Copyright 1999 Federal Document Clearing House, Inc.
Federal Document Clearing House Congressional Testimony
July 20, 1999
SECTION: CAPITOL HILL HEARING TESTIMONY
LENGTH: 2592 words
HEADLINE:
TESTIMONY July 20, 1999 FRAN VISCO HOUSE WAYS AND MEANS HEALTH
PATIENT CONFIDENTIALITY
BODY:
July 19, 1999 The
Honorable Bill Thomas Chairman House Subcommittee on Health United States House
of Representatives Washington, D.C, 20515 The Honorable Pete Stark Ranking
Member House Subcommittee on Health United States House of Representatives
Washington, D.C. 20515 Dear Representatives: On behalf of the National Breast
Cancer Coalition (NBCC), I am writing to you regarding the issue of medical
records privacy. NBCC is a grassroots advocacy organization made up of more than
500 organizations and tens of thousands of individuals working since 1991 to
eradicate this disease through advocacy and action. We appreciate the House Ways
and Means Committee's commitment to enacting medical records privacy legislation
this year. NBCC believes strongly that we need to establish a meaningful and
enforceable national policy that ensures an individual's right to privacy with
respect to personally identifiable health information. We believe that our
diagnosis, treatment and prognosis is very personal information, whethcr we are
breast cancer survivors, women battling breast cancer, or women with a
predisposition to breast cancer. Provisions to safeguard personal health
information, in addition to strong enforcement mechanisms that ensure these
protections, are critical components of any federal medical records privacy
legislation. For women with breast cancer, the entire process- from diagnosis to
treatment and prognosis-is a highly personal and private experience. We
recognize that the misuse of our health information can harm us and our
families. Unauthorized or inadvertent disclosure of our health status, genetic
or family history can make it difficult if not impossible for some women and
their daughters to obtain health insurance. Without appropriate safeguards
against misuse, fewer women will be willing to participate in research efforts,
whether donating tissue or enrolling in clinical trials. At the same time, NBCC
acknowledges the need to allow medical research to Proceed unimpeded by
excessively stringent regulations. Legislation protecting medical
information and privacy must therefore be a combination of protection
and regulation which eliminates public fear of discrimination and simultaneously
builds public trust of biomedical research. Federal standards that safeguard
personal health information and simultaneously protect the ability of
researchers to conduct vital biomedical research are absolutely necessary and
should not exist independently of one another. As a result, NBCC urges you to
pass legislation that strikes the proper balance between the advancement of
medical research and an individual's right to privacy as your committee begins
to address the issue of medical records privacy. Enclosed please find NBCC's
recent testimony on this issue before the House Commerce Subcommittee on Health
and Environment. We look forward to working with you to get a comprehensive and
enforceable privacy bill enacted into law. Please do not hesitate to call me, or
NBCC's Government Relations Manager, Jennifer Katz, at (202) 973-0595 if you
have any questions. Sincerely, Fran Visco President enclosure Testimony of Fran
Visco, President National Breast Cancer Coalition before the House Commerce
Committee Subcommittee on Health and Environment May 27, 1999 Thank you, W.
Chairman and members of the Committee for inviting me to testify today. I am
Fran Visco, President of the National Breast Cancer Coalition and a breast
cancer survivor. I am one of the 2.6 million women living with breast cancer in
the U.S. today. The National Breast Cancer Coalition (NBCC) is a grassroots
advocacy organization dedicated to eradicating breast cancer. We are made up of
500 member organizations and more than 60,000 individual women, their families
and friends. The NBCC seeks to increase the influence of breast cancer survivors
and other activists over public policy in cancer research, clinical trials, and
access to quality health care for al.1 women. The NBCC believes strongly that we
need to establish a national policy that ensures an individual's right to
privacy with respect to personally identifiable health information. We believe
that our illness, diagnosis, treatment and prognosis is very personal
information, whether we are breast cancer survivors, women battling breast
cancer, or women with a predisposition to breast cancer. We also know that the
misuse of our health information can harm us and our families. Unauthorized or
inadvertent disclosure of our health status, genetic or family history can make
it difficult if not impossible for some women and their daughters to obtain
health insurance. At the same time, NBBC believes that legislation protecting
privacy rights should not impede the progress of biomedical, behavioral,
epidemiological and health services research. Research offers women diagnosed or
predisposed to breast cancer the best hope for finding a cure, improving
treatment, and someday preventing breast cancer. NBCC believes that research can
be carried out in a way that protects the privacy rights of individuals and
simultaneously enhances public trust in medical research. We are at a decision
point where we can allow the computer revolution to make access to our personal
health information a free-for-all or where we can harness the new communications
technologies to insure that our personal health information remains private.
Because access to health records and information is so critical to the progress
of research, we may need a new paradigm to protect an individual's privacy -
even if it should cost more. Research can not be held to a lower standard for
protecting privacy: it must be held to a higher standard to ensure the public's
support and trust. How can we maintain the public trust? By establishing key
safeguards for personally identifiable health information. By requiring informed
consent and ensuring that it is not coerced. By limiting disclosure to the
minimal information necessary. By establishing strong penalties for those
individuals who violate these protections and by supporting the highest quality
peer- reviewed research. NBCC believes that Congress needs to provide consumers
with important new rights, including: Access to Medical Records. Individuals
should have certain rights with regard to their medical record and information
in order to understand how they are being used and maintained. Individuals
should have reasonable access to their records to inspect, copy, supplement or
amend their medical records. Individuals should also be able to seek special
protection for certain sensitive information that they do not wish to be
disclosed. For example, many women would not wish to disclose genetic
information such as BRCA 1 and BRCA 2 test results to insurers or employers, but
would want this information made available to their health care providers.
Notice of Information Policies. It is also important that individuals understand
how their medical records are to be used and when and under what circumstances
information will be disclosed to a third party. Plans and other health care
providers should be required to notify individuals about their disclosure
policies and to keep records when information is released, to whom it is
provided, and for what purpose, and make that information available to
individuals. Individuals should also be able to withdraw consent or limit what
information is disclosed. Informed Consent. Any legislation should strictly
limit the use of identifiable health information absent an individual's informed
consent except as explicitly permitted in legislation for public- interest
purposes (such as public health for use in legally authorized disease and injury
reporting, public surveillance or a public health investigation or intervention,
health oversight, and emergency purposes). There should be clear circumstances
when protected health information will not be disclosed, such as for marketing,
insurance underwriting, or employment purposes without authorization of the
individual. Moreover, plans, providers and others should be required to de-
identify as much protected health information as possible and limit disclosure
to only the information necessary for the approved purpose. Medical Research:
There has been much debate about what are appropriate safeguards for personally
identifiable information with regard to research, and much discussion about
whether current federal regulations can sufficiently protect patient
confidentiality. Increasingly, much health services, epidemiological, biological
and statistical research relies on the use of medical or health records and does
not involve any interaction between the researcher and the patients. Researchers
have legitimately raised serious questions about the feasibility of seeking
authorization from thousands or possibly millions of individuals. Other research
such as retrospective or secondary research relies on archival patient
materials, including medical records and tissue specimens also does not involve
interaction directly with individuals. And while the data can be encrypted,
researchers and epidemiologists need to link this data back to individuals in
order to generate meaningful conclusions regarding the benefits and adverse
outcomes of particular treatments, as well as medical effectiveness. The
question for Congress, and for patient advocates like NBCC who care deeply about
the research mission and are committed to privacy protection -- is when to
require voluntary informed consent to conduct research and under what
circumstances to allow the disclosure of protected health information without
patient authorization. Under the common rule, research organizations conducting
federally funded or regulated research projects must establish and operate
institutional review boards (IRBs), which are responsible for reviewing research
protocols and for implementing federal requirements designed to ensure the
safety of human subjects. No human-subjects research may be initiated, and no
ongoing research may continue, in the absence of IRB approval Integral to
conducting research under the common rule is a requirement that there is proper
informed consent and documentation of that consent. There is also a mechanism
under the common rule that allows for the IRB to waive the need for informed
consent -- but only under certain limited situations where: 1) the research
involves no more than minimal risk to the subjects; 2) the waiver or alteration
will not adversely affect the rights and welfare of the subjects; 3) the
research could not practicably be carried out without the waiver or alteration;
and 4) whenever appropriate, the subjects will be provided with additional
information after participation. Thus, IRBs currently deliberate and make
decisions about when informed consent is and is not necessary. The burden is on
the researcher to demonstrate to the members of the IRB why informed consent is
not necessary. There should be another test for deciding on whether to waive the
requirement for informed consent. The MB should be required (in addition to the
criteria above) to determine if the importance of the health research outweighs
the intrusion into the privacy of the individual. In this way, the IRB would be
able to successfully balance the need for the research with an individual's
right to privacy. There are two problems with the current system I would like to
note: first, there are serious problems with institutional review boards; and
second, not all health research is subject to IRB. Increasingly, there is health
research that falls outside the common rule. Ibis raises questions about
building a new system, with an increased responsibility to protect privacy, on a
flawed program. Nevertheless, NBCC believes that IRBs are an appropriate
paradigm to build upon. Before doing that, we recommend that any legislation
require a serious review by the Secretary and a requirement that the Secretary
make recommendations regarding standards for protecting privacy in research and
improvements in the system to ensure its success in meeting its responsibility
to individuals involved in research. We also believe that Congress should extend
the common rule to all research. There is always an opportunity for protected
health information to be disclosed that could be harmful - even if that
information is eventually aggregated. There needs to be one system for
protection that applies to all research; not carve outs for this or that type of
health research. Preemption: in order for any standard to be effective it needs
to be uniform across the states, but we would only support preemption if it sets
a floor for the states and not a ceiling. Many states have already begun to
respond to the many complex issues involved in protecting medical privacy and
have established strong laws. We should not force them to a lower standard.
Penalties : Finally, we believe there should be strong criminal and civil
penalties for intentionally or negligently using individually identifiable
health information. Individuals should also have a civil right of action against
anyone who misuses their protected health information. One area that has been
sorely absent in the debate over medical privacy is the urgent need for adopting
genetic anti- discrimination legislation. Even if we pass the perfect medical
privacy bill, we will not be able to entirely prevent unlawful disclosures. When
privacy is breached, anti- discrimination legislation would prevent misuse of
the information. These two protections go hand-in-hand. Anti-discrimination
legislation in itself is hard to enforce, and therefore it is important to
provide good privacy protection. Breast cancer remains the most common form of
cancer in women. We still do not know the cause or have a cure for this dreaded
disease. Over the past two years, there have been incredible discoveries at a
very rapid rate that offer fascinating insights into the biology of breast
cancer, such as the isolation of breast cancer susceptibility genes and
discoveries about the basic mechanisms of cancer cells. These discoveries have
brought into sharp focus some of the areas of research that hold promise. NBCC
believes that legislation protecting medical information and
privacy should be balanced. We want to see federal standards that
safeguard personal health information and protect the ability of researchers to
conduct vital biomedical research. We don't believe that you can have one
without the other. Knowledge about how to prevent and cure breast cancer will
only come if women participate in research. But without appropriate safeguards
against misuse, public distrust will increase and few women will be willing to
participate in research efforts, whether donating tissue or enrolling in
clinical trials. Only if women believe that their individual health information
will be kept private so that it can't be used against them by insurers or
employers or be made public will they have the confidence to participate in
clinical research. I can't emphasize enough that we must focus our attention on
building public trust. It has to be something real, something believable, if
women am to place their trust in the medical and research process. Mr. Chairman,
and members of the Committee, thank you again for the opportunity to testify. We
look forward to working with you on this critically important issue. I'll be
happy to answer any questions you may have.
LOAD-DATE:
July 21, 1999 
