Committed to compliance with all laws, rules and regulations governing diagnostics business

Compliance, Licensing and Quality Management

At HalioDx, we are committed to compliance with all laws, rules and regulations governing our business and strictly adhere to all our own internal policies and procedures, including the Health Insurance Portability and Accountability Act (HIPAA), the General Data Protection Regulation (GDPR) and others.

Compliance Resources:

Website Privacy Policy
Notice of Privacy Practices for PHI
Privacy Shield Policy

Licensing

HalioDx is licensed under the Clinical Laboratory Improvement Amendment of 1988 (“CLIA”) and is authorized to provide diagnostic laboratory services in the states of California, Maryland, Pennsylvania and Rhode Island. In addition, HalioDx is a participating provider for the Medicare program.

We deliver CLIA & CE-IVD Immunoscore® results to patients worldwide:

HalioDx Inc. | 737N 5th Street | Richmond | Virginia 23219 |USA

CLIA n° 49D2159558

CLIA for California n° COS 00800961

CLIA for Maryland n° 2983

CLIA for Pennsylvania n° 36968

CLIA for Rhode Island n° LCO01317

HalioDx | Luminy Biotech Entreprises 163 Avenue de Luminy | 13288 Marseille Cedex 9 | FRANCE

CLIA n° 99D2131292

CLIA for California n° COS 00800828

CLIA for Maryland n° 2730

CLIA for Pennsylvania n° 35816

Quality & Compliance

With more than 33,000  squared meters of advanced facilities using ISO 13485 & ISO 9001 quality management system, HalioDx has the full capacity to manage and analyze samples from Clinical Trials in accordance with GCP and GCLP.

Accreditations:

ISO 9001:2015 (EN)

ISO 9001:2015 (FR)

ISO 13485:2016 (EN)

ISO 13485:2016 (FR)