Regulatory framework

In July 2021, the UK Government released its Life Sciences Vision, which sets out a 10-year strategy for the Life Sciences sector to address the coronavirus (COVID-19) pandemic and some of our generation's most pressing healthcare challenges, such as cancer, obesity, dementia. This Vision is a high-level document that does not set out the specific programs. The Government will set out its detailed delivery plan later, and the Sector will have the opportunity to decide where it wishes to co-invest.

On July 1, 2021, the updated Framework Contract that defines the social health insurance benefit package in Romania entered into force. The Framework Contract defines the SHI benefits package, the conditions for providing services and payments. The updated Framework Contract will be valid for the years 2021-2022.

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.

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.

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.

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.

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.

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.