AUSTRIA Trends and Developments Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
Organisations in life sciences will need to imple- ment solid security measures, including the fol- lowing. • Risk management policies – ensuring cyber- security risks are identified, assessed, and mitigated effectively. • Incident response plans – developing and maintaining procedures to address and recover from cybersecurity incidents. • Supply chain security – ensuring vendors and partners adhere to cybersecurity require- ments. • Access controls – protecting sensitive research data, intellectual property, and patient information through secure access management. Critical Medicines Act The European Commission has announced its intention to tackle the problem of shortage of essential medicines with a critical medicines act. The impact assessment is still outstanding, and it is uncertain whether the legislative proposal will be presented in the first quarter of 2025. EU Biotech Act The European Commission has announced a Biotech and Biomanufacturing Initiative for 2025 to help boost the biotech sector. The initiative is supposed to simplify market entry for newcom- ers by using regulatory sandboxes and estab- While on hold for a while, the initiative to estab- lish a European Health Data Space was boosted as, in Spring 2024, the European Parliament and the Council reached a political agreement on the Commission’s proposal for the EHDS. The EHDS is intended to foster patients’ portability of electronic health data, create a single market for lishing a new EU biotech hub. European Health Data Space
electronic health record systems and establish a uniform legal framework for the secondary use of health data. After being adopted by the Euro- pean Parliament in December 2024, the EHDS proposal was also adopted by the Council of the EU on 21 January 2025. It will, therefore, soon enter into force. Latest Developments at the National Level Amendment to the Austrian Health Telematics Act (Gesundheitstelematikgesetz) • eVaccination card and full operation: Intro- duction of detailed regulations for the start of full operation of the eVaccination card. • Restructuring of the electronic health records (ELGA) and eHealth support centers: Estab- lishment of an “ELGA and eHealth support facility” with four sub-areas: ELGA ombuds- man’s office (existing), Appeals office (exist- ing), Service line (existing), and new eHealth service point to ensure data quality and avail- ability in the central vaccination register. • Data security measures: Adaptation of the data security precautions laid down in the Austrian Health Telematics Act. • Reducing prohibitions and simplifying through more general formulations to make ELGA and eHealth applications legally secure. Reimbursement of digital therapeutics (DTx) in Austria Digital therapeutics (DTx) are becoming increas- ingly attractive both in terms of commercialisa- tion and clinical application. In Austria, DTx is typically referred to as “ Digitale Gesundheitsan- wendungen ” (DIGAs). Austrian law provides for a system of compulsory health insurance. The legal basis for reimbursement of medical treat- ment for insured persons is laid down in the Austrian General Social Insurance Act (“ASVG”). Currently, no explicit provision is in place to gov- ern the reimbursement of DTx. Therefore, reim-
35
CHAMBERS.COM
Powered by FlippingBook