Healthcare AI 2025

AUSTRIA Law and Practice Contributed by: Harald Strahberger and Florian Sesztak, Kinstellar

9.2 Regulatory Sandboxes and Innovation Programmes Austria participates in regulatory sandboxes and inno - vation funding programmes relevant to healthcare AI, although no AI-specific sandbox has yet been estab - lished nationally. Austrian stakeholders can access EU-wide initiatives such as the Digital Europe Pro - gramme and Horizon Europe, which support pilot test - ing, clinical validation, and regulatory engagement for AI solutions. At the national level, the Austrian FFG provides funding for AI-related health technology projects, especially under the “AI for Green” and “Health Tech Hub” calls. These programmes offer developers opportunities to trial AI applications in controlled clinical environments through collaboration with academics, industry, and regulators. 9.3 International Harmonisation Austria contributes to international harmonisation of healthcare AI regulations primarily through its partici - pation in EU policymaking and alignment with global standards. As an EU member state, Austria adheres to the MDR and the EU AI Act, both of which are developed in coordination with international regula - tory frameworks and technical standards. Austria’s involvement in the European Health Data Space (EHDS) and EMA data-sharing initiatives further posi - tions it to benefit from harmonised regulation and secure, interoperable AI deployment across borders. Austria also actively incorporates recommendations from bodies such as the World Health Organisation (“WHO”), the International Medical Device Regulators Forum (“IMDRF”), and ISO/IEC technical committees. Nevertheless, cross-border regulatory challenges for Austrian AI developers persist, including differing inter - pretations of AI compliance under the MDR across EU countries, as well as the complexity of data trans - fer rules under the GDPR. To navigate these issues, developers often engage legal counsel in each target market, implement standard contractual clauses, and seek EU-wide certification to minimise fragmentation.

digital health guidelines. Most systems qualify as class IIa or IIb SaMD and must comply with data protection and cybersecurity standards. In home settings, clear consent, explainability, and physician involvement are essential. The ÄrztG requires that diagnostic or treat - ment decisions, even if AI-assisted, are confirmed by a physician. 8.5 Drug Discovery and Development AI used in drug discovery is not typically regulated in Austria. However, when applied to clinical trials or patient selection, oversight by BASG or EMA and com - pliance with Good Clinical Practice (“GCP”) apply. If used for individual-level recommendations, the AI Act could also apply. GDPR governs all data processing. Austrian research institutions are actively engaged in AI-driven pharmaceutical R&D, and developers should closely monitor EU guidance as the regulatory envi - ronment evolves. 9. Future Trends and Regulatory Developments in Healthcare AI 9.1 Pending Legislation and Regulation Austria is preparing for the enforcement of the AI Act, which will be the most significant legislative devel - opment affecting healthcare AI. The AI Act classifies most healthcare AI systems, particularly diagnostic and decision-support tools, as high-risk systems. This classification will impose strict obligations on devel - opers and users, including: • risk management frameworks; • human oversight; and • conformity assessments. Austria will enforce the AI Act through existing bod - ies such as the BASG (for medical devices) and DSB (for data protection), which will cooperate with an EU-level AI regulatory board. The AI Act introduces additional technical, ethical, and monitoring require - ments. Developers in Austria must begin aligning their systems now to meet the forthcoming standards.

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