2015: a few predictions (UK-biased)

As intimated in our review of last year’s predictions, we feel little need to change course significantly, however some are now done & dusted, whereas others have a way to go. The latter include a concern about doctors, especially those in hospitals, continuing to use high-risk uncertified apps where the chance of injury or death of a patient is high if there is an error in them. Uncertified dosage calculators are considered particularly concerning.

Of necessity this is an area where clinicians are unwilling to be quoted, and meetings impose Chatham House rules. Suffice to say therefore that the point has now been well taken, and the MHRA are well aware of general concerns. Our first prediction therefore is that:

One or more Royal College/College will advise or instruct its members only to use CE-certified or otherwise risk-assessed medical apps.

The challenge here of course is that a restriction to CE-certified apps-only would be a disaster as many, if not most, apps used by clinicians do not meet the definition of a Medical Device and so could not justifiably be CE-certified. And apps are now a major source of efficiencies in hospitals – you only have to look at the (fully CE-certified) Mersey Burns app to understand the substantial reduction in clinician time, in this case vs manual assessment, plus the improvement in accuracy and thus patient outcomes, that an app can deliver. There would therefore have to be a means of assessing all commonly-used clinician-facing apps to check risk levels, much like the NHS apps library has begun to do – too slowly for many developers – for patient-facing apps. OurMobileHealth performs this role for specific (clinician and patient-facing) apps for specific organisations on a fee basis – this editor is unaware of any other similar clinician-facing service, so this would need sorting before instructions were issued if chaos is to be avoided.

The next (related) carryover from last year is the need for patients and doctors to have confidence in the efficacy of mobile apps before they can take off. This goes beyond the (very important) question of safety addressed in the previous prediction, also to ask how effective they are. Here our prediction is:

After a tumultuous and confusing debate, a mechanism will be found late in the year for NICE’s remit to be expanded to include medical apps; when implemented this will result in widespread prescription/recommendation by GPs, resulting in rapid adoption by patients and a substantial NHS drug cost saving.

In DHACA’s response to the NICE Triennial Consultation (which should be available on the Medical Apps SIG section of DHACA’s website very shortly) we mentioned some of the ideas jostling for attention:

  • One eminent GP & MP is reported as believing apps to be no different to books so not requiring regulation (see our refutation of this, subsequently supported by a leading lawyer in this area – very briefly, apps compute; books don’t);
  • The recent NHS paper entitled Personalised Health & Care to 2020 proposes a concept of ‘kitemarking’ apps which risks developing yet another classification alongside the existing Medical Devices Directive CE classes (and the NHS Apps Library?); by not going into detail in the risk assessment this is claimed as somehow avoiding Medical Device Directive classification (which it cannot actually do, by law: an app is either a Medical Device or is not, dependent on whether it meets the Meddev 2.1/6 definition, not how hard you look at it).

Surely it is better to use a mechanism already in place: NICE is widely recognised as expert at developing appropriate evidence gathering requirements (which will need to be developed for assessing medical apps fast), and would have the huge advantage that the effectiveness of apps could be measured in the same way as drugs, where both are able to treat conditions such as anxiety, depression, and severe pain.

Of course this issue is political, and of course there is a general election in May, so certainly a high risk prediction.

The final hangover from last year, and the only one where was no visible progress, was a prediction of concentration in the medical app market, which we felt should begin to follow the path of pharmaceuticals, increasingly becoming the province of large companies able to afford the expertise to obtain evidence and to analyse fully data received. As interoperability improves, they should also increasingly become components in more extensive service business models too.

The delay of course has been due to the uncertainty surrounding the regulation of apps. When sorted this in turn will begin to drive a concentration inthe supply side of the medical apps market as the cost of obtaining appropriate evidence of effectiveness strains the resources of smaller providers, and the logic of delivering end-end services prevails…which gives our next prediction:

When the regulation of medical apps is resolved, expect the real cost of safety and efficacy testing to drive a concentration in the marketplace.

Of one thing we can be certain: with eight billion mobile devices in use in the world, healthcare innovation will not stop; indeed this set of projections suggests (eg slide 20) that health monitoring will be the biggest single mobile growth area over the next five years. Today it’s apps, tomorrow…well read for example a brief summary of the thoughts of Yulun Wang, president-elect of the American Telemedicine Association…which leads us to an area that clearly deserves at least three predictions as well: wearables. They featured frequently in our posts last year, often with a note of caution at whether the growth rate could be sustained, or pointing out that it’s older, frailer, people who need them most not the twentysomethings to whom they seem apparently targeted.

The imminent arrival of the Apple watch is forecast by many, eg this CNET article, to change the outlook for the different types of wearables dramatically; competition from premium brands like TAG Heuer can only help promote the watch as the way forward (and also Fossil, which you’ll find in the middle of this gallimaufry of items put together by the BBC previewing this week’s CES, which includes a baby’s remote temperature-sensing dummy). In contrast to the UK’s stylish Onyx pendant jewellery, there’s now also a Swarovski Shine activity tracker jewellery range that includes a solar powered version. And trailers for the UK Wearables show are coming thick & fast, as well as Munich, Milan, San Francisco & of course Medica. One commentator has even gone so far as to suggest that the future of the NHS is in Apple’s hands. Certainly this editor, now on his fourth Jawbone Up in 18 months, has doubts about the durability of the more primitive wearables (although the device itself has changed his life greatly for the better). All this activity leads us to our first wearables prediction:

There will be casualties among major wearables companies.

If as seems increasingly to be the suggestion, the intended use of some wearables is monitoring vital signs for those in danger of an exacerbation, they surely cannot continue to escape serious regulation, implying that:

Those wearables with an intended use to help manage high risk patients will be brought within the Medical Device ambit and require to be appropriately safety-checked and MDD CE certified. 

However in a rapidly moving market such as this, the next big thing is never far away, which leads us to our final wearables prediction:

Amidst all the hype about watches and other wearables, look out for signs that the next generation of vital signs measuring devices – implantables – are getting a foothold.

Apart from issues like reliability, which is not unique to implantables (though genuinely a real pain if you have to return one for not working) there are two problems with implanted devices: power and fibrosis. Adding a self-powering mechanism to an implantable clearly makes it bigger, so harder to implant – the solution appears to be appropriately-tuned microwave energy. At a Chatham House rules event in December this editor was also told of a way of preventing fibrosis formation around implantables too. If both those technologies come good, and reliability is high, the outlook for the move from wearables to implantables must be good. Even if problems remain, don’t bet your life savings on wearables, especially if they don’t double up as fashion accessories!

Another area where there is much excitement is point-of-care-testing (POCT). This editor has been particularly impressed by advances in microfluidic manipulation which essentially now means that once you have identified the biomarker(s) for a disease, the panel is done, and the condition diagnosable. Measurement of precise concentrations is possible as well, even down to ppb & below. An example of things to come is DMI’s rHEALTH unit with won the Nokia Sensing XChallenge last month (DMI also has an app called CHAS, which particularly appealed to this editor, standing for Comprehensive Health Assessment System, to walk the user through the process of self-diagnosis). Progress on non-invasive testing, eg for blood glucose level, is advancing fast, too. Our next prediction therefore is that:

POCT, as a means of confirming a diagnosis or monitoring a condition, will become a serious consideration in 2015, limited only by the cost/disposable panel; as this happens, the need to clarify the regulation of POCT devices, alongside wearables & medapps, will grow.

Which brings us on to the topic of diagnosis in general. This editor has for some time viewed the issue of diagnosis as a complex, though essentially logical process, so subject to “deep learning” by machines. Indeed Jeremy Howard has established a company to do this, alongside the likes of Isabel and other longer-standing medical diagnosis systems. However, a recent TEDx presentation by Ayesha Khalid raises the prospect that there will always be those diagnoses that require intuition – which reminds me of the point made forcibly in Erik Brynjolfsson’s most recent book “The second machine age”  that though a machine can always beat a man at chess, a man plus a machine – combining intuition & logic – can always beat a machine. This suggests perhaps more a hope than a prediction:

There will be increasing recognition among mainstream clinicians of the imminent & dramatic changes in the way medicine will be practised that will cause a coming-together among different disciplines to decide how best to organise for the future to deliver the best patient outcomes at lowest cost.

A possible straw in the wind is Tyto which appears to be very much a collaborative tool to encourage doctor and patient (or patient’s representative) to co-create a diagnosis and a treatment plan.

A final consideration is data. Most of the above predictions will result in a swelling of the already large volume of personal healthcare data available to clinicians, data that they cannot hope to analyse manually.  GPs are already complaining about patient-generated data, in spite of the likes of EMIS now offering to store it on electronic patient records. To add further to the challenges, the EU is proposing to enact a new Data Protection Regulation in the coming year that many fear, unless it is substantially amended prior to enactment (which the UK government is lobbying for), will seriously harm the scope for big data analytics (as well as reducing Europe’s ability, for example, to run clinical trials). This gives our final set of predictions:

Data analytics will become an essential part of all successful healthcare programmes involving significant personal data creation.

The reducing cost of telecoms will mean that telecare & telehealth will increasingly be deliverable across national boundaries, limited only by regulations put in place for a different age: alongside health tourism, international telecare may well flourish.

Finally, even though healthcare as we know it will be unrecognisable in ten years’ time, a note on those key aspects of healthcare that still seem to elude even the smartest technologies and will cry out for attention in 2015:

At a recent Academy of Medical Sciences event on medication adherence, the point was made very firmly by a number of eminent speakers that in spite of everything tried to date, some 50% of prescribed medications are still not taken by patients, either at all, or as directed. Just imagine the uproar if GPs only showed up for 50% of appointments with patients, yet this is essentially the same end-result.

Allied to this is the challenge of getting patients to accept responsibility for their own health. As an RSM colleague of this Editor, Clive Flashman, rightly pointed out recently, the fact that the NHS is probably the closest that England has to a national religion, which to quote:

…is paternalistic in the same way that monotheistic religions were in the middle ages. People see no need to manage their own health. The almost unlimited support over the last 65 years has turned many of the English population into people who don’t think about their lifestyles because the NHS is there to pick up the pieces.

Interestingly the rise of employer-driven efforts primarily in the US to encourage employees to take responsibility for their own health continues to grow – the most recent PR seen by this editor is for Yomp (a name that has other resonances for those of us of a certain age).

And finally, a point that both the 2014 & 2013 NHS “Future of Health” conferences pushed is that patients have different concepts of what good health actually means – only when time is taken to establish that at the outset, and accept it will change over time, are we able genuinely to know that a patient’s perceived outcome has been maximised.

Hat tip again to Prof Mike Short, and to David Doherty for their pointers.

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