NHS Digital Data Release Register - reformatted

Device Access Uk Ltd projects

Device Access - HES Application 2019

234 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).

Device Access - HES Application 2019 — DARS-NIC-05429-H7X6R

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - data flow is not identifiable, Anonymised - ICO Code Compliant, No (Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012, Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 - s261 - 'Other dissemination of information', Health and Social Care Act 2012 s261(2)(b)(ii), Health and Social Care Act 2012 s261(2)(a)

Purposes: Yes (Commercial)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2019-06-28 — 2020-06-27 2017.06 — 2023.11. breached contract with "high risk" — audit report.

Access method: Ongoing, One-Off

Data-controller type: DEVICE ACCESS UK LTD

Sublicensing allowed: No

Datasets:

Hospital Episode Statistics Admitted Patient Care
Hospital Episode Statistics Critical Care
Hospital Episode Statistics Accident and Emergency
Hospital Episode Statistics Outpatients
Emergency Care Data Set (ECDS)
HES-ID to MPS-ID HES Accident and Emergency
HES-ID to MPS-ID HES Admitted Patient Care
HES-ID to MPS-ID HES Outpatients
Hospital Episode Statistics Accident and Emergency (HES A and E)
Hospital Episode Statistics Admitted Patient Care (HES APC)
Hospital Episode Statistics Critical Care (HES Critical Care)
Hospital Episode Statistics Outpatients (HES OP)

Objectives:

Overview of objective for processing:

Device Access Limited conduct bespoke analysis on behalf of commercial companies, the NHS, academics and charities. This is a programme of work which identifies where medical and diagnostic technological devices can best be used by NHS providers in NHS patient care pathways to improve patient outcomes and to reduce lengths of stay, elective waiting times and diagnostic waiting times. This programme of work can be split into five distinct project areas as detailed below;

1. NICE applications on behalf of medical technological device companies:

Device Access UK Ltd (DAUK) act as a bridge between medical technological device companies and the NHS by providing these companies with expertise and bespoke analysis in order to complete the NICE (National Institute of Clinical Excellence) process required before new innovations can be recommended and then adopted into the NHS for the benefit of patients.

This activity is commissioned by the Medical Technology Companies, however, DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be presented. The device companies have no influence over the way in which the analysis is processed or the results.

NICE programmes relating to the review of new or existing Medical and diagnostic technologies require a submission based on a detailed understanding of and real evidence around, current NHS patient pathways.

NICE submissions offer relatively speedy assessments of selected innovations, with the aim of making relevant information available quickly to clinicians and NHS hospital decision makers, to support rapid adoption where this is appropriate.

Submissions to NICE require the following which DAUK extract from HES datasets;

• Understanding of the burden of disease; and how the current NHS patient population is diagnosed and / or treated
• The way the potential new technology works differently for this specific population in NHS England
• Potential benefits in terms of improved outcomes, productivity gain, and care pathway services through the adoption of the proposed new technology
• Detailed understanding of cost-effectiveness improvements compared to current NHS pathways

Before accepting a request from a commercial company and prior to any analysis or extraction of data, DAUK ensures that the technology meets the criteria of a potentially successful NICE submission by conducting internal research around the following formula (PICO);

I. Population - Who would the technology treat
II. Indication – how the technology works
III. Comparator –How care is currently delivered to the population
IV. Outcome – Are the benefits in line with the health and social care act 2014

Only once DAUK are satisfied that the technology meets these criteria and will be of benefit to patients and/or the health care system will they then conduct the bespoke analysis required for NICE submissions.

As an example of this work, DAUK are currently providing bespoke analysis for a medical device company who have developed a non-invasive diagnostic technology which enables paramedics to diagnose stroke patients, and ensure they are sent to the relevant centres depending on the type of stroke.

Currently in stroke diagnosis, paramedics are unable to determine whether the patient has had a minor stroke, which can be treated with thrombolysis drug therapy, or a major stroke or large vessel occlusion or LVO. LVO often requires a treatment called thrombectomy, which uses catheters to physically remove the clot from the brain which can only be performed in one of 27 specialist regional neuro centres.

Recent research has shown a 73% reduction in disability over current therapy for the 8,000 patients diagnosed with large vessel occlusion every year. However, the most critical thing is that patients are triaged rapidly to these specialist centres and not an A&E in a District General Hospital who cannot perform the thrombectomy procedure. Delays not getting the right stroke intervention greatly affect patient outcomes.

Through analysing HES with the Major Stroke centre network, DAUK are examining current stroke patient pathways, to understand how this technology will potentially impact and benefit patients and the NHS. The technology has the potential to improve patient outcomes for 44,000 patients a year in the UK that suffer from a stroke. DAUKs work will be used as part of the information required by the NICE submission process for this technology.

2. NIHR research applications on behalf of medical technological device companies:

The objectives for processing the HES data are to provide bespoke analysis to medical technological device companies for their applications for research studies through the NIHR (National Institute for Health Research) . NIHR research is often required to provide clinical evidence for NICE applications.

This activity is commissioned and funded by the Medical Technology Company, but can be funded directly to the Medical Technology Company though NIHR grants.

The bespoke analysis provided by DAUK includes;

• Clinical need analysis, evidence gap analysis and clinical endpoints
• Understanding of the burden of disease; and how the current NHS patient population is diagnosed and or treated
• The way the potential new technology works differently for this specific population in NHS England
• Potential benefits in terms of improved outcomes, productivity gain, and care pathway services through the adoption of the proposed new technology
• Understanding of potential cost-effectiveness improvements compared to current NHS pathways

Using the Stroke diagnostic tool as the example again, DAUK have provided the bespoke analysis which has secured the NIHR research. DAUK have also identified the areas of the country where there is most need thus enabling faster patient enrolment into clinical trials.

3. NHS adoption support on behalf of medical technological device companies:

Device Access UK Ltd provide expertise and bespoke analysis to medical technological device companies and the NHS in order to assist with adoption and diffusion of NICE recommended technologies so new innovations can be adopted into the NHS for the benefit of patients, and the healthcare system.

This analysis is used to support local NHS adoption by providing information relating to benefits for patients in a local area. This information is sent by Device Access to both the commissioning medical device company and also the NHS hospital stake holders to demonstrate the benefit to comply with NICE guidance. This activity is commissioned and paid for by the by the Medical Technology Company.

DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be used. The device companies have no influence over the way in which the analysis is processed or the results.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases:

Device Access UK Ltd provide expertise and bespoke analysis to the NHS in order to assist with identifying new medical technology and diagnostics in support of relevant disease states with a view that these will be adopted into the NHS for the benefit of patients, and NHS hospitals.

This activity is commissioned by the NHS, however, DAUK decide the manner and the process by which the analysis is carried out and how the outputs will be presented.

This work does not include broad based economic consultancy services such as benchmarking but is limited to the purposes described in this document. DAUK would submit an amendment application to NHS Digital if DAUK were to consider a consultancy service which fell outside this agreed purpose.

5. Department for International Trade DIT and Office for Life Sciences:

Since 2010, Device Access UK Ltd has supported the Department of International Trade or DIT, formerly known as the UK Trade and Investment (UKTI) who are part of the Government’s Office for Life Sciences (OLS).

Part of the DIT and OLS objectives are to attract inward investment into the UK from companies across the world, to develop their business here in the life science sectors and DAUK has worked to support the strategy of the OLS and DIT.

OLS and DIT commission DAUK with requests for market information, and DAUK provides free expertise on disease state, procedure volume and reimbursement.

DAUK decide the manner and the process by which the analysis is carried out. DIT and OLS have no influence over the way in which the analysis is processed or the results.

Yielded Benefits:

In 2018 Device Access have a number of new technologies going through NICE approvals; Treatments can be found on the following links NICE Interventional Procedures; https://www.nice.org.uk/guidance/indevelopment/gid-ipg10078 https://www.nice.org.uk/guidance/indevelopment/gid-ipg10061 MedTech Innovation Briefing (Pre-MedTech Guidance) The Vest (Device for airway clearance children with cystic fibrosis and neuromuscular disease) Rezum Steam Ablation for Benign Prostate Hyperplasia Cerebrotech VIPS (Stroke triage technology) to help identify patients with large vessel occlusion stroke for quicker transfer for treatment in the Regional NeuroScience Centres. Understanding NHS Heart Transplant outcomes and patient pathway activity helped us in 2014 to produce a paper to support NICE Approval with a company called Transmedics Inc who supply a new organ transplant system for the Heart. This was shown on a BBC2 documentary recently which highlighted the benefits of reducing the current 71% disposal of donated human hearts for transplantation. Link https://www.bbc.co.uk/programmes/b0b3gfth. We are now embarking on helping introduce the same platform for Lung & Liver transplantation

Expected Benefits:

1. NICE applications on behalf of medical technological device companies:

The transformation programme of the NHS recognises the importance of supporting innovation and enabling the fast adoption of cost-effective new technologies to secure improved patient outcomes.

Device Access UK Ltd are recognised by medical device companies and NICE as experts in the use of HES data to provide robust and trusted analysis which allows the NHS to assess the impact of medical innovation on patients and the health care system.

Without the work DAUK provide, innovation could be delayed in the NICE process and this would have a negative impact on the time it would take for the benefits of such technologies to reach patients and the NHS.

Two examples of the benefits to the health and social care derived from the data supplied by Device Access UK Ltd and NICE approvals are;
I. Benign prostate hyperplasia (BPH). Current NHS Treatments result in an over 2-day length of stay, resulting in over 45,000 bed days. Through data analysis, Device Access helped identify an opportunity for these procedures to be performed on a day case basis supporting best practice, benefiting the patient and making cost savings for the NHS. View the NICE news release here

https://www.nice.org.uk/news/article/thousands-of-men-with-enlarged-prostates-could-be-helped-by-new-nice-guidance-on-laser-device

II. Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death
http://www.bbc.co.uk/news/health-32056350

2. NIHR research applications on behalf of medical technological device companies:

NICE often advise medical device companies that further clinical research would be required as part of the NICE submission process. DAUK provide accurate and trusted bespoke analysis for the medical technological device companies to complete the NIHR evaluation. As with objective 1, DAUK’s work means that NIHR can assess sound analysis helping them evaluate quickly whether further research would be worthwhile. The DAUK analysis also identifies areas of the country where there is most need thus enabling faster patient enrolment into clinical trials. It ensures potential evidence gaps are eliminated and through research with the NIHR, help the NHS determine how to roll out innovations for the benefit of patients.

3. NHS adoption support on behalf of medical technological device companies:

The NHS is a highly complex and fragmented system. The infrastructure to rapidly and efficiently spread medical innovations, in a way that ensures that every patient in the NHS benefits no matter which hospital or which GP practice they visit, does not yet exist. The work of DAUK contributes to the process of helping these innovations reach and get adopted by the NHS in a more efficient way for the benefit of patients and the healthcare system.

Below are 2 examples of NICE approved technologies Device Access is supporting following NICE evaluation within the last 12 months. In the examples, Device Access have provided individual Hospitals directly with information relating to length of stay and bespoke analysis around the cost benefit for adoption which has assisted decision makers in NHS hospitals to commission new care pathways to provide a day case setting for these patients suffering from benign prostate hyperplasia and chronic sinusitis. This has resulted in faster NHS uptake for the technology and clear benefits for these patients.

i. NICE MTG30 XprESS multi sinus dilation system for treating chronic sinusitis-
XprESS multi sinus dilation system for treating uncomplicated chronic sinusitis after medical treatment has failed is supported by NICE. Treatment with XprESS leads to a rapid and sustained improvement for the patient in chronic symptoms, fewer acute episodes and improved quality of life which is comparable to functional endoscopic sinus surgery (FESS). This treatment is of further benefit to the patient by having faster post treatment recovery times, and can more often be done under local anaesthesia.

Cost modelling indicates that XprESS is cost saving compared with FESS when treatment is done using local anaesthetic in an outpatient setting. By adopting this technology, the NHS in England may save around £7.4 million a year by 2020. Estimated savings are mainly achieved through the shift of treatment from operating theatre to outpatient setting.

ii. NICE MTG 29 GreenLight XPS for treating benign prostatic hyperplasia-
GreenLight XPS for treating benign prostatic hyperplasia is supported by NICE in non-high-risk patients. GreenLight XPS is at least as effective in these patients as transurethral resection of the prostate (TURP), but can more often be done as a day-case procedure and is far less invasive for the benefit of the patient.

Cost modelling indicates that in non-high-risk patients, cost savings with GreenLight XPS compared with TURP are determined by the proportion of procedures done as day cases. NICE's resource impact report estimates that the annual cost saving for the NHS in England is around £2.3 million. In a plausible scenario of 70% of treatments being done as day cases, the cost saving may be up to £3.2 million.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases:

Device Access UK Ltd provides bespoke analysis to support NHS clients in their development of medical innovation for the benefit of their patients, local healthcare setting and/or the wider healthcare system.

Examples of bespoke DAUK analysis provided to NHS clients are as follows;

I. Facial palsy;
Device Access worked with clinicians at East Grinstead Hospital who are developing a new rehabilitation system for patients with facial palsy as well as looking at how this illness can be prevented.

To support this work, Device Access supplied analysis relating to the prevalence of Facial palsy and lymes disease. This analysis allowed the clinicians and the facial palsy charity to raise National awareness of the condition and look at developing new rehabilitation therapies across the country, as East Grinstead is currently the only NHS centre offering help for these patients. This new technology is being developed by the team at East Grinstead.

https://www.youtube.com/watch?v=3MA_F7nIxEY&feature=youtu.be

II. Gastro oesophageal reflux disease (GORD) research – understanding 4 Year patient outcomes from Antireflux fundoplication procedures;
Device Access are currently working with Epsom and St Helier NHS Trust and supporting a paper to explain the impacts of the current standard of care for gastro oesophageal reflux disease surgery.
The standard of care for these patients from a surgical perspective is a laparoscopic treatment called nissen fundoplication. DAUK HES analysis has shown that approximately 10% of these treatments result in further revision surgery.

This research paper will be looking at those patients requiring revision surgery and those not in the relevant control group. Looking at risk factors impacting on the condition along with the cost and resource used to treat this group of patients. This will result in a new way of managing these patients and improving patient outcomes through the introduction of an alternative treatment through raising awareness of the current outcomes.

This work was commissioned by the hospital but is being funded by a Medical Technology company who are developing a new therapy for the treatment of GORD.

III. NHS Improvement;
NHS Improvement recently approached Device Access for national information on the cause and incidence of pressure ulcers across NHS England. They wanted to understand what medical device technology is currently available and what impact these devices could have on the cost of pressure ulcers and patient care.

10% of all pressure ulcers that are treated in hospitals are community acquired with the remaining being acquired in hospital. The bespoke analysis completed by DAUK has provided NHS Improvement with an understanding of the most common reasons for admission leading to pressure ulcers. This analysis has been provided to NHS improvement at no cost.

http://nhs.stopthepressure.co.uk

5. Department for International Trade DIT and Office for Life Sciences (OLS):

This free service of providing the OLS and DIT with expertise around the NHS Market size has over the years encouraged several overseas companies to inwardly invest in the United Kingdom Market.

This helps keep the UK as one of the world’s best places for inward investment, the NHS ahead in research, evaluation and adoption of innovative medical technologies, allowing patients to benefit from new innovative treatments sooner.

Outputs:

Commercial companies specifically agree not to use the analysis provided by DAUK within general marketing, or within collateral material used by sales and marketing teams. These include sales brochures, emails, direct or mass mailing and advertising of medical technologies. Device Access Ltd do not allow portal access to the data by clients.

Description of outputs have been provided below;

1. NICE applications on behalf of medical technological device companies:

Device Access UK Ltd uses the HES analysis to support their Medical Technology clients with their submissions to NICE for evaluation. These bespoke outputs come in the form of reports and graphical charts and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used in evidence to support NICE applications.
Below are examples of DAUK analysis which has been used in NICE applications and have resulted in positive NICE guidance in the last 12 months;
NICE MTG 29 GreenLight XPS for treating benign prostatic hyperplasia
NICE MTG30 XprESS multi sinus dilation system for treating chronic sinusitis
NICE IPG549 Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death.
NICE IPG578 Minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain

Prior to 2016, Device Access UK Ltd supported 10 additional NICE Medical Technology approvals leading to guidance;
NICE MT 241 Device for relief of benign prostate hyperplasia
NICE MIB 47 Diagnosis Dry Eye
NICE TA 628 Intraoperative Radiotherapy for Breast Cancer
NICE MIB 8 Airsonett temperature-controlled laminar airflow device for persistent allergic asthma
NICE IPG 479 Device to manage ascities
NICE IP 475 Device for relief of benign prostate hyperplasia
NICE DG 12 Diagnostic Test To Manage Asthma
NICE IPG 431 Laparoscopic insertion of a magnetic bead band for gastro-oesophageal reflux disease
NICE IPG 396 Trabecular stent bypass microsurgery for open angle glaucoma

2. NIHR research applications on behalf of medical technological device companies:

Device Access UK Ltd uses the HES analysis to support their Medical Technology clients with their submissions for NIHR funding. All bespoke outputs come in the form of reports and graphical charts and are aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used in evidence to support NIHR applications.

3. NHS adoption support on behalf of medical technological device companies:

Device Access UK Ltd uses the HES analysis to support their Medical Technology clients with adoption of NICE approved technologies into the NHS.

These bespoke outputs come in the form of reports, graphical charts and cost models and are always aggregated with small numbers suppressed in line with the HES analysis guide. This analysis is then used as evidence to support discussions in NHS Hospitals with key NHS stakeholders including finance directors, clinical managers, clinicians and CCG’s.

4. NHS Consultancy with regards to medical and diagnostic devices for patient diseases:

Device Access UK Ltd uses the HES analysis to support their NHS clients with the development of new medical technology and diagnostics in support of relevant disease states.

These bespoke outputs come in the form of reports, graphical charts and cost models and are always aggregated with small numbers suppressed in line with the HES analysis guide.

This analysis is used as evidence to support medical technology developments in NHS Hospitals with key NHS stakeholders including commissioners, clinicians and researchers

5. Department for International Trade DIT and Office for Life Sciences (OLS):

A basic summary of National HES extracts of disease state, procedure volume and reimbursement analysis is supplied free of charge by DAUK to the DIT and OLS for use in direct and combined discussions with potential overseas companies considering UK market entry. DAUK only provides DIT and OLS with National information, not by hospital or provider. Outputs are therefore aggregated, with small numbers suppressed in line with the HES Analysis Guide.

Processing:

Only substantive employees of Device Access UK Ltd have access to the data and only for the purposes described in this document.

The data is not linked to any other data source or supplied to any third party.

Processing occurs on a client by client basis and is bespoke to each client.

Clients do not have access to any data via a portal.

Processing activities are essentially the same for each project within the programme;

a. DAUK use the HES data to perform the PICO – the analysis to check that the technology meets the criteria described and will be of benefit to patients and/or the healthcare system.
b. DAUK analyse the HES data using industry standard algorithms and extensive expertise to extract the relevant cohort or population
c. The analysis is used to produced bespoke reports and graphical charts which contain only aggregate data with small numbers suppressed in line with the HES Analysis guide
d. Device Access produces HES information on disease state, procedure volume and reimbursement analysis. This analysis is at hospital or provider level, to ensure regional differences and variances in care pathways are analysed. However for project 5 this will only be at a national level.