Although some psychologists do not fully agree on using digital therapeutics, most use them as a useful tool.
Since 2017, the U.S. Food and Drug Administration (FDA) has approved the use of half a dozen digital therapeutics for diagnosing and treating mental health conditions, including cognitive impairment, substance abuse disorder, and even attention-deficit/hyperactivity disorder (ADHD).
The FDA has approved just a handful of such digital mental health interventions, but there are hundreds or maybe in a regulatory gray area, which are available without a prescription.
Rock Health, a full-service seed fund that supports startups working in digital health, found that digital behavioral health companies that create these interventions drew $2.4 billion in venture funding in 2020 alone.
It is unclear how well these digital interventions work and how they should be regulated, which is why experts argue that psychologists or mental health experts should play a key role in the development, approval, and use of digital therapeutics, according to the American Psychological Association (APA).
Psychologist Jonathan Comer of Florida International University said, “The world has changed, and people are using remote technologies in almost every aspect of their lives, including for psychological services. It’s happening whether psychologists are on board or not. We can either opt out or be a part of how people engage with these wellness resources.”
Dr. Stephen Schueller of the University of California, Irvine, said, “We have an enormous supply and demand problem in mental health. There are many more people who want services than there are professionals available to provide them and not by a small margin.”
“Everyone agrees it’s early days for the field,” said Dr. John Torous of Beth Israel Deaconess Medical Center in Boston. “The intention is good, but we don’t really know how well these things work.”
“It’s a good start,” Dr. Torous said, but he said more detailed regulatory guidelines are needed.
The FDA also seems to recognize the need for a more comprehensive approach to digital health technologies, according to the APA. In 2020, the US drug regulatory body launched a Digital Health Center of Excellence to coordinate research, support developers, and help reframe its regulatory approach to digital health technology.
Dr. Jenna Carl, Chief Medical Officer of Big Health, a digital therapeutics company, said, “By far, the majority of digital therapeutics for mental and behavioral health fall under FDA enforcement discretion.”
She said the decision to delay pursuing product claims that require FDA approval was a strategic move to improve access to safe and effective interventions for common mental health issues, according to the APA.
“Most people with mental health conditions don’t actually talk to their provider about them,” Dr. Carl said. “The prescription barrier means most mental health care providers can’t provide access to these behavioral solutions.”
Meanwhile, the APA is taking efforts to address issues in emerging technologies, including a strategic approach for addressing digital therapeutics in psychological care. Earlier this year, the association launched the Office of Health Care Innovation to address these issues.
Some psychologists might see these tools as a threat, but Dr. Carl believes it is more helpful to focus on their potential.
“Other medical professionals are happy to take advantage of these tools,” she said. “There’s a risk in psychologists not seeing this as an opportunity. And the industry wants psychologists—including research psychologists and clinicians—to be involved.”