Below is a summary of regulatory compliance laws, their enforcing agencies, and how together they contribute to the larger goal of improving patient health care and safety:
|Occupational Safety and Health (OSH) Act||1970||Occupational Safety and Health Administration (OSHA)|
Ensures worker and workplace safety by requiring that employers provide a place of employment free from safety and health hazards.
Created the National Institute for Occupational Safety and Health (NIOSH) as well as the Occupational Safety and Health Administration (OSHA).
|Clinical Laboratory Improvement Amendments (CLIA)||1988|
Centers for Medicare and Medicaid Services (CMS)
Food and Drug Administration (FDA)
Centers for Disease Control and Prevention (CDC)
|42 CFR 493|
Ensures quality clinical laboratory testing through levels of testing complexity, quality control, competency assessments, proficiency testing, and inspections.
|Health Insurance Portability and Accountability Act (HIPAA)||1996||U.S. Department of Health and Human Services (HHS); Office of Civil Rights (OCR)|
Privacy Rule (1996)
Security Rule (2003)
HITECH Act (2009)
Omnibus Rule (2013)
Regulates patient confidentiality and information security.
Outlines how protected health information (PHI) and electronic PHI (ePHI) are used, disclosed, and protected.
|Occupational Safety and Health Administration (OSHA)||1970||OSH Act||Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor|
Sets standards and provides training for safe and healthy working conditions.
Outlines worker rights and the required training necessary for workers to safely complete their job duties.
|Centers for Medicare and Medicaid Services (CMS)||1965||CLIA||U.S. Department of Health and Human Services (HHS)|
Runs the Medicare program and works with state governments to administer standards for Medicaid, Children's Health Insurance Program, and HIPAA.
Enforces CLIA regulations by approving organizations to perform inspections and provide proficiency testing programs.
|Food and Drug Administration (FDA)||1906||CLIA||U.S. Department of Health and Human Services (HHS)|
Regulates "public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices."
Enforces CLIA regulations by categorizing tests based on complexity.
|Centers for Disease Control and Prevention (CDC)||1946||CLIA||U.S. Department of Health and Human Services (HHS)|
Protects public health and safety both nationally and internationally
Enforces CLIA regulations by conducting laboratory quality improvement studies and monitoringproficiency testingpractices.
|U.S. Department of Health and Human Services (HHS)||1980||HIPAA||Secretary of Health and Human Services, who is appointed by the President with the advice and consent of the Senate|
Protects the health of all Americans and providing essential human services.
Enforces CMS, FDA, CDC, and HIPAA.