The topic was discussed at the DTx East conference in Boston where the risk assessment of digital therapies, how these risks differ from traditional drugs and how these differences could affect regulation were discussed.

One aspect that has been discussed is the medical prescription of digital therapies and whether it would be appropriate to extend the professions that can carry out this activity. Joel Sangerman, CCO of Click Therapeutics, cited depression as an example. Often people suffering from this disease turn to a psychologist who, in the USA, only in five states and in Guam can prescribe drugs because of the safety risks that this type of product involves. However, if the therapy were digital, there would certainly not be the same risk of an adverse event or side effect. If so, should a therapist, social worker or psychologist be able to prescribe the software as a medical device?

However, it should be noted that since digital therapies are not made up of molecules and therefore do not have the same risk of physical side effects as traditional drugs, this does not mean that there is no risk.

The greatest risk may be the ineffectiveness of the therapy which, if prescribed as an alternative to traditional drugs, could still harm the patient.

But even if digital therapy is effective, there is still a risk that the patient will not take it or have problems with the technology.

We therefore need to be very serious about this issue and to proceed with great caution in the development of digital therapies, as well as to develop and apply rigorous risk analysis. It is a question of tackling and assessing new areas of risk that digital therapies may induce in comparison with traditional pharmaceuticals.

Regulatory bodies will also need to extend their investigation and evaluation criteria to regulate the development and certification of digital therapies and protect both health professionals and patients.