What are the benefits of fast-track approval for Digital Therapeutics (DTx)?

by Pedro Vergara, October 30, 2024

As we have seen, Digital Therapeutics (DTX) go one step beyond Digital Health tools, becoming clinically validated solutions that meet the technical requirements and certifications that are necessary for their use in preventing, managing, or treating conditions and/or diseases. In this way, they differ from other digital solutions that are intended for health monitoring and care, as they must meet those requirements prior to their approval and implementation. 

Considering these features of DTx, as we noted in the article How are Digital Therapeutics (DTx) making headway in the Spanish Health System?, some countries have already found the need for specific regulations that establish a clear roadmap for introducing them into the system and implementing them as quickly as possible. This goal is being pursued in Spain as well, where work has been carried out jointly for several years through alliances like the Consorcio DTx. 

Germany stands out among the countries that have already established these models, using a fast-track process for “DiGA” (Digitale Gesundheitsanwendungen), “Applications for Digital Health” in English. This approach provides provisional approval for a Digital Therapeutic product that meets minimal technical and safety requirements, allowing it to become part of the country’s reimbursement system within a short period of time, with final inclusion awaiting the outcomes of the clinical studies.  

This type of fast-track process offers important benefits for patients, healthcare professionals, digital developers, and health systems in general, as indicated by “The Federal Institute for Drugs and Medical Devices (BfArm)”, as it enables: 

• • Accelerated access to market: patients can access these solutions quickly. 
  • Innovation in patient care: exploring innovative patient-focused solutions promoting efficiency of the health system, improving health outcomes, and optimizing the care process. 
  • Reduction of costs: upon inclusion in the reimbursement system, these solutions are more accessible and affordable for patients. At the same time, by fostering system efficiency, healthcare costs are reduced in general. 
  • Promotion of safety and quality: the need to meet technical and clinical requirements assures the safety and quality of the solutions that become part of the system and are offered to patients.

Because of this, Spain is pursuing a model for fast-track approval similar to that of Germany, encouraging and accelerating the use of these Digital Therapeutics that, because they are tools that evolve rapidly, could become obsolete before they are even approved, thus losing the opportunity to benefit the entire healthcare ecosystem. 

As we can see, Digital Therapeutics have arrived, and are evolving rapidly. As a result, we need to have specific regulatory models that are adapted to the speed of their development. Fast-track processes are a good alternative, as they enable DTx to be introduced within a short period of time, while complying with strict prerequisites for their approval. Considering the successful examples in other countries, it is hoped that Spain will continue along this route, reinforcing the commitment to innovation and development with new patient-focused solutions that will also benefit the healthcare system as a whole. 

#DigitalTherapeutics #DTx #DigitalHealth 

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