Medical Records Privacy: Access Needed for Health Research, but Oversight of Privacy Protections Is Limited

Published by the Government Accountability Office on 1999-02-24.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                 United States General Accounting Office

GAO              Report to Congressional Requesters

February 1999
                 MEDICAL RECORDS
                 Access Needed for
                 Health Research, but
                 Oversight of Privacy
                 Protections Is Limited

      United States
GAO   General Accounting Office
      Washington, D.C. 20548

      Health, Education, and
      Human Services Division


      February 24, 1999

      The Honorable James M. Jeffords
      Chairman, Committee on Health, Education,
        Labor, and Pensions
      United States Senate

      The Honorable Christopher J. Dodd
      Ranking Minority Member
      Subcommittee on Children and Families
      Committee on Health, Education,
        Labor and Pensions
      United States Senate

      Historically, patient medical records were used largely by physicians and
      medical insurers. However, with the creation of electronic records and
      large databases of medical information, the number of health care
      professionals and organizations with access to medical records has
      increased. While such availability allows for research that can improve the
      understanding of diseases and treatments across broad populations, the
      number of parties with routine access to personally identifiable medical
      data has raised concern about the potential misuse of these data and the
      adequacy of the current system of protections.

      Under the current Federal Policy for the Protection of Human Subjects,
      adopted in 1991 and known as the Common Rule, research conducted by
      organizations, such as academic medical centers and pharmaceutical
      companies, that is supported or regulated by any of 17 federal agencies is
      subject to certain federal oversight requirements.1 In accordance with the
      Common Rule, organizations have established local institutional review
      boards (IRB), made up of both scientists and nonscientists, to review
      whether researchers minimize the risks to research subjects and obtain
      their informed consent. When appropriate, IRBs are also supposed to
      consider whether the research projects under their review will protect the
      privacy of subjects and inform them of the extent to which their data will
      be kept confidential. In addition, pharmaceutical companies and other

       Department of Health and Human Services (HHS) regulations—codified at title 45, Part 46, Subpart A
      of the Code of Federal Regulations—apply to research involving human subjects that is conducted,
      supported, or regulated by HHS. In addition, the following agencies have adopted regulations
      incorporating the substance of the HHS regulations: Departments of Agriculture, Commerce, Defense,
      Education, Energy, Housing and Urban Development, Justice, Transportation, and Veterans Affairs;
      the Agency for International Development; the Central Intelligence Agency; the Consumer Product
      Safety Commission; the Environmental Protection Agency; the National Aeronautics and Space
      Administration; the National Science Foundation; and the Social Security Administration.

      Page 1                                                GAO/HEHS-99-55 Medical Records Privacy

manufacturers of certain medical products must also meet Food and Drug
Administration (FDA) regulations, which closely resemble the Common
Rule, for research they conduct in connection with their FDA-regulated
products.2 Organizations conducting research that is not federally
supported or regulated can use IRBs if they choose but are generally not
required to do so.

The Health Insurance Portability and Accountability Act (HIPAA) of 1996
(P.L. 104-191) called for protections for the privacy of medical
information. Pursuant to HIPAA, the Secretary recommended standards
with respect to the privacy of personally identifiable information in
September 1997. If federal legislation is not enacted by August 1999, the
Secretary of HHS must promulgate regulations setting privacy standards
within 6 months. Bills related to medical records privacy introduced in the
105th and 106th Congresses have provisions to address uses of medical
information for a variety of purposes, including research.3 The various bills
attempt to provide for the conduct of medical research while also offering
privacy protections, and some of them call for extending the current
requirements of the Common Rule, including the use of IRBs, to research
that is not federally supported or regulated. No legislation has been

However, little is known about the types of health research conducted
outside the Common Rule and FDA regulations and what safeguards may
already be used for such research. Therefore, you asked us to (1) examine
how medical information is used for research and the need for personally
identifiable information, (2) identify research that is and is not subject to
current federal oversight requirements, (3) examine how IRBs ensure the
confidentiality of health information used in research, and (4) identify the
safeguards health care organizations have put in place to protect the
confidentiality of health information used in research.

To conduct our work, we reviewed health research and privacy literature
and interviewed experts in these fields and officials from various health
industry associations. We also reviewed HHS documents and met with
officials from HHS and, from within the Department, FDA, and the National

 FDA regulations are codified at title 21, Parts 50 and 56 of the Code of Federal Regulations.
 Bills introduced in the 105th and 106th Congresses to set up standards for the privacy of medical
records include S. 2609, 105th Cong. (1998) (introduced by Sen. Bennett); S. 1921, 105th Cong.
(1998) (introduced by Sen. Jeffords); S. 1368, 105th Cong. (1997) (introduced by Sen. Leahy); H.R.
1815, 105th Cong. (1997) (introduced by Rep. McDermott); H.R. 52, 105th Cong. (1997) (introduced by
Rep. Condit); S. 300, 106th Cong. (1999) (introduced by Sen. Lott); and S. 326, 106th Cong.
(1999) (introduced by Sen. Jeffords).

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                   Institutes of Health (NIH). We also interviewed representatives from seven
                   IRBs and officials from two state departments of health. Five of these IRBs
                   were at institutions that conduct research for the federal government, and
                   two are freestanding IRBs that are hired for their services. In addition, we
                   reviewed documents and interviewed officials from 12 organizations that
                   conduct health research not subject to the Common Rule or FDA
                   regulations, including managed care, pharmacy benefit management,
                   pharmaceutical, biotechnology, and health information organizations and
                   integrated health systems. For the most part, organizations provided
                   documentation of their policies on confidentiality and information
                   safeguards; however, we did not assess the implementation of these
                   policies. Given the limited number of organizations in our review, their
                   research and safeguard practices and the practices of the IRBs should not
                   be considered representative of those organizations on the whole. We
                   conducted our work between July 1998 and February 1999 in accordance
                   with generally accepted government auditing standards. A detailed
                   description of our scope and methodology is provided in appendix I.

                   Medical information is used for a number of research purposes—to
Results in Brief   advance biomedical science, understand health care utilization, evaluate
                   and improve health care practices, and determine causes and patterns of
                   disease. While such research is sometimes conducted without information
                   tied to identifiable patient records, other research relies on personal
                   identifiers to track treatment of an individual over time, link multiple
                   sources of patient information, or verify such information.

                   Some of the research conducted by the organizations we contacted must
                   conform to the Common Rule or FDA regulations because the research is
                   either federally supported or regulated. But many of these same
                   organizations voluntarily apply federal rules, including IRB review, to all
                   their research, regardless of source of funding. Other organizations choose
                   not to apply the Common Rule and IRB review where not required. For
                   example, research conducted by pharmacy benefit management
                   companies, which conduct studies for other companies, is not federally
                   supported or regulated and is, therefore, outside the Common Rule, and
                   they do not use IRB review.

                   In any case, IRB review does not ensure the confidentiality of medical
                   information used in research because the provisions of the Common Rule
                   related to confidentiality have limitations. Records-based research is often
                   subject to an expedited review process—under which only one board

                   Page 3                                    GAO/HEHS-99-55 Medical Records Privacy

             member, rather than the full IRB, considers the research proposal. In
             addition, IRBs can waive informed consent requirements, including the
             requirement to inform people of the extent to which their data will be kept
             confidential, if they judge that research subjects are not likely to be
             harmed and that the research could not be carried out without the
             waiver—as in cases where there are too many subjects to inform. The IRBs
             we contacted rely on the existence of general organizational
             confidentiality policies for protecting personal information. While the
             extent to which IRB practices protect the privacy of research subjects is
             not fully known, several examples of breaches of confidentiality reported
             to NIH’s Office for Protection From Research Risks (OPRR), the oversight
             agency for HHS-supported research, illustrate the potential for harm
             resulting when medical information used in research is not adequately

             Although external review of their research is limited, the organizations
             that we contacted reported they have taken steps to limit access to
             personally identifiable information. Most of the organizations have various
             security safeguards to limit internal and external access to paper and
             electronic databases, and many have taken measures to ensure the
             anonymity of research and survey subjects. In addition, all but two of the
             organizations that we contacted have written confidentiality policies
             restricting employee use and access to health information.

             Numerous organizations collect, store, transmit, and use individuals’
Background   medical information, which includes data, documents, records, and
             pathological and diagnostic specimens. These individuals may have little
             or no knowledge of the organizations’ accessing their personal health data.
             For example, records of patient care—whether through a hospital, private
             physician, or managed care setting—may be used for health research. The
             establishment of large computer databases—some with millions of patient
             records—has not only allowed for such research but has increased the
             potential for misuse of private medical information, raising concern over
             issues related to privacy and confidentiality.4 While IRB reviews may help
             protect the privacy of subjects and maintain the confidentiality of data

              Privacy refers to the specific right of an individual to control the collection, use, and disclosure of
             personal information. Confidentiality is a tool for protecting privacy. Confidentiality is implemented
             through specific controls on personal data, limiting access and disclosure. The privacy provisions of
             the Common Rule apply to research on human subjects when the researcher obtains information that
             is individually identifiable. The Common Rule defines a human subject as a living individual about
             whom a researcher obtains (1) data through intervention or interaction with the individual or
             (2) identifiable private information. Information is individually identifiable when the identity of the
             subject is or may be readily ascertained by the researcher or associated with the information.

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used for research, privacy advocates and others argue that any use or
disclosure of an individual’s medical information should require the
individual’s informed consent. They view this as important because the
failure to adequately safeguard sensitive medical information can affect
employment or the ability to receive insurance or lead to other harmful

The federal system of protections was developed largely in response to
biomedical and behavioral research that caused harm to human subjects.
In 1991, many federal agencies standardized their oversight of research
involving human subjects with the adoption of the Common Rule. Each
institution engaged in research subject to the Common Rule must assure
the agency supporting or regulating the research that it follows basic
ethical principles underlying the acceptable conduct of research involving
human subjects. Currently, 17 federal departments and agencies adhere to
the Common Rule.

To protect the rights and welfare of human subjects recruited to
participate in research, the Common Rule requires research organizations
to establish and operate IRBs, which are, in turn, responsible for
implementing federal requirements for research conducted at or
supported by their institutions. IRBs are intended to provide basic
protections for people enrolled in federally supported or regulated
research. Among these are an independent review of the risks and benefits
of the research. Another protection is informed consent, which requires
researchers to inform potential subjects of the risks to which they, as
study participants, agree to be exposed. In addition, IRBs have to make
sure that, when appropriate, there are adequate provisions in the research
plans to protect the privacy of subjects and maintain the confidentiality of

Most of the estimated 3,000 to 5,000 IRBs in the United States are
associated with a hospital, university, or other research institution;
however, IRBs also exist in managed care organizations (MCO), government
agencies, and as independent entities employed by the organizations
conducting the research. Federal requirements specify that IRBs must have
at least five members, including one with primarily scientific interests, one
with primarily nonscientific interests, and one otherwise unaffiliated with
the institution in which the IRB resides. Each of the 17 federal Common
Rule agencies has independent responsibility for oversight of IRBs
reviewing the research that it supports. However, two HHS agencies—NIH
and FDA—exercise the broadest IRB oversight responsibilities. OPRR, located

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within NIH, is responsible for monitoring protection of human subjects
within all HHS-supported biomedical and behavioral research. FDA is
responsible for protecting the rights of human subjects enrolled in
research involving products it regulates—drugs, medical devices,
biologics, foods, and cosmetics. If research supported by HHS also involves
a product regulated by FDA, both agencies have oversight responsibilities.

Pursuant to HIPAA, the Secretary of HHS submitted to the Congress in
September 1997 recommendations on privacy standards that may guide
legislation for protecting individually identifiable information and to
establish penalties for wrongful disclosure of such information. The
Secretary recommended that health care providers and payers be
permitted to disclose identifiable patient information, without consent, for
research under controlled conditions—including approval by an IRB under
conditions essentially the same as the present Common Rule—and that
further disclosure be sharply restricted. The Secretary’s recommendations
would also require researchers who obtain information from providers to
establish and maintain appropriate safeguards for protecting the
confidentiality and security of personally identifiable health information.

Legislative proposals governing medical records privacy under
consideration in the 105th Congress contained provisions resembling the
Secretary’s recommendation. The bills differed, however, in how protected
health information was defined and the extent to which reviews by IRBs or
other entities would be required for research using personally identifiable
health information. If legislation on privacy standards is not enacted by
August 1999, HIPAA provides that the HHS Secretary must promulgate final
regulations containing standards for confidentiality by February 2000.

In the absence of comprehensive federal legislation, the federal
government and some states have enacted laws to protect the privacy of
certain medical information. For example, personal information about
subjects of drug abuse research can be protected under the Federal
Controlled Substances Act. California law permits disclosure of
identifiable health information for research purposes without the patient’s
consent but expressly prohibits any disclosure by the researcher of
information that permits identification of the patient. Minnesota’s law
allows access to medical record information for research unless patients
deny their consent, which must be requested.

Page 6                                   GAO/HEHS-99-55 Medical Records Privacy

                          The organizations that we contacted primarily conduct health research to
Personally Identifiable   advance biomedical science, understand health care use, evaluate and
Health Information Is     improve health care practices, and determine causes and patterns of
Needed for a Variety      disease. Within biomedical research, several of the organizations conduct
                          clinical trials to develop new medical products and devices. All of the
of Research Purposes      organizations conduct studies to improve health care practices, such as
                          studies focusing on the most appropriate care for patients with chronic
                          diseases. In addition, nearly all of the organizations conduct
                          epidemiological research—research on the causes and distribution of

                          Organizations that provide and pay for care, such as MCOs, generate
                          original medical data, which they can then use for their research. Other
                          organizations—such as those that provide health information services
                          ranging from software development to targeted health research—rely on
                          data from health care providers and payers, some of which contain
                          personal identifiers. Some of these organizations’ studies are carried out
                          without personally identifiable health information, but other research
                          requires that, at some point, individual identifiers be known.

Patient Data to Conduct   The organizations we contacted use health-related information on
Research Come From        hundreds of thousands, and in some cases millions, of individuals in
Various Sources           conducting their research. There are primarily three sources of data that
                          organizations rely on. Some organizations use data that they generate in
                          providing health care services, and some rely on data acquired from
                          others; some organizations also use data generated as part of their

                          The MCOs and integrated health systems5 that we contacted primarily rely
                          on data that are self-generated—through either service delivery or
                          research. They use medical record data, which are generated in the course
                          of treating patients, to conduct epidemiological research and health
                          services research, such as outcomes and quality improvement studies.6
                          One MCO cited over 40 outcomes studies it conducted on prevention,
                          disease management, and issues related to the structure of the health care
                          delivery system. Another MCO, in conducting a quality improvement study,

                           Integrated health systems are systems of care that can include hospitals, academic medical centers,
                          and primary care physicians and specialists.
                           Health services research examines the use, costs, quality, accessibility, delivery, organization,
                          financing, and outcomes of health care services to increase the knowledge and understanding of health
                          services for individuals and populations. It includes outcomes research on the benefits and harms of
                          alternative strategies for preventing, diagnosing, or treating illness.

                          Page 7                                                  GAO/HEHS-99-55 Medical Records Privacy

used its claims database, along with published treatment guidelines, to
determine whether patients with vascular disease were receiving
appropriate medications. The MCO then provided each patient’s treating
physician a report based on this analysis to encourage them to review the
case; verify the accuracy of the data; and determine whether, in the
physician’s judgment, any actions were appropriate, such as arranging
return visits for these patients and amending their drug regimens.

The pharmaceutical and biotechnology companies that we contacted rely
on data from each of the three sources. To support their applications for
new drugs and medical devices, they sponsor clinical trials conducted at
MCOs and academic medical centers. These companies also conduct health
services and epidemiological research; but unlike MCOs and integrated
health systems, they rely on data from other organizations for this type of
research. For example, one pharmaceutical company’s epidemiology
department conducts large-scale studies to monitor the effectiveness of
treatments in clinical practice and studies to track the effects of drugs on
certain populations. These studies rely on data the company obtains from
MCOs and health information organizations.

Pharmacy benefit management (PBM) firms, which administer prescription
drug benefits for health insurance plans, typically generate their own data
and obtain data from other organizations. For the PBMs we contacted, a
primary source of data is prescription information derived from
prescriptions dispensed by mail or claims received from retail pharmacies.
The PBMs also use data from other organizations, such as MCOs, to design
and evaluate programs that are intended to improve the quality of care for
patients who have specific diseases or risk factors while controlling total
health care costs. For example, one PBM develops disease management
programs, which depend on the ability to identify individuals with
conditions, such as diabetes, that require more intensive treatment

The health information organizations that we contacted rely solely on data
from other organizations. Typically, they collect medical claims data from
their clients or obtain it from publicly available sources, such as Medicare
and Medicaid.7 They may also acquire data through employer contracts
that stipulate that all of the employers’ plans provide complete data to a
health information organization. Examples of research projects include

 Clients of health information organizations may include health care providers, health plans and plan
administrators, employers, and government health programs.

Page 8                                                  GAO/HEHS-99-55 Medical Records Privacy

                           studies of the effects of low birth weight on costs of medical care and the
                           effectiveness of alternative drug therapies for schizophrenia.

Personally Identifiable    Officials at the organizations we contacted believe that a number of
Information Is Essential   studies require personally identifiable information to ensure study validity
for Some Research          or to simply answer the study question. For example, to validate initial
                           selection of individuals meeting diagnostic and other criteria as research
                           subjects, researchers may need to review individual patient records. In the
                           case of a research project involving registry data, researchers first
                           determine the feasibility of a study by identifying the likely number of
                           patients meeting certain criteria.8 They then review patient records to
                           obtain more specific information and to validate the study cohort.

                           Officials at the organizations we contacted also indicated that their
                           researchers may need to contact patients or review medical records to
                           validate the quality of data used in their research studies. To prevent error,
                           researchers at one MCO use identifiable data to check for duplicate records
                           or redundant cases. If some item in the analysis appears to show an
                           unusual result for an individual, the researchers may need to check the
                           original file to determine if the information was miscoded. Officials at
                           another MCO described a project that required verifying existing claims
                           data on prenatal visits to evaluate whether women had received prenatal
                           care in the first trimester of pregnancy. To verify the data, researchers
                           telephoned patients to obtain information and subsequently conducted a
                           medical records review. Both the self-reported data and the medical
                           records review showed much higher rates of early prenatal care than the
                           claims data had indicated.

                           Researchers may also need to link multiple sources of information, such as
                           electronic databases and patient records, to compile sufficient data to
                           answer the research question. For example, officials at one health
                           information organization we contacted stated that without patient names
                           or assigned patient codes, it would not have been possible to complete a
                           number of studies—including studies of the effects of length-of-hospital
                           stay on maternal and child health following delivery and studies on patient
                           care costs of cancer clinical trials. For longitudinal studies, researchers
                           may need to track patients’ care over time and link events that occur

                            Registries are databases that collect information on the experience of populations or special groups
                           over time and can be used by researchers to investigate disease characteristics, the impact of various
                           treatments, and to answer other research questions. For example, a registry maintained by one
                           company might pool physician-contributed patient data on individuals with a particular disease to
                           learn about the disease’s natural history, its expected course, and patient response to treatment.

                           Page 9                                                  GAO/HEHS-99-55 Medical Records Privacy

                       during the course of treatment with their outcomes. For example, officials
                       at an MCO we contacted used identifiable patient data to link asthma
                       patients’ records over time to determine if specialist care for the disease
                       improved patient outcomes and lowered costs.

                       Health care organizations acknowledge that some types of their research
                       can be accomplished without access to information that is fully
                       identifiable. For example, according to officials at one pharmaceutical
                       company we contacted, the company conducts epidemiological research
                       to understand the kinds of patients that are likely to develop a disease, the
                       effectiveness of existing treatments, the types and rates of complications,
                       and the costs and medical care associated with the disease. They said that
                       much of their research is based on data on unidentified individuals that
                       come from federally sponsored surveys or databases, such as survey data
                       from the National Center for Health Statistics or Medicare data from the
                       Health Care Financing Administration.

                       Some of the research conducted by the organizations we contacted must
Federal Requirements   conform to the Common Rule or FDA regulations because the research is
Do Not Apply to All    either supported or regulated by the federal government. Several MCOs that
Research, but Some     we contacted obtain grants from the Centers for Disease Control and
                       Prevention and other federal agencies, and one health information
Organizations          organization that we contacted conducts research for the Agency for
Voluntarily Apply      Health Care Policy and Research and similar federal clients. Some of the
                       organizations that we contacted, including the integrated health systems
Those Requirements     and several MCOs, operate IRBs to comply with federal requirements.
to All Studies
                       While privately funded research that is not in support of a regulated
                       product is not subject to federal requirements, some organizations that
                       conduct both federally supported or regulated research and privately
                       funded research apply the requirements uniformly to all studies involving
                       human subjects, regardless of the source of funding. Organizations
                       conducting a large number of HHS-supported studies may enter into a
                       multiple project assurance (MPA) that commits them to comply with
                       federal regulations on all their research projects involving human subjects,
                       not just those funded by HHS. Even without an MPA, some organizations
                       have adopted internal policies requiring that all studies that meet their
                       definition of research follow Common Rule requirements. As a result,
                       application of the Common Rule to various types of health services
                       research can vary within and across organizations.

                       Page 10                                   GAO/HEHS-99-55 Medical Records Privacy

Universities and other major research centers that conduct a substantial
number of HHS-supported studies and have demonstrated a willingness and
the expertise to comply with human subject protections often apply for
MPAs with HHS, which are approved by OPRR. Through an MPA, an
organization commits itself to full compliance with informed consent and
other federal standards. In addition, an institution with an MPA does not
need to apply to OPRR for eligibility to receive HHS funds for each new study
approved by its IRB. Two of the organizations we visited—both integrated
health systems—have MPAs.

Some organizations that do not have an MPA still adopt a policy requiring
IRB review of all projects. Two of the MCOs we contacted voluntarily
subjected their research to scrutiny by an IRB. At one, the IRB administrator
told us that the MCO’s IRB gives non-federally funded research the same
scrutiny as federally funded research. The IRB at the other MCO, which was
established when the MCO’s research center was created, follows federal
guidelines for the protection of study participants and reviews all studies
conducted by the center.

Other organizations that we contacted that carry out both publicly funded
and privately funded research do not commit to an MPA. Rather, they apply
the federal rules where required, often relying on IRB review at
collaborators’ institutions, and do not apply the rules to their privately
funded research. For example, one MCO that we contacted has a separate
research unit that carries out a variety of health studies—some initiated by
the MCO, some funded by other private sources, and some federally funded
in collaboration with universities or other research institutions. Since the
MCO does not maintain its own IRB, it relies on IRB reviews at collaborators’
institutions. Still other organizations, such as pharmaceutical and
biotechnology companies, rely on the academic medical centers where
they sponsor research to have in place procedures for informed consent
and IRB review.9

However, even where organizations submit both publicly funded and
privately funded research to an IRB, certain activities that involve
identifiable medical information may not be included because the
organization does not define the project as research. For example, at
several MCOs, officials told us that they did not define records-based quality
improvement activities as research, so these projects are not submitted for

 Pharmaceutical and biotechnology companies that conduct clinical research in-house for
FDA-regulated products are required to have IRB review and informed consent procedures for that

Page 11                                               GAO/HEHS-99-55 Medical Records Privacy

                           IRBreview. Some organizations, however, do submit quality improvement
                           studies for IRB review, where they define the studies as research.

                           Finally, at some organizations, none of the research is covered by the
                           Common Rule or FDA regulations and no research receives IRB review. For
                           example, one PBM in our study, which conducts research for other
                           companies, does not receive federal support and, thus, is not subject to the
                           Common Rule in any of its research. Their research includes developing
                           disease management programs. While they do not have an IRB, this PBM
                           uses external advisory boards to review research proposals. Another type
                           of research that for some companies does not fall under the Common Rule
                           or FDA regulations is research that uses disease or population-related
                           registry data. Pharmaceutical and biotechnology companies maintain such
                           registries to monitor how a particular population responds to drugs and to
                           better understand certain diseases.

                           While many organizations have in place IRB review procedures, recent
IRB Reviews Provide        studies that pointed to weaknesses in the IRB system, as well as the
Limited Oversight of       provisions of the Common Rule itself, suggest that IRB reviews do not
Confidentiality            ensure the confidentiality of medical information used in research. The IRB
                           officials we spoke with told us that, for some research, they waive consent
                           provisions and conduct expedited reviews, as permitted by the Common
                           Rule. Most IRBs that we contacted told us that they rely on the existence of
                           general organizational confidentiality policies to protect information.
                           While the extent to which IRB practices protect the privacy of research
                           subjects is not fully known, several examples of confidentiality breaches
                           reported to OPRR illustrate the harm resulting when medical information
                           used in research is not adequately protected.

Earlier Studies Revealed   In recent years, concern has been raised about the adequacy of the IRB
Weaknesses in the IRB      system for overseeing the protection of human subjects. While not
System                     focusing specifically on confidentiality, previous studies by GAO and by
                           HHS’ Office of Inspector General have found multiple factors that weaken
                           institutional and federal human subjects protection efforts.10 In 1996, we
                           found that IRBs faced a number of pressures that made oversight of
                           research difficult, including the heavy workloads of and competing

                            Scientific Research: Continued Vigilance Critical to Protecting Human Subjects (GAO/HEHS-96-72,
                           Mar. 8, 1996) and HHS Office of Inspector General, “Institutional Review Boards: A Time for Reform,”
                           OEI-01-97-00193 (June 1998). With the HHS report, there are three companion reports, entitled “IRBs:
                           Their Role in Reviewing Approved Research,” “IRBs: Promising Approaches,” and “IRBs: The
                           Emergence of Independent Boards.”

                           Page 12                                                GAO/HEHS-99-55 Medical Records Privacy

                             professional demands on members who are not paid for their IRB services.
                             We also concluded that the effectiveness of human subjects protections
                             can be weakened by the complexity and volume of research under review
                             and the difficulty of ensuring that individuals understand the risks they
                             may experience as research subjects.

                             Similarly, a 1998 HHS Office of Inspector General report found IRBs unable
                             to cope with major changes in the research environment, concluding that
                             they review too many studies too quickly and with too little expertise. HHS’
                             Inspector General also concluded that IRBs conduct only minimal oversight
                             of approved studies, face conflicts of interest that threaten their
                             independence, and provide little training for investigators and board
                             members. The Inspector General noted that neither IRBs nor HHS staff
                             devote much attention to evaluating IRB effectiveness and made
                             recommendations for changes to improve the flexibility, accountability,
                             training, and resources of IRBs.

Federal Regulations          The Common Rule, which was developed largely to protect the rights and
Contain Limited Provisions   safety of human subjects, contains two general provisions to protect the
for Overseeing               privacy of human subjects and the confidentiality of data that identify
                             research subjects.11 Specifically, IRBs are directed to approve research only
Confidentiality              after they have determined that (1) there are provisions to protect the
                             privacy of subjects and maintain the confidentiality of data, when
                             appropriate, and (2) as one of the elements of informed consent, research
                             subjects are adequately informed of the extent to which their data will be
                             kept confidential. According to the Director of OPRR, confidentiality
                             protections are not a major thrust of the Common Rule and IRBs tend to
                             give it less attention than other research risks because they have the
                             flexibility to decide when it is appropriate to review confidentiality
                             protection issues.

                             In addition, the Common Rule assumes that the risks presented by some
                             research are sufficiently low that more limited types of review of privacy
                             protection will be adequate. According to the Common Rule, research with
                             medical information can be exempted from review by IRBs and from
                             requirements for prior informed consent when (1) the data are existing at
                             the time the research is proposed and (2) either the sources are publicly
                             available or information is recorded by the investigator in such a manner
                             that subjects cannot be identified—directly or through identifiers linked to

                               HHS or FDA may also award a Certificate of Confidentiality for a research project, which provides
                             immunity from compelled disclosure, such as subpoenas seeking the identities of subjects enrolled in
                             the study.

                             Page 13                                                GAO/HEHS-99-55 Medical Records Privacy

                           the subjects. Alternatively, research involving medical records that
                           presents no more than minimal risk of harm to subjects may be reviewed
                           by the IRB under expedited procedures, even when the data are personally
                           identifiable. Under expedited procedures, the review may be carried out
                           by the chairperson or a chair-appointed IRB member, rather than the full

                           Further, research using individually identifiable information may be
                           permitted by an IRB with a waiver or modification of informed consent if
                           the IRB finds and documents that each of the following criteria has been

                           (1) the research involves no more than minimal risk to subjects (that is, no
                           greater harm than ordinarily encountered in daily life);

                           (2) the rights and welfare of subjects will not be adversely affected;

                           (3) the research could not practicably be carried out without the waiver or
                           alteration of the consent requirement; and

                           (4) whenever appropriate, subjects will be provided with pertinent
                           information after participation.12

IRBs Follow Common Rule    Consistent with federal regulations, the seven IRBs that we contacted told
Criteria for Waiving       us that they generally waive informed consent requirements in cases
Consent Requirements and   involving medical records-based research. For research using individually
                           identifiable medical information that does not involve direct contact with
Providing Expedited        patients, IRBs often conduct an expedited review and usually do not
Reviews for Some           require researchers to obtain specific authorization from patients before
Research                   using their medical records for research.

                           Under the Common Rule, the IRB may waive consent requirements if the
                           research meets the four criteria above, including that it cannot practicably
                           be carried out without the waiver or alteration of the requirements. If the
                           IRB waives consent requirements, medical records may be available for
                           research without the knowledge or consent of the subjects, even when
                           they are individually identifiable. For some studies, especially
                           epidemiological studies, researchers need to review thousands of records
                           to identify appropriate subjects for their study. Researchers at the

                             Regulations governing clinical research conducted on FDA regulated products involving no greater
                           than minimal risk do not permit a waiver of consent.

                           Page 14                                                GAO/HEHS-99-55 Medical Records Privacy

organizations we visited contend that it is often difficult, if not impossible,
to obtain the permission of every subject whose medical records are
contained in the files. The director of research at one integrated health
system described a study that tracked about 30,000 patients over several
years to determine hospitalization rates for asthmatic patients treated with
inhaled steroids. He stated that it would have been impossible to obtain
the informed consent of every patient because treatment was provided
over a long period of time. Obtaining consent from the patients whose
records were used would have been time consuming and expensive, he
said, and some patients would have died or would no longer be members.

The Common Rule also permits IRBs to use expedited review
procedures—which involve review by only the chairperson or a
chair-appointed IRB member, rather than the full board—if the research
presents no more than minimal risk of harm to subjects, even when the
medical record data used in the research are personally identifiable. A
recent NIH-sponsored study found that 58 percent of IRBs affiliated with
major research institutions with multiple project assurances performed an
expedited review of research using individually identifiable information.13
The study concluded that the IRBs’ standard practice was to use expedited
procedures to review research that involves minimal risk.

The IRBs that we contacted told us that they routinely examine all research
plans using individually identifiable medical information to determine
whether the research is exempt from further review, can receive an
expedited review, or requires a full review. Further, in reviewing research
using individually identifiable genetic data, two of the IRBs had policies to
consider additional confidentiality provisions in approving such research.

Several IRBs that we interviewed have some special requirements to ensure
that researchers had adequate provisions to protect the confidentiality of
individually identifiable information. To obtain IRB approval of research
using individually identifiable medical information, three organizations
required their researchers to complete applications that included detailed
discussions of provisions to protect the privacy of subjects and to
maintain the confidentiality of data. The applications typically address
who will access research information and how confidentiality of records
will be maintained. In another study requiring analysis of personal data on
health plan members, the IRB required that everyone involved in
conducting the study sign strict confidentiality agreements.

 James Bell Associates, “Final Report: Evaluation of NIH Implementation of Section 491 of the Public
Health Service Act, Mandating a Program of Protection for Research Subjects,” prepared for NIH’s
Office of Extramural Research (June 1998).

Page 15                                                GAO/HEHS-99-55 Medical Records Privacy

IRBs Rely on                 The IRBs in our study told us that they rely on organizational policies to
Organizational Policies to   ensure the confidentiality of information used in projects using personally
Ensure Confidentiality       identifiable medical information. For example, the IRB chair and
                             administrator at one integrated health system told us that they rely on the
                             general expectation that all employees will safeguard information about
                             patient medical records. They viewed this as part of the culture of the
                             organization and saw it as a primary mechanism for protecting patient

                             Organizational policies to protect information may include restricting
                             access to personally identifiable information to authorized individuals. For
                             example, two integrated health systems we met with require that
                             researchers have an IRB project number, indicating approval to access
                             individually identifiable data. Organizations may also have data security
                             safeguards and policies for imposing sanctions for unauthorized access to
                             or dissemination of personally identifiable medical information.

Some Breaches of Privacy     The actual number of instances in which patient privacy is breached is not
Have Been Reported           fully known. While there are few documented cases of privacy breaches,
                             other reports provide evidence that such problems occur. For example, in
                             an NIH-sponsored study, IRB chairs reported that complaints about the lack
                             of privacy and confidentiality were among the most common complaints
                             made by research subjects. Over the past 8 years, OPRR’s compliance staff
                             have investigated several allegations involving human subject protection
                             violations resulting from a breach of confidentiality. In the 10 cases
                             provided to us, complaints related both to research subject to IRB review
                             and to research outside federal protection.14

                             In certain cases involving a breach in confidentiality, OPRR has authority,
                             for example, to restrict an institution’s authority to conduct research that
                             involves human subjects or to require corrective action. For example, in
                             one investigation, a university inadvertently released the names of multiple
                             study participants testing positive for HIV to parties outside the research
                             project, including a local television station. In this case, OPRR worked with
                             the university to evaluate the extent of the breach of confidentiality and
                             form a plan to discuss the events with study subjects. In response, the
                             university revised internal systems to prevent the release of private
                             information in the future.

                               Additional cases may have been reported to OPRR, but these were examples the staff could readily
                             identify that involved breaches of confidentiality.

                             Page 16                                                GAO/HEHS-99-55 Medical Records Privacy

                          However, in other cases, OPRR determined that it could not take action
                          because the research was not subject to the Common Rule and, thus, it
                          lacked jurisdiction. For example, in one reported case, OPRR learned that
                          during a research presentation at a national meeting, notes on a patient
                          suffering from extreme depression and suicidal impulses stemming from a
                          history of childhood sexual abuse were distributed. The notes included the
                          patient’s identity, medical history, mental status and diagnosis, as well as
                          extensive intimate details about the patient’s experience. In another case,
                          which was reported in the media, OPRR learned of an experiment that
                          plastic surgeons had performed on 21 patients using two different facelift
                          operations—one on each half of the face—to see which came out better.
                          OPRR staff learned that the study was not approved by an IRB and that the
                          physicians did not give the patients consent forms explaining in detail the
                          procedures and risks associated with the experiment. In addition, the
                          surgeons published a journal article describing their research that
                          included before and after photographs of the patients. Because the
                          research was performed in physician practices and was not federally
                          supported, it fell outside the Common Rule and OPRR could take no action.

                          Each organization that we contacted reported that it has taken one or
Organizations             more steps to limit access to personally identifiable information in its
Conducting Research       research. Many have limited the number of individuals who are afforded
Have Measures to          access to personally identifiable information or limited the span of time
                          they are given access to the information, or both. Some have used
Reduce Access to          encrypted or encoded identifiers to enhance the protection of research
Personally Identifiable   and survey subjects.15 Most, but not all, of the organizations have
                          additional management practices to protect medical information,
Information               including written policies governing confidentiality. Some organizations
                          have also instituted a number of technical measures and physical
                          safeguards to protect the confidentiality of information.

                          While each organization has taken one or more of these measures, not all
                          have written policies. Officials from two of the companies that we
                          contacted told us that they did not have written policies to share with us,
                          and two other companies were unable to provide us with such
                          documentation, although officials described several practices related to

                            Data are considered “encoded” or “encrypted” when personal identifiers and means of directly
                          contacting an individual (for example, name, address, and social security number) are replaced with
                          numeric or other coding. “Anonymized” data are those from which all personal identifiers have been
                          removed or information aggregated in a manner so that individuals cannot be identified. Medical and
                          health data used by organizations when they conduct health research is viewed as fully identifiable
                          when a name, address, or another identifier is associated with the data.

                          Page 17                                                GAO/HEHS-99-55 Medical Records Privacy

                             confidentiality. The organizations that did provide us with documentation
                             appear to use similar management practices and technical measures to
                             protect health information used in their health research, whether they
                             generate patient records or receive them from other organizations.
                             Officials at one integrated health system that we contacted told us that
                             they have an institutional policy on confidentiality of health information,
                             an institutional policy directing access to and security of medical records
                             information, and a human resources policy for maintaining the
                             confidentiality and privacy of personally identifiable patient data.

Special Databases and        To limit access, several organizations have created special subset
Encrypted Data Help          databases to enable them to limit researchers’ access to information that is
Organizations Limit Access   relevant to their studies. For example, researchers at one MCO conduct
                             studies using a special research database that links hospital, physician
to Patient Data              visit, and pharmacy claims data for each enrollee and includes information
                             on procedures, diagnoses, and costs of care. Typically, data—with each
                             patient’s identity encoded—are extracted from this database for analysis.
                             The researchers do not have routine access to the MCO’s larger, fully
                             identifiable claims database.

                             In addition to limiting access to certain individuals for specific purposes,
                             some organizations have encrypted or encoded patient information. For
                             example, researchers at one integrated health system that we contacted do
                             not see fully identifiable information. Rather, they work with information
                             that has been encoded by computer programmers on the research
                             team—the only individuals who have access to the fully identifiable data.
                             The pharmaceutical companies that we contacted also limit access to and
                             encode personally identifiable health information used in research. For
                             example, the clinical trials data that they receive typically do not include
                             the identities of the patients enrolled. Instead, the pharmaceutical
                             companies receive data files with identities encoded, and the identifiable
                             data are retained at the research site. Only designated company officials
                             can access the identifiable information during site visits and only for
                             purposes of monitoring the progress of a clinical trial.

                             In conducting collaborative research, the organizations that we contacted
                             tend to use special data sets and contracting processes to protect medical
                             information. For example, one MCO, which conducts over half of its
                             research with government agencies and academic and research
                             institutions, transfers data in either encrypted or anonymized form and
                             provides detailed specifications in its contracts that limit use of the data to

                             Page 18                                    GAO/HEHS-99-55 Medical Records Privacy

                           the specific research project. The contracts specify that collaborators are
                           not permitted to reidentify or transfer the data. Another MCO that we
                           contacted uses multiple measures to ensure confidentiality of its medical
                           data. In addition to requiring collaborators to follow the same
                           confidentiality requirements as the MCO, they can only access medical data
                           through an MCO researcher assigned to the project. Most of the data are
                           aggregated, but any patient-specific data that are provided are encrypted
                           and the coding methodology remains in-house. In addition, research data
                           provided on a computer disk and mailed are tracked to verify delivery.

                           At another MCO, the lead investigators annually review a list of the names
                           of the individuals who have access to each research project to ensure that
                           the list is current, which is acknowledged by the investigators’ signatures.
                           Similarly, one of the integrated health systems that we contacted requires
                           researchers from outside the organization to seek collaborative
                           relationships with internal researchers and obtain approval for an adjunct
                           appointment. The adjunct researchers would then become subject to the
                           organization’s policies and controls.

Management Practices       Most of the organizations we contacted have established confidentiality
Establish Parameters for   policies delineating who can have access to what information, and most
Protections                provide employee education and training programs on these policies. Most
                           also have established monitoring practices and sanctions for breaches of
                           confidentiality. Some organizations also used employee agreements and
                           their contract processes to ensure confidentiality.

                           Ten of the 12 organizations that we contacted had written confidentiality
                           policies that limit and control access to personally identifiable
                           information, although 2 of the 10 did not provide us with documentation of
                           their policies. The policies define the circumstances under which such
                           information may be disclosed and the penalties for unauthorized release of
                           confidential information. Most company policies permit access only to the
                           information that is needed to perform one’s job; some dictate that such
                           information should be shared with other employees only on a
                           need-to-know basis. Some organizations provide training to ensure
                           employees understand the confidentiality policy in effect. One MCO’s
                           training sessions teach employees to keep records in locked file cabinets,
                           shut down computers when not in use, and not share data with associates.
                           Eight of the 12 organizations that we contacted also require their
                           employees to sign agreements—typically upon hiring and annually

                           Page 19                                   GAO/HEHS-99-55 Medical Records Privacy

                          thereafter—stating that they will maintain the privacy of protected health

                          To ensure adherence to confidentiality policies, the organizations
                          reportedly have established various monitoring and disciplinary
                          mechanisms. One MCO told us it reviews a sample of all active research
                          projects and conducts reviews of research study files. In addition to
                          periodic reviews of local area network files, the MCO said it also conducts
                          quarterly inspections of its databases. The MCO’s parent organization
                          reportedly conducts internal audits to determine compliance with
                          approved protocols and reviews third-party vendor contracts and system
                          security controls. Each organization that we contacted said it uses
                          disciplinary sanctions to address employee violations of confidentiality or
                          failure to protect medical information from accidental or unauthorized
                          access. Generally, officials at organizations that we contacted said that an
                          intentional breach of confidentiality could result in employee
                          termination—which may be immediate. But they also pointed out that few
                          employees have been terminated, and when they have, the incidents were
                          not related to the conduct of research. According to officials at one health
                          information organization, the company’s overriding principle regarding
                          health information is that each employee is responsible for keeping patient
                          data confidential consistent with the organization’s policies and
                          prescribed practices.

Companies Report Use of   The organizations that we contacted said they use a number of electronic
Electronic and Physical   measures to safeguard their electronic health data. Most reported using
Safeguards                individual user authentications or personal passwords—controls that
                          ensure users access only the information that they need. These
                          organizations may also use encryption or coding technologies to mask
                          personally identifiable data and other technical information system
                          mechanisms, including firewalls, to prevent external access to computer
                          systems. Officials at one MCO we visited said that their computer system
                          maintains an electronic record of each employee that accesses medical
                          data. The MCO periodically reviews the records to determine if use was

                          In addition to electronic security, officials at some of the organizations we
                          contacted told us they use various security measures to prevent
                          unauthorized physical access to medical record-based information,
                          including computer workstations and servers. For example, officials at
                          one MCO told us that protections for paper records include storing the

                          Page 20                                   GAO/HEHS-99-55 Medical Records Privacy

                    information in locked offices and file cabinets and shredding paper-based
                    information when it is no longer needed.

                    Personally identifiable information is often an important component of
Conclusions         research using medical records, and the companies we met with provided
                    many examples of useful research that could not have been conducted
                    without it. Because our study focused on only a limited number of
                    companies—in particular, those that were willing to share information
                    about corporate practices—it is difficult to judge the extent to which their
                    policies may be typical, nor do we know the extent to which their policies
                    are followed. Nevertheless, most of the organizations we surveyed do have
                    policies to limit and control access to medical information that identifies
                    individuals, and many of them have adopted techniques, such as
                    encryption and encoding, to further safeguard individual privacy.

                    However, while reasonable safeguards may be in place in these
                    companies, external oversight of their research is limited. Not all research
                    is subject to outside review, and even in those cases where IRBs are
                    involved, they are not required to give substantial attention to privacy
                    protection. Further, in light of the problems that IRBs have had in meeting
                    current workloads—a key finding in our earlier work as well as in work
                    conducted by HHS’ Office of Inspector General—it is not clear that the
                    current IRB-based system could accommodate more extensive review
                    responsibilities. In weighing the desirability of additional oversight of
                    medical records-based research, it will be important to take account of
                    existing constraints on the IRB system and the recommendations that have
                    already been made for changes to that system.

                    We obtained technical comments from officials at several HHS agencies
Agency and Other    with significant research responsibilities—FDA, the Centers for Disease
Reviewer Comments   Control and Prevention, the Agency for Health Care Policy and Research,
                    and NIH, including its OPRR—and HHS’ Privacy Advocate. We also obtained
                    comments from two outside reviewers with expertise in medical research
                    and privacy issues. A number of the HHS program officials provided
                    additional or corrective information on the provisions of the Common
                    Rule and aspects of research, which we incorporated in the report. Our
                    other expert reviewers found the report to be, on the whole, helpful in the
                    current debate on privacy and research. One of these reviewers, however,
                    questioned our conclusion about how well the IRB system protects privacy,
                    arguing that the evidence pointed out that the system is working well. Our

                    Page 21                                   GAO/HEHS-99-55 Medical Records Privacy

second reviewer, on the other hand, agreed that the IRB system is already
heavily burdened. In response to their concerns and views, we made some
changes where we believed it was appropriate to do so, but we continue to
believe that the IRB system has limitations that need to be highlighted as
policymakers consider expanding its responsibilities.

We are sending copies of this report to the Secretary of HHS and other
interested parties. We will also make copies available to others upon
request. If you have any questions or would like additional information,
please call one of the major contributors listed in appendix II.

Sincerely yours,

Bernice Steinhardt
Director, Health Services Quality
  and Public Health Issues

Page 22                                  GAO/HEHS-99-55 Medical Records Privacy
Page 23   GAO/HEHS-99-55 Medical Records Privacy

Letter                                                                                             1

Appendix I                                                                                        26

Scope and
Appendix II                                                                                       28

Major Contributors to
This Report


                        FDA       Food and Drug Administration
                        HHS       Department of Health and Human Services
                        HIPAA     Health Insurance Portability and Accountability Act
                        IRB       institutional review board
                        MCO       managed care organization
                        MPA       multiple project assurance
                        NIH       National Institutes of Health
                        OPRR      Office for Protection From Research Risks
                        PBM       pharmacy benefit management

                        Page 24                                GAO/HEHS-99-55 Medical Records Privacy
Page 25   GAO/HEHS-99-55 Medical Records Privacy
Appendix I

Scope and Methodology

             To help us understand the nature of research that uses medical records
             and the types of oversight and safeguards that might be used, we identified
             and reviewed literature on the use of medical information in health
             research and met with individuals and representatives from associations
             and organizations knowledgeable about issues surrounding the use of
             medical information in health research. We also met with officials and
             reviewed documents from NIH, the Office for Protection From Research
             Risks, FDA, and the National Bioethics Advisory Commission. Additionally,
             we met with HHS’ Privacy Advocate. We also met with officials of two state
             departments of public health.

             For this work, we used the Common Rule’s definition of research: “a
             systematic investigation . . . designed to develop or contribute to
             generalizable knowledge.” After we determined that there is no inventory
             of health research conducted outside Common Rule requirements, with
             the exception of an informal categorical listing developed by OPRR, we
             focused our examination on health care organizations conducting research
             with extensive databases. We chose such organizations because of the
             potential risk to large numbers of individuals if medical information is not
             adequately safeguarded. Twelve organizations that conduct health
             research participated in our review, including managed care organizations,
             integrated health systems, pharmaceutical companies, health information
             organizations, pharmacy benefit management companies, and
             biotechnology companies.

             We also screened indemnity insurers, utilization review organizations, and
             similar organizations for possible participation in our review. Indemnity
             insurers told us that they do not carry out research on the fee-for-service
             portion of their business, noting the limitations of existing data on medical
             care received on a fee-for-service basis. They often do not know the
             identities of family members of subscribers. They also pointed out that
             claims are often filed under one policyholder number, and as a result, the
             care received by one individual cannot be separated from the care
             received by another for purposes of analysis. The utilization review
             organizations that we contacted stated that their activities only cover
             utilization patterns for specific individuals, which they do not classify as

             We interviewed representatives of the 12 organizations that participated
             and, to the extent available, reviewed their policies for safeguarding
             identifiable medical information. However, three organizations did not
             provide us with these policies. In addition, we did not verify the

             Page 26                                   GAO/HEHS-99-55 Medical Records Privacy
Appendix I
Scope and Methodology

information received from the nine other organizations. Although the
organizations identified their procedures to us, we did not assess the
implementation of those procedures. Because of the small number of
organizations included in our study, the information we collected is not
generalizable to the health care industry as a whole. Further, four
organizations we contacted were unwilling to participate in this study.

In addition, we obtained information from seven IRBs. Five of these IRBs
were at institutions that conduct research for the federal government, and
two are freestanding IRBs that are hired for their services. Again, because
of the small number of review boards in our study, the information we
collected from IRBs is not generalizable. We conducted our work between
July 1998 and February 1999 in accordance with generally accepted
government auditing standards.

Page 27                                  GAO/HEHS-99-55 Medical Records Privacy
Appendix II

Major Contributors to This Report

               Marcia Crosse, Assistant Director, (202) 512-3407
               Nancy Donovan, Evaluator-in-Charge, (202) 512-7136
               Donna Bulvin, Senior Evaluator
               Roy Hogberg, Senior Evaluator
               Gloria Taylor, Senior Evaluator
               Barry Bedrick, Associate General Counsel
               Dayna Shah, Assistant General Counsel
               Mary Reich, Senior Attorney
               Karen Sloan, Writer

(108378)       Page 28                               GAO/HEHS-99-55 Medical Records Privacy
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