Experience with DiGA fast track process in Germany after one year
The BfArM assesses medical apps and digital health treatments (DiGA) in terms of patient benefit, positive effects on care, data protection and
Category: News and updates
How are digital health applications assessed in Germany?
On 19 Dec 2019, the DVG came into force in Germany. This meant that since 2020, clinicians can prescribe and SHI funds
The G-BA accepts treatment per video call
Introduction of DVPMG law On 9 June 2021, the law on the digital modernization of care (DVPMG) came into force. The key
The G-BA specifies QA requirements for cell and gene therapies in Germany
In the previous assessments of Kymriah, Yescarta, Tecartus, and Zolgensma, the G-BA had defined specific QA requirements for the use of these
G-BA assessment of orphan drug gene therapies, Zolgensma and Libmeldy
The gene therapies Zolgensma and Libmeldy, both, are targeting very rare, severe, genetic diseases in children. The G-BA has now assessed the
