[22] The first mention of the term in a peer-reviewed research publication was in 2015, in which Dr. Cameron Sepah formally defined the field as: "Digital therapeutics are evidence-based behavioral treatments delivered online that can increase accessibility and effectiveness of health care.
"[24] Digital therapeutics are different from wellness apps or medication reminders in that they require rigorous clinical evidence to substantiate intended use and impact on disease state.
For instance, a patient with prediabetes may be prescribed digital therapeutics as a method to change their diet and behavior that could otherwise lead to a diabetes diagnosis.
Many approaches use methods based upon cognitive behavioral therapy to spur patients to make lifestyle changes, reinforced with gamification, peer support, and in some cases telehealth such as coaching or psychotherapy.
[2][16][17][11] Methodologies can be as simple as psychoeducation or sending notifications designed to alter behavior to patients who are at risk of obesity or diabetes[15][2] and as complex as administering an ingestible radio tag that communicates with an external sensor to monitor the efficacy of a given medication.
[29] The general consensus among researchers in the field of digital therapeutics is that the discipline requires more clinical data and investigation to be fully evaluated.
[3][11][26] In a meta-analysis of 85 such studies comprising a total sample size of over 43,000 participants, researchers discovered that digital therapeutics have a "statistically small but significant effect on health-related behavior."
The study also showed that a broader use of theory, behavior change techniques, and modes of delivery (especially regular notifications) improved the efficacy of a given program.
[34] In response, regulators in the United States such as the Food and Drug Administration have developed regulatory frameworks such as software as a medical device (SaMD)[35] which require manufacturers to prove that their apps are safe, effective, and that rigorous quality management system processes are in place to ensure that remains the case as software updates occur.
However, in an assessment of 4,936 apps that fall under the SaMD umbrella in the United States published in 2019, only 105 (2.13%) included a specific summary of their cybersecurity content.
[37] Accordingly, digital therapeutics companies pursue a range of business models: To help build the business case for their usage, DTx companies often commission health economics evaluations of their interventions to show that their use ultimately lowers healthcare costs in the medium-long term, such as by reducing the need for hospital admissions or expensive surgeries.