Federal Ministry of Health Publishes Criteria for Inclusion in the Directory of Digital Care Applications
On January 16, 2025, the German Federal Ministry of Health (BMG) released a new article titled “20/14526: Kleine Anfrage Kriterien zur Aufnahme in das Verzeichnis für Digitale Pflegeanwendungen (PDF).” This article outlines the criteria that digital care applications must meet in order to be included in the Directory of Digital Care Applications (DiPA).
The DiPA is a publicly accessible directory that lists digital care applications that have been assessed and certified by the Federal Institute for Drugs and Medical Devices (BfArM). The aim of the DiPA is to provide transparency and guidance to healthcare professionals and patients about which digital care applications are safe and effective.
To be included in the DiPA, digital care applications must meet the following criteria:
- Be intended for use in the prevention, diagnosis, monitoring, treatment or alleviation of diseases or injuries.
- Be based on scientific evidence and have a positive benefit-risk ratio.
- Be safe and effective.
- Be user-friendly and accessible.
- Be interoperable with other healthcare applications.
The BMG has also developed a set of guidelines to help developers create digital care applications that meet the DiPA criteria. These guidelines cover a wide range of topics, including:
- Clinical evaluation
- Data protection
- Usability
- Interoperability
The BMG is committed to supporting the development and adoption of digital care applications. The DiPA and the associated guidelines are important steps towards ensuring that patients have access to safe and effective digital care applications.
20/14526: Kleine Anfrage Kriterien zur Aufnahme in das Verzeichnis für Digitale Pflegeanwendungen (PDF)
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