Most digital health companies deploy software modules as an enhancement, or even a substitute, to a prescription drug. They are affordable and effective and poised to become a critical component of digital health, thereby substantially improving the efficiency of American healthcare. Digital therapeutics is already roughly a $500 million market and positioned to balloon into a $6 billion market, according to a research report by Goldman Sachs, supported by analysis by digital health venture firm Psilos Group.See the New York based venture capital firm Psilos here. See the San Francisco incubator and dHealth early investor Rockhealth here.
Digital therapeutics improves health outcomes by addressing chronic conditions such as Type 2 diabetes, depression and anxiety, and drug addiction through behavioral changes, before they become worse and require elaborate treatment. This 21st century modality marries the latest developments in behavioral economics, smartphone apps, gameification, biometric sensors, data analytics and artificial intelligence. In some cases, digital therapeutics modalities get approval from the U.S. Food and Drug Administration.
For an 8 page report by Psilos, here. For a 54 page report by Goldman Sachs, here. For a 200-page, $5000 commercial report, from July 2016, here.
The term "digital therapeutics" currently has 13,000 Google hits and is being employed by cutting-edge companies like Omada (here), which provides online courses for pre-diabetes prevention programs. Medicare recently determined it will cover both bricks-and-mortar and virtually delivered diabetes prevention programs (CMS homepage, here).
For a 39-page report on the prospects for digitization of England's NHS, from September 2016, here.
Can digital health make much of a dent in healthcare performance and costs? There are plenty of skeptics. For the modern economy as a whole, in a recent book economist Robert Gordon argues that leapfrog gains in industry productivity occurred 50-100 years ago and the "digital age" is just less important for the real-world economy (the economy of things; see Gordon's book here.) On the other hand, a recent New York Times article about the digitization of GE reported that jet engine development times had been halved by next-generation digital technologies (here).
As of November 2016, "digital therapeutics" has 13,000 hits on Google but only 3 on Pubmed.
In December 2016, the FDA approved the first iPhone based Type 2 Diabetes insulin management app Insulia, from the French company Voluntis (here). A physician prescription code is required for the app to be activated. Voluntis raised $29M in 2014 and is CE marked since 2013 for its "Diabeo" product. The 21st Century Cures Act clarifies FDA handling of medical software (here). According to RAPS,
[Section 3060] identifies five specific categories of medical software that, given certain conditions, will not be regulated as a medical device by FDA based on their low level of risk to patients. This section also provides FDA with the authority to regulate software in these categories if there is found to be safety concerns.