that the term “medical device” was explicitly defined. Under this definition, diagnostic tests are classified as medical devices.


Clinical Laboratory Improvement Amendments (CLIA). Enacted in 1988, CLIA establishes quality standards for all non-research laboratory testing performed on human specimens for the purpose of providing information for diagnosing, preventing or treating disease or for assessing health.3 Laboratories performing these tests must be certified by the Centers for Medicare and Medicaid Services. Although CLIA is a federal law, two states—New York and Washington—are exempt from CLIA because their state-level regulations have been determined to meet or exceed CLIA’s requirements.


Health Insurance Portability and Accountability Act (HIPAA). Enacted in 1996 to protect health insurance coverage for workers—and their families—who change or lose their jobs, a major provision of HIPAA was to require the Department of Health and Human Services to write regulations aimed at protecting the privacy of individuals’ identifiable personal health information should Congress fail to enact legislation offering such protection before August 31, 1999.4


Genetic Information Nondiscrimination Act (GINA). Enacted in 2008 and in force since 2009, GINA5 protects the public from discrimination based on genetic information in health insurance and employment settings. It prohibits employers from requesting, requiring, purchasing or using genetic information about an individual or family member in any job-related decision. This codifies the Equal Employment Opportunity Commission’s interpretation of the Americans with Disabilities Act—never tested in court—by prohibiting workplace discrimination based on genetic information. It also prohibits health insurers (both group and individual) from requesting, requiring or using a person’s

3

The Centers for Medicare and Medicaid Services, CLIA Overview. Available at: www.cms.hhs.gov//clia/, Accessed: March 29, 2010.

4

U.S. Department of Health and Human Services, Health Information Privacy: The Health Insurance Portability and Accountability Act of 1996 (HIPAA), Available at: www.hhs.gov/ocr/privacy/, Accessed: March 29, 2010.

5

Department of Health and Human Services (HHS), “GINA,” The Genetic Information Non-discrimination Act of 2008: Information for Researchers and Health Care Professionals, April 6, 2009. Available at: www.genome.gov/Pages/PolicyEthics/GeneticDiscrimination/GINAInfoDoc.pdf, Accessed: March 29, 2010.



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