Healthcare AI 2025

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

2. Legal Framework for Healthcare AI 2.1 Regulatory Definition and Classification of Healthcare AI In Austria, healthcare AI systems are regulated under the EU Medical Devices Regulation (“MDR”) and the Austrian Medical Devices Act ( Medizinproduktegesetz – “MPG”). This is because, the MDR (and so does the MPG) also classifies software as medical device if it is intended by the manufacturer to be used, alone or in combination, for human beings for diagnosis, pre - vention, monitoring, prediction, prognosis, treatment or alleviation of disease, and/or diagnosis, monitor - ing, treatment, alleviation of, or compensation for, an injury or disability, and/or investigation, replacement or modification of the anatomy or a physiological or pathological process or state, and/or providing infor - mation by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immu - nological or metabolic means, in or on the human body. Therefore, AI systems intended for the above pur - poses are classified as software as a medical device (“SaMD”). According to Rule 11 of Annex VIII of the MDR, software intended to provide information that is used to make decisions for diagnostic and therapeutic purposes falls into class IIa, unless the decisions may cause death or an irreversible deterioration of a per - son’s state of health (in this case it falls into class III), or a serious deterioration of a person’s state of health or a surgical intervention (in this case it falls into class IIb). Software intended to monitor physiological pro - cesses falls into Class IIa, except when it is intended for monitoring vital physiological parameters, where the nature of variations in those parameters is such that they could result in immediate danger to the patient; in such cases, it falls into Class IIb. All other software is classified as class I. With the adoption of the EU Artificial Intelligence Act (“AI Act”), AI systems already classified as medical devices under the MDR are now also considered “high-risk AI systems” under Article 6 (1) AI Act and must therefore comply with the provisions of the AI Act.

2.2 Key Laws and Regulations In Austria, the governance of AI in healthcare is shaped by a combination of national laws and EU regulations. The most important regulatory frameworks are: EU Regulations (Directly Applicable in Austria) • General Data Protection Regulation (“GDPR”): Applies EU-wide and ensures data protection, transparency, and patient rights in any AI handling personal or health-related data. • MDR: AI software with medical purposes (eg, diagnosis, treatment, etc) is considered a medical device and must comply with the specifications for placing medicinal products on the market (eg, CE certification, etc). • AI Act: If AI systems used in the healthcare sector are medical devices, they are considered “high-risk AI systems” and must therefore comply with the strict regulatory requirements of the AI Act. Austrian Regulations • Medicinal Products Act ( Arzneimittelgesetz – “AMG”): Regulates the development, approval, and distribution of medicinal products. AI tools involved in drug prescription, interaction checks, or phar - maceutical processes must comply with relevant regulations. • MPG: AI software with medical purposes (eg, diagnosis, treatment, etc) is considered a medical device and must, in addition to the provisions of the MDR, comply with the specifications for plac - ing medicinal products on the market. • Physicians Act ( Ärztegesetz – “ÄrzteG”): Regulates the professional responsibilities and exclusive competencies of licensed physicians; under Sec - tion 49 ÄrzteG, core medical tasks such as diagno - sis and treatment decisions may not be delegated to AI systems and require human medical over - sight. • Health and Nursing Care Act ( Gesundheits- und Krankenpflegegesetz – “GuKG”): Defines profes - sional duties and standards for healthcare workers. AI used in clinical practice must align with these standards to ensure safe patient care. • Data Protection Act 2018 ( Datenschutzgesetz – “DSG”): National implementation of GDPR with Austria-specific rules. Regulates the lawful pro - cessing of sensitive health data by AI systems.

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