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Our Certifications
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Our Certifications
BiomarkersLabs.com operates under the highest international compliance and certification standards — ensuring every test meets rigorous clinical, regulatory, and data protection requirements worldwide.
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International compliance standards we uphold
Every certification applies directly to how we operate our platform, handle your data, and supply certified lab tests to licensed practitioners globally.
HIPAA
Health Insurance Portability and Accountability Act
US federal law governing protection of patient health information. BiomarkersLabs complies with the HIPAA Privacy Rule, Security Rule, and Breach Notification Rule.
- All PHI stored on HIPAA-compliant encrypted serversBusiness
- Associate Agreements (BAA) available
GDPR
General Data Protection Regulation
EU's comprehensive data protection framework. BiomarkersLabs acts as Data Controller and fully complies with all GDPR obligations for practitioners across the EU and UK.
- Lawful basis established for all data processing
- All 8 data subject rights fully supported
- 72-hour breach notification to supervisory authority
PIPEDA
Personal Information Protection and Electronic Documents Act
Canada's federal privacy law. BiomarkersLabs.com complies with all 10 PIPEDA fair information principles for Canadian practitioners.
- All 10 PIPEDA fair information principles upheld
- Consent-based data collection for Canadian users
- Individual access rights fully supported
CLIA
Clinical Laboratory Improvement Amendments
CLIA certification ensures all laboratory testing meets strict federal quality standards. All BiomarkersLabs US partner laboratories hold active CLIA certification.
- All US partner labs hold active CLIA certificates
- Federally regulated testing quality standards
- Same labs used by hospitals and physicians
IVDR
In Vitro Diagnostic Regulation (EU) 2017/746
EU regulatory framework for in vitro diagnostic medical devices. All tests supplied to EU practitioners comply with IVDR requirements.
- All EU tests meet IVDR 2017/746 requirements
- Performance evaluation and post-market surveillance
- Applies to all diagnostic tests supplied in the EU
CE Marking
Conformité Européenne - European Conformity
CE marking certifies that a product meets EU safety, health and environmental protection standards. All diagnostic tests supplied to EU/UK practitioners carry CE marking where required.
- CE marked tests meet EU safety & quality standards
- Applies to all IVD products supplied in EU/UK
- Regulatory compliance verified per product category
About Us
Why compliance certification matters for your practice
When you order through BiomarkersLabs.com, every test, result, and piece of patient data is handled in full accordance with the most rigorous international regulatory standards — protecting you, your patients, and your practice.
- Fully compliant with USA, EU and Canadian regulations
- Patient data protected under HIPAA, GDPR and PIPEDA
- All lab partners hold active CLIA certification
- EU tests CE marked and IVDR compliant
- Business Associate Agreements available on request
- Annual compliance reviews and security audits
Lab partner standards
Our certified laboratory partner requirements
6
International compliance certifications
3
Jurisdictions covered — USA, EU, Canada
AES-256
Encryption standard for all data at rest
72hrs
Maximum breach notification time under GDPR
CLIA certified
All US partner labs hold active CLIA certification — the same standard used by hospitals and physician offices.
CAP accredited
We prioritise labs accredited by the College of American Pathologists. the gold standard in lab quality assurance.
ISO 15189 standard
International lab partners adhere to ISO 15189 — the international standard for medical laboratory quality.
Regular audits
All partner labs undergo regular compliance audits as a condition of their partnership with BiomarkersLabs
Data security agreements
All lab partners sign Data Processing Agreements and BAAs before any patient data is shared.
Coverage by region
Certifications by jurisdiction
United States
🇺🇸
HIPAA | CLIA | CAP
European Union
🇪🇺
GDPR | IVDR | CE
Canada
🇨🇦
PIPEDA | CLIA
United Kingdom
🇬🇧
UK GDPR | CE | IVDR
Questions about compliance?
Need a BAA or compliance documentation?
For Business Associate Agreements, compliance certificates, or any regulatory queries — our compliance team is ready to assist verified practitioners.
