As someone outside government who was drawn into the digital health stream of the AAR, this blog aims to capture key learnings from the experience.
The initial list of obstacles to innovation in the NHS was depressingly long, until carefully differentiated. Top of the pile were items like the NHS’s asymmetric attitude to risk – successful innovations are forgotten, unsuccessful innovations are a life sentence for those involved – which are soluble only by those at the very top.
Then there were the surmountable challenges – for example the fear, uncertainty and doubt over digital health regulation was overcome by DHACA’s 44-page summary of the processes for commissioning, developing and acquiring medical apps. Another such was the difficulty of assessing the benefit of a medical app vs other types of intervention, such as comparing an anti-depressant vs a CBT app to reduce depression: that is the topic of the NIB Workstream 1.2 process. Yet another is concern about personal data security, being dealt with by the EC data privacy code for medical apps (still in draft).
Finally there are items that are essentially facts of life that have to be lived with. For example, recent innovations do not have long track records; smaller companies tend to be more innovative and innovations have immature business models.
Unlike for medicines and medtech, there wasn’t a digital health process to accelerate, apart from the primarily-regulatory focus of the DHACA process mentioned earlier, so we had to build one from different pieces, which proved hard: for apps that qualify as a medical device, a clinical evaluation is necessary before they receive CE certification, whereas the Workstream 1.2 process has the equivalent of a clinical trial at Stage 3, well after CE certification. This duplication is currently unavoidable as the MHRA is legally bound not to disclose information, even to NICE: clearly an issue for resolution…and one now well recognised.
To tender or not to tender?
Of perhaps greatest interest to digital health suppliers is how it is sold to the NHS. Competitive tender provides a viable route that complies with EU law though SMEs continue to be at a disadvantage in contrast to larger and more established innovators. SMEs – by far the largest creators of digital health innovation – can neither afford dedicated bid writers nor easily answer requests like:
- Please give details of three existing implementations of your product…
- Please provide financial accounts for the past three years…
- Please detail savings already achieved using this product over the past five years…
There is of course an exemption below which competitive tendering is not required by EU law. However local regulations may void that: as the NHS will not allow the holding of inter-year balances, in order not to lose funds they are often transferred to another public body (e.g. a council). Then, local regulations apply – for example it’s not uncommon for a full competitive tender to be required for purchases over £5k whether toilet paper or telehealth. Even if a sensible agreement can be reached for a trial below EC competition rule levels, it will of necessity be small, and small trials hit digital health especially hard.
The importance of the right care pathway
This is the key issue. Medicines typically work chemically. Therefore even if only a small trial of a medicine takes place, almost irrespective of the care pathway in which that trial sits (there are some limits), the chemistry is likely to work and the medicine will have its effects.
Digital health however normally works differently: it is a technology that enables care to be delivered in a fundamentally different way. Therefore it is only effective in its own care pathway. For example if you give patients telehealth and the community health team continues to treat them as previously, costs will rise and benefits will be small (sound familiar?).
Therefore small trials are a particularly inappropriate way to introduce digital health. The size and the use of the word ‘pilot’ or ‘trial’ mean that staff have little incentive to change care pathways at all, or sufficiently, to deliver the benefit, because it is a small part of their daily work, and “it’ll be gone soon anyway”.
Other ways of buying
So what of the options? Well there are of course framework contracts, of which perhaps the best known in the UK for digital health services is the UK Government’s Digital Marketplace, which because they are based on a competitive tender are fully EU compliant. ESPO is also developing a new telecare and telehealth products category. These are instantly accessible by purchasers without further tender as long as local rules don’t prevent it.
A different tack, used most visibly by mental health technology companies like IESO & Big White Wall is to wrap the technology up as an overall service. That overcomes care pathway-related issues as the supplier is then in control of at least part of the pathway. Of course it relies on the NHS being willing to tender the service – however if it does, the ability of technology-enabled services to stand alongside conventionally delivered ones cuts out many of the technology adoption-related issues, albeit at the expense of criticisms of ‘privatising the NHS’. (It’s also interesting to note that research shows that the better way to become a millionaire is to build apps into a service, not sell them on their own.) Unfortunately some apps with huge potential to improve patient outcomes and reduce costs cannot easily be turned into services without significant NHS engagement, such as Humetrix’s SOS QR. This saves valuable time in an emergency and reduces avoidable clinical error, though requires significant and currently unavoidable NHS engagement.
Medicines of course have been around much longer than digital health products and services, so it’s unsurprising that there are lessons to learn here, in particular that many claim uniqueness. Genuine uniqueness of course negates the need to tender, and sufficient evidence of effectiveness gets the drug into the British National Formulary (BNF) from where it can be prescribed by professionals. It is encouraging that the AAR and NIB are considering what the commissioning offer is for apps that pass all four stages of the workstream 1.2 process.
The AAR team, from Sir Hugh Taylor down, are to be congratulated on the extent to which they have explored how best to accelerate the uptake of innovation into the health service. There are now many more people in government who understand the topic well and so will work to improve uptake. I am optimistic that the one remaining issue of improving SME access to the NHS can be sorted. Perhaps then we can look people in the eye who remind us that the average time for an innovation to be accepted by the NHS was 17 years and say “no more!”.
Thanks in particular to all the AAR team, and to Andrew Chitty for their improvement suggestions.
(Disclosure: Charles Lowe is Managing Director of DHACA and was managing editor of DHACA’s 44-page summary of the processes for commissioning, developing and acquiring medical apps – the team producing this was led by Rob Turpin of BSI. Charles also gives occasional advice to Humetrix Inc., supplier of SOS QR)