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Digital Home-Monitoring of Patients after Kidney Transplantation: The MACCS Platform

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[Digital health applications from a regulatory perspective-Experiences and current developments].

Florian Strauch¹, Karl Broich²

¹Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland.

|August 18, 2025

Summary

Digital health applications (DiGAs) are now prescribed and reimbursed, pioneering digital therapeutics. These apps require BfArM approval, ensuring quality and positive patient care outcomes, especially for psychiatric conditions.

Keywords:

DiGA directory DiGA guide Digital Act Fast track Psychiatric indications

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Area of Science:

Digital Health Applications (DiGAs)
Digital Therapeutics
Health Technology Assessment

Context:

Since 2020, DiGAs can be prescribed and reimbursed, integrating digital therapeutics into patient care.
The Federal Institute for Drugs and Medical Devices (BfArM) evaluates DiGAs for inclusion in a public directory.
DiGAs must meet stringent quality, data protection, and security standards.

Purpose:

To outline the regulatory framework and integration of DiGAs in Germany.
To highlight the role of DiGAs in patient care, particularly for psychiatric indications.
To inform about the evaluation process and requirements for DiGA approval.

Summary:

DiGAs are approved digital health applications available by prescription, with 28 focusing on psychiatric conditions.
Positive effects on care are primarily demonstrated through randomized controlled trials.
DiGAs serve as preparation or supplement to therapy, prescribed by various healthcare providers.

Impact:

DiGAs enhance patient care by offering accessible, self-management tools.
Patients value the convenience, information access, and therapeutic support provided by DiGAs.
The availability of DiGAs signifies a shift towards integrating digital solutions in healthcare.