A definition of digital therapy can be found in the December 2023 ISO standards, which state that it is “health software intended to treat or alleviate a disease, disorder, condition or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on the patient’s health.†(ISO/TR 11147:2023).
Each DTx can be used independently or combined with drugs, devices, or other therapies, as long as the software is the driving component of the therapeutic effect. In fact, DTxs include a digital active ingredient (the therapeutic algorithm responsible for the clinical outcome) and digital excipients such as: medication reminder services or other remote healthcare assistance aimed at keeping the patient engaged.
As defined in Regulation (EU) 2017/745 (MDR), DTxs fall under the category of medical devices. In fact, Regulation 11 states that medical device software is divided into four categories based on the risks associated with the intended use: from Class I (low risk) to Class III (high risk).
For Class I devices, a manufacturer’s declaration is sufficient for CE marking purposes, while all other classes require the involvement of a certified body. The MDR explicitly classifies two categories of medical device software:
- Software intended to provide information used to make decisions for diagnostic or therapeutic purposes (Class IIa or IIb or III, depending on the severity of the potential consequences to a person’s health);
- Software intended to monitor physiological processes (Class IIa or IIb).
All other software falls under Class I. Given that software for therapeutic purposes is not specifically mentioned, it could be argued that DTxs fall under Class I; this raises concerns that highly innovative software having a potentially significant impact on patient health is not being evaluated by a certified body.
Other issues of concern regarding DTx are:
- The rapid developments and changes in DTx;
- The lack of harmonization of applicable regulations; and
- The absence of a standardized EU framework for assessing eligibility for social security reimbursement.
Two digital therapies have been given the green light by the Ministry of Health and are currently being tested in Italy. The first, KidneYou – a platform developed by AstraZeneca and AdvicePharma for the treatment of chronic kidney disease – facilitates the collection, storage, and visualization of clinical data of individuals undergoing DTx enabling healthcare personnel to better monitor treatment, dietary and physical activity of patients. The second, DTxO, a digital therapy for the outpatient management of obesity (developed by AdvicePharma with Theras Lifetech) provides personalized diet plans, counselling, exercise and assessment programs, as well as cognitive-behavioural support.
