DHACA (the Digital Health & Care Alliance) is a not-for-profit member-driven organisation set up by Innovate UK to help catalyse the market in digital health and care by addressing some key obstacles and points of market failure on a bottom-up, consensus-based approach. Key topics being addressed include:
- Interoperability and consensus on basic architectures
- Information governance, identity and consent
- Evaluation of impact and benefits of new products and services ( for example, in testbeds)
- Business models
- Models for supported self-care
- Certification and quality-assurance processes for mobile apps
These have been identified as the main barriers, both to SMEs and innovators entering the market, and to health service managers attempting to improve services using digital technologies. SMEs particularly really struggle to get past the “pilot” or “demonstrator” stage. DHACA’s work is specifically aimed at making it much easier for SMEs, for example by working out and agreeing more pragmatic approaches to evaluation of impact and generation of evidence than the “RCT” clinical trial model , which is a particular barrier that few digital health SMEs currently manage to surmount. Interoperability and interaction between patient-facing digital health services and professional clinical systems is another critical barrier that DHACA is addressing.
DHACA is ensuring that the learning from the DALLAS programme is being carried forward, made available to, and enriched by, the digital health & care community in the UK. Innovate UK support means that DHACA can remain accessible to all SMEs, unlike other expensive trade organisations and lobbying groups that effectively exclude all but the larger UK organisations and multinationals. DHACA is truly open and includes representation from global healthcare companies, NHS trusts, local authorities, SMEs, and micro-startups, and is unique in this space in its inclusivity, breadth, and technical depth.
A striking feature of DHACA’s NIB engagement has been the extent to which our opinions and views have been sought by senior figures with a health & care interest. To date, we have met/spoken with, among others, the MHRA (to CEO), NICE (to Board Director level), Department of Health (to Deputy Director), Monitor, Office of Life Sciences, NHS England (to Board Director level), HSCIC, Public Health England (to Deputy Director), AHSNs (esp NWC & KSS, to CEO), MediCity (to CEO), NHS Scotland (to CMO), European Commission (to Director), Barclays Bank (to Senior Director level), European Connected Healthcare Alliance (to CEO), Wragges, Baker Botts & other lawyers (Partner), DHI Edinburgh (CEO), Scottish Centre for Telehealth & Telecare (CEO), ADASS, BSI (Director), NIHR, etc.
As a result, DHACA can claim to have a significant influencing role, both to members and from members which over the coming year we will seek to develop further, particularly policy makers & commissioners.
The emerging theme from all the work DHACA has done with its members so far is the promotion of self-care as a major contributor to enabling the NHS to thrive in the 21st century in the face of significant demographic change and raised patient expectations. The following section describes the workplan for 2015-6, with a brief reference to recent history. The work can be summarised as:
- Regulatory – ensuring that a fair regime for medical devices (notably apps) is equitably applied and well-understood by all parties, that minimises the risk of death or injury, without unduly restraining innovation;
- Trust-building – engaging in initiatives to encourage trust in technology use by both professional & end users;
- Clarifying – working for a simple means of determining the applicability and relative effectiveness of technological interventions, and where appropriate giving a fair comparison with drug and other interventions;
- Simplifying – the development process, so that it is well understood by all parties, encouraging interoperability, accelerating the i2i (innovation to first intervention) time for medical technologies;
- Educating – both professional & end users on the benefits of self-care.
We plan to continue running four of these events per year. Their primary purposes are to seek member feedback on priorities, to disseminate new information, and to sustain & grow the SIG activity.
For our event on 23rd September, we are experimenting with making a small charge (£25+VAT), with the objective of making them at least cash-neutral after covering catering costs, assuming as is the case for the September meeting, we can secure a meeting place free or at low cost. (Applicable to 1-5 above).
The plan for DHACA days has primarily involved a mix of member engagement, presentations, networking and SIG work, although the most recent one (and according to many attendees most successful) at the RSM was dedicated entirely to consultation feedback & SIG work.
Another key role is disseminating information to members to ensure the community is aware of important developments. This is done at quarterly meetings, via regular emails, and on our website. In addition, regular blogs from both the DHACA and the TelecareAware websites keep the wider membership and thinking-of-membership well informed.
To support the earlier comments about influence, DHACA plans to develop this activity further to become the touchstone for interaction between Innovate UK, the wider health & care hierarchies, and DHACA members.
National Information Board (NIB) responses
Following extensive responses from DHACA to the Personalising Health & Care to 2020 paper from the NHS NIB, DHACA has been invited to join the advisory boards of:
- Workstream 1.2 – medical apps
- Workstream 5 – life-saving interventions
- Workstream 6 – educating the workforce
As a result, DHACA has played a key role in assembling and passing on comments from members. As yet there is no independent revenue stream evident for DHACA from this work; although it is clearly vital to ensure that the views in particular of healthcare technology SMEs are represented whilst plans are still being formulated. (1-4 above)
EC Code of Practice for Medical Apps
DHACA made a major response to the EC Green Paper on mHealth last year, with substantial membership engagement, with the result that we were invited to take part in the development of a voluntary code for information privacy for medical apps. With the experience of being in the group that produced the BSI PAS277 voluntary standard for medical apps in the UK, DHACA now participates actively in the ‘core’ EC group producing the EU code. Plans have been laid thereafter to work on assessing the efficacy of medical apps (a key DHACA interest) and extending the PAS 277 to the EU. As this work is not remunerated by the EC, DHACA is the only organisation involved representing small businesses; with the exception of Digital Europe, the other seven participants all represent large multinational technology companies or legal firms. (2 above)
MHRA & NICE intervention
Another key role DHACA is beginning to play is to ensure that the medical device regulatory system is working fairly in the UK. To date this has primarily involved the MHRA although we have also met with various people from NICE too. DHACA was the first (and we believe only) organisation to get the MHRA to remove a dangerous app – Mole Detective – from the Google Play app store, and to challenge the MHRA to establish a process for advising current users of bad apps of the dangers of their continued use. A recent meeting with the MHRA revealed that they were now becoming increasingly proactive, having recently contacted 46 insulin dosage apps that should have been CE certified, 45 of which had been shown to be dangerously inaccurate. We shall continue to perform this important – though unremunerated – activity on behalf of our members in the hope of avoiding a serious incident that could seriously set back the use of mobile technology to improve patient outcomes. (1 above)
Accelerated Access Review (AAR)
Perhaps because of our extensive responses on behalf of members to both the NICE & MHRA Triennial Reviews earlier in the year, DHACA has been invited to the Advisory Board of the AAR, being run primarily by the OLS. Recently we have given considerable assistance on behalf of members in producing draft consultative material, and look forward to aggregating a full response from our members. This is essentially short term, and of course not independently remunerated. However we remain active in looking for longer term – hopefully remunerated – opportunities, as the AAR delivers. (4 above)
Digital Health Institute
DHACA has been invited on to the Advisory Board of the DHI and has already begun playing an active role. The principal roles of the DHI fit well with DHACA’s:
- Promoting accelerated uptake of digital health in the Greater London area, to improve patient outcomes and:
- …to promote exports of London-originating digital health technology & expertise.
DHACA anticipates taking an active role on behalf of members in the establishment of the Institute, to ensure that health & care SMEs get a good opportunity to benefit. (1-5 above)
DHACA spent a significant amount of time in the spring as part of a consortium of EU organisations bidding for EU funding under PHC 25 which covers integration of services for multimorbid patients. The resulting proposal, for Connecare, which also had a strong self-care focus, achieved a score of 14.5/15 which sadly meant it only ended up as first reserve – fingers are crossed that the top-rated project fails to make contract though the likelihood is small.
DHACA will continue to seek out aligned project opportunities from UK and EU funding mechanisms such as future Innovate UK programmes and AAL, H2020 such as this to participate in as it has much expertise and experience to offer via its 500-plus membership.
On 23rd September, DHACA will publish the first major result of our SIG work, covering processes for commissioning, developing and selecting medical apps. Currently these run to 36 pages and will be going out to comment by the full membership very shortly in anticipation of the final publication date. (4 above)
Over the year, publications on wearables and on patient education (5 above) are in plan.
Data governance & device security
As mentioned earlier, DHACA is actively participating in the EC code of practice which covers data governance for medical apps. This remains an important area for the Alliance and is now joined by the allied issue of device security, which we are hoping we can create a SIG for. (2 above)
AHSNs & other organisations
We believe we have been successful in obtaining funding from the NWC AHSN to co-brand deliverables such as the medical apps process document. We will continue to secure additional funding from other organisations alongside this. (any of 1-5 above, potentially)
Other consultations, competitions
For the past year DHACA has responded on behalf of its members to a range of consultations from health & care-related organisations and anticipates continuing to in future.