Terms of Use and Platform Terms

1. Scope of Application

1.1 These Terms of Use ("Terms") govern the access to and use of the website operated by Isaree GmbH ("Isaree") as well as any related services, applications, tools, content, and functionalities made available therein, including any sandbox, beta, or platform features (together, the "Services").

1.2 By accessing or using the Services, the user ("User") agrees to be bound by these Terms. If the User does not agree, access to or use of the Services is not permitted.

1.3 These Terms apply in addition to any supplementary agreements that may be concluded between Isaree and the User, in particular data processing agreements or enterprise agreements.

1.4 These Terms apply exclusively to users acting in the course of their professional or commercial activity (Unternehmer im Sinne des § 14 BGB). Use by consumers within the meaning of § 13 BGB is not permitted.

2. Description of Services

2.1 The Services include, inter alia:

• informational content relating to AI-supported clinical workflows and healthcare innovation
• AI-based support tools (e.g. transcription, summarisation, workflow assistance)
• experimental, beta, or sandbox functionalities
• functionalities enabling Users to create, configure, share, or otherwise make available AI-based agents or workflows

2.2 The Services, in whole or in part, may be in a development or testing phase and are provided for evaluation and informational purposes only.

2.3 The Services constitute digital services within the meaning of §§ 327 et seq. German Civil Code (BGB). Unless expressly agreed otherwise, Isaree does not owe any specific result (Erfolg), but only the provision of the Services.

2.4 Isaree reserves the right to modify, restrict, or discontinue any part of the Services at any time without prior notice.

3. No Medical Advice; User Responsibility

3.1 The Services and any outputs generated by AI-based functionalities do not constitute medical advice, diagnosis, or treatment recommendations.

3.2 The Services are intended solely to support qualified healthcare professionals and do not replace professional judgment or decision-making.

3.3 The User shall independently review, validate, and verify all outputs prior to any clinical or professional use.

3.4 The User bears sole responsibility for all medical, clinical, or professional decisions and actions taken on the basis of or in connection with the Services.

4. Regulatory Status

4.1 Unless expressly designated otherwise, the Services are not certified as a medical device within the meaning of Regulation (EU) 2017/745 (MDR).

4.2 The User acknowledges that the regulatory classification of software, including AI-based systems, depends on the specific use case and that the User remains responsible for ensuring compliance with applicable regulatory requirements in their respective professional context.

5. Eligibility and Professional Use

5.1 Access to and use of certain functionalities of the Services, in particular AI-based tools and platform features, is restricted to licensed healthcare professionals or persons acting under appropriate professional supervision.

5.2 The User warrants that they possess the necessary qualifications and authorisations required under applicable professional law (including ärztliches Berufsrecht) and other applicable regulations.

6. Acceptable Use

6.1 The User shall use the Services solely in compliance with applicable laws and these Terms.

6.2 In particular, the User shall not:

• a) upload, process, or otherwise use personal data, in particular health data within the meaning of Art. 9 GDPR, without a valid legal basis;
• b) upload identifiable patient data in sandbox or test environments unless explicitly authorised;
• c) rely on AI-generated outputs without appropriate professional validation;
• d) create, configure, or distribute AI agents that are misleading, unsafe, unlawful, or not suitable for the intended clinical context;
• e) use the Services for any unlawful or harmful purpose.

7. User Content and AI Agents

7.1 Responsibility

Where the User creates, uploads, shares, or otherwise makes available any content, including AI agents, workflows, or configurations ("User Content"), the User shall:

• ensure that such User Content complies with all applicable laws and professional standards;
• ensure that they are authorised to use and share such content;
• assume full responsibility for the functionality, outputs, and consequences of such User Content.

7.2 Grant of Rights

The User grants Isaree a non-exclusive, worldwide, royalty-free right to use, reproduce, analyse, and process User Content to the extent necessary for the operation, testing, and improvement of the Services.

7.3 Moderation and Enforcement

Isaree reserves the right, at its sole discretion, to:

• review, monitor, or audit User Content;
• restrict, disable, or remove any User Content;
• suspend or terminate access to the Services

where this is necessary to ensure compliance with these Terms, applicable law, or to mitigate risks to users, patients, or third parties.

7.4 Notice and Takedown

Users may report unlawful or non-compliant content to Isaree. Upon becoming aware of illegal content, Isaree will take appropriate measures in accordance with applicable law, including removal or disabling access where required.

8. AI Transparency and Limitations

8.1 The User acknowledges that AI-based systems:

• may generate inaccurate, incomplete, or biased outputs;
• are not deterministic and may produce varying results;
• do not possess clinical understanding or contextual awareness equivalent to that of a qualified professional.

8.2 The use of AI-generated outputs requires continuous human oversight.

9. Intellectual Property

9.1 All rights in and to the Services and their content, excluding User Content, are owned by Isaree or its licensors and are protected by applicable intellectual property laws.

9.2 The User is granted a limited, non-exclusive, non-transferable right to use the Services solely for their intended purposes in accordance with these Terms.

10. Third-Party Content

10.1 The Services may contain links to or integrations with third-party content or services.

10.2 Isaree does not control and assumes no responsibility for such third-party content or services.

11. Data Protection

11.1 Information regarding the processing of personal data is set out in the Privacy Policy.

11.2 Depending on the specific use case, Isaree may act as controller, processor, or joint controller within the meaning of the GDPR.

11.3 The User remains responsible for ensuring that any processing of personal data carried out via the Services is lawful.

12. Availability

12.1 The Services are provided "as is" and "as available".

12.2 Isaree does not guarantee uninterrupted availability, error-free operation, or specific performance characteristics.

12.3 To the extent permitted by law, Isaree does not assume any warranty (Gewährleistung) for the Services, in particular with regard to availability, accuracy, fitness for a particular purpose, or freedom from defects, except where mandatory statutory provisions apply.

13. Liability

13.1 General Limitation

To the maximum extent permitted by applicable law, Isaree shall not be liable for damages arising from or in connection with:

• the use of or reliance on AI-generated outputs;
• User Content, including AI agents created or shared by Users;
• inaccuracies, omissions, or errors in the Services.

13.2 Limitation under German Law

Liability for damages caused by simple negligence is excluded, except in the event of a breach of essential contractual obligations (Kardinalpflichten). Essential contractual obligations are those obligations whose fulfilment is essential for the proper performance of the contract and on whose compliance the User may regularly rely. In such cases, liability shall be limited to foreseeable, typical damages.

13.3 Mandatory Liability

The foregoing limitations shall not apply in cases of:

• intent (Vorsatz) or gross negligence (grobe Fahrlässigkeit);
• injury to life, body, or health;
• liability under mandatory statutory provisions.

13.4 Clinical Responsibility

Isaree shall not be liable for:

• medical decisions taken by the User;
• treatment outcomes;
• any use of the Services in a clinical context.

14. Indemnification

The User shall indemnify and hold harmless Isaree from and against all claims, damages, liabilities, and costs arising from:

• the User's use of the Services;
• User Content;
• any violation of these Terms or applicable law.

15. Monitoring and Audit

Isaree may log, monitor, and analyse usage of the Services to:

• ensure security and compliance;
• detect misuse;
• improve system performance and safety.

16. Amendments

Isaree reserves the right to amend these Terms at any time. The version applicable shall be the version in force at the time of use.

17. Term and Termination

17.1 The contractual relationship commences upon the User's first use of the Services.

17.2 The User may cease using the Services at any time.

17.3 Isaree may suspend or terminate access to the Services with immediate effect for good cause (wichtiger Grund), in particular in the event of:

• violations of these Terms,
• misuse of the Services,
• risks to patient safety, legal compliance, or system integrity.

17.4 Statutory rights of termination remain unaffected.

18. Governing Law and Jurisdiction

These Terms shall be governed by the laws of the Federal Republic of Germany. To the extent legally permissible, the exclusive place of jurisdiction shall be Berlin, Germany.

19. Severability

Should any provision of these Terms be invalid or unenforceable, the validity of the remaining provisions shall remain unaffected.

20. Contact

Isaree GmbH Email: info@isaree.ai

21. Language

These Terms are provided in English. In case of translations, the English version shall prevail, unless otherwise required by mandatory law.