Regulatory framework


Jun 2020

The application portal for inclusion in the directory of digital health apps (DiGA) at the Federal Office for Drugs and Medical Devices (BfArM) has been online since May 27, 2020. The application, which can be submitted only electronically, is the first step for the respective health app to be reimbursed in the future as part of regular care. Read more


May 2020

In late April 2020, the European Parliament has postponed the come-into-force of the EU Medical Device Regulation (MDR) by one year. Medical devices can thus be placed on the market for another year under the previous regulations. The end date of the transition period will remain May 26, 2024. Read more


May 2020

Since January 1, 2020, the nursing staff costs of the hospitals are excluded from the DRG case flat rates and financed in parallel to the DRG case flat rates using a hospital-specific care budget based on the principle of cost coverage. Read more


Mar 2020

On January 1, 2020, as a part of healthcare reform in Austria, the Austrian health insurance fund (Die Österreichische Gesundheitskasse (ÖGK)) was created by merging the nine former regional health insurance funds. The ÖGK is based in Vienna. Read more


Oct 2019

In June of 2019, order on changes of procedure for the development of standards of health care was issued regarding the development of health standards based on approved clinical recommendations. Read more


Jan 2018

Since January 1, 2018, responsibility for managing the product regulations for medical devices is transferred from the Norwegian Directorate of Health to the Norwegian Medicines Agency. Read more