Under Disclaimers & Regulatory Disclosures

Use of Artificial Intelligence (AI)

Clear Health Pass Holdings, LLC, and its subsidiaries leverage Artificial Intelligence (AI) technology across multiple domains, including research and development (R&D), virtual testing, client interactions, and data analysis. The integration of AI allows us to enhance the accuracy, efficiency, and effectiveness of our diagnostic, operational, and customer service processes. This statement provides an overview of how AI is used in our operations, outlines the limitations of AI technology, and includes disclaimers on its application.

Potential Uses of AI in Clear Health Pass Holdings Operations

• Research and Development (R&D)

• 1. Data Analysis and Modeling: AI-driven algorithms analyze large datasets to identify trends, develop predictive models, and explore correlations between biomarkers and disease states. This allows us to enhance the development of new assays, diagnostic methods, and treatment protocols.
  2. AI-Enhanced Drug Discovery: AI may be used in preclinical research stages to simulate chemical interactions, predict drug efficacy, and assess safety profiles, accelerating the discovery process.
  3. Genomics and Bioinformatics: Machine learning algorithms support genomics research by analyzing genetic data, identifying disease markers, and helping to tailor personalized medicine approaches.

• Virtual Testing and Diagnostics

• 1. Simulated Testing Environments: AI technology enables virtual testing environments where algorithms simulate clinical scenarios, allowing for virtual validation of diagnostic assays before physical implementation. This is particularly valuable for Laboratory-Developed Tests (LDTs) that require rapid adaptation.
  2. Predictive Diagnostics: AI models are used to predict outcomes based on historical data and real-time inputs, providing early indicators of health conditions. These insights aid healthcare providers in assessing potential risks or outcomes based on patients’ unique profiles.

• Client Interaction and Customer Support

• 1. AI Chatbots and Virtual Assistants: AI-powered chatbots are used to enhance customer service by addressing common inquiries, guiding clients through services, and scheduling appointments. While AI tools improve accessibility, all complex or clinical inquiries are handled by qualified staff.
  2. Personalized Client Communication: Machine learning algorithms may tailor client communications based on preferences, prior interactions, and specific needs, improving the user experience and ensuring relevant information is provided.

• Operational Efficiency

• 1. Process Automation: AI supports process automation, streamlining workflows in scheduling, logistics, billing, and reporting. This enables Clear Health Pass Holdings to reduce operational costs and improve service delivery timelines.
  2. Quality Control and Compliance Monitoring: AI algorithms are used to monitor quality metrics, detect anomalies, and ensure that operations remain in compliance with regulatory standards, including CLIA and CAP.

Disclaimers on AI Usage

• Limitations of AI Technology

• 1. Non-Substitute for Medical Expertise: AI outputs, such as predictive diagnostics and virtual testing results, are tools to assist professionals and are not a substitute for clinical judgment, diagnosis, or treatment by licensed medical professionals. All final diagnostic interpretations and healthcare decisions should be made by qualified individuals.
  2. Data Limitations: AI predictions and models are based on historical data and may not fully represent real-world complexities or individual variations. AI models can sometimes produce inaccurate predictions, and reliance on these models should be exercised with caution.
  3. Accuracy and Bias: While AI models are trained for high accuracy, they can be limited by biases present in training data or assumptions in the algorithm. We strive to reduce these biases, but users should be aware of inherent limitations in AI outputs, especially in clinical contexts.

• Privacy and Data Security

• 1. HIPAA Compliance: All AI applications that process personal health information (PHI) are designed to comply with HIPAA regulations, ensuring the confidentiality and security of patient data. AI systems are secured through encryption, access controls, and regular audits.
  2. Data Collection and Usage: AI models may use aggregated and anonymized data for continuous improvement and accuracy. Clear Health Pass Holdings ensures that any data used in AI applications complies with applicable privacy laws and does not compromise patient confidentiality.

• Ethical Use of AI

• 1. Transparency and Informed Consent: Patients and clients are informed when AI is used in diagnostics, customer support, or other interactions. Clear Health Pass Holdings is committed to transparency, providing users with the option to opt out of AI-driven interactions where possible.
  2. AI in Decision-Making: Clear Health Pass Holdings’ AI applications are intended to support, not replace, human decision-making. All AI-driven recommendations and outputs are reviewed by qualified staff, especially in scenarios involving patient care or diagnostic interpretation.

• Disclaimer on AI-Generated Recommendations

• 1. No Guarantee of Accuracy or Outcome: While AI technology aims to provide accurate and reliable insights, Clear Health Pass Holdings does not guarantee the accuracy, reliability, or completeness of AI-generated recommendations or outputs. Patients and clients are advised not to rely solely on AI-driven insights and to consult healthcare professionals for final decisions.
  2. Liability Limitations: Clear Health Pass Holdings disclaims liability for any decisions made based on AI-generated recommendations or outputs. The information provided by AI systems is intended for informational purposes only and should be independently verified by a qualified healthcare provider before making any healthcare or operational decisions.

• Continuous Improvement and Model Updates

• 1. AI Model Training and Updates: Our AI models are periodically updated to improve accuracy and incorporate new data. These updates are designed to enhance model performance but may result in changes to outputs or recommendations. Users should be aware that AI-based predictions are dynamic and may evolve over time.

Conclusion

Clear Health Pass Holdings, LLC, is committed to the ethical and compliant use of AI to enhance our diagnostic, operational, and customer service capabilities. Our goal is to leverage AI to support healthcare professionals, improve operational efficiency, and enhance patient care, while upholding the highest standards of quality, accuracy, and data privacy. By using our services, clients acknowledge and accept the terms of this AI disclosure and agree to consult qualified professionals for decisions involving health and diagnostics.

CLIA Certification and Laboratory Accreditation

All testing is conducted by Clear Health Pass Diagnostics, LLC, a College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified High Complexity Laboratory (CLIA #45D2133663) located in Irving, TX. We are committed to maintaining the highest standards of laboratory quality and accuracy in compliance with federal and industry regulations. Our laboratory certification and accreditation reflect our dedication to precision, reliability, and excellence in diagnostic testing.

• CLIA Certification
  Clear Health Pass Diagnostics is certified under the Clinical Laboratory Improvement Amendments (CLIA) as a high-complexity laboratory, which enables us to perform complex diagnostic tests that require a higher degree of skill and expertise. Our CLIA certification (#45D2133663) demonstrates that we meet or exceed the rigorous standards set forth by the Centers for Medicare & Medicaid Services (CMS) under 42 U.S.C. § 263a and 42 CFR Part 493. This certification mandates stringent requirements for laboratory operations, including quality control, personnel qualifications, proficiency testing, and validation of testing methods, ensuring that all test results are accurate and reliable.
• CAP Accreditation
  Clear Health Pass Diagnostics is also accredited by the College of American Pathologists (CAP), an independent organization recognized globally for its commitment to quality in laboratory practices. CAP accreditation ensures that our laboratory undergoes regular, comprehensive inspections and adheres to best practices for laboratory management, specimen handling, quality assurance, and test accuracy. CAP accreditation requires us to meet high standards in lab protocols, staff qualifications, and equipment maintenance, further ensuring the reliability and quality of every diagnostic test we conduct.
• Use of CLIA-Certified Affiliate Lab Network
  Clear Health Pass Diagnostics may, on occasion, collaborate with a network of CLIA-certified affiliate laboratories to expand testing capacity, especially in cases of increased demand. Each affiliate lab within our network is fully CLIA-certified, ensuring that all tests outsourced meet the same federal quality standards required by CMS. This collaborative approach allows us to maintain the highest standards of accuracy, efficiency, and compliance with federal regulations while enhancing our ability to provide timely and reliable diagnostic results.
• Commitment to Quality and Compliance
  Our dual compliance with CLIA and CAP standards represents our commitment to delivering the highest quality of care through laboratory testing. Every test result generated by Clear Health Pass Diagnostics and our affiliate lab network is produced following strict regulatory and accreditation standards, reflecting our dedication to excellence, accuracy, and reliability. By adhering to both CLIA and CAP guidelines, Clear Health Pass Diagnostics ensures that patients, healthcare providers, and stakeholders can trust the quality of our services.

Click Here to verify our CLIA certification via the CMS public portal

HIPAA Compliance and Data Security

Clear Health Pass Diagnostics, LLC, is fully committed to protecting patient privacy and safeguarding all personal health information (PHI) in accordance with the Health Insurance Portability and Accountability Act (HIPAA), including the HIPAA Privacy Rule, Security Rule, and Breach Notification Rule. These rules collectively establish national standards for protecting sensitive patient data, as outlined in 45 CFR Parts 160, 162, and 164.

• Privacy Practices
  Clear Health Pass Diagnostics follows the HIPAA Privacy Rule, which regulates the use and disclosure of PHI (45 CFR § 164.500-534). We are dedicated to using PHI solely for diagnostic purposes, patient care, and authorized business operations. Access to PHI is strictly controlled and limited to authorized personnel who need the information to perform their duties, ensuring compliance with federal regulations.
• Data Security Measures
  In accordance with the HIPAA Security Rule (45 CFR §§ 164.300-318), Clear Health Pass Diagnostics has implemented rigorous administrative, technical, and physical safeguards to secure electronic PHI (ePHI) from unauthorized access, loss, or misuse. These security measures include:
  1. 1. Data Encryption: We use encryption protocols for all data both in transit and at rest, ensuring ePHI remains secure and unreadable by unauthorized individuals.
     2. Access Controls: We employ multi-factor authentication, role-based access, and continuous monitoring to protect data integrity and control access.
     3. Regular Audits: Our systems undergo regular security audits and risk assessments to identify and mitigate potential vulnerabilities, aligning with federal security standards.
     4. Patient Rights
        Patients have specific rights regarding their health information under HIPAA, including the right to access their medical records, request amendments, and obtain information about disclosures of their PHI. Clear Health Pass Diagnostics provides mechanisms for patients to exercise these rights as outlined in 45 CFR § 164.524-528. To learn more about your rights, please refer to the official HIPAA regulations.
     5. Breach Notification Policy
        Clear Health Pass Diagnostics follows the HIPAA Breach Notification Rule (45 CFR §§ 164.400-414), which mandates that we promptly notify affected individuals, the Department of Health and Human Services (HHS), and any other required parties in the event of a data breach involving unsecured PHI. We are committed to full transparency and timely communication in compliance with federal law to minimize any potential impact on affected patients.
     6. Third-Party Compliance
        Clear Health Pass Diagnostics only partners with third-party vendors and service providers who are compliant with HIPAA regulations and other applicable privacy standards. All vendors who may encounter PHI are required to sign Business Associate Agreements (BAAs), ensuring their commitment to safeguarding patient data and compliance with HIPAA regulations (45 CFR § 164.314).
     7. Disclaimer
        While Clear Health Pass Diagnostics takes every possible precaution to secure and protect patient information, no method of transmission or electronic storage is completely secure. Patients are encouraged to contact us with any questions or concerns regarding our data security practices. By using our services, patients acknowledge and accept our privacy and security practices as outlined in this disclosure.

For further information on HIPAA regulations, visit the official HIPAA Regulations page.

FDA Compliance for Laboratory-Developed Tests (LDTs)

Clear Health Pass Diagnostics, LLC, as an affiliated entity of Clear Health Pass Holdings, LLC—a recognized tribal agent of a Section 17 federally recognized, wholly owned corporation, or a federally recognized tribe under 25 U.S.C. § 477—commits to ensuring compliance with applicable federal regulations governing Laboratory-Developed Tests (LDTs). We recognize and adhere to the regulatory guidance provided by the Food and Drug Administration (FDA) to maintain the safety, efficacy, and accuracy of our diagnostic services.

FDA Regulatory Standards
While Laboratory-Developed Tests (LDTs) have historically been regulated under the Clinical Laboratory Improvement Amendments (CLIA) and are currently not subject to FDA premarket review, Clear Health Pass Diagnostics follows FDA guidance where applicable. Our laboratory maintains high standards for test development, validation, and reporting in alignment with the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 301 et seq., to ensure that all tests we develop and utilize are safe, accurate, and clinically meaningful.

Quality and Safety of LDTs
Clear Health Pass Diagnostics upholds the quality and safety of Laboratory-Developed Tests through strict adherence to CLIA and other relevant federal quality standards. Although the FDA has exercised enforcement discretion for LDTs, our commitment to quality means we adhere to internal validation processes aligned with FDA’s recommendations for test sensitivity, specificity, and reproducibility, per FDA guidance on Laboratory Developed Tests.

Tribal Sovereignty and Compliance

As a Tribal Agent of a Federally Recognized, Section 17 Corporation, Clear Health Pass Diagnostics operates under the sovereignty of federally recognized tribal status. Section 17 of the Indian Reorganization Act of 1934, codified at 25 U.S.C. § 5124 (formerly § 477), authorizes the Secretary of the Interior to issue charters of incorporation to federally recognized tribes. These charters enable tribes to create federally chartered corporations—often referred to as “Section 17 corporations”—which possess distinct legal identities separate from the tribal government. This structure allows tribes to engage in business activities with certain legal protections and benefits. Clear Health Pass Diagnostics, operating under tribal domicile, benefits from this unique status, providing certain flexibilities in business operations and allowing adherence to both federal guidelines and tribal regulations. Our commitment to regulatory compliance is upheld as part of our dedication to providing reliable and safe diagnostic services to both tribal and non-tribal communities.

• Disclosure of Special Federal Relationships

The Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), and Department of Health and Human Services (HHS) recognize the unique relationship between the U.S. government and federally recognized tribes, which is grounded in tribal sovereignty and federal trust responsibilities. Each agency has established policies to ensure meaningful consultation with tribal nations before issuing new guidance or regulations that may impact tribal communities. The FDA’s Tribal Consultation Policy and CMS’s Tribal Consultation Framework are designed to actively engage tribal leaders and seek their input on regulatory changes or guidance that could affect tribal health services, economic enterprises, and regulatory autonomy. These policies align with the HHS Tribal Consultation Policy, which mandates collaboration with tribes in a government-to-government relationship as outlined in Executive Order 13175. This order requires that federal agencies provide tribal governments with the opportunity to shape policies with tribal implications, recognizing tribes’ rights to self-governance. By consulting with tribal entities before finalizing guidance or regulatory measures, these agencies uphold their commitment to tribal sovereignty, address the unique needs of tribal health systems, and ensure that tribal voices are integral to federal policy development impacting Native communities.

For further reference, you can review each agency’s specific policies:

• FDA Tribal Consultation Policy
• CMS Tribal Affairs Overview
• HHS Tribal Consultation Policy

Disclaimer
Clear Health Pass Diagnostics discloses that Laboratory-Developed Tests (LDTs) are not subject to FDA premarket review, and as such, they have not been evaluated by the FDA in the same manner as in vitro diagnostic tests that require premarket approval. Patients and healthcare providers should be aware that LDTs are performed in accordance with CLIA standards and follow FDA guidance where applicable, but they are not formally FDA-approved. For more information on FDA’s guidance regarding LDTs, please see the FDA’s LDT Guidance page.

Clear Health Pass Diagnostics is dedicated to maintaining the highest standards for all diagnostic testing, leveraging both tribal sovereignty and adherence to federal guidelines to provide safe, effective, and high-quality laboratory services.

1. Medical Disclaimer

Clear Health Pass Diagnostics, LLC provides diagnostic testing services and information that are intended solely for informational purposes. All results, reports, and content generated by Clear Health Pass Diagnostics are not intended to diagnose, treat, cure, or prevent any disease. The information provided should not be used as a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider for questions regarding your health or any medical condition.

• No Substitute for Medical Advice
  The test results and health information provided by Clear Health Pass Diagnostics are not intended to replace the professional judgment or advice of healthcare providers. Under 21 U.S.C. § 321(h), diagnostic tests are considered “devices” by the FDA when used to diagnose or manage medical conditions, and Clear Health Pass Diagnostics adheres to all relevant regulatory standards. However, our tests are not designed to replace consultation with your primary healthcare provider or licensed medical professional.
• Scope of Services
  Clear Health Pass Diagnostics conducts testing within the limits of our CLIA and CAP certifications and as regulated by the Clinical Laboratory Improvement Amendments (42 U.S.C. § 263a). While we strive to provide accurate and timely information, users should not rely on test results as definitive or sole indicators for making any health-related decisions. It is the responsibility of the patient and their healthcare provider to interpret test results in the context of their overall health condition and history.
• Limitations of Laboratory-Developed Tests (LDTs)
  Some tests offered by Clear Health Pass Diagnostics may be Laboratory-Developed Tests (LDTs), which are regulated by the Centers for Medicare & Medicaid Services (CMS) under CLIA standards but are not subject to the same level of FDA review as other medical devices. Per FDA guidance and 42 CFR Part 493, the use of LDTs is regulated under CLIA but does not constitute FDA approval or endorsement. Patients should be aware that LDTs are used as part of a broader diagnostic approach and should be interpreted in conjunction with other clinical evaluations by healthcare providers.
• Reliance on Data and Limitations of Liability
  Clear Health Pass Diagnostics exercises reasonable care in generating accurate and reliable test results. However, we cannot guarantee that test results will be 100% accurate or applicable to every individual. Under 42 CFR § 493.1291, Clear Health Pass adheres to CLIA standards for reporting results, but we are not liable for any decisions or actions taken based on the information provided through our services. Users accept full responsibility for any reliance on the provided test information and assume the risks involved.
• Patient Responsibility
  It is the patient’s responsibility to ensure that all healthcare decisions are made in consultation with licensed medical providers. Clear Health Pass Diagnostics strongly encourages users to discuss any test results with a healthcare provider, especially before starting, stopping, or changing any treatment. Under 45 CFR Part 164, Clear Health Pass protects the confidentiality of all personal health information; however, patients are responsible for ensuring proper handling of their health information outside our facility.
• No Warranties or Guarantees
  Clear Health Pass Diagnostics provides test results “as is” without warranties or guarantees of any kind. Under 15 U.S.C. § 2301 et seq. (Magnuson-Moss Warranty Act), Clear Health Pass makes no express or implied warranties regarding the accuracy, completeness, or reliability of test results for any specific application or use. Clear Health Pass Diagnostics disclaims any liability for incidental or consequential damages resulting from the use of our test results.

Medical Disclaimer for Lab Testing and Result Interpretation

Clear Health Pass Holdings, LLC, and its subsidiaries provide various lab testing services, including 510(k)-cleared tests and Laboratory-Developed Tests (LDTs). ALL TESTING IS FOR RISK ASSESSMENT AND INFORMATIONAL PURPOSES ONLY. These tests are designed to identify specific genomic markers, gene expression patterns, or biomarkers associated with certain health conditions. However, these results are not intended to diagnose, treat, cure, or prevent any disease or condition. TEST RESULTS FROM CLEAR HEALTH PASS DIAGNOSTICS SHOULD BE INTERPRETED ONLY BY TRAINED MEDICAL PROFESSIONALS AS PART OF A COMPREHENSIVE CLINICAL EVALUATION.

Limitations of Test Results

1. Informational Purposes Only
   The results provided by Clear Health Pass Diagnostics are intended exclusively for informational purposes and are not a substitute for professional medical diagnosis, advice, or treatment. These results should be used as part of a broader health risk assessment and are not definitive medical advice. Patients should consult a licensed healthcare provider for any health-related questions or concerns.
2. Risk Assessment, Not Diagnosis
   The tests offered by Clear Health Pass Diagnostics are intended to assess the presence of certain genomic markers or biomarkers that may indicate increased risk for specific health conditions. These tests are not approved by the U.S. Food and Drug Administration (FDA) for diagnostic use and are conducted under the Clinical Laboratory Improvement Amendments (CLIA) framework (42 U.S.C. § 263a; 42 CFR Part 493). Clear Health Pass complies with FDA guidance on LDTs, intended as healthcare aids, not standalone diagnostic tools.
3. Interpretation by Qualified Healthcare Professionals
   Results from these tests should be interpreted only by qualified healthcare providers who can assess genetic and biomarker information within the context of the patient’s health history, clinical background, and family history. Test results should be used by healthcare providers to make clinical decisions in conjunction with other clinical assessments.
4. No Guarantee of Predictive or Diagnostic Value
   While Clear Health Pass Diagnostics strives to deliver accurate and scientifically validated tests, the predictive value of genomic markers or biomarkers may vary by individual factors, including environment and lifestyle. There is no guarantee that certain markers or biomarkers will result in specific health outcomes. Results should be used as part of a comprehensive health assessment and not as definitive indicators of disease presence or progression.
5. FDA and CLIA Compliance
   LDTs provided by Clear Health Pass Diagnostics are regulated under the CLIA standards for laboratory quality but are not subject to FDA premarket approval for diagnostic purposes. Clear Health Pass adheres to relevant FDA guidelines for LDTs, which are developed, validated, and offered within a single CLIA-certified lab to support personalized risk assessments rather than as a substitute for traditional diagnostic testing.

• For more information on LDT regulations, refer to the FDA’s Laboratory Developed Tests (LDTs) Guidance.

Disclaimers

1. Indemnification and Liability Limitation
   By using Clear Health Pass Diagnostics’ tests, patients acknowledge that results are for risk assessment and informational purposes only. Clear Health Pass Holdings, LLC, and its subsidiaries disclaim any liability for decisions or actions taken based on test results. Patients and healthcare providers agree to hold Clear Health Pass Holdings harmless from any claims or damages arising from the use or interpretation of these results.
2. No Warranties or Guarantees
   Clear Health Pass Diagnostics provides testing services and results “as is,” without express or implied warranties. Under the Magnuson-Moss Warranty Act (15 U.S.C. § 2301 et seq.), Clear Health Pass Holdings disclaims implied warranties regarding the completeness, accuracy, or reliability of test results for clinical use. Patients and healthcare providers should interpret these results as part of a larger clinical assessment and not as definitive indicators of health outcomes.
3. Full Disclaimer of Interpretation
   All results from Clear Health Pass Diagnostics are subject to further interpretation by qualified healthcare providers. Clear Health Pass Diagnostics does not provide medical advice, and all interpretations should be made in consultation with a healthcare professional. Patients should not make health decisions based solely on test results and are advised to discuss findings with a healthcare provider within the context of their broader clinical profile.

Important Notice to Patients

By using the services provided by Clear Health Pass Holdings, LLC, and its subsidiaries, you acknowledge and accept that:

• The results from testing are intended for risk assessment only and should not be used to diagnose or treat any health condition.
• The presence of specific genomic markers or biomarkers provides limited information and must be evaluated by a trained healthcare provider in conjunction with other clinical assessments.
• The FDA has not approved LDTs as diagnostic tools, and they are regulated under CLIA for laboratory quality assurance purposes only.

Clear Health Pass Holdings, LLC, is dedicated to providing reliable and high-quality laboratory services. We encourage all users to consult licensed healthcare professionals with any questions or concerns regarding test results.

For further information on LDT regulation and FDA guidance, please visit the FDA’s Laboratory Developed Tests (LDTs) Guidance page.

Quality Assurance Commitment

Clear Health Pass Diagnostics, LLC is committed to maintaining the highest standards of accuracy, reliability, and consistency in all our laboratory testing and diagnostic services. Our quality assurance program is designed to comply with regulatory requirements and industry standards, ensuring that every test result is produced with meticulous care and precision.

Regulatory Compliance
Clear Health Pass Diagnostics operates as a High Complexity Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited facility. Our laboratory complies with all CLIA regulations under 42 U.S.C. § 263a and 42 CFR Part 493, which mandate strict requirements for laboratory operations, including personnel qualifications, proficiency testing, and quality control. The CAP accreditation further underscores our commitment to laboratory excellence, as it involves rigorous audits, quality management practices, and adherence to best-in-class standards for diagnostic accuracy and laboratory operations.

Personnel Training and Qualifications
Our team comprises highly qualified laboratory professionals, all of whom meet or exceed the qualifications required for high-complexity testing under CLIA guidelines (42 CFR § 493.1441 – § 493.1495). Every laboratory technician, technologist, and supervisor undergoes continual training and skill assessments to ensure they adhere to best practices in diagnostic testing, specimen handling, and laboratory safety.

Quality Control and Proficiency Testing
As part of our quality assurance program, Clear Health Pass Diagnostics implements rigorous quality control procedures and participates in regular proficiency testing programs as mandated by CLIA regulations (42 CFR § 493.801). Quality control processes include routine checks on equipment calibration, test method validation, and process reviews to prevent errors and maintain the consistency of test results. Proficiency testing involves sending specimens to third-party evaluators to verify our accuracy, allowing our laboratory to benchmark its performance against national standards.

Accuracy and Reliability of Test Results
Clear Health Pass Diagnostics is committed to delivering accurate and reliable test results. We follow strict validation processes for all testing methodologies, ensuring that each assay meets or exceeds industry standards for sensitivity and specificity. Our quality assurance program also includes continuous monitoring and evaluation of test methods, equipment, and processes to identify and rectify any potential issues before they affect patient results.

Ongoing Quality Improvement
Our laboratory continuously seeks to improve its quality assurance practices by staying informed of the latest developments in laboratory science, diagnostics, and regulatory requirements. We conduct regular internal audits and performance reviews to identify areas for enhancement and implement corrective actions as necessary to maintain our standards of excellence.

Data Integrity and Patient Safety
Clear Health Pass Diagnostics takes data integrity seriously, following best practices to secure patient information, prevent errors, and ensure the accuracy of each patient’s health data. Our laboratory systems are equipped with multiple safeguards, and all test results are reviewed by qualified personnel before they are reported to healthcare providers.

Disclaimers

• Limitations of Laboratory Testing
  While Clear Health Pass Diagnostics exercises the highest levels of quality control and precision, no laboratory testing is infallible. Factors such as specimen quality, timing of sample collection, and inherent limitations of specific assays may affect test results. Patients and healthcare providers should interpret results within the full clinical context.
• Liability Disclaimer
  Clear Health Pass Diagnostics disclaims any liability for decisions made based on test results provided. Test results are intended to assist healthcare providers in diagnosing and managing patient health but are not definitive diagnoses. All medical decisions should be made by qualified healthcare professionals, who should consider other clinical evaluations, symptoms, and patient history in conjunction with laboratory findings.
• No Warranties or Guarantees
  While Clear Health Pass Diagnostics adheres to rigorous standards, we provide results “as is” without any warranties or guarantees of accuracy beyond what is standard for laboratory practices. Under the Magnuson-Moss Warranty Act (15 U.S.C. § 2301 et seq.), Clear Health Pass Diagnostics disclaims any implied warranties regarding the suitability of test results for any particular medical decision.
• Continuous Improvement Disclaimer
  Quality assurance practices and protocols at Clear Health Pass Diagnostics are subject to continuous review and improvement. As such, testing procedures, equipment, and methodologies may change over time to reflect the latest advancements in laboratory science and regulatory standards. Any updates to these practices are implemented with the goal of enhancing diagnostic accuracy and reliability.

Clear Health Pass Diagnostics is dedicated to ensuring that every patient receives the highest standard of care through accurate, reliable, and compliant laboratory testing. Our commitment to quality assurance reflects our dedication to providing healthcare providers with trustworthy diagnostic information essential for patient care.

Third-Party Vendor Compliance (HIPAA and CLIA)

Clear Health Pass Diagnostics, LLC, is committed to ensuring that all third-party vendors and service providers who may access, process, or handle sensitive patient data adhere to the same stringent standards of compliance, confidentiality, and security that we uphold within our own operations. Our commitment to HIPAA and CLIA compliance extends to all external partners and is enforced through contractual obligations, regular assessments, and strict data protection practices.

• HIPAA Compliance for Third-Party Vendors
  Under the Health Insurance Portability and Accountability Act (HIPAA), Clear Health Pass Diagnostics enters into Business Associate Agreements (BAAs) with each third-party vendor that may access Protected Health Information (PHI) on our behalf. These agreements establish that vendors must adhere to the HIPAA Privacy Rule, Security Rule, and Breach Notification Rule requirements as outlined in 45 CFR Parts 160 and 164. All vendors are required to implement safeguards to protect the confidentiality, integrity, and availability of PHI, ensuring that data is only used for authorized purposes and managed in accordance with HIPAA standards.
• CLIA Compliance for Laboratory Services
  When Clear Health Pass Diagnostics outsources or collaborates with other laboratories in our network, we ensure that each third-party lab is fully compliant with the Clinical Laboratory Improvement Amendments (CLIA), specifically 42 U.S.C. § 263a and 42 CFR Part 493. Every affiliated lab is required to hold a CLIA certification appropriate to the complexity of the testing they perform. Clear Health Pass Diagnostics conducts due diligence to verify that all partner laboratories maintain the same high standards of accuracy, reliability, and regulatory compliance in their testing processes.
• Data Security and Access Control
  Clear Health Pass Diagnostics mandates that all third-party vendors follow strict data security practices to prevent unauthorized access, breaches, or misuse of patient data. Vendors must implement data encryption, access controls, and monitoring practices in alignment with HIPAA and industry standards. Regular audits and assessments are conducted to ensure that all security practices are upheld, minimizing the risk of data breaches or unauthorized disclosures.
• Ongoing Monitoring and Compliance Audits
  We perform regular compliance audits and reviews of our third-party vendors to verify adherence to HIPAA and CLIA standards. Any vendor that fails to meet our compliance requirements is subject to corrective action, including contract termination if necessary. Continuous monitoring of vendor practices ensures that Clear Health Pass Diagnostics maintains a network of reliable and compliant partners.

Disclaimers

• Limitations of Liability for Third-Party Actions
  While Clear Health Pass Diagnostics takes every measure to ensure that third-party vendors are compliant with HIPAA and CLIA, we cannot be held liable for any unauthorized actions or data breaches that occur solely due to the actions or negligence of these third parties. Each vendor operates as an independent entity and is responsible for their own compliance practices. Clear Health Pass Diagnostics encourages patients to consult with our customer service for any questions or concerns regarding third-party data handling.
• No Warranties on Third-Party Vendor Compliance
  Clear Health Pass Diagnostics disclaims any implied warranties regarding the performance, data security, or compliance practices of third-party vendors. While we conduct thorough vetting and monitoring, Clear Health Pass Diagnostics does not guarantee that third-party vendors are infallible. Patients should be aware that data shared with or processed by third parties is subject to the third party’s data handling policies and practices.
• Right to Change Third-Party Vendors
  Clear Health Pass Diagnostics reserves the right to change, add, or remove third-party vendors as needed to maintain high standards of service and compliance. Any changes to our third-party vendor network are made with consideration of patient privacy, regulatory requirements, and quality of service. By using our services, patients acknowledge and accept that certain aspects of their data may be processed by vetted third-party vendors in compliance with HIPAA and CLIA.

Clear Health Pass Diagnostics is dedicated to protecting patient information, ensuring the integrity of diagnostic services, and working exclusively with vendors who share our commitment to compliance and security.

Safe Harbor Statement (If Applicable for Investor Information)

This website and any materials provided by Clear Health Pass Holdings, LLC, contain forward-looking statements, which are based on current expectations, assumptions, estimates, and projections about our business and industry. These statements involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to differ materially from those expressed or implied by these forward-looking statements. Such risks include, but are not limited to, business strategy, market acceptance, regulatory changes, and the economic environment. Clear Health Pass Holdings undertakes no obligation to update or revise any forward-looking statements publicly.

Exemption Filing Under Rule 506(c) of Regulation D

Clear Health Pass Holdings, LLC, is conducting certain investment offerings pursuant to an exemption from registration under Rule 506(c) of Regulation D, as provided by the Securities Act of 1933. Under Rule 506(c), Clear Health Pass Holdings may generally solicit and advertise its securities offering; however, investments can only be made by “accredited investors” as defined by Rule 501 of Regulation D. Accredited investors must meet income or net worth thresholds and provide verification of their status before participating in any investment opportunity offered by Clear Health Pass Holdings.

1. General Solicitation and Accredited Investor Verification
   Clear Health Pass Holdings, under Rule 506(c), may utilize general solicitation and advertising to communicate information about its investment opportunities. However, investment in any offering is limited to individuals or entities that qualify as accredited investors under 17 CFR § 230.501(a). Investors must undergo a verification process to confirm their accredited status, which may include providing financial statements, third-party verification, or other methods specified by the SEC.
2. Forward-Looking Statements Disclaimer
   The information provided in this website or other communications may include forward-looking statements that involve significant risks and uncertainties. Factors that could affect actual results include regulatory changes, market conditions, operational performance, and other risks outlined in our offering materials. Investors should not place undue reliance on these forward-looking statements, as they reflect the company’s perspective as of the date of publication. Clear Health Pass Holdings disclaims any obligation to update or revise forward-looking statements in response to new information, future events, or other factors.
3. Risk Disclosure for Investors
   Investment in Clear Health Pass Holdings involves a high degree of risk, including the potential loss of the entire investment. Investors should be aware that these securities are illiquid, may not have a public market, and may be subject to resale restrictions. Prospective investors are encouraged to consult with their financial advisors, accountants, or attorneys before making any investment decision. This investment is intended for individuals who can bear the financial risk of such an investment, and there is no guarantee of return.
4. Limitations of Liability and No Guarantees of Performance
   Clear Health Pass Holdings makes no guarantees regarding the future performance of any investment and expressly disclaims liability for any loss or damages that may occur as a result of an investor’s reliance on information provided. Past performance is not indicative of future results. Investors are solely responsible for their own due diligence and investment decisions.
5. No Registration with the SEC
   Clear Health Pass Holdings’ offerings under Rule 506(c) of Regulation D are exempt from registration with the U.S. Securities and Exchange Commission (SEC). As a result, the SEC has not reviewed or approved any offering materials or information about Clear Health Pass Holdings. Exempt securities offerings are not subject to the same regulatory requirements as registered securities, and prospective investors should be aware of the increased risks involved in non-registered offerings.
6. Exemption from State Registration and Blue Sky Laws
   Offerings conducted under Rule 506(c) are exempt from state-level registration requirements, known as “Blue Sky Laws,” which may ordinarily require registration or qualification of securities at the state level. However, Clear Health Pass Holdings complies with any required state filings for exemptions where applicable.

Disclaimer

By accessing this website or any materials provided by Clear Health Pass Holdings, LLC, you acknowledge and agree that:

• Investment opportunities are available only to accredited investors, and Clear Health Pass Holdings is not soliciting investments from non-accredited individuals.
• All investment opportunities are exempt from registration under Rule 506(c) of Regulation D and carry a high level of financial risk.
• No federal or state securities regulators have passed upon or endorsed any offering or the accuracy or adequacy of the information provided.

Important Notice
The content on this website is not intended as an offer to sell or a solicitation of an offer to buy any securities. Any offers to invest will only be made through private offering documents provided by Clear Health Pass Holdings. This Safe Harbor Statement is intended to comply with the requirements of Rule 506(c) of Regulation D and relevant securities laws.

Click Here for Clear Health Pass Holding’s Notice of Exempt Offering of Securities