Predictive Health Legislative Update: GINA, HIPSA and more ...

If you are interested in U.S. legislative developments that may impact the progress of predictive health and genetic research, you've probably heard of The Genetic Information Nondiscrimination Act (GINA). If enacted, GINA (S.358) would "prohibit discrimination on the basis of genetic information with respect to health insurance and employment". Although widely supported, GINA's progress has been stalled by the opposition of one legislator, Sen. Coburn [OK]. Coburn has placed a block on the bill and offers an evolving account for his opposition. As reported in Wired, November 17, 2007, Coburn objects to "the possibility that an employer who provides health insurance for its workers could be sued both as an insurer and as an employer". The bill's sponsor, Rep. Slaughter (NY), dismissed the latest justification for Coburn's hold as "creative".

Although GINA has received the most attention from the press and legislators (and rightly so, as it is only one roadblock away from a vote) other bills relevant to predictive health research have also been introduced. Like GINA, two of these were written with the intent to enhance the privacy of medical records. Both of these are currently waiting for review in the Senate's Committee on Health, Education, Labor, and Pensions:

S.1455 National Health Information Technology and Privacy Advancement Act of 2007
Introduced May 23, 2007, this bill aims "to provide for the establishment of a health information technology and privacy system". The bill's sponsor, Sen. Sheldon Whitehouse [RI], and four cosponsors ask for creation of the "Office of the National Coordinator for Health Information Technology". Among other things, this new "nonprofit national health information technology and privacy corporation" would identify rules for the research use of non-identifiable health care data.

S.1814 Health Information Privacy and Security Act (HIPSA)
HIPSA, reviewed here at PredictER Blog, was introduced by Sen. Leahy [VT] on July 18, 2007. While intending, in part, to "promote the use of non-identifiable information for health research", the bill strengthens personal privacy protections. If passed, individuals would be permitted to inspect a copy of this information and would be notified of security breaches. HIPSA also requires the Health and Human Services Secretary to provide "model written authorization for the disclosure" of health information and establishes criminal and civil penalties for intentional violations.

Readers interested in the development of biobanks and genetic databases for pediatric research, will want to follow the progress of a third bill: S.911 Conquer Childhood Cancer Act of 2007. This bill amends the Public Health Service Act to establish a grant mechanism to sponsor the creation of a national, population-based database for pediatric cancer research—the Childhood Cancer Research Network. The Act, introduced by Sen. Reed [RI], would also provide grants for Research Fellowships and for the public awareness and communication efforts of relevant advocacy organizations. This bill was recently reviewed by the Senate's Committee on Health, Education, Labor, and Pensions and placed on the Senate Legislative Calendar (see General Orders, No. 535). A version of the bill is also making its way through the House of Representatives; H.R.1553 is sponsored by Rep. Deborah Pryce of Ohio and was referred to the House Subcommittee on Health on March 16, 2007. - J.O.

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HIPSA: The Health Information Privacy and Security Act of 2007

Revising HIPAA
Yesterday, July 18, 2007, Senators Leahy and Kennedy introduced legislation to revise HIPAA. Although Section 215 makes disclosure exceptions for “Law Enforcement, National Security, and Intelligence”, the new bill would tighten HIPAA loopholes. The bill “requires that any health information intended to be used for medi[c]al research first be stripped of personally identifying information to protect an individual’s privacy”. Senator Leahy's website provides a copy of the statement and a summary of the legislation: http://leahy.senate.gov/press/200707/071807c.html

Additional Excerpts from Leahy’s Statement:

Our bill also requires that patients be notified of a data security breach involving their health information within 15 days of discovery of the breach. ....

[O]ur bill addresses the growing fear of many Americans that they will not be able to obtain important health information about a parent or child in situations involving a medical emergency, because of confusion about the requirements of current health privacy laws. ....

The bill also establishes a national office of health information privacy within the Department of Health and Human Services to aid American consumers in learning about their health privacy rights. ....

The bill makes it a federal crime to knowingly and intentionally disclose or use sensitive health information without an individual’s consent. Violators of this provision are subject to a criminal penalty of up to $500,000 and up to 10 years in prison, if the violation is committed with the intent to sell or use sensitive health information for economic gain.

To read the full statement and a summary of the legislation: Visit Sen. Leahy's press release at: http://leahy.senate.gov/press/200707/071807c.html

Related Press:
Sen. Leahy cites “Keeping Patients’ Details Private, Even From Kin”. July 3, 2007, The New York Times.

Also see: “Senators introduce stringent health records privacy bill”. Government Health IT, July 18, 2007.