Policy

Privacy, Confidentiality and Patients' Rights

Confidentiality of genetic information and enforceable protections against related discrimination are critical to building public confidence in caretailored to an individual’s genetic makeup. Without these protections, patients may be less willing to participate in studies that search for linkages between genes and disease, to enroll in clinical trials for new targeted drugs, or to provide samples for DNA analysis to optimize their own disease prevention and treatment.

The 2008 approval of the Genetic Information Nondiscrimination Act (GINA) was a major victory for personalized medicine. GINA was unanimously approved in the Senate, passed in the House by a vote of 414-1, and signed into law by President Bush. With the protections outlined in GINA, all Americans will be free to optimize their health care based on genetic information and to participate in genetic research, without having to fear that the information will be misused by employers or insurers.

GINA closed important gaps in the patchwork of federal and state protections against the misuse of genetic information. Past federal statutes for protecting medical information, including the Health Insurance Portability and Accountability Act (HIPAA), did not prohibit insurers from requiring genetic testing or from denying coverage based on genetic information; and while the Americans with Disabilities Act (ADA) protects individuals with symptomatic genetic disabilities, it is not clear if it explicitly covers discrimination based on unexpressed genetic susceptibility to disease. Only a few states have strong protections against genetic discrimination, leaving some individuals more vulnerable depending on where they live.

By prohibiting insurers and employers from requesting or requiring genetic tests, and from using genetic information to discriminate, GINA provides the national framework of enforceable protections needed to advance both medical research and public health. GINA also, for the first time, creates federal rules to protect the insured in the individual market as well.

Presidential Commission for the Study of Bioethical Issues

• Commission Report, Privacy and Progress in Whole Genome Sequencing
• PMC Public Comments to Commission

Genetic Non-Discrimination

• PMC Applauds Senate Approval of the Genetic Information Nondiscrimination Act
• Policy Background
• Genetic Information Nondiscrimination in Health Insurance Act (PL 110-343)
• California Genetic Information Nondiscrimination Act
  • Genomics Law Report A New Law to Raise GINA’s Floor in California 12-7-2011