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

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.