Telemedicine – advanced medical care at a distance
Telemedicine is defined in various ways, but at its core, it is about providing medical care at a distance by utilising information and communication technologies (ICT). While it was originally only used sporadically via telephone or radio, today it encompasses a variety of concepts that characterise modern healthcare.
Telemedicine overlaps with the terms eHealth, mHealth and dHealth. While eHealth is a generic term for digitalisation in the healthcare sector, telemedicine focuses more on remote medical treatment.
Medical devices and digital health applications (DiGA)
Medical devices play a central role in telemedicine, particularly in recording and transmitting patient data. There are clear legal requirements:
- Medical Device Regulation (MDR) regulates quality and safety.
- Categorisation according to risk classes determines the requirements (from simple measuring devices to implanted devices).
- Reimbursement by statutory health insurance funds (GKK) is only made for products from official lists.
DiGA – Digitalisation in patient care
Digital health applications (DiGAs) are a new category of medical devices up to Risk Class IIb that have been specially developed for the care of patients:
- A fast-track procedure enables faster inclusion within the scope of standard care.
- Reimbursement of costs without authorisation facilitates access.
Although DiGAs offer great potential for telemedicine, their focus to date has mostly been on supporting patient self-management. It is expected that the involvement of doctors will increase with the authorisation of products in higher risk classes. For manufacturers of DiGA, the inclusion of their products in the DiGA directory of the Federal Institute for Drugs and Medical Devices [BfArM] will be all the more worthwhile in future. The free reuschlaw DiGA Fast-Track-Check shows how good the chances of inclusion in the directory are and what still needs to be done to achieve inclusion.
Conclusion
Medical devices play a central role in telemedicine, especially for the recording and transmission of patient data. DiGAs represent a new product category that is intended to facilitate the use of digital health applications in standard care through an accelerated authorisation procedure and without the need for approval, thus expanding the potential for telemedical applications, particularly in the area of telemonitoring.
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