Bolstered by FDA's policy shift, ‘digiceuticals’ could soon carve out a bigger role in healthcare

Despite some caution from venture capitalists, digital apps could take on a more formal role in treating disease.

In some cases, that could mean an app that is prescribed a physician, either as a standalone treatment or in conjunction with traditional drugs.

Digital therapeutics or “digiceuticals” still haven’t emerged as a widely-used treatment option for doctors. But that could change with more interest from drug companies and as more mobile solutions gain approval from the Food and Drug Administration (FDA).

As many as 150 firms around the world are developing digital therapeutics, according to the Economist. But funding for those ventures hasn’t quite hit its stride, since many venture capital firms are waiting to see how existing solutions play out—including how insurers will reimburse for apps that get the FDA’s stamp of approval.

At the same time, the number of studies on digital health efficacy has increased steadily over the last decade, including a noticeable increased in observational studies and randomized control trials.

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Reset, a mobile medical application that received FDA approval in September to treat substance abuse disorders, set the stage for other app developers to pursue FDA review, Charles Curie, the former director of the Substance Abuse and Mental Health Services Administration (SAMHSA) at the Department of Health and Human Services previously told FierceHealthcare. It offered a signal to developers—particularly in the substance abuse industry—that validated mobile solutions could be a bigger part of addiction treatment.

Broadly, the digital health industry is getting notable headwind from the FDA. Beyond providing additional guidance on mobile health apps, the agency launched a pilot program last year to change the way it regulates mobile apps. Pear Therapeutics, which built the Reset app, is among the pilot’s nine participants, along with Apple, Google and Fitbit. The goal of the precertification pilot is to develop a pathway that allows regulators to evaluate companies rather than specific products, which could further ease the regulatory burdens associated with getting FDA approval.