Terms of Service

1. Acceptance of Terms

These Terms of Service ("Terms") constitute a legally binding agreement between you ("User", "Clinician", "you") and Fertility CDS ("we", "us", "our", "the Platform") governing your access to and use of the Fertility Clinical Decision Support platform, including all software, services, documentation, and related materials (collectively, the "Service").

By creating an account, accessing the Platform, or using any part of the Service, you acknowledge that you have read, understood, and agree to be bound by these Terms, our Privacy Policy, and all applicable laws and regulations. If you do not agree to these Terms, you must immediately cease all use of the Service.

2. Regulatory Status and Intended Use

2.1 Not a Medical Device

The Fertility CDS Platform is NOT an FDA-cleared, MHRA-registered, or CE-marked medical device.It is classified as a Clinical Decision Support (CDS) tool under:

• FDA 2019 Clinical Decision Support Software Guidance (21st Century Cures Act, Section 3060)
• UK MHRA Software and AI as a Medical Device Guidance (2023)
• EU Medical Device Regulation (MDR 2017/745) Article 2(2) exclusion for non-device software

2.2 Intended Purpose

The Platform is intended to support, not replace, the clinical judgment of qualified healthcare professionals in the assessment and management of male and female infertility. It provides:

• Evidence-based recommendations aligned with international clinical guidelines
• Risk stratification based on clinical parameters
• Structured documentation templates for patient assessments
• Educational references to peer-reviewed literature

2.3 Intended Users

The Platform is intended for use exclusively by:

• Licensed physicians specializing in reproductive medicine, obstetrics and gynecology, or urology
• Reproductive endocrinologists and andrologists
• Clinical embryologists and laboratory directors
• Nurse practitioners, physician assistants, and clinical staff working under physician supervision

2.4 Contraindications and Limitations

The Platform is NOT intended for:

• Emergency or acute care decision-making
• Direct patient use or patient self-assessment
• Automated clinical decision-making without clinician review
• Diagnosis or treatment of life-threatening conditions
• Replacement of comprehensive clinical evaluation, laboratory testing, or imaging studies

3. Clinical Responsibility and Professional Judgment

3.1 Clinician Responsibility

You acknowledge and agree that:

• You are solely responsible for all clinical decisions made using the Platform
• All recommendations generated by the Platform must be independently verified and validated by you
• You must exercise your own professional judgment and consider the complete clinical context, including patient history, examination findings, laboratory results, and imaging studies
• You are responsible for ensuring that all patient data entered into the Platform is accurate and complete
• You must comply with all applicable laws, regulations, and professional standards governing your practice

3.2 No Guarantee of Outcomes

The Platform provides evidence-based recommendations but does not guarantee any specific clinical outcome, treatment success, pregnancy rate, or live birth rate. Fertility treatment outcomes vary significantly based on patient age, diagnosis, treatment protocol, clinic expertise, and numerous other factors beyond the scope of this tool.

3.3 Guideline Versions and Updates

The Platform's recommendations are based on the following clinical guidelines (current as of January 2025):

• WHO Laboratory Manual for the Examination and Processing of Human Semen (6th Edition, 2021)
• American Society for Reproductive Medicine (ASRM) Practice Guidelines (2023)
• European Society of Human Reproduction and Embryology (ESHRE) Guidelines (2023)
• UK National Institute for Health and Care Excellence (NICE) Clinical Guideline CG156 (2023 update)
• American College of Obstetricians and Gynecologists (ACOG) Practice Bulletins (2023)
• European Association of Urology (EAU) Guidelines on Male Infertility (2023)

You are responsible for staying current with guideline updates and determining whether the Platform's recommendations align with the most recent evidence and your local standards of care.

4. Data Protection and Privacy

4.1 HIPAA Compliance (United States)

For users in the United States, we act as a Business Associate under the Health Insurance Portability and Accountability Act (HIPAA). By using the Platform to process Protected Health Information (PHI), you represent that you are a Covered Entity or Business Associate under HIPAA and agree to execute a Business Associate Agreement (BAA) with us. To request a BAA, contact compliance@fertilitycds.com.

4.2 GDPR Compliance (European Union)

For users in the European Union, we process personal data in accordance with the General Data Protection Regulation (GDPR, Regulation 2016/679). We act as a Data Processor on your behalf when you use the Platform to process patient data. You are the Data Controller and are responsible for:

• Obtaining valid consent from patients for data processing under GDPR Article 6(1)(a) and Article 9(2)(a) (special category health data)
• Providing patients with transparent information about data processing activities
• Honoring patient rights including access, rectification, erasure, restriction, portability, and objection
• Maintaining records of processing activities under GDPR Article 30

4.3 UK GDPR Compliance (United Kingdom)

For users in the United Kingdom, we process personal data in accordance with the UK General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018. We are registered with the UK Information Commissioner's Office (ICO) under registration number [ICO-XXXXXX]. The same Data Controller/Processor responsibilities apply as outlined in Section 4.2 above.

4.4 Right to Withdraw Consent

Under GDPR and UK GDPR, patients have the right to withdraw consent for data processing at any time. You are responsible for implementing processes to honor such requests and for deleting or anonymizing patient data in the Platform upon request. To request data deletion, use the "Right to Erasure Request" feature in Settings or contact dpo@fertilitycds.com.

4.5 Data Retention

Patient data stored in the Platform is retained in accordance with applicable medical record retention laws:

• United States: Minimum 7 years from last patient contact (varies by state; some states require longer retention)
• United Kingdom: 8 years after last treatment (NHS Records Management Code of Practice)
• European Union: Varies by member state; typically 10-30 years for medical records

You are responsible for ensuring compliance with retention requirements in your jurisdiction.

5. Account Registration and Security

5.1 Account Eligibility

To create an account, you must:

• Be a licensed healthcare professional authorized to practice in your jurisdiction
• Provide accurate, current, and complete registration information
• Be at least 18 years of age
• Agree to these Terms and our Privacy Policy

5.2 Account Security

You are responsible for:

• Maintaining the confidentiality of your account credentials
• All activities that occur under your account
• Notifying us immediately of any unauthorized access or security breach
• Ensuring that your account is not shared with unauthorized individuals

5.3 Account Termination

We reserve the right to suspend or terminate your account if:

• You violate these Terms
• You provide false or misleading information
• You are not a qualified healthcare professional
• Your use of the Platform poses a risk to patient safety or data security
• Required by law or regulatory authority

6. Intellectual Property Rights

6.1 Platform Ownership

The Platform, including all software, algorithms, user interfaces, documentation, and content (excluding user-generated content), is owned by Fertility CDS and is protected by copyright, trademark, patent, and other intellectual property laws. You are granted a limited, non-exclusive, non-transferable, revocable license to access and use the Platform solely for your clinical practice.

6.2 User Data Ownership

You retain all ownership rights to patient data and clinical information you enter into the Platform. By using the Platform, you grant us a limited license to process this data solely for the purpose of providing the Service to you.

6.3 Restrictions

You may not:

• Copy, modify, distribute, sell, or lease any part of the Platform
• Reverse engineer, decompile, or attempt to extract the source code
• Remove or alter any proprietary notices or labels
• Use the Platform to develop a competing product or service
• Access the Platform through automated means (bots, scrapers) without written permission

7. Disclaimers and Limitations of Liability

7.1 No Warranty

THE PLATFORM IS PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR ACCURACY. WE DO NOT WARRANT THAT THE PLATFORM WILL BE UNINTERRUPTED, ERROR-FREE, OR FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS.

7.2 Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW, FERTILITY CDS SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING BUT NOT LIMITED TO LOSS OF PROFITS, DATA, USE, GOODWILL, OR OTHER INTANGIBLE LOSSES, RESULTING FROM:

• Your use or inability to use the Platform
• Any clinical decisions made based on Platform recommendations
• Unauthorized access to or alteration of your data
• Any errors, omissions, or inaccuracies in Platform content
• Any patient harm or adverse outcome

IN NO EVENT SHALL OUR TOTAL LIABILITY TO YOU FOR ALL CLAIMS EXCEED THE AMOUNT YOU PAID US IN THE 12 MONTHS PRECEDING THE CLAIM, OR $100 USD, WHICHEVER IS GREATER.

7.3 Indemnification

You agree to indemnify, defend, and hold harmless Fertility CDS, its officers, directors, employees, and agents from any claims, liabilities, damages, losses, costs, or expenses (including reasonable attorneys' fees) arising from:

• Your use of the Platform
• Your violation of these Terms
• Your violation of any law or regulation
• Your violation of any third-party rights, including patient privacy rights
• Any clinical decisions or patient care you provide

8. Governing Law and Dispute Resolution

8.1 Multi-Jurisdiction Governing Law

The governing law and jurisdiction for disputes arising from these Terms shall be determined based on your primary place of practice:

8.2 Class Action Waiver (US Users Only)

For users in the United States, you agree that any arbitration or legal proceeding shall be conducted on an individual basis and not as a class action, consolidated action, or representative action. You waive any right to participate in a class action lawsuit or class-wide arbitration.

9. Changes to These Terms

We reserve the right to modify these Terms at any time. We will notify you of material changes by:

• Posting the updated Terms on the Platform with a new "Last Updated" date
• Sending an email notification to your registered email address
• Displaying an in-app notification upon your next login

Your continued use of the Platform after the effective date of the updated Terms constitutes your acceptance of the changes. If you do not agree to the updated Terms, you must stop using the Platform and may request account deletion.

10. Contact Information

For questions, concerns, or requests related to these Terms, please contact us: