Aungst TD, Vogenberg FR, “Digital Health: A New-Age Spectrum of Therapeutics”. PT, 2019, Vol 44(11), pp 691–693.

Digital health and a wide spectrum of digital therapeutic products have begun arriving in the U.S. marketplace for use by consumers or patients and for prescribing by health care professionals (HCPs). This is relevant for P&T committees as the landscape for medical devices undergoes rapid and expansive change, both in the number and type of devices and their therapeutic uses. Similar to the experience seen with biologic and specialty drugs over the past 10 years, digital health applications represent another growth engine affecting care outcomes, costs of care, and sources of revenue.

The 21st Century Cures Act, which became law in December 2016, was designed to accelerate drug development and drive innovation to reach patients more efficiently. It also strengthened mental and substance use disorder care, established new thinking on clinical trial designs, and modernized review processes along with FDA resources—all of which would speed the development and review of novel medical products. In addition, the act established that certain kinds of medical software are no longer considered to constitute a medical device and is not regulated as such a device.

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