Member Groups

Digital Health

Overview

Building on unique opportunities in the NHS, academic institutions and third sector, the Digital Health Group works with national organisations to ensure the UK maximises opportunities for citizen health and economic wealth by investment in data-driven healthcare and creates a strong infrastructure and commercial environment to support development of the best HealthTech solutions.

Leadership
  • Chair - Dr Roberto Liddi, NuraLogix Corporation
  • Vice Chair - Anne Dreyer, Roche Diagnostics & Michael Shenouda, Open Medical
Achievements
  • Published White Paper on Digital Health Regulations to take an industry leadership position.
  • Established a Task and Finish group under the Accelerated Access Collaborative to address specific Digital Health market access issues.
  • Supported MPs to establish and provide ongoing secretariat support for an All Party Parliamentary group on Digital Health.
  • Provided industry input into a wide range of policy initiatives including:
    NICE Digital Assessment programme and Multi Agency Advice Service, NHSX, Digital Technology Assessment Criteria, Scottish Life Science Group, Health Data Research Uk Innovation Portal and the Office for Life Sciences Health Data Policy.
Priorities 

     1. Market Access

  • Highlight issues within the financial system that hinder adoption of digital health technologies and make formal recommendations, for changes and additions to assessment and reimbursement mechanisms.
    ABHI Paper: Health Digital Reimbursement

     2. Data

  • Ensure industry recommendations are incorporated in data strategies, policies and processes, focusing on streamlined IG process and the implementation of SDE programme.
    ABHI Paper: Health Data Access & Use

     3. Regulation

  • Work with relevant organisations and wider regulatory activities to get industry recommendations on regulation across product and data built into legislation and working processes. 
    ABHI Paper: Digital Health Regulation

     4. AI  

  • Work with health system, academia and third parties to establish processes, standards and guidelines to support development and deployment of AI technologies.

     5. Cyber Security

  • Share global best practice and develop ‘safe harbour’ forum to discuss threats and vulnerabilities.

Adoption

Leverage ‘Policy to Practice’ report to recommended changes required for the UK health and care system to rapidly and systematically adopt new technologies and the benefits to be gained for both NHS and UK economy.

Useful Resources

Click here to view the latest updates, minutes and future meeting dates for the group. 

Get Involved

To join the ABHI Digital Health group, contact andrew.davies@abhi.org.uk 

“Since the groups inception two years ago I have been proud to work with members to develop an active programme of work and engagement with external stakeholders. Focusing on three key areas of regulation, reimbursement and data access strategy, we have enabled members to interact with a wide range of external speakers and stakeholders, as well as share experiences between group members. We have clearly laid out positions on key topics which are disseminated through the broader platforms available via the ABHI interactions with government ministers, senior officials and NHS leaders. Digital HealthTech is one of the fastest growing sectors in the medical device world, working at the intersection between regulation, software technology, ethics and information governance, and it is imperative for the industry that all of those angles are covered adequately.”
Dr Roberto Liddi, Vice President, Sword Health & Chair, ABHI Digital Health

 


Digital Health News & Updates 

30th June 2023

The Health and Social Care Committee's report into digital transformation in the NHS.


June 2023

The June update of Data for R&D covers everything from HM Treasury approval for their business case, to Lord O’Shaughnessy's review of UK commercial clinical trials, the latest from the Innovation, Research and Life Sciences team, and more. Access it here.


20th April 2023

Imperial College London has published a report: NHS Data - Maximising Impact for All. This is a useful summary of the current data landscape and makes recommendations across a range of areas to do with data access. 


22nd March 2023

On 15th March 2023, the ICO issued updated Guidance on Artificial Intelligence and Data Protection. The updated Guidance follows ‘requests from UK industry to clarify requirements for fairness in AI” and aims to support the UK government’s vision of a “pro-innovation approach to AI regulation” and more specifically its intention to “embed considerations of fairness into AI”. A summary from DLA Piper is available here


3rd March 2023

A useful summary of the data protection landscape and future developments from ABHI members McDermott Will & Emery.


28th February 2023

Analysis by HSJ shows the government has failed to meet most of its own deadlines for commitments to improve how the NHS uses data. The delays include work to store and analyse patient data more securely, building public trust in the NHS’ use of patient data, and agreeing national strategies on cybersecurity and cloud technology. Article contains a useful spreadsheet colour coding all commitments within Data Saves Lives and their status.


27th February 2023

How New Cybersecurity Regulations Are Shaping the Medical Device Industry. This article provides a useful round up of cybersecurity initiatives across the US, EU and Japan.


17th February 2023

The Health and Social Care Committee’s Expert Panel on digitisation of the NHS has reported on the Government’s progress against its commitments and found that progress is inadequate. There are some bright spots where progress has been good but too many areas are behind target with many commitments unmet.


13th February 2023

According to EURACTIV's Luca Bertuzzi, the latest political meetings on the AI Act in the European Parliament have been on the AI definition, scope, prohibited practices, and high-risk categories. The AI definition now being considered is based on the US National Institute of Standards and Technology's definition. This definition clarifies that the "objectives" of the AI model relate to the parameter optimisation process, and not the final purpose of the system. Furthermore, the definition has been moved from the annex to the body of the law, making it unamendable by the European Commission. A new article outlines general principles for all AI systems that do not fall under the high-risk category. These principles include human oversight, technical robustness, compliance with data protection rules, appropriate explainability, non-discrimination and fairness, as well as social and environmental well-being. Compliance with these principles is voluntary, and, if they are adopted, the Commission and AI Office would issue recommendations on how to comply with them.


10th February 2023

In February, NHS England held a public board meeting at which key technology and data projects from NHS Transformation Directorate were discussed. An update on a range of programmes were shared, including the frontline digitisation programme, federated data platform, shared care records, patient access, waitlist management, and other areas.


11th January 2023

Please find attached an update from NHS England on the formation of the national and sub national Secure Data Environments. This outlines the infrastructure for the SDEs, the initial awardees and funding for the sub-national SDEs as well as high level strategy on commercial contracting.


11th January 2023

New legislation gives the FDA new authorities to establish medical device security requirements for manufacturers. Specifically, the law gives the authority to ensure all new medical devices brought to market are designed with security in mind. That means, in the near future, all medical device submissions will be required to include a software bill of materials and adequate evidence to demonstrate the product can be updated and patched.

6th January 2023

This interesting survey of EU AI companies (particularly start-ups) highlights the impact of the AI Act. In summary:

  • 73% of the surveyed VCs expect that the AI Act will reduce or significantly reduce the competitiveness of European start-ups.
  • 33% - 50% of the AI Systems would classify as High-Risk over double that indicated by the Policy Impact Assessment by the EU Commission.
  • 50% of the AI start-ups believe the AI Act will slow down AI Innovation in Europe. 16% consider stopping to develop AI or relocation outside the EU.
  • For High-Risk AI Systems, the additional requirements and obligations are a significant challenge for start-ups in terms of technical and organisational complexity and compliance cost.
  • VC investments shift toward AI Systems with a specific purpose, in low-risk applications, and, to some extent, to non-AI start-ups and outside of Europe.

18th July 2022

In September 2021, the government launched its consultation, ‘Data: a new direction’. This was designed to inform the development of proposals to reform the UK’s data protection laws, in order to secure a pro-growth and trusted data regime as part of the UK’s National Data Strategy.

The government has now responded to that consultation, giving an indication of how legislation may be shaped in the future, which builds on the key elements of the current UK General Data Protection Regulation (UK GDPR). An overview can be found here

1st July 2022

The Government has announced its plans to transform health and social care through digital technology. The plan, which follows the recent 'Data Saves Lives' publication, was announced by Health Secretary Sajid Javid this week, and sets out an ambition to give patients access to quicker and more effective care "at their fingertips", whilst saving the health and care system time and money. Further details can be found here

21st June 2022

The final version of “Data Saves Lives” has now been published. This follows the previous draft version and subsequent consultation and engagement events, which have included ABHI.

This strategy sets out the Health Secretary's vision for how data will be used to improve the health and care of the population in a safe, trusted and transparent way.

As Andrew Davies details in this update for members, the publication is promising and there is much to welcome within it, though the follow-up detail in the implementation plan, and from key stakeholders like the MHRA, the Office for AI and the Department for Digital, Culture, Media and Sport, will be key to addressing the wider policy landscape.

8th April 2022

The PHG Foundation have described the Goldacre review as a hard-hitting report with recommendations for enabling the proper use of NHS health and care data for research, to drive improvements in health and care. This long-anticipated report does not disappoint. It is highly technical – because it proposes solutions to, in many cases, highly technical problems – but also outlines broader policy actions.


7th April 2022

HSJNHS England has cut the number of procurement frameworks for digital and IT products by a third, with guidance issued to trusts endorses 36 frameworks (down from current 57) as “the most optimal routes to market”, nearly two-thirds are run by Crown Commercial Services. The reduction is aimed at helping to “simplify the digital and IT framework landscape, remove duplication and reduce costs”, the guidance says. The guidance is framed as recommendations rather than mandatory, but says: “Non-endorsed routes will also ordinarily preclude trusts or other buying organisations accessing shared or central funding for the services in question.”


6th April 2022

DigitalHealth.net: NHS England has announced plans to develop a £240million ‘Federated Data Platform’ (FDP) via an open procurement. The data platform will be an “essential enabler to transformational improvements” across the NHS and will be an “ecosystem of technologies and services”. It will be built around five major use cases

  1. Population health and person insight
  2. Care coordination (with focus on ICS)
  3. Elective recovery (with focus on trusts)
  4. Vaccines and immunisation
  5. Supply chain

NHS England says it intends to hold a supplier briefing session in relation to the project on 13 April 2022 and estimates the publication of the contract notice to be on 6 June 2022.


30th March 2022

NHS Transformation Directorate have recently published an online NHS AI Lab roadmap. It will give you a good snapshot of what they’ve achieved since our programmes started in 2020 and a summary of the broad scope of AI policy and projects that are on the horizon.


18th March 2022

NPJ Digital Medicine: Study compares the national policy approaches currently in development/use for health apps in nine countries.


2nd March 2022

Gov.uk£260 million to boost healthcare research and manufacturing.
Government commits up to £200 million to support NHS-led health research into diagnostics and treatment through Trusted Research Environments and digital clinical trial services. This will make crucial data more securely and quickly available for research, while offering the highest levels of privacy. The funding will deliver on government commitments set out in the Life Sciences Vision, to harness NHS data to drive health research and innovation.


2nd February 2022

HSJDetails are emerging of the plans from NHS England’s new transformation directorate to speed up digitisation and ensure the “safe and effective use” of computer assisted processes and clinical decision support becomes the normal way of working for clinicians. A massive increase in clinicians’ use of technology forms a major part of the draft plans and specifically, as previously outlined a focus on EPRs with every NHS Trust to have a system installed and every ICS to create virtual wards of around 500 beds each by 2025.

NHSE will be developing national standards for Clinical Decision Support systems and the transformation directorate will “set clear interoperability standards” and agree a “common architecture”.


28th January 2022

Further to the Wade-Gery review and the amalgamation of NHSX and NHS Digital into NHS England things are starting to take shape as transformation director Tim Ferris starts building his new directorate which will comprise staff from NHSE, NHSX and NHS Digital. With NHS Digital unable to formally merge until legislation allows, NHSX staff will be first to be absorbed into the Transformation Directorate.

It is reported that Dr Ferris is being given much of the power to make decisions about which teams go where, and he is poised to announce full transition arrangements for NHSX staff imminently. Some NHSX teams in the CCIO directorate – currently led by NHSX deputy CEO Simon Eccles – have been told they are being sent in different directions with new line managing arrangements imminent. These changes to structure and reporting lines are being billed as temporary transition arrangements. A more discursive and consultative process will take place for any changes that are made permanent and it is likely that a more formal consultation with NHS Digital staff will happen upon merger.

It is understood that there will work to improve trusts’ use of electronic patient records will be prioritised, which could see funding focused here at the expense of other programmes that seek to improve IT standards and interoperability. Other NHSX workstreams whose budgets may be reduced include digital maternity, primary care, and screening, with the cash earmarked for projects aiming to support HealthTech's role in the life sciences agenda.


25th January 2022

The Cabinet Office has published the first Government Cyber Security Strategy specifically for the public sector. It has two core pillars, firstly “build a strong foundation of organisational cyber security resilience” ensuring the right structures, mechanisms, tools and support are in place. Secondly “defend as one” focusing on a more comprehensive and joined up response. This builds on the recent publication of the National Cyber Strategy, which takes in the whole economy and sets out an ambition for a ‘whole of society’ effort between public, private and third sectors.

The strategy identifies five objectives to provide a consistent framework and common language: manage cyber security and risk; protect against cyber attack; detect cyber security events; minimise the impact of incidents; and develop the right cyber security skills, knowledge and culture.


20th January 2022

HSJ: Outgoing NICE CEO, Gillian Leng, has outlined the challenges she sees with the ‘tsunami’ of digital health technologies being adopted by the NHS. She stated that NICE was reviewing how it could expand its review of digital technologies being used by the NHS. As NICE really can’t look at all of them they are having to prioritise where they will best add value in determining which technologies will cost effective or cost saving. Dr Leng said: “I can definitely say it would be wonderful to have more funding”, and acknowledged the regulator had “some flexibility” in how it spent its money, but added this was constrained by the requirement to assess all new drugs and added it was “an interesting question as whether we might charge MedTech or digital companies for assessing their products”. She believed It would be really good if the system could be clearer about the reimbursement mechanisms for digital technologies and MedTech.


24th December 2021

NHS England has issued planning guidance for 2022/23 outlining 10 priorities for the system. A number of these relate to use of digital technology.

  • Improve the responsiveness of urgent and emergency care (UEC) and build community care capacity … by creating the equivalent of 5,000 additional beds, in particular through expansion of virtual ward models
  • Continue to develop our approach to population health management, prevent ill health and address health inequalities – using data and analytics to redesign care pathways and measure outcomes with a focus on improving access and health equity for underserved communities.
  • Exploit the potential of digital technologies to transform the delivery of care and patient outcomes – achieving a core level of digitisation in every service across systems.

This latter point is expanded upon to highlight that there will be “ support health and care systems to ‘level-up’ their digital maturity, and ensure they have a core level of infrastructure, digitisation and skills”.

Whilst a couple of others will undoubtedly also incorporate the need to accelerate use of digital health solutions:

  • Respond to COVID-19 ever more effectively – delivering the NHS COVID-19 vaccination programme and meeting the needs of patients with COVID-19.
  • Deliver significantly more elective care to tackle the elective backlog, reduce long waits and improve performance against cancer waiting times standards.

16th December 2021

The MHRA has issued its first in a series of guidelines on real world data (RWD) for companies to consider when planning clinical research using RWD to support regulatory decision-making. RWD are defined as data relating to patient health status or delivery of health care collected outside of a clinical study. The first of the series focuses on data quality; specifically points to consider when evaluating whether a RWD source is of sufficient quality for the intended data use.


1st December 2021

Aimed at NHS frontline leaders, NHSX has published its delivery plan describe what it has commissioned, and what is being delivered, when. The intent was to look ahead for the next 3 years, however the single-year Comprehensive Spending Review in 2020 has meant the delivery commitments set out in the plan are mainly focussed on the year up until the end of March 2022, and dates and deliverables beyond March 2022 will be subject to change.


22nd November 2021

HSJ are reporting that NHS Digital will be merged into NHS England as part of a re-organisation of the healthcare technology landscape. This follows the previous merger of NHSX into the Innovation Directorate at NHSE. As part of the changes, interim NHSD CEO Simon Bolton will become chief information officer of NHSE. He will report to NHSE’s transformation chief Tim Ferris, with a “reporting line” to NHSE CEO Amanda Pritchard. Both NHSX and NHS Digital will ‘retire’ their individual names. The Merger of NHS Digital will happen as soon as legislative changes can be put in place.


18th November 2021

During a speech at the NHS Providers conference on 17th November, Sajid Javid described the way digital technology is led in the NHS as ‘odd’, stating: “Although we’ve seen some phenomenal work on digital transformation during this pandemic from so many people, it does strike me as a bit odd, let’s say, that digital leadership is currently split between NHSE, NHSX and NHS Digital.” Adding “I’m very interested in seeing how we can bring together critical decision makers, whether it’s at a local or national level.”

There is some interesting background to his comments as we still anticipate the, much delayed (it was due late 2020), publication of a review of NHS tech leadership by Laura Wade-Gery, that was commissioned by Matt Hancock last year.

Given development elsewhere with HEE being incorporated into NHSE it’s possible that anything could be on the table.


19th October 2021

HSJThe “digital aspirant” programme, switched the focus from the best-in-class trusts to the laggards whose digital maturity remained low, awarding funding up to £6m of funding over several years to bring their tech infrastructure up to a “core” level. Now more than 30 trusts have joined the programme and two clear patterns have emerged. Firstly, that many of the aspirants have decided to team up with neighbouring organisations to pool their allocated resource for an integrated care system-wide project. Secondly that EPRs are by far the most common technology requirement among the second and third cohorts of aspirants, be that to either increase the functionality of their existing systems, or review and potentially buy new systems.


11th October 2021

Health Data Research UK funding to inform design of UK digital research environments

HDRUK, UKRI, and Administrative Data Research UK have launched a £2 million fund to develop and progress a UK-wide digital research infrastructure. The programme aims to attracts 10 ‘Sprint Exemplar Projects’ that will inform its DARE UK programme on developing a ‘Trusted and Connected Data and Analytics Research Environment’.
DARE UK was launched in July to consult on approaches for Trusted Research Environments with an aim to ensure efficient sharing, linkage and advanced analysis of data in an ethical and secure manner.

The call is looking for technology that can help improve data discovery, improve metadata management or support application programming interfaces, such as for the development of federated analytics, data visualisation or automation. It’s also seeking support for the development of privacy enhancing technology, in line with its outline on trusted research environment processes.


10th September 2021

NHSX has released an Information Governance Framework for Integrated Health and Care on Shared Care Records (ShCR), previously known as Local Health and Care Records, to provide an example of a structured approach to deliver a ShCR, based on a model where ‘controllership continues to remain local’. It states: “Local agreements will be in place to set out what data is shared and who can access it in a safe, secure and appropriate manner.”
It’s expected that all Integrated Care Systems (ICSs) will develop or join a ShCR. The IG Framework also provides professionals with the tools and templates they need to support implementation of Shared Care Records.

The following requirements are described as “essential for IG compliance and good practice

  • Have a consistent approach to IG policies, processes and systems to ensure good practice
  • Identify the flows of data, and at each point in the process to determine who the controllers and/or processors are
  • Identify and understand the legal basis for processing data for every function including ensuring transparency about purpose and process, supporting good practice, and promoting public engagement
  • Manage access controls and records management
  • Consider patient and service user objections to processing
  • Adhere to current published guidance on cyber security for health and care
  • Ensure that any relevant due diligence checks are carried out where processors or sub-processors are involved
  • Document the decision-making process to demonstrate accountability.

23rd August 2021

The Council for Science and Technology, co-chaired by Sir Patrick Vallance and Lord John Browne, has published a report “Harnessing technology for the long-term sustainability of the UK’s healthcare system”. It sets out two priority areas:

Priority 1: Supporting a step-change to improve and maintain population health, centred around new ways of engaging and supporting individuals and communities, enabled by data and evidence focusing on 4 areas

  1. Monitoring population health risk factors:
  2. Enable informed choices:
  3. Digital engagement for improving health literacy:
  4. Designing user-centred approaches to improve services:

Priority 2: Re-engineering the health system to support integrated ‘pathways’ for prevention, treatment and care and better outcomes for individuals. This relates to Digital consultation tools, diagnostics and advances in remote monitoring and increased use of hospital at home.

It provides three recommendations to government for implementation:

  • Recommendation 1: The government should set up at least two significant scale Demonstrators to test the system-wide application of healthcare technologies
  • Recommendation 2: The government should establish a ‘National Centre for Health System Improvement’ to build capacity and skills for system transformation
  • Recommendation 3: The government should work with NICE, regulators and the research community to promote the development of an evidence base to underpin effective use of digital health technologies as part of care pathways.

17th August 2021

Health Tech Newspaper: NHSX has opened up applications for digital perioperative pathway support, through a new fund, with the aim of helping Integrated Care Systems (ICSs) to streamline services. The Perioperative Care Adoption Fund, part of a wider collaboration between NHSX, NHS England and NHS Improvement, and Getting It Right First Time (GIRFT), will allow applicants to apply for up to £500,000 for an organisation.

NHSX is seeking initiatives that will digitise the perioperative care pathway, with preoperative assessment “that are pathway agnostic” and “eConsenting”, the priorities for this financial year, with a “focus on Enhanced Recovery After Surgery to follow”. Although, NHSX adds that “solutions which scale the end-to-end pathway are highly desirable and welcome”, too. The focus of the fund will be on the transformation of High Volume Low Complexity pathways.


16th August 2021

In May, the European Union became the first governmental body in the world to issue comprehensive draft regulations aimed specifically at the development and use of AI. The regulations would have extraterritorial reach, so any AI system providing output within the EU would be subject to it, regardless of where the provider or user is located. This article from McKinsey provides a good summary of the proposals as well as suggestinos on how organizations may prepare for their future introduction EU.


27th July 2021

NHS Digital launches Data Uses Register to improve transparency about how patient data is accessed. NHS Digital aims to continue to improve transparency through the Data Release Register. The new interactive tool makes it easier to see which organisations access data, the purposes for which they are permitted to use it and the expected benefits. Organisations using the data may be public sector bodies, charities or commercial organisations. They must all have a legal basis and legitimate need to use the data, which will only be used for health and care planning and research purposes.


21st July 2021

A Healthwatch (HW) poll warns that despite people largely trusting the NHS, they lack confidence that companies will be held accountable if they misuse the data. Among the findings were:

  • People still largely trust the NHS with their data. 83% of people rated it as either “very” or “moderately trustworthy” when asked if they thought the health service would keep their data safe. However, this has fallen from 92% from similar research conducted in 2018.
  • Willingness to share data appears to have dropped considerably. 53% of people said they were happy to share their data compared to 73% found during the 2018 study.
  • People are not necessarily actively against their data being used. Almost a third (29%) of respondents said they were undecided about whether to opt out or not of the latest plans. In 2018, when we asked a similar question, only 16% were unsure.
  • Over half of respondents (54%) said they were not confident that companies that misuse data would be fined appropriately. Yet, 46% said they would be less likely to opt-out (i.e. more likely to share their data) if this was addressed.

20th July 2021: GPDPR September implementation date is scrapped

The implementation date of the GP Data for Planning and Research (GPDPR) programme, originally planned to go live from 1 July 2021, has been scrapped and instead data collection will now only begin when the following criteria are in place:

  • The ability to delete data if patients choose to opt-out of sharing their GP data with NHS Digital, even if this is after their data has been uploaded
  • The backlog of opt-outs has been fully cleared
  • A Trusted Research Environment has been developed and implemented in NHS Digital
  • Patients have been made more aware of the scheme through a campaign of engagement and communication.

Full details can be found in the a letter from Jo Churchill (minister for primary care and health promotion), which set out a new process for commencing data collection.

The letter also outlines developments in the opt-out process “to make the position around opt-out much simpler” and also addresses issues of data security and governance stating that “access to GP data will only be via a Trusted Research Environment (TRE) and never copied or shipped outside the NHS secure environment, except where individuals have consented to their data being accessed e.g. written consent for a research study”.


1st July 2021

NHSX has launched The Digital Health Partnership Award, a scheme created to help NHS organisations in England bid for funding to accelerate the adoption of digital health technologies that support patients with long-term conditions and are proven and ready to scale ‘at pace’. The award focuses on scaling digital products and services that can enable people to remotely monitor their health, either at home or in the community.

The three categories of funding available will be for projects requiring support of up to £100,000, £250,000, or £500,000.

The minimum eligibility criteria involves: being able to demonstrate productivity impact, effectiveness and sustainability of investment; whether the project has had previous, similar national funding; a clear and coherent delivery plan; local digital capability and sponsorship; financial sustainability to continue the work post 2021 to 2022. All winning bids will be required to meet and adhere to standards such as the Digital Technology Assessment Criteria (DTAC) and deliver evidence of success.