There is a widespread expectation that mobile health technology will eventually solve a myriad of healthcare problems while slashing costs, but Healthcare has been shown to have more entrenched interests and greater barriers to change than most other industries.
Given a renewed interest in mobile healthcare with Apple’s new HealthKit, I suggest here some pragmatic key questions for assessing mobile health solutions before investing or executing. These enduring strategy questions are applicable to all fields, but have been frequently disregarded or poorly executed in the initial excitement of mobile health. And they lead to a final question: If you’re not going to do it well, have you got the wisdom not to do it at all?
Are the needs defined effectively and how well does the solution meet the needs?
As a first step, carefully review anything where the primary premise is aggregating or moving data. Throwing data at the problem is perhaps the biggest fallacy in mobile healthcare. It is the obvious thing that mobile healthcare can do, hence many solutions have started with data aggregation or transmission. But transmission or aggregation is rarely the root problem that needs solving. The valuable innovation will be in doing something with the data. If you haven’t worked out what will be done with the data and what you are doing to help that happen, you aren’t going to add much value.
For a fuller assessment, can you explain what problem is being solved in terms of the outcome that will be achieved, and how much of the work is actually being done by the new ‘solution’ and how much is left to someone else to make it work?
Who has to change and what’s in it for them?
In healthcare, someone is going to have to change their behaviour or practice to incorporate a new solution, perhaps the patient, perhaps one or more healthcare professionals, perhaps the payer.
Behaviour change is a vastly underrated barrier. Even solutions that have a clear benefit for the user may not persuade them to accept and implement a needed change to their behaviour. So what chance for solutions where the person who needs to change is not motivated or incentivized? E.g. where a patient is expected to gather data that primarily benefits the pharmaceutical company or the payer (developers wrongly assume that many of the general population share their interest in data for its own sake!)
Where your assessment shows that behaviour change is required, this has to be reflected in increased project and timescale risk. Companies need to plan for a thorough step-wise approach through pilot demonstrations, studies and local roll-outs. Small companies may need to accept that the implementation barrier requires manpower and resources that may only come from larger companies.
Can you deliver on the ‘requirements to play’ as well as on your core offering?
The heavy regulation of healthcare and medical data imposes strict requirements just for you to get into the game, for example to gain regulatory approval, or to demonstrate compliance with privacy and security of medical data. For example, as mobile health solutions deliver more value for the user, their risk category rises and they become more regulated. Furthermore, novelty brings its own uncertain regulatory pathways and mobile health has suffered here in its early days. On the plus side, some areas of regulation are resolving and becoming less burdensome, e.g. the FDA’s recent reclassification of secondary display of CGM data from Class III to Class II with special controls.
The costs and resources required to fulfill ‘requirements to play’ is a major drag on speed and certainty. In your assessment, if your solution is adding real value and doing something new, project and timescale risk will be higher. If the regulatory and risk pathway is simple, revert to question 1 and ask are you really adding value?
Can your value be measured and will someone actually pay for it?
Value and reimbursement for mobile health is fraught with difficulty, especially in the field of chronic disease. Basic challenges with reimbursement have been widely reported. For example, HCPs may not be reimbursed for the additional time required to review data or analysis sent back from a remote health monitor (one of the hidden but high costs of telehealth is the common use of personnel for high-touch back end activities).
There are less well reported but still endemic problems, some especially frustrating to the innovator. In chronic diseases, where surrogate measures are often used to guide treatment, the value of the problem you are solving or the measure you are impacting may be surprisingly poorly understood by the payers and the current market incumbents. The payer may not actually be able to place a value on the outcome that is the basis of guiding treatment decisions!
Robustly challenge reimbursement assumptions early in the process, mapping how payers will assess your product, what their comparators are, and why they would pay for it. If you are doing something new, payers will need time to evaluate and decide if or how to pay. Consider also that savings may come from a different budget to the cost of acquiring your solution, and of course the simple but cash-burning delay in actually getting paid.
More rigor is needed from companies and investors in this field. The internet start-up spirit needs to be tempered with an understanding of timescales, risks, and resistance to change in healthcare. And big pharma needs to control its C-suite mollifying tendencies that lead teams to do something only in order to be seen to be doing it.
Especially, we need to robustly challenge whether the problem to be solved is well defined and well solved for all of the participants, whether they are user, doctor, nurse, payer, pharmacist, regulator or mobile phone carrier! Apple did not change the music industry with just the iPod, but by being the only company to address the whole solution chain, from buying music, to storing and arranging it, to accessing it on the go, to sharing and so on.
Without this scale of vision and level of rigor, too much of mobile healthcare will just add to the back catalogue of apps, and a lot more investment will be burnt with little to show for all the enthusiasm and efforts. If you’re not going to do it well, have you got the courage and the wisdom not to do it at all?
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