DiGAs with an AI-based main function and DiGAs that serve to identify, monitor, treat or alleviate rare diseases (orphan diseases) are expressly excluded from the maximum price regulation for digital health applications.
Of the 54 DiGAs in the DiGA directory, some applications already benefit from this exception through the use of artificial intelligence (AI). However, not a single one is dedicated to orphan diseases.
A disease is considered an orphan disease if it is listed in the Orphanet consortium (orpha.net) at the time of application for inclusion in the DiGA directory or if no more than five in 10,000 people in the EU are affected by the disease
(s. Framework agreement between the National Association of Statutory Health Insurance Funds and the associations of manufacturers of digital health applications, p. 14