There is an abundance of excitement and enthusiasm in the world of Digital Health. One example is the growth in venture funding, another is the announcement of new partnerships between incumbents and the technology companies, such as Astrazeneca's partnership with Adherium to develop a 'smart inhaler.' We see more accelerators, more incubators, and more hackathons. It really is an incredible era. One of the major challenges is that the world of healthcare requires more than excitement and enthusiasm, it requires evidence. Apps may be cool and fashionable in the modern age, but apps that are proven to save lives are what decision makers in healthcare are seeking. News articles may cite that 165,000 health apps now exist, but that’s a headline statistic, as it’s simply evidence of increased activity. If we don’t start seriously thinking about validating these new technologies, chances are that the industry will fail to make the impact it hopes to. Even worse, widespread use of digital interventions that have not been validated may cause unnecessary harm to patients.
Now, evidence means different things to different people. In the world of startups, evidence might be $1 million in seed funding and 5,000 active users of an app. In the world of healthcare, evidence might be a randomised clinical trial with results published in a peer reviewed journal. I have observed a gulf between these two worlds, and that's a problem. How many startups have evidence generation in their business plans given that half of Digital Health startups fail within 2 years? Generating evidence is expensive when you're trying to get your business off the ground. Omada Health is cited as one of the leading examples of a startup that has worked hard to generate evidence, and they state, "Omada’s commitment to generating, analyzing, and sharing clinical data is central to our identity."
What is evidence in the 21st century? This is a critical question, and one not being asked enough. Maybe if healthcare systems eventually start collecting patient outcome data in real-time, evidence may be easier to obtain? Perhaps as we collect different types of data, the evidence that is gathered could change? The time and costs needed to gather evidence using traditional methods may not be suitable to enable the swift development of Digital Health. Even when we have schemes for validating Digital Health, it’s not always plain sailing. Take the NHS example, and the news that some accredited health apps were found to be putting users' privacy at risk. My fear is that traditional organisations, under pressure to be seen to ‘accelerating innovation’ or ‘transforming healthcare with digital’ act in haste with regard to these new tools, and throw caution to the wind. Changing the world of healthcare is going to be a relatively slow moving process when done properly, no matter what you hear about the next disruptive idea. Maybe we mistakenly assume that a digital intervention is always going to be brilliant, which is quite a dangerous assumption to be carrying around. Again, that’s where evidence is useful, as maybe the evidence will show that a particular digital intervention does not offer any additional benefit over existing non-digital interventions.
There are people out there starting to look at validating new ideas in Digital Health. It's interesting to note how a new startup accelerator, Rockstart, from the Netherlands has quite a strong focus on validation and evidence generation, which is a step in the right direction. There is also Evidation Health, which has a focus on, "Defining and demonstrating value in Digital Health." Also, the Global Consortium for Digital Medicine has been established, with a focus on Evidence based Digital Health.
This is good news, and quite frankly, we need more people working on this. I am so curious about trends in generating evidence that I've flown out today to California to attend the inaugural Digital Medicine conference at Scripps, where the focus of the 2 day event will be, "A thoughtful exploration of the clinical evidence necessary to drive the widespread uptake of mobile health solutions." There seems to be a growing momentum for pushing this conversation forward. I note that the Hacking Medicine Institute will be hosting their first "Measuring Digital Health Outcomes Summit" next week. I'm excited that the Institute has the aim of "convening healthcare leaders around the world to accelerate data, evidence and adoption of effective new medical technologies." I suspect those organizations building Digital Health products that have not thought enough about evidence are likely to be viewed differently in 2016 and beyond.
The quest for evidence in Digital Health is underway, and hopefully, we'll soon be able to sort out the wheat from the chaff.
[Disclosure: I have no commercial ties to any of the individuals or organizations mentioned in this post]