Digital Health and Introducing Innovative Technologies in the NHS 22 September 2015 NATIONAL INFORMATION BOARD techuk.org @techuk #techuk
Digital Health and introducing innovative technologies in the NHS 22 September 2015 Exploring the opportunities and challenges for unlocking digital health investment and supporting the uptake of digital health technologies
Role of the Office for Life Sciences Office for Life Sciences (OLS) overarching mission: To make the UK the best place in the world to discover, design, manufacture, and adopt 21st Century healthcare and life sciences technologies Generating: maximum health benefit for each 1 spent the wealth to pay for our rising healthcare costs high quality jobs Digital health one of the Department of Health s growth priorities: To create a more productive, digitised NHS and a world-leading digital health industry OLS contribution to create the right policy and business environment to stimulate a thriving digital health industry in the UK and to help facilitate quicker NHS adoption of effective digital health technology through the Accelerated Access Review 3 3
Ambition for a digitised health and care system By 2020: - all care records will be digital, real-time and interoperable 2015 2016 2017 2018 2019 2020 Pilot NHS app assessment process NHS.UK alpha New innovation prize for digital tools to improve mental health outcomes Test bed collaborations selected Accelerated Access review considers digital health adoption All patients can access own GP electronic record online in full Review of security standards for patient data Guidelines for protection of personal data New consent and opt out model for patients One quarter of all UK smart phone users accessing NHS services and records online We will be paper-free at the point of care in primary, urgent and emergency settings Patients can access a record of all of their health and care interactions Key healthcare professionals will have access to digital skills development All care records including social care will be digital, real time and interoperable 4
Ambition for a world leading digital health industry By 2020: - the UK digital health market will increase in value to 3.5bn and digital health employment will rise from 11,000 today 40.0% 35.0% 30.0% 25.0% UK digital health markets 2014-2018 growth forecast 35.1% 24.6% 24.0% UK digital health market, 2014 4% 5% 5% 8% 20.0% 15.0% 10.0% 5.0% 4.4% 13.2% 6.0% 66% 13% 0.0% Telecare Telehealth Applications Wearables Health Analytics Projected Compound Annual Growth Rate (CAGR) - 2014-2018 Digital Health Systems Applications Telehealth Wearables Health Analytics Telecare Digital Health Systems Source: Deloitte Analysis for the Office for Life Sciences 5
Known challenges to digital health adoption Investment in underpinning infrastructure Data standards System and organisational interoperability Multiple buyers and purchasing practices Technical Proprietary systems Budget silos Nascent business models Regulatory pathways Structures & processes in the healthcare system Market & supply Evaluation methods that keep pace with tech time Clinical testing grounds Cultural Procurement rules Public trust in health data and tech Clinical enthusiasm Changes to ways of working Information governance and data sharing Lack of health informatics skills 6
Current activity to support the uptake of digital health National Information Board A collaboration of health and care organisations from the NHS, social care, public health, clinical science, central and local government setting the direction for the transition to a paperless health and care system by 2020 Challenges addressed: - Technical (interoperability and data standards) - Cultural (digital leadership and skills of healthcare professionals; public trust; information governance) - Structures & processes (app assessment) 500+ global innovators attended London briefing event 375 Expressions of interest from companies. 39 potential test bed sites 260 selected to brokering events Partnership building TEST BEDS Accelerated Access Review An independent review aiming to speed up access to innovative drugs, devices and digital health treatments for NHS patients Test beds Sites for testing the real world impact of technologies, with a digital element including internet of things, at scale. Matching innovations with the challenges faced by local areas in England. Challenges addressed: - Structures & processes (articulating need for innovation; accelerated development pathways; affordable national funding models; uptake and adoption) Challenges addressed: - Structures & processes (clinical testing grounds) - Cultural (changes to ways of working, clinical enthusiasm) - Technical (system and organisational interoperability) 7
NATIONAL INFORMATION BOARD Helen Arthur The work of the National Information Board
Digital health in the Accelerated Access Review Tuesday 22 nd September 2015
The review aims to accelerate access to innovative drugs, devices, diagnostics and digital products for NHS patients. Good for patients o Opportunity to access novel drugs and treatments more quickly Good for the NHS o o Simplifying and joining up processes Making good, cost-effective, products available to patients more quickly driving potential for better outcomes at the same/lower cost. Affordability will be front and centre of the review. Good for research organisations and charities o Embedding them and their patient populations in the process from the start Good for business o o Simplifying pathways and joining up assets in existing landscape Giving good products earlier access to patients (generating data, demonstrating value) Good for this country o Making us the best place in the world to design, develop and deploy innovative products 10
Context: The review is focussing on end-to-end pathways, drawing together four workstreams underpinned by patient views. Three end to end pathways: a Medicines: to include developing/refining future-proofed pathways for genomics and precision medicines (with companion diagnostics). b Medical technologies: to include developing/refining future-proofed pathways for standalone diagnostics. c Digital health: to include designing pathways tailored specifically towards next generation digital products and addressing particular issues e.g. designing technology risk stratification principles and acknowledging data interoperability requirements Addressed via four workstreams, each with an external champion: 1 Articulating need, priorities and principles for innovation Dr Stuart Dollow, Vermilion 2 3 4 Affordable Accelerated national funding development models to drive pathways innovation Prof Richard Barker, CASMI Richard Murray, King s Fund Supporting affordable uptake and adoption Rob Webster, NHS Confed Underpinned by patient and user engagement: Patient and user engagement Hilary Newiss, National Voices 11
There is a clearly defined decision-making process within the review s governance structure. As the review s independent Chair, Sir Hugh Taylor will make recommendations to relevant ministers (Minister for Life Sciences/SofS Health) Sir Hugh s recommendations will have input from: o Professor Sir John Bell and the review s External Advisory Group; o The review s strategic steering group, Chaired by Una O Brien; o The review s Stakeholder Reference Group o The workstream champions; o The review team, staffed by OLS and DH officials and secondees from key stakeholder organisations; and, o Wider stakeholders. None of these groups have a veto on recommendations made by the review s final report, which will be made by Sir Hugh Taylor. 12
Each workstream has a clear purpose and scope, and workstream leads will work closely to ensure that their recommendations focus on joined-up, end-to-end pathways. Workstream 1 will develop a transparent framework for early dialogue and collaboration which drives transformative innovation and supports partnerships from end to end. Scope: Horizon scanning; Identifying patient and NHS needs and sharing with innovators; Early dialogue on value of innovation; Early advice services; Strengthening partnership and collaboration. Workstream 4 aims to accelerate the speed at which clinically and cost effective innovative products are commissioned and get to NHS patients. Scope: Commissioning, adoption and diffusion i.e. from agreement on reimbursement levels to the point at which a product is being used across England; Incentivising decision makers to drive uptake of appropriate innovation, inc. financial incentives; Streamlining routes to market/contracting; Leverage of wider govt/alb initiative. Patient input Workstream 2 aims to streamline regulatory processes and articulate a clear accelerated process for innovative products; or to build a best practice pathway where this does not exist. Scope: Regulatory processes (fast-tracking opportunities); Evidence requirements agreed across stakeholders, inc. for products with small patient populations; Review of Early Access to Medicines Scheme; EU legislation flexibilities, medium term reform. Workstream 3 will propose solutions to integrate or accelerate national reimbursement processes and fund clinically and cost-effective innovation across the pathway. Scope: NICE framework and scope Flexible reimbursement models Tariff Concepts of affordability and value Out of scope: 2014 PPRS, QALY design and threshold
Aim of today s workshop What are we trying to achieve? Digital health products are part of the new innovative solutions to which we want to accelerate access, so we need to ensure that the Review s workstreams are sufficiently considering issues relating to digital alongside pharma, med tech and diagnostics. Today s workshop aims to: Ensure the review considers the digital pathway to the same degree as the pharmaceutical pathway. Engage the right stakeholders from across the digital landscape to help us ensure we know what the issues are and can identify solutions (specific to all four workstreams) Begin to find potential solutions to the barriers across all workstreams
Scope: The scope for digital health in the review is being bench-marked against the following criteria: 1) Is it an innovation for the NHS and citizens and 2) does it focus on treatment. The work of the National Information Board (NIB) will be of relevance for the review. In particular, NIB workstream 1.2 focusing on providing citizens with access to an endorsed set of NHS and social care apps. DIGITAL HEALTH In scope Out of scope Telecare Telehealthcare Telehealth Wearables mhealth Applications Digitised Health Systems Health Analytics Activity/fall monitoring Medication management * LTC monitoring Video consultation Digitised Med Devices e.g. consumer grade devices and clinical grade devices Medical Apps Website/Social Media Gamification Patient health digital records Hospital held digital records Genomics Precision medicine * Data Analytics Wellness Apps Fitness Apps * where this is directly contributing to treatment e.g. data analytics to interpret data from telehealth monitoring.
Overlap with MedTech Stand-alone software including apps Some software applications (apps), which are used on smart phones and computers, can be considered a medical device in their own right if they have a medical purpose. These are called stand-alone software or stand-alone medical devices. This doesn t include software that is part of an existing medical device such as software that controls a CT scanner as it is seen to be part of the device already and not stand-alone in its own right. Medical purpose Software that has a medical purpose could be a medical device. A medical device is defined in the Medical Device Directive (MDD) as software intended by the manufacturer to be used for the purpose of: Diagnosis, prevention, monitoring, treatment or alleviation of disease Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap Investigation, replacement or modification of the anatomy or of a physiological process Control of conception If a software/app meets the definition of a medical device, it must be regulated by MHRA as a medical device. This is where the digital health strand of the AAR cuts across MedTech.
Barriers Initial conversations have already identified some barriers to uptake that are specific to digital health. These fall into one or more of the review s workstreams: Success and failure receive asymmetric rewards successful innovations often don't benefit the NHS innovator much, whereas failure can be a life sentence. This in turn can result in: Procurement that is lengthier than it need be, and favours established suppliers (workstreams 3 and 4) An unwillingness for large companies to promote innovation; (worksteam 4) Clinical risk aversion; (worksteam 4) Much better cross organisation/departmental cooperation is required because: Investment and benefit realisation can take place in different places, so the investing organisation does not automatically receive the rewards of success; Digital health typically requires disruptive process change to deliver efficiencies; Budget silos promote the status quo; Absent an appropriate campaign to persuade, the public still votes for retention of hospital beds.
Barriers (cont d) Clinicians resist change, in part because of a fear of loss of control (workstream 4) Although it exists for pharma, there is no agreed realistic means yet of appraising the effectiveness of digital health innovations; What should be the role of NICE? (workstream 3) There is confusion over the regulatory pathway for digital health innovation (workstream 2) The public requires greater assurance of personal data security/privacy (workstream 4 and 5) Outside the Testbed programme, there is a lack of adequate real world testing facilities (workstream 2) There is a lack of: Interoperability across systems (workstream 4) Appropriate data standards (workstream 4) Visibility of what s available (workstream 4)
Barriers (cont d) As a disruptive innovation, digital health throws up opportunities that are hard to anticipate well in advance, so some lack of clarity between clinical need and clinical deliverable is unavoidable (workstream 1) Small start-ups are the main source of digital innovations, yet have little experience of selling to the NHS; engaging with these can be difficult (workstreams 3 and 4) Innovations have immature business models, and short track records (workstream 4) There is a lack of provision for iteration and improvement on the design of digital health apps that reach the hands of clinicians. This is partly an effect of procurement processes, but may be a barrier to the adoption of other digital innovations in future; a concern that poor design will make it more hassle than it s worth (workstreams 1 and 4)
Accelerated Access Review Table discussions 1 An opportunity to discuss issues faced by digital health innovators selling into the NHS focus on work streams 3 and 4
Accelerated Access Review Table discussions 2 Continuing the conversation and discussing the issues faced by digital health innovators - focus on work streams 1 and 2
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