Table 1 Non-exhaustive examples of Digital Health Technologies in scope of existing fit-for-purpose policy frameworks in Germany, France, and Belgium

Digital Therapeutics (DTx)

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 a patient’s health.

Cognitive-behavioural therapy delivered via a patient-facing mobile application to treat anxiety or depression, supported by evidence of a relevant clinical benefit.

Yes – provided the software is certified as a medical device and shown to have a demonstrable positive health impact, as defined by national fit-for-purpose health technology assessment frameworks (see section “Fit-for-Purpose and Dynamic Health Technology Assessments” and Tables 2 and 3).

Remote Patient Monitoring (RPM) Devices

Digital health technologies to collect and transmit patients’ health data to healthcare providers for health monitoring and management.

Software applications that collect vital signs from connected wearables or electronic patient-reported outcomes (ePROs) through validated digital questionnaires, transmitting data securely to clinicians and, thereby, enabling relevant demonstrable health improvements.

Yes – provided the software is certified as a medical device and shown to have a demonstrable positive health impact, as defined by national fit-for-purpose health technology assessment frameworks (see section “Fit-for-Purpose and Dynamic Health Technology Assessments” and Tables 2 and 3).

Digital care support programs

Digital solutions intended to help patients better manage their care of a specific disease or medical condition.

A patient-facing software application providing structured education and self-management support for chronic diseases, such as medication reminders, nutritional guidance, and lifestyle tracking, contributing to measurable care benefits.

Yes – provided the software is certified as a medical device and shown to have a demonstrable positive health impact, as defined by national fit-for-purpose health technology assessment frameworks (see section “Fit-for-Purpose and Dynamic Health Technology Assessments” and Tables 2 and 3).