There’s no denying that digital therapeutics look and feel different than traditional medications. Instead of popping open a medication bottle, users are logging into an app to access treatment. But the differences don’t stop at the look. While the risk of toxicity is an ever-looming question in the pharma space, the same isn’t true for digital solutions. 

Stakeholders at the digital therapeutics conference DTx East grappled with questions about risk assessment in digital, how those risks differs from pharma and how those difference might shape the way digital therapeutics regulations are examined. 

“The FDA exists because of risk. The reason these regulatory bodies have been formed is because of some risk happened decades ago, and a body has been required to assess products related to human health,” Anil Jina, chief medical officer, Akili Interactive Labs, said during a panel. “Inherently the majority of digital interventions that we are talking about and representing are zero or very low risk. So, my naive or simplistic view point moving into the industry was the risk is zero, so therefore the benefit risk profile is in your favor. ... It’s interesting because that is not the only hurdle. The benefit has to be there, and the benefit has to be meaningful.” 

Many traditional digital therapeutics are designed to require a prescription from a physician; however, conversations are sprouting up about expanding the list of care providers able to prescribe these therapeutics.  

“This is a very important question actually: should healthcare practitioners such as therapists be allowed to prescribe prescription digital therapeutics to their patients?" Joel Sangerman, CCO at Click Therapeutics, said during a talk. "So, if you think about the question and the example — where do you go if you have depression? You usually go to a psychologist first, right? But there’s only five states and Guam that allow psychologists to prescribe medication, and that’s presumably because of the safety risk. But when we talk about digital therapeutics, particularly for depression, do we have the same adverse event risk, do we have the same side effect risk? Probably not, so should a therapist, social worker, psychologist be able to prescribe software as a medical device?”

While digital therapeutics aren't molecules and therefore don't have the same risk for physical side effects, that doesn’t mean there isn’t risk. 

“As we develop and grow and have new interventions I don’t think we should go to the assumption that risk is low,” Randall Kaye, chief medical officer, Click Therapeutics, said. “I think we should go with the assumption that risk might be there and we have to find it. I think we tend to think of risk as causing a harm—like you take this drug and it causes injury to the liver. Sometimes with a digital therapeutic risk or harm could be an act of omission.”

For example, if the patient does not engage with the digital therapeutic or if the technology does not work there is the potential for the condition to worsen, said Kayne. 

Digital health is also witnessing new entrance to the health space not as familiar with patient outcomes and risk, notably tech. 

“I think we need to have a great deal of seriousness [around risk]. Especially companies that are coming from the tech space,” Ed Cox, CEO of Dthera Sciences said. “Their view is how dangerous can it be? Either you use it or you don’t use it. If someone doesn’t use it and it [this leads to] a dangerous outcome for the patient, these are I think one of the reasons that most of us are pushing for everyone in the industry to go and get regulated.”

Overall, the message from those on stage was to proceed with caution, and remember that these products could have a major impact on their users. 

“If you have a consumer app and you say 'If you use this every day and you definitely won’t kill yourself,' holy smokes that is a really, really spooky claim.” Cox said. "You better hope that doesn’t happen. So, I think that is an important thing to say — it’s not without safety, but we need to come at it from a place of seriousness and we need to not be cavalier about what we are trying to do.”