Congress Inadvertently Legalizes Sharing of Genetic Information Without Patient Consent

Tue May 6, 2008 8:00am EDT

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Congress Inadvertently Legalizes Sharing of Genetic Information Without
Patient Consent

WASHINGTON, May 6 /PRNewswire-USNewswire/ -- "While authors of the recently
passed Genetic Information Nondiscrimination Act of 2008 (H.R. 493) had good
intentions, the bill inadvertently legalizes the sharing of genetic
information without patient consent," says Sue Blevins, president of the
Institute for Health Freedom (IHF). "It does so by applying HIPAA regulations
to genetic data."

Blevins points out, "HIPAA regulations permit data sharing without patient
consent in connection with treatment, payment, and oversight of the
health-care system ('health-care operations'). Thus, by passing a bill that
says HIPAA regulations apply to genetic information, Congress unintentionally
legalized the sharing of information among many health-care 'covered entities'
without patient permission."

The bill passed the Senate late last month, a year after the House approved
its own version. Differences between the two were resolved May 1, and the
final bill has been sent to President Bush.

In a letter published in the Baltimore Sun regarding the Senate's vote on the
anti-discrimination bill, Janis G. Chester, M.D., president of the American
Association of Practicing Psychiatrists, stressed: "...A person's genetic test
results, and all of his or her medical data, should not be available to anyone
without the patient's consent. One's employer should not even know he or she
has had testing done, let alone know the results. The sad fact is that the
regulations under the Health Insurance Portability and Accountability Act
[HIPAA], which were intended to extend patient privacy as we moved from a
paper-based system of medical records to a digital system, are a sham. HIPAA
allows the routine release of personal health information without patient
consent or knowledge, and even over a patient's objection...."

Amending HIPAA Privacy Regulations Without Public Input

H.R. 493 forbids the "use or disclosure" of genetic information for
underwriting purposes by insurers under HIPAA regulations. But the bill fails
to give individuals the final say on whether their genetic data can be shared
for many other purposes permitted under the HIPAA rule. In fact, it requires
the [HHS] Secretary to amend the HIPAA regulations to cover genetic
information, so that genetic information "shall" be treated as health
information. And the bill says that the revised HIPAA rule "shall be effective
upon publication [in the Federal Register], without opportunity for any prior
public comment, but may be revised, consistent with this section, after
opportunity for public comment." (Emphasis added.) In effect, this means:

    --  HHS must publish a notice in the Federal Register to amend the HIPAA
        regulations without an opportunity for public comment.
    --  Once the amended HIPAA regulations take effect, then the public may
        comment on the revised rule.
    --  At that point, the rule may (or may not) be revised again.
    --  In the meantime, genetic information will be defined legally as
        "health information" under HIPAA regulations, which permit the
        sharing of health information for many purposes without patient

Health Plans Permitted to Obtain Genetic Data for Making Payment

The bill amends the Employee Retirement Income Security Act of 1974 (ERISA),
the Public Health Service Act (PHSA), and the Internal Revenue Code to
"prohibit a group health plan from adjusting premium or contribution amounts
for a group on the basis of genetic information." Also, group health plans are
prohibited from requesting or requiring individuals or their family members
from undergoing genetic testing. However, the legislation says that such
prohibition may not "limit the authority of a health care professional to
request an individual to undergo a genetic test" or "preclude a group health
plan from obtaining and using the results of a genetic test in making a
determination regarding payment." In other words, insurers cannot establish
insurance rates on the basis of genetics, but they can determine payment
amounts on that basis.

Do Exceptions Nullify Genetic Privacy Guarantees?

H.R. 493 also makes it illegal for employers to discriminate based on
employees' genetic information. And it supposedly makes it unlawful for
employers to acquire employees' genetic information. The bill states, "It
shall be an unlawful employment practice for an employer to request, require,
or purchase genetic information with respect to an employee or a family member
of the employee except..." It then goes on to list six exceptions. For
example, an exception to the employer nondiscrimination clause includes:
"Where an employer inadvertently requests or requires family medical history
of the employee or family member of the employee." (Emphasis added.)

History of Genetic Data Abuse 

The legislation includes these findings (among others) regarding abuse of
genetic information:

    --  "The early science of genetics became the basis of State laws that
        provided for the sterilization of persons having presumed genetic
        'defects' such as mental retardation, mental disease,
        epilepsy, blindness, and hearing loss, among other conditions. The
        sterilization law was enacted in the State of Indiana in 1907. By
        a majority of States adopted sterilization laws to 'correct'
        apparent genetic traits or tendencies. Many of these State laws have
        since been repealed, and many have been modified to include essential
        constitutional requirements of due process and equal protection.
        However, the current explosion in the science of genetics, and the
        history of sterilization laws by the States based on early genetic
        science, compels Congressional action in this area."

    --  "Although genes are facially neutral markers, many genetic
        conditions and disorders are associated with particular racial and
        ethnic groups and gender. Because some genetic traits are most
        in particular groups, members of a particular group may be stigmatized
        or discriminated against as a result of that genetic information. This
        form of discrimination was evident in the 1970s, which saw the advent
        programs to screen and identify carriers of sickle cell anemia, a
        disease which afflicts African-Americans. Once again, State
        began to enact discriminatory laws in [this] area, and in the early
        1970s began mandating genetic screening of all African Americans for
        sickle cell anemia, leading to discrimination and unnecessary fear. To
        alleviate some of this stigma, Congress in 1972 passed the National
        Sickle Cell Anemia Control Act, which withholds Federal funding from
        States unless sickle cell testing is voluntary." (Emphasis added.)

    --  "Congress has been informed of examples of genetic discrimination
        in the workplace. These include the use of pre-employment genetic
        screening at Lawrence Berkeley Laboratory, which led to a court
        in favor of the employees in [the] case Norman-Bloodsaw v. Lawrence
        Berkeley Laboratory (135 F.3d 1260, 1269 (9th Cir. 1998)). Congress
        clearly has a compelling public interest in relieving the fear of
        discrimination and in prohibiting its actual practice in employment
        health insurance."

Consent, Ownership and Genetic-Privacy Rights Still Needed

If Congress and President Bush want to ensure that unethical uses of genetic
information are not repeated in years to come, they should pass a law that
states clearly:

    --  Genetic testing is voluntary.
    --  Individuals own their genetic information.
    --  Genetic information may not be shared without the individual's

"Unfortunately, the recently passed Genetic Information Nondiscrimination Act
of 2008 falls short of upholding the ethics of consent, ownership and genetic
privacy," Blevins said.

The Institute for Health Freedom (IHF) is a Washington, D.C.-based nonprofit
think tank whose mission is to bring the issues of personal health freedom to
the forefront of the American health-policy debate. IHF monitors and reports
on national policies that affect citizens' freedom to choose their health-care
treatments and providers, and to maintain their health privacy--including
genetic privacy.


    --  "Genetic Information Nondiscrimination Act of 2008." To read
        the complete bill, visit the congressional legislative database and
        search for bill number H.R. 493:
    --  "Medical Privacy Still Isn't Protected," Baltimore Sun,
        letter to the editor by Janis G. Chester, president of the American
        Association of Practicing Psychiatrists, May 1, 2008:,0,6
    --  "The Final Federal Medical Privacy Rule: The Definitive
        Guide," Institute for Health Freedom, March 6, 2003:

SOURCE  Institute for Health Freedom

Sue Blevins of Institute for Health Freedom, +1-202-429-6610
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