For 2 out of 3 DiGAs, no positive healthcare effect could be proven so far
The DiGA directory currently lists 31 applications (22.03.2022), of which the largest percentage deals with neurotic, stress, and somatoform disorders (14.6 %).
On 6 March, the newest DiGA „Meine Tinnitus App - Das digitale Tinnitus Counseling“ was added to the directory. DiGAs are provided by a total of 23 companies, with GAIA AG and
GET.ON Institut für Online Gesundheitstrainings GmbH being the top performers each with four digital health apps. To be included in the DiGA directory, manufacturers must specify the positive
healthcare effect the digital application is intended to lead to. With 71%, a large proportion of DiGAs aim to create a medical benefit for the patient (see figure 1).
More information is available at in our German speaking sites.
The Hospital Structure Act (KHSG) of 01.01.2016 is the legal basis for the conclusion of quality contracts in which the aim is to test "the extent to which a
further improvement in the provision of inpatient treatment services can be achieved, in particular through the agreement of incentives as well as higher-value quality requirements" (Section 110a
(1) SGB V).
on overview of the G-BA on the German site
In August 2019, the “Gesetz für mehr Sicherheit in der Arzneimittelversorgung“ (GSAV) came into force. The law aims to improve the quality and safety of medicines.
The contents of the GSAV also affect the supply of biotechnologically produced drugs, known as biologics. The Federal Joint Committee (G-BA) was instructed to regulate notes on the
interchangeability of biologics with their biological reference drugs (so-called biosimilars) at the pharmacy level. The aut-idem regulation is thus to be extended to biologics. Previously, this
regulation was not permissible, as biosimilars are not generics of biologics. Due to the complex manufacturing process, biosimilars and biologics are not completely identical. By August 2022 at
the latest, the G-BA should have regulated more details on interchangeability at the pharmacy level.
Learn more on overview of the G-BA on
the German site
Real World Evidence, Evidence Generation
A brief video summary of our latest study using a Discrete Choice Experiment (DCE); health services research: