// July 05, 2018

Digital Therapeutics: How to Ensure Quality in an Emerging Field

A tablet is used to treat a health condition.

Imagine using software on your phone or tablet to treat health conditions that, until now, could only be treated with medications. Now stop imagining, because for some conditions, such as attention deficit disorder and substance dependency, it is already a reality.

I’m talking about the new field of digital therapeutics (DTx). The US Food and Drug Administration (FDA) has recently approved several of these digital therapies, which treat substance use disorders, type 2 diabetes, respiratory disease, schizophrenia and other disorders. Together, these disorders affect more than 100 million  Americans*. And more digital therapeutics are on their way, as several other similar therapies are in late-stage development and are poised to provide patients with digital, or digitally enhanced, options to treat their chronic health conditions.

As digital therapies represent an emerging science that can offer exciting alternatives for some patients, it is important to ask how the quality of these therapies can be assured. This is why USP is exploring ways to keep pace with this new evolution of medicine. What do digital therapies mean for USP and its mission to improve public health? How should we be involved in helping to ensure quality of these therapies?

The answers aren’t simple and require a robust discussion among experts in this area. For example, USP standards are used to confirm the identity, potency, purity, and performance of medicines. But what is the meaning of the “identity” of a digital therapeutic? For a chemical medicine, this question focuses on the chemical composition and structure that is unique to the substance. For a digital therapeutic, which involves computer code, the definition of “identity” will have to change, but it is difficult to know exactly in what way it needs to evolve.

But these are the types of questions I love. And leading the Research & Innovation department at USP gives me the enviable opportunity to peek into the future of health care and think through the potential quality implications of emerging technologies.

As USP has done many times in the past, we need to assess, and potentially adapt to emerging technologies. For example, today’s quality standards look very different from the “recipes” for tinctures and extracts that were included in the first pharmacopeia we published nearly 200 years ago. Technology and chemistry evolved immensely since the 1800s and USP has evolved with them. This need to evolve never stops. That is why we are taking an early look at digital therapies.

To start exploring the role USP could play in this area, we signed a collaborative agreement with the recently formed Digital Therapeutics Alliance. This agreement provides a framework for us to work together -- and with other partners -- to think through quality considerations for digital therapeutics. Our first joint activity was to co-host a roundtable discussion with USP experts and nearly 40 members of the health care industry that are involved in digital therapeutics. We discussed the meaning of quality in the context of these therapies and whether the existing structure of quality standards provides a useful way to think of quality for digital therapeutics.

Our discussion was fascinating, rich, and thought provoking. Together, the groups concluded that it may be possible to map essential concepts contained within our existing quality standards to digital therapeutics.

There is much work to be done, however, before deciding whether to embark on developing quality standards for DTx. Many more discussions, and significant technical work, will be needed to answer a number of critical and deceivingly simple questions to help ensure quality, including those I explored above. Only by working with the various stakeholders, including the FDA, will we be able to advance this, and other important questions.

Importantly, participants of this first roundtable on digital therapeutics were enthusiastic about the discussion and open to thinking about quality in a new way than they may have in the past. All of us agreed with the need for continued dialog and a truly collaborative approach to figuring this out. Coming out of the discussion, I am energized and excited to continue to explore this emerging field.


* Diabetes: 30 million. Substance use disorders: nearly 21 million. Asthma: 26.5 million.