General Terms and Conditions of Business and Use (AGB / Terms of Use)
for the use of the "Ghostwriter" software
Version / Effective Date: 2025-10-13
Preamble
These General Terms and Conditions of Business and Use ("AGB / Terms of Use") govern both
(a) the contractual relationship between Artificial Intelligence in Medicine UG (haftungsbeschränkt) ("Service Provider") and registered users of the "Ghostwriter" software (General Terms and Conditions under German law, §§ 305 ff. BGB), and
(b) the use of the services provided via the website and associated platform (Terms of Use).
They apply exclusively to professional users (B2B). By registering or using the software, the user agrees to these Terms in their current version.
1. Service Provider
Artificial Intelligence in Medicine UG (haftungsbeschränkt), Zugspitzstr. 1, 82166 Gräfelfing, Germany. Email: contact@radiology-ghostwriter.com, Phone: +49 160 91889330.
2. Eligible Users (B2B) & Professional Attestation
The Software may only be used within the European Union, the European Economic Area, Switzerland and the United Kingdom. Use outside these regions is prohibited. Any use from third countries constitutes a breach of contract and does not establish a valid contractual relationship. Any liability of the Service Provider under foreign law is excluded to the extent legally permissible. German law and the venue Munich shall remain decisive.
The Software is intended exclusively for professional users (in particular physicians/radiologists and medical institutions). Upon registration, the user attests that the Software is used predominantly for professional purposes and that the user is not a consumer. Employed professionals paying in their own name qualify as professional users. The Service Provider may require appropriate proof (e.g., profession, institution).
3. Service Description (Not a medical device)
The Software is designed exclusively as a text processing and formatting tool for administrative purposes and does not fulfill any of the specific medical purposes defined in Art. 2 No. 1 of the MDR. The Software specifically is not intended for:
• the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of diseases;
• the diagnosis, monitoring, treatment, alleviation of or compensation for injuries or disabilities;
• the investigation, replacement or modification of anatomy or a physiological or pathological process or condition.
Radiological diagnosis is performed exclusively by a specialist in radiology.
Service components may include, inter alia: AI‑assisted report generation, voice‑to‑text dictation, template‑based formatting, multilingual output, and personal style/template matching. All output must be fully reviewed and approved by the user.
4. Professional Responsibility
Use is limited to qualified medical professionals. Full professional responsibility remains with the user; the Software does not replace clinical judgment. Any use of the texts created using the software must be checked in advance by the user, in particular before transfer to the Radiology Information System (RIS) or another information system.
5. Registration, Account & Approval
Registration requires accurate information (email and, where applicable, a registration/invitation code). Credentials are personal and non‑transferable. Users are responsible for account security. Accounts may be subject to review/verification and may be approved, restricted or rejected by the Service Provider.
6. Fees, VAT & Billing
Prices are generally quoted net (excluding VAT, where applicable). German VAT is charged to German customers. For EU B2B customers with a valid VAT ID, the reverse charge mechanism may apply; without a valid VAT ID, statutory VAT is charged. Billing may be via credits/top‑ups, pay‑as‑you‑go, or (subject to review) institutional invoicing (e.g., Net 30, late interest/fees may apply). Consumed services/credits are non‑refundable. Price changes with reasonable prior notice (e.g., 30 days).
7. Invoices
Top‑ups are prepaid credit packages (e.g., a defined number of reports) made available immediately. Each top‑up constitutes a separate service; multiple top‑ups within a period are permitted. For amounts up to and including EUR 250.00 gross, the Service Provider issues small‑amount invoices pursuant to Section 33 UStDV via email (PDF) (including the Service Provider's name/address, service description, issue date, the total amount incl. VAT and the applicable VAT rate). For amounts exceeding EUR 250.00 gross or upon request with a postal billing address, a full invoice is issued. The payment method (e.g., private card/PayPal) may differ from the billing address; for tax purposes the billing address is decisive.
8. Data Protection & No Patient Data
The Software is designed not to process personal input-data, especially identifiable patient data (in the following referred to as "Patient Data"). The user must not input personal data and bears data‑protection responsibility for input data. The Service Provider may process anonymized usage data to improve the service.
8a. Input Safeguards (Privacy by Design)
To substantially reduce the input of identifiable patient data, the Software implements appropriate technical and organizational measures (TOMs) (client/server-side filters, pattern/regex checks, AI assisted detection of sensitive information, masking/aborts). These mechanisms improve safety but may yield false positives/negatives and do not relieve the user from the duty to avoid entering identifiable patient data. The Service Provider is not obliged to actively monitor user content; in case of suspected violations, processing may be aborted, content deleted, and access suspended. For enterprise customers, stricter DLP/filter policies can be configured upon request.
8b. Data Processing Agreement (DPA)
The software is designed so that no processing of personal data on behalf of the customer takes place. If, in exceptional cases, an institutional customer intends to use the software with personal data, a Data Processing Agreement (DPA) pursuant to Art. 28 GDPR must be concluded in advance. The current Standard Contractual Clauses of the European Commission may be used as a template (link to EU template).
In the event that personal data is entered or processed contrary to the intended use, this DPA shall automatically apply to such processing to the extent legally permissible.
9. IP & Content Rights
All rights in the software/platform remain with the Service Provider; a non‑transferable, non‑sublicensable, purpose‑limited right of use is granted. The user retains rights to their inputs. Generated reports—subject to third‑party rights—become available to the user upon generation. The user grants the Service Provider the limited rights necessary to operate/improve the service during the term. Reverse engineering, decompilation, and circumvention of technical safeguards are prohibited.
10. Acceptable Use
Prohibited uses include, inter alia: non‑medical/abusive use, credential sharing, circumvention of safeguards, unlawful content, false/misleading medical information, use beyond agreed user/volume limits.
11. Technology & AI Limitations
AI outputs may contain errors; availability/performance may be affected by third parties (e.g., API). There is no entitlement to uninterrupted operation or a specific level of accuracy; maintenance windows may occur.
12. Medical Disclaimer
The Software does not replace professional medical judgment. Any generated text must be reviewed/adapted by qualified personnel, responsibility rests with the user.
13. Liability
13.1. The Service Provider shall only be liable for damages, irrespective of the legal grounds, including in the event of breach of contractual obligations or claims in tort, in the following cases:
13.1.1. Intention
13.1.2. Culpably caused injury to life, body or health
13.1.3. Gross negligence; and/or
13.1.4. In other cases, in the event of a breach of a material contractual obligation, i.e. an obligation, the fulfilment of which is a prerequisite for the proper performance of this Agreement and on the fulfilment of which the Client regularly relies and may rely and/or the breach of which jeopardizes the purpose of this Agreement.
In all other respects, the Service Provider's liability is excluded.
13.2. In the cases of subparagraphs 13.1.4 the Service Provider's liability shall be limited to the typical and foreseeable damage.
13.3. The exclusions or limitations of liability pursuant to sections 13.1 to 13.2 shall also apply to the same extent to the actions of the Service Provider's legal representatives and vicarious agents. Furthermore, the Service Provider shall not be liable for the grossly negligent breach of non-essential contractual obligations by simple, non-managerial vicarious agents.
13.4. The client is solely liable for the content and correctness of the final report.
13.5. If claims are made against the Client and/or the Service Provider by third parties in relation to Patient Data, the Client shall expressly indemnify the Service Provider in full against all claims, irrespective of the legal grounds. This also includes any necessary court and legal costs.
14. Indemnification
The user shall indemnify and hold the Service Provider harmless from third‑party claims arising from user‑caused legal violations, breaches of these Terms, or misuse.
15. Compliance & Regulations
The user ensures compliance with professional regulations, medical standards, data protection laws, institutional policies, and any required consents/confidentiality obligations. The user further ensures that use of the Software complies with professional duties (including medical professional rules and advertising restrictions), with applicable institutional requirements, and with relevant competition and healthcare advertising laws. Use directed at patients or for patient-targeted advertising is excluded.
16. AI Act Compliance
The user is obliged to comply with the requirements of EU Regulation 2024/1689 ("AI Act"), in particular the obligation to undergo appropriate training/education in the use of AI systems. The Service Provider will provide suitable references and, where applicable, links to recognized training offerings.
17. Term & Termination
The Service Provider may suspend or terminate accounts for violations, non‑payment, suspected fraud, or pursuant to legal/regulatory orders. Access ends upon termination; statutory retention obligations remain unaffected. Unused credits may be forfeited upon termination.
18. Changes to the Terms
Material changes with reasonable prior notice (e.g., 30 days) to registered users; continued use constitutes acceptance. If not accepted, the user may terminate the agreement.
19. Language & Precedence
These Terms are available in German and English. In case of discrepancies, the German version prevails.
20. Governing Law & Jurisdiction
German law applies exclusively; where permitted, venue is Munich, Germany.
21. Severability & Contact
Invalidity of any provision does not affect the remainder.
Contact: contact@radiology-ghostwriter.com