1. Digital health in the Accelerated Access Review DHACA Day Event Monday 11 th January 2016

2. The Accelerated Access Review 2 Digital health products are part of the new innovative solutions to which we want to accelerate access, and so we have been engaging the digital sector to ensure that the Review is sufficiently considering issues relating to digital alongside pharma, med tech and diagnostics. The Accelerated Access Review independently chaired by Sir Hugh Taylor aims to revolutionise the speed at which 21st century innovations in medicines, medical technologies and digital products get to NHS patients and their families.

3. The review so far 3

4. Accelerated Access Review interim report The AAR’s interim report was published on 27 th October. It sets out a vision of a lit runway for innovation that: accelerates access for NHS patients to the small number of new products that promise to be truly transformative, and supports all innovators through the regulatory, evaluation and reimbursement stages of the pathway to give their product the best chance of succeeding. This is underpinned by a focus on: empowering patients by giving them the opportunity to be an active participant in decision-making, and harnessing and enhancing existing structures in the health system to align their goals and help deliver the aims of the review. The review is centred on five propositions that set out this vision in more detail and describe the areas of focus for the next phase of the review: Getting ahead of the curve Galvanise the NHS Putting the patient centre stage Delivering change Supporting all innovators 4

5. 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. 5 Mobile health Apps (medical apps, prevention, CBT, med management) Wearables Game-ification Telehealth and telecare Activity/fall monitoring Remote consultations Digital medtech Intelligent orthopaedics Medical imaging Diagnosis Chronic conditions Wellbeing Infrastructure Acute care A digitised health and care system Clinical software e.g. e-health records Digital services e.g. transactions, e- prescribing Secure data storage Data enabled health Health analytics Bioinformatics Data for decisions LTC monitoring Ingestible/ implantable sensors 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”.

6. Known barriers to uptake 6 Technical Market & supply Cultural Structures & processes in the healthcare system Multiple buyers and purchasing practices Budget silos Clinical testing grounds Public trust in health data and tech Clinical enthusiasm Changes to ways of working Procurement rules Data standards System and organisational interoperability Information governance and data sharing Investment in underpinning infrastructure Unfamiliar business models Winning business in the NHS We regularly hear that these in particular are the key issues for app developers. Regulatory pathways Evaluation methods that keep pace with tech time Lack of health informatics skills Tendering requirement

7. Proposed areas for recommendation 7 HORIZON SCANNING: ROLE OF AHSNs: DIGITAL PATHWAY: TENDERING: COMMISSIONING & PAYMENT: Developing stronger, more systematic mechanisms for horizon scanning and a more transparent decision making process for identifying and prioritising the most promising digital health solutions. Developing the network of AHSNs to strengthen their coordination role and facilitate a network of local innovation exchanges that ensure the patient voice is heard by innovators, commissioners and providers.  Setting out a new pathway for digital products that clarifies the steps involved in getting to market.  Setting out a managed access pathway with an early promise designation for the most promising digital health solutions.  Building the work of the NIB 1.2 app assessment process into the review’s recommended pathways.  Recognising the heavy tendering data requirements which often disadvantage SMEs.  Promoting the use of digital health solutions in tender specifications and other documentation for CCGs.  Recognise the barriers to commissioning digital health and issues faced by SMEs having to sell to over 200 CCGs – no standard template for evidence requirements. Propose that NHS England works to address these.  Flexible funding models for most promising digital health solutions.  Explore the use of Article IX of the drug tariff for primary care prescribing of digital. SUPPORTING INNOVATORS:  Developing ‘how to guides’ for navigating the innovation pathway  Guidance for AHSNs and CCGs around commissioning and uptake of digital health solutions.

8. Emerging recommendations – what could the digital pathway look like? Ongoing dialogue to provide support at checkpoints throughout the accelerated access pathway Early dialogue via innovation exchanges Promising Device Designation Marketed product available to NHS via routine commissioning with supported uptake Business case development via provider-innovator partnerships Regulatory approval CE mark awarded, If appropriate Full endorsement Temporary/ permanent funding decision Self-evaluation Community evaluation Business case development via provider- innovator partnerships Business case developed NIB workstream 1.2 RWD collection (clinical and economic data) Clinical studies Uptake assessment Business case developed Other products Patient-facing products (within scope of NIB workstream 1.2) Innovator & AHSNsInnovator & providersNotified BodyInnovator & NHS (national) InnovatorAHSN with support from innovators Innovator, NIHR, NHS National Innovation Partnership (core members: DH, NHSE, MHRA and NICE with delivery partners across the devolved administrations) CE mark required for devices entering the NIB 1.2 process Managed Access Pathway HTA Recommended for routine commissioning 8

9. January February March April 15 Pharma Pathway Event 19 Digital Pathway Event 28 Med Tech & Diagnostics Pathway Event RAND research How to guide production Int review Report Writing redrafting Report sent to PS(LS) 26 National Voices Event 4 Engagement Site Closes Evidence analysisEvidence Centre Report RAND Report How to guide 2 nd Draft Report Ext review redrafting Govt response production 1 st Draft Report Pre launch pitch-rolling Final Report & Govt response Policy Development 15 EAG 7 EAG 7 SSG ?1 SRG21 X-govt PWC work PWC Report SHT GF catch up Recs drafting NEXT STEPS – AAR TIMELINE 9

10. Any questions? 10 CONTACTS  Tamsin Berry, Head, Accelerated Access Review Team – (Tamsin.Berry@officeforlifesciences.gsi.gov.uk)Tamsin.Berry@officeforlifesciences.gsi.gov.uk  Jazz Bhogal, Incoming Head of AAR Team – (Jazz.Bhogal@dh.gsi.gov.uk)Jazz.Bhogal@dh.gsi.gov.uk  Usama Edoo, Digital Policy Lead for AAR – (Usama.Edoo@officeforlifesciences.gsi.gov.uk)Usama.Edoo@officeforlifesciences.gsi.gov.uk