One place to find official compliance sources

42 CFR Part 2: Confidentiality of Substance Use Disorder Patient Records

HHS rule protecting the confidentiality of substance use disorder patient records; the HHS Office for Civil Rights enforces it.

AS9100D Quality Management Systems: Requirements for Aviation, Space, and Defense Organizations

AS9100D is the aviation, space and defense quality management system standard, published by SAE International and built on ISO 9001:2015.

Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition

CDC and NIH advisory guidance on biosafety practices and containment levels for laboratories working with infectious agents and toxins.

Building and Fire Codes for Laboratory Facilities

Model building and fire codes used for laboratory and research facilities, published by the ICC and NFPA and adopted by state and local governments.

California Confidentiality of Medical Information Act (CMIA)

California law (Civil Code §56 et seq.) limiting how health care providers, health plans, contractors and others use and disclose medical information.

California Consumer Privacy Act (CCPA), as amended by the CPRA

California consumer privacy law, amended by the CPRA, enforced by the Attorney General and the California Privacy Protection Agency (CalPrivacy).

CAP Laboratory Accreditation Program

College of American Pathologists accreditation programs for laboratories, including the Laboratory Accreditation Program and CAP 15189.

Clinical Laboratory Improvement Amendments (CLIA)

Federal quality standards for US laboratories testing human specimens, administered by CMS with CDC and FDA under 42 CFR Part 493.

Clinical Laboratory Improvement Amendments (CLIA) and Clinical Genetic Testing

CLIA sets federal quality standards for clinical laboratory testing on humans, including genetic tests; CMS runs the program with FDA and CDC.

CMS Emergency Preparedness Rule

CMS rule requiring Medicare and Medicaid participating providers and suppliers to maintain emergency plans, procedures, communication, training and …

Common Rule (45 CFR Part 46) and IRB Oversight

HHS regulations at 45 CFR Part 46 protecting human research subjects and governing IRB review, overseen by the Office for Human Research Protections.

Contract Drug Manufacturing under cGMP

FDA current good manufacturing practice rules as they apply to contract drug manufacturers and to quality agreements between owners and contract …