, and with autism by increasing annual health checks for people with learning disabilities, including for those who also have autism. The NHS is working to reduce variation and improve care for physical health conditions that disproportionately impact on people with learning disabilities who also may have autism, including epilepsy and cancer. NHS England has commissioned the world's first Learning Disability Mortality Review Programme to support local areas to review deaths of people with learning disabilities and to use the information to improve service provision. This review programme for people with learning disabilities includes those who also have autism.

Think Autism set out a clear, cross Government programme of action, developed alongside people with autism, their families and carers to improve their lives and reduce premature mortality through better access to healthcare by making adjustments to services. This includes supporting the Royal College of General Practitioners (RCGPs) Autism Initiative to improve understanding of autism amongst GPs.

As part of the Government strategy to tackle child sexual abuse the Department has engaged with other Government departments including the Department for Education to deliver the actions set out in in the Government’s Tackling Child Sexual Exploitation report of March 2015, on how to improve services to vulnerable groups including children who have experienced abuse. We shall consider how local data collected through this process might be made available nationally.

The clusters in which the data are grouped reflect the mental health clusters which are the mandated currencies for mental health services. These reflect groupings of service users with similar levels of need, and whose care will cost on average a similar amount. For the purposes of payment, Health and Social Care Information Centre reports by cluster are required.

The National Institute for Health and Care Excellence guidance Multiple sclerosis: management of multiple sclerosis in primary and secondary care, updated in October 2014, sets out best practice on the diagnosis, treatment, care and support of people with multiple sclerosis (MS). The guidance makes a range of recommendations on drug based treatments for MS, but also highlights the importance of involving professionals who can meet the needs of the patient in the best way, such as physiotherapists and occupational therapists.

With regard to early diagnosis, MS is a difficult condition to diagnose as a number of the symptoms such as fatigue, depression or dizziness may be unrelated. The guidance sets out a number of initial presentations that clinicians should be aware of when looking for signs of MS. It also recommends a number of assessments a clinician should make, including testing of vision and blood tests before referral to a consultant neurologist, who can confirm or exclude a diagnosis of MS, subject to investigation.

We are continuing to explore ways of improving the capture of ethnicity data in National Health Service data collections, as recommended by the Board.

NHS England will be producing a position paper in early 2015 on equality and health inequalities data monitoring. The paper will assess the data collection process with regard to individuals’ equality and health inequalities characteristics taking account of the 2001 and the 2011 ONS Census ethnicity questions. Inclusion Health groups would be considered as part of this exercise.

Work on information standards for equality data monitoring is being led by NHS England, in partnership with key stakeholder organisations through the national Equality and Diversity Council. The Council will look towards ratifying data monitoring information standards covering the protected characteristics under the Equality Act 2010, including ethnicity.

The Chief Coroner attended a meeting of the Department's National Suicide Prevention Strategy Advisory Group on 14 March 2013 where the issue of collecting sexual orientation data on people who have committed suicide was discussed.

NHS England advises that software to provide a database for familial hypercholesterolaemia (FH) is available and will be increasingly used in England as FH services are established.

The responsibility for commissioning of FH services lies with local clinical commissioning groups (CCGs).

Provision of services will take into account the needs of the population overall. The CCG's decisions are underpinned by clinical insight and knowledge of local healthcare needs.

NHS England would expect organisations to have mechanisms in place to determine whether or not the National Institute for Health and Care Excellence (NICE) guideline CG71: “Identification and management of familial hypercholesterolaemia” is applicable to them. If guidance is applicable, there is an expectation organisations would review their current practice against NICE guidance.

In addition, the Health and Social Care Act (2012) places a duty on NHS England to have regard to NICE Quality Standards, including when producing any commissioning guidance.

The National Clinical Director for Heart Disease at NHS England is working with the Strategic Clinical Networks to promote cascade testing for the relatives of people who have hypercholesterolaemia.