Terms of Use – Guidelines

1. Acceptance of Terms

By creating an account, subscribing to, or using the ClinEthix Guidelines platform (the “Platform”), operated by ClinEthix LLC (“we”, “us”, “our”), you agree to be bound by these Terms of Use (“Terms”), our Terms of Service, and our Privacy Policy.

If you do not agree, do not use the Platform.

2. Description of the Platform

ClinEthix Guidelines is a clinical decision support tool that provides healthcare professionals with structured access to official medical guidelines published by recognized institutions (WHO, ESC, NICE, HAS, AHA, and others).

3. Regulatory Status

3.1 United States – FDA classification

ClinEthix Guidelines is classified as Clinical Decision Support (CDS) software exempt from FDA regulation under the 21st Century Cures Act (Section 3060(a), codified at 21 U.S.C. § 360j(o)), as further clarified by the FDA‘s final guidance on Clinical Decision Support Software (March 2026). The Platform meets all four criteria for this exemption:

• Not intended to acquire, process, or analyze a medical image, signal, or specimen: the Platform processes text-based clinical queries only
• Intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information: the Platform displays published guideline recommendations relevant to clinical questions
• Intended for use by a healthcare professional: access is restricted to licensed healthcare professionals, medical students, and healthcare institutions
• Allows the healthcare professional to independently review the basis for the recommendation: every response includes the source institution, document, year, and recommendation grade, enabling full verification

As such, ClinEthix Guidelines is not a medical device under US federal law and is not subject to FDA premarket review, clearance, or approval. In accordance with the FDA‘s 2026 transparency expectations for CDS software, the Platform provides clear documentation of its methodology: every response cites the originating institution, document, publication year, and recommendation grade, enabling independent verification by the healthcare professional. This classification is subject to change if the FDA modifies its guidance on CDS software.

HIPAA clarification

ClinEthix Guidelines does not collect, store, process, or transmit Protected Health Information (PHI) as defined under the Health Insurance Portability and Accountability Act (HIPAA). The Platform processes anonymized clinical queries only – users formulate general clinical questions (e.g., “first-line treatment for stage II hypertension”) without entering patient-identifying data. As such, ClinEthix LLC is not a Covered Entity or Business Associate under HIPAA. We do not enter into Business Associate Agreements (BAAs). Users must not enter any patient-identifiable information into the Platform. Any violation of this requirement is the sole responsibility of the user.

3.2 European Union – MDR classification

Under the EU Medical Devices Regulation (MDR 2017/745), software qualifies as a medical device if it is intended to be used for a medical purpose as defined in Article 2(1). ClinEthix Guidelines functions as a reference and information retrieval tool – it presents existing published guidelines without performing patient-specific analysis, diagnosis, or treatment recommendations.

We believe the Platform falls outside the scope of the MDR. However, the classification of medical software under the MDR is evolving. We continuously monitor regulatory guidance from the MDCG (Medical Device Coordination Group), including MDCG 2019-11 (Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745), and will pursue CE marking and conformity assessment if the regulatory landscape requires it.

EU Artificial Intelligence Act

Regulation (EU) 2024/1689 (the EU AI Act) establishes a risk-based framework for artificial intelligence systems. ClinEthix Guidelines uses AI-assisted retrieval to surface published clinical guidelines; it does not autonomously generate diagnoses, treatment plans, or risk assessments for individual patients. While Annex III, point 5(a) of the AI Act classifies AI systems intended for use as medical devices as “high-risk”, this provision applies to software that qualifies as a medical device under the MDR. Since the Platform falls outside the scope of the MDR (see Section 3.2 above), Annex III, point 5(a) does not apply. The Platform is therefore not intended as a “high-risk AI system” within the meaning of Article 6, as it does not directly influence clinical decisions regarding specific patients. We will reassess this classification as implementing acts and harmonized standards are published, and we will comply with any applicable transparency or registration obligations that may arise.

3.3 United Kingdom

Following the UK’s withdrawal from the European Union, medical device regulation in the UK is governed by the UK Medical Devices Regulations 2002 (as amended) and the MHRA (Medicines and Healthcare products Regulatory Agency). Our analysis under the MDR (Section 3.2) applies equally to the UK regime: the Platform functions as a reference and information retrieval tool and is not intended as a medical device requiring UKCA marking. We monitor MHRA guidance on software classification and will pursue conformity assessment if required.

Data protection for UK users is governed by the UK GDPR (retained EU law) and the Data Protection Act 2018. Our data protection practices described in the Privacy Policy apply equally under UK GDPR.

3.4 Other jurisdictions

Regulatory classification of clinical decision support software varies by jurisdiction. Users are responsible for ensuring that their use of the Platform complies with local healthcare regulations. If you are uncertain about whether the Platform is approved for use in your jurisdiction, please contact us before subscribing.

4. Eligibility

The Platform is intended for:

• Licensed healthcare professionals (physicians, pharmacists, nurses, allied health professionals)
• Medical students and residents aged 18+ (under institutional supervision)
• Healthcare institutions and organizations
• Medical researchers and educators

By registering, you represent and warrant that you meet these eligibility requirements and that the information you provide is accurate.

5. Account Registration and Security

• You must provide accurate, current, and complete registration information
• You are responsible for maintaining the confidentiality of your account credentials
• You are responsible for all activity that occurs under your account
• You must notify us immediately at contact@clinethix.com of any unauthorized access or security breach
• One account per individual; account sharing or credential sharing is strictly prohibited
• We reserve the right to suspend accounts that we reasonably believe are compromised

6. Subscription Plans and Pricing

Plan	Price	Features
Discovery	Free	Limited queries per month, access to select guidelines, basic source citations
Pro	$29/month	Unlimited queries, full guideline corpus (1,500+ guidelines, 40+ specialties), complete source traceability with recommendation grades, priority support
Institution	Custom pricing	Multi-user access, dedicated account manager, API integration options, usage analytics dashboard, custom onboarding

All prices are in US dollars and exclude any applicable taxes (sales tax, VAT, GST). Tax will be calculated and added at checkout based on your location. We reserve the right to modify pricing with at least 30 days’ written notice to active subscribers. Price changes do not apply retroactively to the current billing period.

6.1 Early access program

We offer an early-access program limited to the first 200 subscribers or 90 days after public launch, whichever comes first. Early-access subscribers receive the Pro plan at a reduced rate, locked for the lifetime of their subscription.

• Locked-for-life guarantee: your early-access rate remains unchanged as long as your subscription stays active and in good standing
• Payment grace period: if a payment fails, you have 15 calendar days to update your payment method and retain your early-access rate. After 15 days without successful payment, your account is downgraded to Discovery and the early-access rate is forfeited
• Voluntary cancellation: if you cancel and later resubscribe, the early-access rate is no longer available – the standard rate applies
• The number of remaining early-access spots is displayed on the pricing page

6.2 Other promotional pricing

We may offer additional promotional rates at our discretion. The terms of each promotion are specified at enrollment and honored for the duration stated.

7. Billing and Payment

• Pro subscriptions are billed monthly in advance on the anniversary of your subscription start date
• Payment is processed securely by our PCI DSS-compliant payment processor; we do not store your full card details
• If a payment fails, we will retry up to 3 times over 10 days and notify you by email. If payment remains unsuccessful, your account will be downgraded to the Discovery plan
• You are responsible for ensuring your payment method is current and valid
• Institution plans are billed according to the terms of the individual enterprise agreement

8. Cancellation and Refunds

8.1 Cancellation

• You may cancel your Pro subscription at any time from your account settings or by emailing contact@clinethix.com
• Cancellation takes effect at the end of the current billing period – you retain full Pro access until then
• After the billing period ends, your account automatically reverts to the Discovery (free) plan
• Your data (account, query history) is retained for 12 months after cancellation, then deleted unless you request earlier deletion

8.2 Refund policy – United States

Under US law, there is no mandatory cooling-off period for digital subscriptions. However, ClinEthix voluntarily provides the following refund guarantee:

• 14-day satisfaction guarantee: if you are unsatisfied with the Pro plan, you may request a full refund within 14 calendar days of your initial subscription payment
• After the 14-day window: no refund for partial months. You retain access through the end of the paid period
• This guarantee applies to the first subscription payment only. Subsequent monthly payments are non-refundable

8.3 Refund policy – European Union / EEA

Under the EU Consumer Rights Directive (2011/83/EU), you have a 14-day right of withdrawal from the date of subscription. However:

• By subscribing and accessing the Platform, you expressly consent to the immediate provision of the digital service and acknowledge that you lose your right of withdrawal once you first access the Pro features
• This consent is requested during the checkout process in compliance with Article 16(m) of the Directive
• If you do not access the Pro features within 14 days, you may exercise your right of withdrawal for a full refund
• Regardless of the above, we voluntarily offer a 14-day satisfaction guarantee identical to our US policy: if you are genuinely unsatisfied, contact us and we will process a refund

8.4 Refund policy – Other jurisdictions

If your local consumer protection law provides a mandatory refund or withdrawal right that exceeds our 14-day satisfaction guarantee, the more favorable provision applies. Contact us to exercise any locally mandated right.

8.5 How to request a refund

Step	Details
Email	contact@clinethix.com
Subject line	“Refund Request – [Your Name] – [Subscription Date]”
Processing time	5-10 business days after approval
Refund method	Original payment method

9. Medical Disclaimer

• The Platform provides structured access to published medical guidelines as a reference and decision support tool
• It does NOT generate medical diagnoses, prescriptions, or treatment plans
• It does NOT perform patient-specific analysis or risk assessment
• All clinical decisions remain the sole responsibility of the treating healthcare professional
• Guidelines may not reflect the most recent updates; always verify with the original source document
• The Platform does not account for individual patient circumstances, comorbidities, contraindications, drug interactions, or local protocols
• National or regional adaptations of international guidelines may differ; local guidance takes precedence
• In case of medical emergency, contact your local emergency services immediately

10. AI and Content Accuracy

10.1 Source-first architecture

The Platform is built on a source-first architecture: every response is grounded exclusively in official published guidelines. Unlike general-purpose AI assistants, the Platform does not generate speculative, hallucinated, or unsupported content. Each answer references the originating institution, document, publication year, and recommendation grade.

10.2 Limitations and accuracy

Despite our rigorous approach, no system is infallible:

• Minor inaccuracies in extraction, structuring, or presentation of guideline content may occur
• There may be a delay between a guideline update or new publication and its indexing on the Platform
• Not all guidelines from all institutions worldwide are indexed; coverage is continuously expanding
• Automated structuring of complex clinical recommendations involves interpretation that may occasionally differ from the original context
• We encourage users to verify critical clinical information against the original source document, which is always referenced

10.3 Guideline corpus updates

We update our guideline corpus on an ongoing basis. Our target is to index new or revised guidelines within 30 days of official publication by the source institution. Major guideline updates from tier-1 institutions (WHO, ESC, AHA, NICE, HAS) are prioritized. Users will be notified of significant corpus updates via in-app notifications or email.

10.4 Reporting errors

If you identify an inaccuracy, outdated reference, or missing guideline, please report it to contact@clinethix.com with subject “Content Report”. We investigate all reports and aim to address confirmed errors promptly, prioritizing critical clinical inaccuracies.

11. Acceptable Use

You agree to use the Platform only for lawful, professional purposes. You may NOT:

• Enter patient-identifiable information (names, dates of birth, medical record numbers, social security numbers, or any data that could identify an individual patient)
• Use the Platform to replace a proper clinical assessment, physical examination, or diagnostic workup
• Redistribute, resell, sublicense, or commercially exploit Platform content or results without written authorization
• Present Platform output as your own original work or professional opinion without verification
• Attempt to reverse-engineer, decompile, disassemble, or extract the underlying algorithms, data structures, or source code
• Use automated scripts, bots, scrapers, or other programmatic means to access the Platform without prior written API authorization
• Share your account credentials with other individuals
• Circumvent any access controls, rate limits, or security mechanisms
• Use the Platform in any way that violates applicable healthcare regulations, professional codes of conduct, or ethical standards

12. Data Sovereignty and Processing

• Query data is encrypted in transit (TLS 1.3) and at rest (AES-256)
• Access to query data is restricted to authorized personnel under strict confidentiality obligations
• You can request full deletion of your query history at any time via account settings or by contacting us
• Anonymized, aggregated usage data may be used to improve Platform accuracy, coverage, and performance – no individual queries are identifiable in aggregated data
• For detailed information on data processing, retention, and your rights, see our Privacy Policy

13. Intellectual Property

13.1 Platform content

The Platform’s interface, design, branding, algorithms, structured data format, and proprietary indexing and retrieval systems are the exclusive property of ClinEthix LLC and are protected by US and international intellectual property laws. The underlying medical guidelines remain the intellectual property of their respective publishing institutions.

13.2 Your content

You retain full ownership of the queries you submit. By using the Platform, you grant us a limited, non-exclusive, revocable license to process your queries solely for the purpose of delivering results and improving our services. This license terminates when you delete your account or request data deletion.

14. Service Level and Availability

We use commercially reasonable efforts to maintain high availability of the Platform. Our operational targets are:

Metric	Target	Details
Uptime	99.5% monthly	Best-effort target, not a guarantee
Planned maintenance	Advance notice when feasible	Scheduled outside peak hours when possible
Unplanned downtime	Prompt resolution	Best-effort basis for critical issues
Support response	24 hours (Pro)	Business days; Institution plans have dedicated SLA

These targets reflect our operational goals and are not contractual guarantees. In the event of significant or prolonged downtime, we may, at our sole discretion, offer affected Pro subscribers a goodwill credit toward future billing. No credit obligation arises automatically from downtime.

Institution plans may include a dedicated SLA with contractual availability and credit terms defined in the enterprise agreement.

15. Limitation of Liability

To the maximum extent permitted by applicable law:

• ClinEthix LLC shall not be liable for any clinical outcome, medical error, adverse event, patient harm, or malpractice claim arising from the use of – or reliance on – information provided by the Platform
• The Platform is a supplementary reference tool; the treating healthcare professional bears sole responsibility for clinical decisions
• Our total aggregate liability for any claim arising under these Terms shall not exceed the greater of (a) the total amount you paid for the Platform in the 12 months preceding the claim, or (b) one hundred US dollars ($100.00)
• We shall not be liable for any indirect, incidental, special, consequential, exemplary, or punitive damages, including loss of profits, data, reputation, or clinical outcomes

For EU/EEA residents: nothing in these Terms limits or excludes our liability for fraud, gross negligence, death or personal injury caused by our negligence, or any other liability that cannot be excluded under mandatory EU consumer protection law.

16. Indemnification

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

• Your use of or reliance on the Platform
• Your violation of these Terms
• Any clinical decision made using information obtained from the Platform
• Any violation of applicable laws, regulations, or professional standards
• Entry of patient-identifiable information in violation of Section 11

For EU/EEA residents: this indemnification clause applies only to the extent that the claims result from your willful misconduct or gross negligence, consistent with mandatory consumer protection law.

17. Dispute Resolution

17.1 Informal resolution

Before initiating any formal proceedings, both parties agree to attempt to resolve any dispute through good-faith negotiation. Contact us at contact@clinethix.com with subject “Dispute – [Description]”. We will respond within 15 business days.

17.2 Binding arbitration (US users)

If informal resolution fails and you are located in the United States, any dispute shall be resolved through binding arbitration administered by the American Arbitration Association (AAA) under its Commercial Arbitration Rules. Arbitration shall take place in Wyoming, or remotely by mutual agreement. The arbitrator’s award is final and binding. Both parties waive the right to a jury trial and to participate in class actions or class arbitrations.

17.3 EU/EEA/UK residents

The arbitration clause in Section 17.2 does not apply to EU, EEA, or UK residents. You retain the right to bring proceedings in your local courts under mandatory consumer protection law. You may also use the European Commission’s Online Dispute Resolution platform at https://ec.europa.eu/odr.

18. Force Majeure

Neither party shall be liable for any failure or delay in performance due to circumstances beyond reasonable control, including but not limited to: natural disasters, pandemics, acts of war or terrorism, government actions, sanctions, embargoes, power or internet outages, cyberattacks, or disruptions to third-party infrastructure on which the Platform depends.

19. Geographic Availability

The Platform is available globally, but:

• Guideline coverage varies by region; we prioritize guidelines from major international and national institutions
• The Platform may not be authorized as a medical device or clinical decision support tool in all jurisdictions (see Section 3)
• Users in jurisdictions where clinical decision support software requires specific regulatory approval are responsible for verifying local compliance before use
• We reserve the right to restrict access from jurisdictions where legal, regulatory, or sanctions requirements prevent us from operating

20. Termination

• You may terminate your account at any time through account settings or by contacting us
• We may suspend or terminate your access immediately if you materially violate these Terms, with written notice specifying the violation
• We may terminate your access with 30 days’ notice for any reason, with a pro-rata refund of any prepaid fees
• Upon termination, your right to access the Platform ceases immediately
• Data retention after termination follows our Privacy Policy (12 months, then deleted)
• Sections 9, 10, 13, 15, 16, and 17 survive termination

21. Modifications to These Terms

We may update these Terms from time to time. When we make changes:

• Material changes: notified via email to all active subscribers at least 30 days before taking effect. If you do not agree, you may cancel before the effective date for a pro-rata refund
• Minor changes: reflected by the updated “Last updated” date. Continued use constitutes acceptance
• Previous versions are available upon request

22. Governing Law

These Terms are governed by and construed in accordance with the laws of the State of Wyoming, United States, without regard to its conflict of law provisions. This choice of law does not deprive EU/EEA consumers of the protections afforded by the mandatory provisions of their country of habitual residence.

23. Severability

If any provision of these Terms is found invalid, illegal, or unenforceable by a court of competent jurisdiction, the remaining provisions continue in full force and effect. The invalid provision shall be reformed to the minimum extent necessary to make it valid and enforceable while preserving its original intent.

24. Entire Agreement

These Terms, together with the Terms of Service and Privacy Policy, constitute the entire agreement between you and ClinEthix LLC regarding your use of the ClinEthix Guidelines platform. For Institution plan subscribers, the enterprise agreement takes precedence in case of conflict.

25. Contact

For questions about these Terms of Use:

Type	Email	Response time
General and legal inquiries	contact@clinethix.com	We aim to respond promptly
Refund requests	contact@clinethix.com	We aim to respond promptly
Content error reports	contact@clinethix.com	We aim to respond promptly
Dispute resolution	contact@clinethix.com	We aim to respond promptly