Two notices of proposed rulemaking and a proposed interim final rule, all interpreting the Genetic Information Nondiscrimination Act of 2008, or GINA, have been issued by various federal departments and agencies, HHS' Civil Rights Office announced.
The civil rights office has issued its notice of proposed rulemaking to address privacy issues regarding genetic information, the Health Insurance Portability and Accountability Act of 1996 and GINA, according to a news release. The release says that the proposed rule would amend the HIPAA privacy rule “to clarify that genetic information is health information and to prohibit the use and disclosure of genetic information by health plans for underwriting purposes.” The civil rights office has responsibility for enforcing the HIPAA privacy and security rules. The public will have 60 days to comment on the 51-page proposed rule.
In addition, the CMS, Labor Department and the Internal Revenue Service have released for public comment a 137-page interim final rule on GINA, also covering the use of genetic information by payers.
Finally, the Equal Employment Opportunity Commission, which is responsible for issuing rules under GINA covering protections against discrimination in employment from the use of genetic information, also has issued a notice of proposed rulemaking. It takes up 16 pages in the Federal Register.