Legal and Compliance
Genomic Sentinel operates under a comprehensive legal and regulatory framework designed to protect patient rights, ensure data security, and maintain the highest standards of ethical conduct in genomic medicine.
Compliance Certifications
SOC 2 Type II
Certified
HIPAA Compliant
Verified
GDPR Compliant
Verified
ISO 27001
In Progress
HITRUST CSF
In Progress
CLIA Certified
Certified
Applicable Regulatory Frameworks
Our operations comply with all applicable federal, state, and international regulations governing genetic information, healthcare data, and clinical laboratory services.
HIPAA
Health Insurance Portability and Accountability Act
Federal law protecting sensitive patient health information from disclosure without consent.
+2 more requirements
GINA
Genetic Information Nondiscrimination Act
Federal law prohibiting discrimination based on genetic information in health insurance and employment.
+2 more requirements
GDPR
General Data Protection Regulation
European Union regulation on data protection and privacy for individuals within the EU and EEA.
+2 more requirements
21 CFR Part 11
FDA Electronic Records and Signatures
FDA regulations for electronic records and electronic signatures in pharmaceutical and medical device industries.
+2 more requirements
CLIA
Clinical Laboratory Improvement Amendments
Federal regulatory standards for all clinical laboratory testing performed on humans in the United States.
+2 more requirements
State Genetic Privacy Laws
State-Specific Genetic Information Protections
Various state laws providing additional protections for genetic information beyond federal requirements.
+2 more requirements
Comprehensive Legal Framework
Detailed legal terms governing the use of Genomic Sentinel services, data handling, intellectual property, and dispute resolution.
Important Legal Notices
Please read these important notices carefully before using our services.
Not a Substitute for Medical Advice
Genomic Sentinel services are intended for use by qualified healthcare professionals and do not constitute medical advice, diagnosis, or treatment. All clinical decisions should be made by licensed healthcare providers in consultation with their patients.
Evolving Science
Genomic science is rapidly evolving. Variant classifications and clinical interpretations may change as new evidence emerges. Our Living Intelligence platform is designed to incorporate these updates, but users should be aware that interpretations represent current scientific understanding and may be revised over time.
Family Implications
Genetic information may have implications for biological relatives. Users should consider the potential impact on family members when making decisions about genetic testing and information sharing. Genetic counseling is recommended before and after testing.
Regulatory Jurisdiction
Genomic Sentinel services are provided globally and are subject to U.S. federal and state laws. Users in other jurisdictions should ensure that their use of our services complies with applicable local laws and regulations.
Questions About Our Legal Framework?
Our legal and compliance team is available to address questions about our regulatory compliance, data handling practices, or contractual terms.
Genomic Sentinel, Inc. | [email protected]