Copyright 2000 Federal News Service, Inc.
Federal News Service
April 26, 2000, Wednesday
SECTION: PREPARED TESTIMONY
LENGTH: 3519 words
HEADLINE:
PREPARED TESTIMONY OF JOANNA HOROBIN, MD EXECUTIVE VICE PRESIDENT FOR COMMERCIAL
DEVELOPMENT ENTREMED, INC. ON BEHALF OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION
(BIO)
BEFORE THE SENATE COMMITTEE ON HEALTH,
EDUCATION, LABOR AND PENSIONS
RE: CONFIDENTIALITY OF MEDICAL
RECORDS APRIL 26, 2000
BODY:
EXECUTIVE
SUMMARY
The Biotechnology Industry Organization (BIO) is encouraged that
the Committee is holding this hearing to discuss protecting the confidentiality
of patient medical records. BIO supports enactment of comprehensive Federal
legislation.to protect the confidentiality of personal medical information.
Although it is critical to protect patients' confidentiality rights, federal
proposals must be carefully written to assure the continuation of vital medical
research on diseases and conditions faced by these same patients. The Clinton
Administration's proposed confidentiality rule fails this test. In contrast to
the Chairman's mark from last year, the Administration's proposal does not
recognize that medical researchers must use - and share - identity-encoded
medical information where there is no potential for compromises in patient
confidentiality. To encumber this use and sharing of this encoded information
would be damaging to biomedical research. In addition, federal legislation is
needed to create national, uniform confidentiality protections, rather than
leaving researchers subject to a patchwork of different and sometimes
inconsistent state laws. While it is important to protect patients, imposing
unnecessary and inappropriate restrictions on access to important medical data
will slow research efforts to treat and cure these patients. Federal legislation
and regulation must facilitate the legitimate research uses and sharing of
medical information to help ensure that the biotechnology industry will continue
to bring breakthrough products to the bedside for patients with deadly and
disabling diseases. This is the balance we find in the Chairman's mark.
STATEMENT
Good morning. My name is Joanna Horobin. I am Executive Vice
President for Commercial Development for EntreMed, Inc., a biotechnology company
in Rockville, Maryland. I am testifying on behalf of the Biotechnology Industry
Organization (BIG). BIG represents 916 companies, academic institutions and
state biotechnology centers engaged in biotechnology research on medicines,
diagnostics, agriculture, pollution control and industrial applications.
EntreMed is developing antiangiogenic drugs designed to inhibit the
abnormal new blood vessel growth associated with a broad range of diseases such
as cancer and heart disease. Our company has several products currently in
clinical trials being conducted at major cancer centers in four states. As the
program on these products expands, multi-center protocols will be initiated at
several centers in different states and potentially overseas.My objective
throughout my career - whether as a prescribing physician, clinical researcher,
or as a business executive responsible for the launch of new drugs - has always
been to provide the best therapeutic options for patients.
Let me make
three points.
BIO Support for Confidentiality Protections
First,
BIO has consistently supported national legislation to protect the
confidentiality of medical information. BIO strongly supports enactment of a law
that protects patients' confidentiality, just as we supported barring
discrimination on the pan of group health plans based on "genetic information".
We view it as a moral duty - and good public policy - to assure the public that
the great promise of biotechnology research will not be tarnished by abuses of
this technology.
We are proud of the fact that BIO worked effectively in
1996 to secure enactment of an amendment to the Health Insurance Portability and
Accessibility Act that provides important protections against discrimination by
health insurance companies based ,on "genetic information" about the individual.
The protections against discrimination based on "genetic information" were not
included in original House or Senate version of the legislation. The bills
provided protections against discrimination based on "pre-existing conditions,"
but this was defined as a condition for which there had been a diagnosis and
treatment. Adding "genetic discrimination" means that individuals who take a
predictive genetic test to determine if they will or are likely to manifest
symptoms of a genetic-based disease are also protected. In fact, they have
greater protections than individuals with pre-existing conditions (not being
subjected to a waiting period for health benefits coverage).
We now need
to supplement this first ban on discrimination based on genetic information with
confidentiality protections for this and other medical information.
BIO
Support for Confidentiality Legislation
Second, BIO supports enactment
of a national law to protect the confidentiality of medical information. As you
know, despite the best efforts of the Chairman, the Ranking Member and many
others, legislation has not yet been enacted on this subject. We urge the
Committee to continue to work towards enactment of legislation. As we will
explain, it is the best way to secure the protections patients need in a way
that is compatible with medical research.
We specifically support the
legislative proposal that you, Chairman Jeffords, presented in your Chairman's
mark. Specifically, it contained a bi-partisan proposal crafted by Senators
Frist and Kennedy and was agreed to by the Administration- for oversight of
research not subject to the Common Rule that would provide privacy protection to
individuals without hurting research. These provisions created an effective
mechanism for reviewing privacy issues raised by proposed uses of health
information for research purposes. The mark also created a definition of
"nonidentifiable health information" that included coded data, thereby
facilitating use of scientifically valuable information by
medical researchers without jeopardizing patient
privacy.Mr. Chairman, we also need federal legislation to
create a set of national, uniform confidentiality protections. Clinical trials
are multi-state ventures. National standards would allow researchers to create
informed consent and other procedures that will be legal in all states. The fact
that this is not true today is becoming an increasingly vexing problem for
biotechnology companies. A 1999 study of state health privacy laws showed the
vast differences among the states. In addition to existing differences, state
laws in this area are in flux. During this past state legislative session, 26
states debated laws concerning privacy. This environment will slow important
research efforts.
It is important to note that with respect to the
research implications, the differences among states do not seem to start from
differences in the level or degree of protection, but reflect different state
legislature's' views of the specific procedures or requirements for
accomplishing the same objective. Nonetheless, the requirements and penalties
are different enough to require every researcher to hire lawyers to assure
compliance with the laws of more than 50 states and local jurisdictions in
designing informed consent documents for a multi-state trial.
Strong
national standards will also give the public peace of mind because they will
know that their medical information is subject to appropriate protections. This,
in turn, will make them more willing to share information with medical
researchers.
The Executive Branch does not have the authority to create
such a system. That's why Congress must act. Thus, BIO urges Congress to pass
necessary legislation. It should contain language that will pre-empt all state
laws that would inhibit access to information important to research.
BIO
Position on Pending Confidentiality Regulations
Finally, until we are
able to secure enactment of Federal legislation, we need to ensure that the
medical confidentiality regulations proposed by the Secretary of DHHS strike
this same balance. The current proposal does not do so.
As with the
Chairman's mark, federal privacy regulations must be carefully written to allow
the continuation of vital medical research. This research is essential if we are
to realize the promise of developing new treatments and cures for many diseases.
Legislation or regulations that unreasonably restrict researchers' access to and
use of medical information will slow, and could halt, research efforts, thereby
creating a barrier to the development of new drugs and biologics.
Regulatory proposals must protect patients' privacy rights while
creating an environment that encourages vitally important medical research to
continue. These goals are not mutually exclusive. During the public debate over
this issue, no one - from patient groups to privacy advocates, providers,
payers, and government officials - has said that research should be made more
difficult or costly by the legal framework established to protect medical
privacy.
Unfortunately, the proposed rule has precisely that unintended
adverse effect on research, h will severely hurt medical research. Although the
proposed rule does not directly regulate BIO's member companies, virtually all
data used in the clinical phases of biotechnology research and in monitoring the
safety and efficacy of products after marketing comes from patients who are
receiving care from a "covered entity" (e.g., hospital, health plan) subject to
the proposed rule. As a result of its significant new requirements on covered
entities and its restrictions on their use of data, the proposal will have a
substantial adverse impact on biotechnology companies' ability to carry out
research.
BIO has submitted formal comments to the proposed rule that
describe in detail our analysis and recommendations. I would like to focus on a
few critical issues today.
The proposed rule creates barriers to
information for companies, engaged in research and clinical trials.
BIO
believes a covered entity should be permitted to disclose protected health
information after making reasonable efforts to ensure that disclosure is limited
to the minimum information necessary. A covered entity should be permitted to
rely upon the determinations of its own IRB or the central IRB in a multi-center
clinical trial for purposes of determining whether disclosures have been
appropriately limited. However, the proposed rule would impose civil and
criminal sanctions on an entity unless it can prove it made "all reasonable
efforts" to limit disclosures. This will be a disincentive for covered entities
to share information and will deter them from responding to the recent call of
the Institute of Medicine to reduce the frequency of medical errors by affording
all providers in the chain of care timely access to an integrated clinical
information system.
Moreover, the proposed regulation requires each
covered entity to make its own independent "minimum necessary" determination for
every research use or disclosure. This means that the covered entity must reach
an independent judgment that the purpose of each use or disclosure could not be
reasonably accomplished with information that is not identifiable. This is
simply unworkable within the context of a large, multi-canter clinical trial.
IRBs that review biotechnology research protocols must make complex
judgments about the value of the research, the scope of disclosure in the
consent form, and the sufficiency of protections for patient privacy. Existing
federal regulations permit institutions cooperating in multi-center clinical
trials to delegate basic decisions about the structure of the research protocol,
the contents of the consent form, and the scope of any patient waivers or
authorizations to a central IRB. Delegation of review authority allows
participating sites in a multi-center trial to rely upon an IRB whose members
have special expertise and understanding of the proposed research. Unnecessary
duplication of effort and expense is avoided, data collection is standardized,
and the trial coordinator does not face the administrative burden of managing
data and patient records from multiple sites whose IRBs might otherwise place
differing requirements and limitations upon the protocol.
These
arrangements likely would not be feasible under the "minimum necessary" rule, as
drafted. Covered entities arguably could no longer delegate the substantive
review of protocols and consent forms to the central IRB in a multi-center
trial, because such review necessarily involves determinations about the amount
of information necessary for the research purpose.
BIO recommends that
these provisions in the proposed rule be appropriately modified.
The
proposed rule creates an unworkable scheme for creating "de- identified"
information.
Researchers often use data sets of de-identified
information (information that is made anonymous or coded so an individual's
identity is not revealed and cannot readily be determined by the researcher).
Such research projects include epidemiological studies, outcomes analyses, and
studies of incidence of disease or access to care across populations, areas or
time. For biotechnology companies, these studies are essential to identify unmet
medical needs and develop hypotheses about the environmental, social,
behavioral, and genetic roots of diseases and conditions.
Whether
information meets the proposal's definition of"de-identified" is critical
because if it does not, it is deemed to be "protected health information", and
its use or disclosure without compliance with the proposed rule's provisions
will subject the user and discloser to civil and criminal penalties.
The
proposed rule says that encrypted and coded data is de-identified. However, to
avoid risk of civil and criminal penalties, entities with health information are
likely to only share that information with medical researchers if they meet the
rule's two-part test that determines if the health information can be presumed
to be de- identified.
The first part of the test lists 18 specific
identifiers. If any are present, the information cannot be presumed to be
de-identified. However, removing all of the elements on the list of asserted
identifiers would result in medical history data of questionable completeness*,
raising serious doubts about the validity of conclusions drawn from any research
using a de-identified database. For example, one listed identifier is birth
date. There would be serious questions about the validity of most studies that
failed to specify the age of the subjects.
In addition, the last item in
the list of identifiers would require removal of "(a)ny other unique
identifying.., characteristic ... that the (discloser of information) has reason
to believe may be available to an anticipated recipient of the information." For
biotechnology companies, the disease or condition under investigation often
afflicts a limited population of individuals. Therefore, the disease under
investigation arguably could be considered a "unique identifying characteristic"
available to the researcher, who (as a clinical expert in the disease) may
otherwise be able to identify the patients afflicted with the disease. Thus,
information from patients with rare diseases or conditions might never be
presumed to be de-identified.
The second prong of the proposed rule's
de-identification test requires that the entity providing the information to the
researcher have "no reason to believe that any anticipated recipient of such
information could use the information, alone or in combination with other
information, to identify an individual." This creates an extremely high
standard, and the proposed regulation provides no guidance regarding how to meet
the "reason to believe" standard, even though failure to meet the standard could
lead to civil and criminal penalties.
Thus, BIO believes that the
proposed rule's provisions governing de- identified data are too restrictive.
When combined with civil and criminal penalty provisions, the proposed rule
creates a strong disincentive to use this type of data, thereby depriving
biomedical researchers access to critical information. The proposed role should
be changed to create a more reasonable set of identifiers that may be used to
meet a test of presumptively de-identified data.
The proposed rule
creates burdensome restrictions on the disclosure and use of protected
information not subject to the Common Rule.
Under current law, FDA
regulations and the "Common Rule" protect patients who participate in clinical
trials. This includes safeguards such as oversight by Institutional Review
Boards (IRBs), informed consent requirements, and other protections.
Some medical research, however, falls outside the Common Rule. Examples
include medical record review and certain "pre-clinical" research.
The
proposed rule, in effect, extends the Common Rule to all research. Not only does
this go beyond the Secretary's authority under HIPAA, but it will also impose
excessive restrictions or layers of bureaucracy on this research.
Instead of the language in the proposed rule, BIO supports the structure
developed in the FristKennedy provisions contained in the Chairman's mark.
Conclusion
As the Congress reviews and debates issues relating
to the privacy of personal health information, our industry urges you to
remember that the public has a strong interest in the medical achievements of
biotechnology. The biotechnology industry is on the cusp of developing promising
new drugs and treatments for people with serious diseases.
While it is
critical to protect patients' confidentiality rights, imposing too many
restrictions on access to important data will slow research efforts. Congress
must facilitate the positive uses of medical information to continue the
breakthrough scientific achievements into the next century.
I appreciate
the opportunity to testify and look forward to working with you in this
endeavor.
END
LOAD-DATE: April 27, 2000
