Looking back over our predictions made on 31st December last year, it’s hard to quibble with any, and worth hanging on to those that didn’t come good this year.
Our first was
Security and data privacy issues will become a serious mHealth issue in 2014; developers failing to take great care over security and privacy issues will risk very adverse publicity and worse.
Job done: that certainly proved correct, with many being exposed as either selling or potentially selling private information. Clinicians were not immune from privacy invasion either. Here is a US summary of the issues. Attention was drawn to an EU Article 29 data protection opinion (actually published in 2013) that sought to clarify the legal framework applicable to the processing of personal data in the development, distribution and usage of apps on smart devices, and the obligations to take adequate security measures. Many apps got hacked too, including FDA-approved ones. There were also items, such as this one, demonstrating how complex the law is in this area in the US. In the EU, the arrival of the Data Protection Regulation in 2015 (now some say 2016) will undoubtedly improve data privacy significantly, though the failure to treat data used for health purposes differently from use for marketing purposes will hamper big data analytics unless the draft regulation is amended significantly.
The second was:
“Unless steps are taken quickly to ensure that doctors cease using uncertified apps, there is a high probability of use of such an app being implicated in the injury or death of a patient in 2014;
Thankfully no app has so far been implicated. In February 2014 the JMIR published a paper by Rachel Bierbrier, Vivian Lo & Robert C Wu suggesting that most apps that the authors tested were ok although they found worrying errors in two functions: the Child-Pugh scores and Model for End-Stage Liver Disease (MELD) scores on eight apps (out of 17). The authors state that 47% of the errors were clinically significant resulting in a significant change in prognosis.
In April 2014Dr Richard Brady gave a talk at the RSM’s sellout Appday on the “Bad Apps – Mistakes that can be dangerous” (available on RSM video here) in which he drew attention to many of the shortcomings of unregulated apps, including Opioid converters, melanoma monitors (here, here & here), and a blood pressure smartphone app problem as well as also mentioning the Bierbrier paper in the last paragraph. Others have expressed concern too.
(Richard presents again at the Royal Society of Medicine’s Appday, this year entitled “Mainstreaming medical apps; reducing nhs costs; improving patient outcomes” on 9th April 2015 where the few remaining tickets are fast disappearing)
As uncertified medical apps are increasingly being used by hospital doctors, most notably for dosage calculation, and the NHS is spending money on drugs when in some cases apps would provide more effective cures for far less, there is now a desperate need to sort the regulation of medical apps out in the UK, including providing effective policing.
The third was:
Growth in use of mHealth apps will only really take off once patients and doctors can have confidence in their efficacy.
Continuing the point made in the previous item, this prediction has proved correct in the negative, in that without such confidence, doctors and patients have yet to embrace apps as an integral part of delivering improved patient outcomes. Mobihealthnews, for example, carried the results of a survey in the US showing that 90% of those asked wanted government oversight of medical apps. The New England Journal of Medicine carried a paper on FDA regulation too (For those without NEJM access, there is a summary here.). It has been this editors’ own crusade for 2014 to: widen NICE’s remit to include assessing the efficacy of medical apps. The opportunity to support the case through the NICE triennial consultation has now closed – do find other ways to lobby though, to influence the DH & NHS England.
The fourth was:
Marketing and sales of serious mHealth apps will, as with pharmaceuticals, increasingly become the province of large companies able to afford the expertise to obtain evidence and to analyse fully data received.
Slightly surprisingly, this hasn’t happened – indeed there have been a slew of articles about how big pharma has, so far, failed to make much impact in this area (eg here and here) , and other large organisations such as CSC and IBM, both very active in the healthcare market, are not overtly using their brands or muscle to promote app usage.
In discussions about the regulation of apps, many developers have commented on the potential cost, to which this editor’s comment has always been that drugs are rarely brought to market by small companies because the health & safety concerns require extensive testing which needs deep pockets; why should an app that, for example might determine warfarin or insulin dosage, or flag up a change of behaviour that indicates a potentially dangerous psychotic state, be somehow exempted from such extensive review? It would seem natural therefore that if our regulatory bodies do get their acts together and determine a proper regime for medical apps and other similar medical hardware/software combinations, that apps that could kill or seriously harm if in error should require appropriate examination and testing before they can be used, and that examination & testing may require the involvement of well-funded organisations…and they may not be free to users, either.
The fifth was:
2014 will be the year when remote consultation between patients and doctors becomes accepted practice.
Job done: definitely a winner here – the list of such services now available on a private basis includes Dr Mortons, Babylon and of course the 3G Doctor in the UK/Eire, and the likes of American Well, Doctor on Demand (and many others) in the US. NHS patients can now also consult remotely, notably if their practice is part of the large London Hurley Group. In the US the ATA has already begun accrediting providers, something I have suggested to the TSA they might also consider. Benefits are considered to be huge, compared to physical visits (see also here and here). Indeed this editor’s local West London practice is now seriously considering the idea following SystmOne’s integration with Skype. The two significant companies, V-Connect and Speakset (in which this editor has a very small involvement), providing video to television services, to enable video consultations with older people who do not have appropriate smartphone, tablets or PCs are on a roll.
Enterprising organisations such as Airedale NHS Foundation Trust are also using remote consultation to increase business for their specialist service, whilst saving the NHS – and in this case the Prison Service – a packet by avoiding the costs of clinicians visiting prisons, or prisoners being escorted to hospitals.
A smart move by Harry Longman at GP Access to encourage online consultation has been to introduce askmygp into the UK – this service begins with the patient providing a detailed summary online of their reason for seeking to consult with the their GP, who then decides what action to take, either continuing the remote consultation or inviting hte patient in.
A further twist is the use of remote consultation to market pharmaceutical services, as exemplified by the recent move by Walgreens in the US. Lloyds Pharmacy in the UK has been offering the Dr Thom service for some time.
Telemedicine & eHealth hosted a paper on the patient perceptions of video consultation that showed 56.1% of patients surveyed to be likely or very likely to accept an invitation to consult their doctor by video – I wonder if that might be even more positive if the video consultation was offered earlier than a physical one? Mobihealthnews summarised a FICO survey of 2,239 adult smartphone users from the UK, Australia, Brazil, China, France, Germany, India, Italy, Japan, Korea, Mexico, Russia, Turkey, and the United States saying that 80% wanted to access their GP with their smartphone.
The sixth was:
2014 will be the year when the use of 3D printing for medical purposes is taken seriously by clinicians.
Job done: not much point in spending lots of time on proving this prediction: as dentists and audiologists use 3D printing as a standard part of the service they provide now, there are few news clips to link to – this Guardian one sums up progress quite nicely . It’s still a little more experimental for reconstructive surgery, and of course the holy grail of organ printing gets ever closer. See here for Organovo’s description of the process.
3D printing of lenses to convert smartphones into cheap microscopes was also covered, by 3ders.
The seventh was:
The growing availability of vital signs measurement capability on ordinary smartphones will begin the transformation of the doctor:patient relationship in 2014.
Job done: the widespread discussion by both patients and doctors about remote consultations (see above), it just one example of how the relationship is changing. This excellent perceptive video by Dr Ayesha Khaled raises a range of thoughts about how a change in the relationship will help doctors and patients, and hints at some of the upcoming challenges as machines get smarter.
And machines certainly are getting smarter: this editor was privileged to see a prototype of a smartphone recently that should be available in the late summer of 2015 that will I was assured measure blood pressure, pulse, respiration rate, SpO2, temperature (to 0.1° Centigrade – sufficient apparently to detect a woman’s maximum period of fertility) and one-lead ECG. It is even rumoured that early models are sufficiently sensitive that they can measure the flexibility of the walls of blood vessels, and so estimate the age of a user which could be an additional anti-fraud weapon.
No wonder Alivecor has slashed both the size and the cost of their third generation ECG smartphone add-on; this time next year the market for standalone ECG smartphone add-ons might have vanished.
Perhaps even more excitingly, the range of point-of-care testing kit, especially for biomarkers, is rapidly expanding which is stepping on the toes of our predictions for 2015, coming very soon – keep watching this space!
Many thanks to all those who passed on news items to blog during 2014, notably Prof Mike Short, Dr Nicholas Robinson, David Doherty and Dr Richard Brady.