Digital Therapeutics Alliance

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How Can Digital Therapies Be Used? The goal is to equate the software active ingredients of DTx with the traditional active ingredients of drugs in the way they are regulated and prescribed.

Il dott. Recchia della Fondazione Smith Kline ha scritto:“Digital Therapeutics (DTx) are emerging therapeutic interventions in which the active ingredient is an algorithm. Similarly to the “pharmaceutical form” of drugs, the “technological form” of DTx may be an app, a game, a virtual reality system, a sensor.

Digital Therapeutics are developed with R&D programs based on the highest degree of evidence, almost always a Randomized Controlled Clinical Trial (RCT), in most cases in a real-world environment.

Digital Therapeutics are approved for their use by regulatory bodies, may be reimbursed by public health systems and/or private insurances and are prescribed by a physician. Therefore, it is the experimental research and the consequent evidence that qualifies these Digital Health Technologies as “therapy”.”

which translated into Italian means: “Digital Therapeutics (DTx) are emerging therapeutic interventions in which the active principle is an algorithm. Similarly to the “pharmaceutical form” of drugs, the “technological form” of DTxs can be an app, a game, a virtual reality system, a sensor.

How are digital therapies developed?

Digital therapies are developed with research and development programs based on the highest degree of evidence, almost always a randomized controlled clinical trial (RCT), in most cases in a real-world setting.

Digital Therapeutics are approved for use by regulatory bodies, can be reimbursed by public health systems and / or private insurance, and are prescribed by a doctor. Therefore, it is the experimental research and the resulting evidence that qualifies these digital health technologies as “therapy”. ”

In the emerging field of DTx, there are still various open fronts of research and regulation, such as defining different classes based on their characteristics and business model, similar to the categories defined by the , to determine which

DTxs can be equated. to drugs (and to all intents and purposes of “digital drugs”) and which instead can be considered over the counter products (ie over the counter (OTC)) without the need for a prescription. Furthermore, the category of Software as a Medical Device (SaMD) already exists but probably needs to be expanded to include new emerging technologies of medical assistance and prevention.

Examples of Digital TherapiesExamples of DTxs approved by regulatory bodies are:

  • Deprexis (EU 2009)
  • Reset (FDA 2017)
  • Reset-O (FDA 2017)
  • Insulia (EU, FDA, CA)
  • Oleena (FDA 2019)

Appendix: What is Connected Health?The term connected health is used in a socio-technological context in which the aspect of interconnectivity / interconnection of devices, services and solutions related to health is emphasized, whose areas are extended to include remote assistance (such as assistance at home or while traveling).

In practice, connected health is used as an “umbrella term” to include and replace a number of other terms such as:telemedicine (telemedicine)telehealthmHealthmedical IoTIoMT (Internet of Medical Things)healthcare IoT, etc.

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