Appendix: What Are Digital Therapies (DTx)?According to the Digital Therapeutics Alliance:
Digital therapies (DTx) offer evidence-based therapeutic interventions to patients who are guided by high-quality software programs to prevent, manage or treat a wide range of physical, mental and behavioral conditions.
Digital therapies form an independent category of evidence-based products in the broader digital health landscape and are distinct from pure adherence, diagnostic and telehealth products.which is the translation of:
Digital therapeutics (DTx) deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a broad spectrum of physical, mental, and behavioral conditions.
Digital therapeutics form an independent category of evidence-based products within the broader digital health landscape, and are distinct from pure-play adherence, diagnostic, and telehealth products.
In a nutshell, DTxs are specialized software (for example, apps) that can effectively and measurably guide a patient’s progress towards improving their medical condition.DTx Alliance TwitterWhat Are Some Examples of?
An interesting example of digital therapeutics made in Italy is AmicoMed: an app that can be used, for example, through medical insurance plans that helps people improve their lifestyle to keep their blood pressure under control without the use of drugs.What is the usefulness of digital therapies?Also according to the Alliance, DTxs have the potential to:
Improve and support current medical treatmentsProvide patients, providers and payers with new treatment options for unmet medical needsBe used independently (stand-alone) or in combination with other therapies (combination therapies)Reduce dependence on certain pharmaceuticals or other therapiesIntegrate into medical guidelines and best practices
How Are Digital Therapies Regulated?
Digital therapies are commonly regulated under the term Software as a Medical Device, Software as a Medical Device (SaMD), developed by the International Medical Device Regulatory Forum (IMDRF), although not all SaMD-type products are digital therapies.
Also according to the Alliance, all DTx products must therefore adhere to the fundamental principles adopted by the industry, be subjected to adequate and well-controlled clinical investigations that establish that the product is safe and effective. Products must also conduct ongoing analyzes and applications of real-world testing and product performance data to ensure continued safety and efficacy.
What Categories of Digital Therapies Exist?There are several distinct categories of DTx based on their purpose:
- Coping with a medical condition
- Manage or prevent a medical disorder or disease
- Optimize a dressing
- Treating a medical disorder or disease
For case 1, such as a DTx for wellness, regulatory discretion is recommended (without explicit control). On the other hand, in cases 2 to 4, third party validation of the efficacy and safety claims by a national regulatory body or equivalent is required.