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Articles on Liability
- Law & regulation
Informed consent 2026: what has changed legally for physicians and hospitals
The basic framework of informed consent is stable, but the requirements for evidence, individualisation and documentation are rising. In Germany, the treating party bears the burden of proof for a proper consent discussion (§ 630h(2) BGB); general template forms are not sufficient if there are particular risk factors. Since August 2026, the transparency obligations of the EU AI Act also apply, for example to chatbots and AI-generated content. Common errors are missing proof of timing, standard forms without individualisation, undocumented conversations, ignored language barriers and analogue archiving.
· 9 min read - Law & regulation
Legally sound patient education in 2025: why comprehensive information is indispensable today – insights from current case law and digital innovation
Under both German and Austrian law, patient information must be complete, individual, comprehensible and provable (Germany: Sections 630a–630e of the German Civil Code, BGB; Austria: ABGB and patients' rights). Courts examine not only whether patients were informed, but how individually and how well this was documented. This includes rare but serious risks and genuine treatment alternatives. Digital patient education can strengthen comprehensibility and documentation; the personal consent discussion with a physician remains mandatory.
· 5 min read - Law & regulation
Cloud or on-premise in hospitals: what IT security and liability law actually require
Since 2024, the German legislator has expressly permitted cloud use for health data in § 393 SGB V — under clearly defined, verifiable conditions: processing in Germany or in the EU, an establishment of the processing entity in Germany, technical and organisational measures in line with the state of the art, and a current BSI C5 attestation. A blanket “cloud is not an option for us” is therefore no longer a legal position but an operational decision, subject to the same obligations to provide evidence as any other. What matters is not where the data is processed, but who operates an internet-facing service — and who can prove that the protective measures were adequate in the event of a dispute.
· 20 min read - Law & regulation
Burden of proof for informed consent: why a signature is not enough in a liability case
Under Section 630h(2) of the German Civil Code (BGB), the treating party bears the burden of proving patient information and consent — not the patient. A signed consent form only proves that a document was signed, not that the patient was informed individually, comprehensibly and in good time. The hospital's position becomes robust when the entire consent process can be reconstructed: which content was viewed when, which questions were asked and when the document was signed. In Austria, established OGH case law applies a comparable allocation of the burden of proof.
· 7 min read - Law & regulation
Why generic consent sheets become a liability risk in hospitals
Under Section 630e of the German Civil Code (BGB), patient information must be tailored to the specific patient. Generic consent sheets document that information was provided, but do not prove that the patient was informed about the risks relevant to them individually. Three sources of risk stand out: lack of relevance to the individual risk profile, outdated content and foreign-language versions that are not kept in sync with the German version. Consent documents generated individually for each patient address all three.
· 7 min read