Genomics Regulatory Compliance

BioInfera operates under strict regulatory oversight and maintains full compliance with healthcare, data privacy, and genomics research regulations across all jurisdictions where we operate.

HIPAA Compliant GDPR Ready ISO 27001 Certified

Comprehensive Regulatory Framework

We operate under the oversight of multiple regulatory bodies to ensure data protection, patient privacy, and ethical genomics research.

Health Insurance Portability and Accountability Act (HIPAA)
Patient Data Privacy

BioInfera is fully HIPAA compliant, ensuring the confidentiality, integrity, and security of protected health information (PHI) in all genomics workflows.

  • Strict patient data privacy controls
  • Regular compliance audits
  • Comprehensive data access policies
  • Secure data storage and transmission
General Data Protection Regulation (GDPR)
Data Protection & Privacy

BioInfera is GDPR ready, ensuring the protection of personal data for all users and research participants in the European Union and globally.

  • Explicit consent for data use
  • Right to access and erasure
  • Data minimization and purpose limitation
  • Transparent data processing
ISO 27001 Certification
Information Security Management

BioInfera is ISO 27001 certified, demonstrating our commitment to the highest standards of information security for genomics data and research.

  • End-to-end data encryption
  • Continuous risk assessment
  • Incident response protocols
  • Independent security audits
International Genomics Compliance
Global Regulatory Standards

We maintain compliance with international regulations including GDPR, local health data laws, and other regional requirements for our global genomics research partners.

  • GDPR data protection compliance
  • Local health data regulations
  • Cross-border data transfer controls
  • Multi-jurisdictional oversight

Compliance Programs & Controls

Comprehensive compliance programs ensure adherence to all applicable regulations and industry best practices.

Data Governance

A comprehensive data governance framework ensures the quality, integrity, and security of all genomic data on our platform.

  • Data quality checks
  • Data lineage tracking
  • Access control and auditing
  • Data retention policies
Ethical Research

We adhere to the highest ethical standards for genomics research, including informed consent and data de-identification.

  • Informed consent verification
  • Data de-identification protocols
  • Institutional Review Board (IRB) compliance
  • Ethical use of data
Data Quality & Integrity

We employ rigorous data quality checks and validation pipelines to ensure the accuracy and reliability of research results.

  • Automated QC pipelines
  • Data validation and verification
  • Reproducible research workflows
  • Data integrity checks

Compliance Reporting & Transparency

Compliance Reports

Regularly updated compliance reports for HIPAA, GDPR, and ISO 27001 are available to our partners and clients.

Security Audits

Independent third-party audits of our security infrastructure and data protection controls are conducted annually.

Data Processing Records

We maintain detailed records of all data processing activities to ensure transparency and accountability.

Compliance Metrics
HIPAA Audits ✓ Passed
Data Breach Incidents 0
GDPR Compliance 100%
Request a Compliance Report

International Research Compliance

We maintain compliance with regulatory requirements across multiple jurisdictions to serve our global research partners.

United States
  • HIPAA/HITECH
  • Common Rule (45 CFR 46)
  • CLIA (for clinical labs)
  • State-specific privacy laws
European Union
  • GDPR
  • Clinical Trials Regulation
  • EMA Guidelines
  • National data protection laws
Canada
  • PIPEDA
  • TCPS 2
  • Provincial health privacy laws
Asia Pacific
  • APPI (Japan)
  • PDPA (Singapore)
  • Australian Privacy Act

Compliance Questions or Reporting

Our compliance team is available to address regulatory questions and handle compliance-related matters.

Compliance Officer

General compliance inquiries

compliance@bioinfera.com
Regulatory Filings

Access disclosure documents

View Documents
Important Disclosures

BioInfera is committed to upholding the highest standards of compliance in genomics and healthcare data management. Our certifications and regulatory adherence ensure the privacy and security of all research and patient data.

All genomics research and data processing involve strict protocols for privacy, security, and ethical use. This material is for informational purposes only and does not constitute medical or legal advice.