The precise definition of digital therapeutics has been a hot topic as the new technology category has been discussed and debated in event sessions and articles over the last few years. Now the Digital Therapeutics Alliance, a consortium of industry stakeholders, is hoping to put that to rest with an official definition, released this week in a whitepaper.
The definition reads as follows:
DTx products incorporate advanced technology best practices relating to design, clinical validation, usability, and data security. They are reviewed and cleared or approved by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use.
Digital therapeutics empower patients, healthcare providers, and payers with intelligent and accessible tools for addressing a wide range of conditions through high quality, safe, and effective data-driven interventions."
Beyond the definition itself, the whitepaper also attempts to lay out other groundworks for the industry, including how digital therapeutics fit into the larger digital health landscape; how and when digital therapeutics should be regulated; and industry best practices for design, development, manufacture, security and clinical validation.
Why it matters
Following prominent successes from the likes of Pear Therapeutics, Akili Labs and Proteus Digital Health, digital therapeutics are rapidly becoming an important area of digital health. But as the category becomes hyped, companies are apt to affix the label widely, which runs the risk of it becoming meaningless.
This first major publication from the Digital Therapeutics Alliance demonstrates another way in which the space is maturing, and will hopefully provide guidance for new entrants.
What's the trend
The category of digital therapeutics experienced a slew of high-profile wins late last year and early this year. Some of these defining moments included Pear Therapeutics’ de novo FDA clearance for its software-only substance abuse therapy, reSET; Proteus Digital Health and Otsuka Pharmaceutical’s clearance of a sensor-equipped pill that pairs with a companion app; and Akili’s recently concluded multi-center trial and very public filing for FDA approval. These milestones and others each landed within the span of a few months and, according to Pear Therapeutics’s Chief Commercial Officer Alex Waldron, bestowed digital therapeutics with a legitimacy that is hard for major players in the health industry to ignore.
"Everyone is very curious about how this model is going to play out because the physicians, payers, and patients are looking at this as a third segment: small molecules, biologics and then digital therapeutics,” Waldron told MobiHealthNews last year. “It’s another way to be able to treat diseases that maybe have not been able to be treated to date.”
The Digital Therapeutics Alliance launched a just over a year ago, in October 2017. The group has been working on formulating this definition ever since. Members include Pear, Akili, Propeller Health, WellDoc, Omada Health and Voluntis.
“The integration of digital therapeutics into healthcare is no longer a theoretical conversation," Megan Coder, executive director of the Digital Therapeutics Alliance, said in a statement. "As an Alliance, we are focused on building a strong foundation for this rapidly growing industry. We are committed to empowering patients, healthcare providers, and payers with engaging and accessible tools that deliver meaningful clinical outcomes across a broad spectrum of physical, mental, and behavioral disorders.”
The definition, standing on its own, is broader than many expected. When MobiHealthNews interviewed leaders in the space in March, many of them expected things like FDA Class 2 clearance or proven clinical outcomes to be part of the definition. But the final definition doesn't include any of those sorts of hard limiters. It does exclude pure wellness plays (digital therapeutics must "prevent, manage or treat a medical disorder or disease"). It stipulates that digital therapeutics must be evidence based and it refers to a more extensive list of best practices elsewhere in the paper, which include some stricter requirements for clinical validation.