Digital Therapeutics (DTx) are therapeutic interventions indicated for a specific disease and designed to modify the behaviour of a patient in order to improve the outcomes of his disease.
There are some definitions proposed by bodies or associations, among which the most used is the one proposed by the Digital Therapeutic Alliance, a global non-profit association of companies in the sector and stakeholders involved in the development of Digital Therapeutics:
- Digital therapeutics deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease.
- They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.
- Digital therapeutics products incorporate advanced technology best practices relating to design, clinical validation, usability, and data security.
- They are reviewed and cleared or approved by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use.
- Digital therapeutics empower patients, healthcare providers, and payers with intelligent and accessible tools for addressing a wide range of conditions through high quality, safe, and effective data-driven interventions.
It is therefore an operational definition, indicating what Digital therapeutics do rather than defining what they are.
To define what they are, it is necessary to describe them in their essential elements, as therapies:
- developed through randomized and controlled clinical trials,
- authorised for use in clinical practice by regulatory bodies,
- subject, where necessary for the purposes of reimbursement, to assessments of HTAs
- reimbursed in some cases knows public health services, such as in England and Germany or by insurance companies
- prescribed – in most cases – by the doctor, although some therapy that meets all these criteria are offered to the patient directly by the manufacturer, as in the case of over-the-counter drugs.
What differentiates Digital Therapeutics from pharmacological therapies is the nature of the active ingredient, which is the element responsible for the clinical effect. This s a chemical or protein molecule in the case of the drug, an algorithm in the case of Digital Therapeutics.