As recently as June 2016, the CEO of the American Medical Association accused mobile health (mHealth) – and medical ‘apps’ in particular – as nothing better than ‘snake oil’. Address to the House of Delegates at the American Medical Association (AMA) Annual Meeting, AMA CEO James L Madara, M.D. June 2016
Is his point a valid one that stands up to scrutiny, or an expression of an innate desire to preserve the status quo; the physician at the centre of treatment?
The market of health and wellness apps has exploded in recent years, and continues to grow dramatically. The market value is currently $10bn, forecast to rise at 15% CAGR until 2020, when it will be worth $31bn. The number of such apps is currently around the 600,000 figure. Growing in parallel with this space is the wearable device market.
History shows that any new, valuable market attracts both the good and the bad. Is it therefore probable that some of the space is occupied by companies who are nothing more than virtual ‘pop up shops’? Some- but not all- vendors put unproven, unsupported and unregulated platforms on the various ‘app shops’, make some quick bucks and move on.
A number of well documented court actions are in progress currently. Admittedly, the majority of these are concerned with manufacturer claims as to the accuracy of step counting, calorific intake and burn rate and the like. Some are concerned with accuracy of heart rate monitors. The overarching response from manufacturers is that these are merely for entertainment, and in no way designed to be accurate and certified medical devices….really?
Of 30,000 health and wellness apps examined, only 17 had professional input! Presented at the European Obesity Summit, 2016. Nikolaou, C et al
If people with, for example, long term chronic conditions start to rely on their smartphone for advice, what are the possible consequences? Maybe they are now relying on the wisdom of an app developer rather than their healthcare professional……good or bad?
Looking at the other side of the coin, it could be argued that the space is reaping what it has sown. The disincentives for going down the approved medical device route are numerous the incentives for not doing so and ‘barriers to entry’ are startling small.
So what is to be done?
Certainly in the UK, there is a huge desire to integrate mHealth into the NHS. The reasoning and logic behind this desire are obvious. Done well, mHealth has the opportunity to place responsibility for the management of long term conditions firmly with the patient. In turn, this opens the possibility for more appropriate and cost effective care. But there are serious caveats. If the credibility of mHealth is to stand scrutiny over the coming years, we have to move towards a fusion of the Pharmaceutical model of ‘clinical trials’ and the massive opportunity that technology provides.
A new category of ‘app’ needs to become the new standard; a new ‘fast track’ approval process must be put in place. By means of a working title, let me call this new category ‘validated apps’
What will a validated app look like?
It will tick the following boxes:
- It will have a defined role in the management of long term medical conditions
- It will have academic input – the development process must demonstrate inputs from a University or Clinician in a related field
- Input and testing from those who will use the app
- Tracking (eg of blood glucose levels or BMI) in isolation is not a criteria for inclusion
- The user must be given (certified) advice on how to positively affect such metrics
- It will have the capability of Cloud based data collection and aggregation, hence being a platform for ‘real world study’ of the disease.
- It will have undergone a test period and validation prior to launch
- It will demonstrate integration with multiple devices
- It will have the functionality for real time access (on a patient cohort as well as individual patient level) to allow Healthcare Professionals (HCPs) prioritise clinic times
- It will have proven reduction in key metric markers –for example reduction in blood glucose levels or systolic blood pressure
- It will provide the patient with personalised education and information in how best to reduce the risk of their disease progression
- It has a proven effect on outcomes and hence offers the Health Service provider the opportunity to reduce costs.
A starter for 10 then – the height of the bar for entry into the exclusive’ validated app club’ has to be raised from the ‘wild west’ climate that prevails currently.
By demonstrating that the platform the patient is using has validated app status, trust, usefulness and high duration of use will increase exponentially. For the patient there is the prospect of altering the trajectory of their disease progression positively; for the Payer, the opportunity is to add a cost, effective, contemporary solution to their armamentarium.
The opportunity for making a real difference to how people can live better with long-term conditions is right here, right now. mHealth has an important role to play in the coming years- but we can’t go on the way we are…