Can the expected medical device shortages in Germany be stopped?
Serious medical device shortages in Germany have been observed – and more are expected – as a consequence of the new EU
Category: Method assessments
BfArM tightens data protection requirements for DiGAs – A new certification is needed
Since 2020, clinicians can prescribe – and SHI funds will reimburse – medical apps and digital health treatments, the so-called “DiGAs”. The BfArM assesses these DiGAs
The G-BA increases the fees for consultations
Manufacturers of drugs or medical devices can apply for a consultation meeting with the G-BA before submitting a dossier. This consultation offers
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
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