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
Three new methods were added to the catalogue of SHI funds
Before a new diagnostic and treatment method can be offered and reimbursed in the outpatient sector, two important steps need to be
G-BA assesses method of allogeneic SCT in ALL, AML and NHL
Did you know that some hospital methods are not covered by SHI funds? In Germany, non-drug interventions are assessed as methods. Methods
The process of method assessments in Germany
The G-BA, physicians, hospitals, SHI funds or patient organizations can request the assessment of a new method. If the request was accepted,
NUB method assessments to become faster
Early benefit assessments are completed within 12 months, while method assessments used to take around 3 years. In 2020, the G-BA introduced
IQWiG published a new method assessment
The whole IQWiG project can be accessed here.