Terms of Service

Please read these Terms of Service ("Terms") carefully before using [healthtechpathways.org] the Health Tech Pathways platform ("Health Tech Pathways" or the "Platform"). These Terms govern your access to and use of Health Tech Pathways. By accessing or using Health Tech Pathways, you agree to be bound by these Terms. If you do not agree with any part of these Terms, you may not access or use Health Tech Pathways.

Health Tech Pathways is operated by: Health Tech Hub Copenhagen CVR: 40479007 Registered in Denmark Contact: legal@healthtechhub.org

Health Tech Pathways is an AI-supported decision-support and educational platform designed to help users understand, structure, and prepare regulatory pathways and documentation for health-tech products in the European Union. Health Tech Pathways: • provides guidance and tooling only, • does not replace professional, legal, or regulatory advice, • does not constitute medical advice, diagnosis, or treatment recommendations; and • is not a medical device or in vitro diagnostic medical device as defined under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR)

Health Tech Pathways is not: • a Notified Body, • a Competent Authority, • a certification or accreditation body. Health Tech Pathways does not: • certify, approve, or validate products, • submit regulatory applications on behalf of users, • provide legally binding regulatory determinations. All outputs are non-binding and advisory. The Platform provides a preliminary framework for guidance only and is not a substitute for a comprehensive legal or regulatory audit. Users remain solely responsible for all regulatory decisions, submissions, and outcomes.

Subject to these Terms, Health Tech Pathways grants you a limited, non-exclusive, non-transferable, revocable licence to access and use for internal professional or business purposes only. All rights not expressly granted are reserved.

You agree not to do any of the following: • reverse engineer, decompile, disassemble, or attempt to discover the source code or underlying algorithms of the Platform, • use the Platform to develop a competing product or service, • share your account credentials with third parties, • upload any "Patient Health Information" (PHI), real patient data, or any data that could identify a natural person as a patient. The Platform is designed for regulatory documentation processing, not for processing sensitive medical records, • Use the Platform to generate, create, or facilitate the submission of fraudulent, false, or misleading documentation, including but not limited to fabricated clinical data, counterfeit certificates, or deceptive regulatory submissions, • use the Platform for any illegal or unauthorized purpose.

Health Tech Pathways uses Azure OpenAI GPT-based large language models to generate structured guidance, explanations, and recommendations. The AI system: • operates in an automated manner, • is intended solely as decision support, • does not make decisions on behalf of users. AI-generated outputs may be incomplete, outdated, or inaccurate. Users are required to maintain "human-in-the-loop" oversight, meaning that every output must be independently verified by a qualified regulatory professional before use.

User Content: You retain all rights to the data, text, and documents you upload to the Platform ("User Content"). AI Outputs: Subject to your compliance with these Terms, Health Tech Pathways assigns to you all its right, title, and interest in and to the output generated by the Platform based on your User Content. You are free to use these outputs for your regulatory documentation. Platform IP: Health Tech Pathways and its licensors own all rights, title, and interest in the Platform, including its interface, proprietary prompts, code, and branding.

Health Tech Pathways processes personal data in accordance with our Privacy Policy, available at: https://healthtechhub.org/privacy-policy/. • User data is stored securely using appropriate technical and organisational safeguards. • Confidential and commercially sensitive information uploaded by users is treated as confidential. • User data is not sold and not used to train external or third-party AI models. • Users retain control over their data. They may delete their data at any time through the Platform's user interface. Users may export their data and may request account deletion, upon which associated data will be deleted, subject to legal obligations.

TO THE MAXIMUM EXTENT PERMITTED BY LAW, THE PLATFORM IS PROVIDED "AS IS" AND "AS AVAILABLE," WITHOUT WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. WE DO NOT WARRANT THAT THE PLATFORM WILL BE UNINTERRUPTED, SECURE, OR ERROR-FREE.

TO THE MAXIMUM EXTENT PERMITTED BY LAW, HEALTH TECH HUB COPENHAGEN SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, OR ANY LOSS OF PROFITS OR REVENUES, WHETHER INCURRED DIRECTLY OR INDIRECTLY, OR ANY LOSS OF DATA, USE, GOODWILL, OR OTHER INTANGIBLE LOSSES, RESULTING FROM: (A) YOUR ACCESS TO OR USE OF OR INABILITY TO ACCESS OR USE THE PLATFORM; (B) ANY CONDUCT OR CONTENT OF ANY THIRD PARTY ON THE PLATFORM; OR (C) UNAUTHORIZED ACCESS, USE, OR ALTERATION OF YOUR TRANSMISSIONS OR CONTENT. IN NO EVENT SHALL THE AGGREGATE LIABILITY OF HEALTH TECH HUB COPENHAGEN EXCEED THE GREATER OF DKK 5000 OR THE AMOUNT YOU PAID FOR HEALTH TECH PATHWAYS, IF ANY, IN THE PAST TWELVE MONTHS.

You agree to defend, indemnify, and hold harmless Health Tech Hub Copenhagen and its officers, directors, employees, and agents from and against any claims, liabilities, damages, losses, and expenses, including, without limitation, reasonable legal and accounting fees, arising out of or in any way connected with your access to or use of the Platform or your violation of these Terms.

We may terminate or suspend your access to the Platform immediately, without prior notice or liability, for any reason whatsoever, including without limitation if you breach the Terms. Upon termination, your right to use the Platform will immediately cease.

These Terms are governed by the laws of Denmark. Any disputes shall be subject to the exclusive jurisdiction of competent courts of Denmark.

For legal or privacy inquiries: legal@healthtechhub.org