Here at the opening of the 23rd annual international meeting of ISPOR in Baltimore – 10 years after we started attending this event – the theme of digital health pervades the floor in almost every session for the first time. The prominence of the topic at a conference that historically has focused squarely on pure drug and medical device development highlights the significant emerging impact that digital health is having on the development of new health interventions, as well as reinvention of old technologies. There are persistent discussions on the seemingly overwhelming obstacles to adoption of digital health – but the very fact that they are being discussed, rather than dismissed or ignored, reinforces the willingness to explore the revolutionary role that this area can play in healthcare decision-making.

The problem for a group such as ISPOR, which puts validated evidence, clinical outcomes and modelling techniques at the heart of its very existence, is that this is precisely where digital health falls very dramatically short. Nobody doubts the growing influence of almost all areas of digital health – in 2016 a survey pointed to 88% of respondents using at least one app to track or manage their health. And the potential benefits are equally clear: rapid, accurate detection and monitoring of health, increased patient adherence, important medical knowledge sharing, digital therapeutics, and many more. This fills an important gap for many illnesses – it is interesting to note from the sessions that by the largest proportion of health-related apps target diseases such as mental health, depression and autism, which are conversely the diseases where the global pharmaceutical industry has significantly reduced its investments.

But there continues to be a dearth of evidence generation in this area. Out of the hundreds of apps on the market, there are less than a dozen with health outcomes studies, and only half of those showed clinically meaningful results. This makes value communication very difficult, and highlights fundamental differences in the business models between digital health companies and traditional pharmaceutical organizations. Indeed, while the theme of the conference is digital health, it is unclear whether critical elements of the digital health industry are even in the audience.

Part of the problem is also the lack of clear understanding of how regulators and payers approach this new industry segment. Our own data suggests that payers only account for 4% of total sales of consumer medical devices, compared to 77% from retail bricks and mortar sales – and that this balance is not forecast to shift any time soon. In fact, the only area that is growing substantially is online sales, which now accounts for a fifth of the market.

And there are more problems – notably access to technology and internet in rural and poor areas, as well as significant privacy and security concerns. But the conclusion remains that digital health is infiltrating almost all areas of healthcare delivery, and represents one of the most dramatic patient-empowering advances in an era where real world evidence has increased prominence. Patient associations are beginning to take notice, and some are beginning to include the use of particular healthcare apps in their guidelines, while some payers are showing interest in adapting their approach to incorporate these technologies.

So, here at the home of Edgar Allan Poe in Baltimore, it seems appropriate to conclude that we can nevermore underestimate the role of digital health – it is here to stay, and represents an important component in the development of any new healthcare intervention.

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