Background

According to the Institute of Medicine, the federal government has a  central role in shaping nearly all aspects of the health care industry  as a regulator, purchaser, health care provider, and sponsor of  research, education, and training. According to HHS, federal  agencies fund more than a third of the nation’s total health care  costs. Given the level of the federal government’s participation in  providing health care, it has been urged to take a leadership role in  driving change to improve the quality and effectiveness of medical  care in the United States, including expanded adoption of IT.
In April 2004, President Bush called for the widespread adoption of  interoperable electronic health records within 10 years and issued  an executive order that established the position of the National  Coordinator for Health Information Technology within HHS as the  government official responsible for the development and execution  of a strategic plan to guide the nationwide implementation of  interoperable health IT in both the public and private sectors. In  July 2004, HHS released The Decade of Health Information  Technology: Delivering Consumer-centric and Information-rich  Health Care—Framework for Strategic Action. This framework  described goals for achieving nationwide interoperability of health  IT and actions to be taken by both the public and private sectors in  implementing a strategy. HHS’s Office of the National Coordinator  for Health IT updated the framework’s goals in June 2006 and  included an objective for protecting consumer privacy. It identified  two specific strategies for meeting this objective—(1) support the  development and implementation of appropriate privacy and  security policies, practices, and standards for electronic health  information exchange and (2) develop and support policies to  protect against discrimination based on personal health information  such as denial of medical insurance or employment.
In July 2004, we testified on the benefits that effective  implementation of IT can bring to the health care industry and the  need for HHS to provide continued leadership, clear direction, and  mechanisms to monitor progress in order to bring about measurable  improvements. Since then, we have reported or testified on several  occasions on HHS’s efforts to define its national strategy for health  IT. We have recommended that HHS develop the detailed plans and  milestones needed to ensure that its goals are met and HHS agreed  with our recommendation and has taken some steps to define more  detailed plans. In our report and testimonies, we have described a  number of actions that HHS, through the Office of the National  Coordinator for Health IT, has taken toward accelerating the use of  IT to transform the health care industry, including the development  of its framework for strategic action. We have also described the  Office of the National Coordinator’s continuing efforts to work with  other federal agencies to revise and refine the goals and strategies  identified in its initial framework. The current draft framework— The Office of the National Coordinator: Goals, Objectives, and  Strategies—identifies objectives for accomplishing each of four  goals, along with 32 high-level strategies for meeting the objectives,  including the two strategies for protecting consumer privacy.

		Health Insurance Portability and Accountability Act of 1996

Federal health care reform initiatives of the early- to mid-1990s were  inspired in part by public concern about the privacy of personal  medical information as the use of health IT increased. Congress,  recognizing that benefits and efficiencies could be gained by the use  of information technology in health care, also recognized the need  for comprehensive federal medical privacy protections and  consequently passed the Health Insurance Portability and  Accountability Act of 1996 (HIPAA). This law provided for the  Secretary of HHS to establish the first broadly applicable federal  privacy and security protections designed to protect individual  health care information.
HIPAA required the Secretary of HHS to promulgate regulatory  standards to protect certain personal health information held by  covered entities, which are certain health plans, health care  providers, and health care clearinghouses. It also required the  Secretary of HHS to adopt security standards for covered entities  that maintain or transmit health information to maintain reasonable  and appropriate safeguards. The law requires that covered entities  take certain measures to ensure the confidentiality and integrity of  the information and to protect it against reasonably anticipated  unauthorized use or disclosure and threats or hazards to its security.
HIPAA provides authority to the Secretary to enforce these  standards. The Secretary has delegated administration and  enforcement of privacy standards to the department’s Office for  Civil Rights and enforcement of the security standards to the  department’s Centers for Medicare and Medicaid Services.
Most states have statutes that in varying degrees protect the privacy  of personal health information. HIPAA recognizes this and  specifically provides that its implementing regulations do not  preempt contrary provisions of state law if the state laws impose  more stringent requirements, standards, or specifications than the  federal privacy rule. In this way, the law and its implementing rules  establish a baseline of mandatory minimum privacy protections and  define basic principles for protecting personal health information.
The Secretary of HHS first issued HIPAA’s Privacy Rule in  December 2000, following public notice and comment, but later  modified the rule in August 2002. Subsequent to the issuance of the  Privacy Rule, the Secretary issued the Security Rule in February  2003 to safeguard electronic protected health information and help  ensure that covered entities have proper security controls in place  to provide assurance that the information is protected from  unwarranted or unintentional disclosure.
The Privacy Rule reflects basic privacy principles for ensuring the  protection of personal health information. Table 1 summarizes these  principles.

	HHS Has Initiated Actions to Identify Solutions for Protecting Personal Health Information but Has Not Defined an Overall Approach for Addressing Privacy

HHS and its Office of the National Coordinator for Health IT have  initiated actions to identify solutions for protecting health  information. Specifically, HHS awarded several health IT contracts  that include requirements for developing solutions that comply with  federal privacy and security requirements, consulted with the  National Committee on Vital and Health Statistics (NCVHS) to  develop recommendations regarding privacy and confidentiality in  the Nationwide Health Information Network, and formed the  American Health Information Community (AHIC) Confidentiality,  Privacy, and Security Workgroup to frame privacy and security  policy issues and identify viable options or processes to address  these issues. The Office of the National Coordinator for Health IT  intends to use the results of these activities to identify technology  and policy solutions for protecting personal health information as  part of its continuing efforts to complete a national strategy to guide  the nationwide implementation of health IT. However, HHS is in the  early stages of identifying solutions for protecting personal health  information and has not yet defined an overall approach for  integrating its various privacy-related initiatives and for addressing  key privacy principles.

		HHS’s Contracts Are to Address Privacy and Security Policy and Standards for Nationwide Health Information Exchange

HHS awarded four major health IT contracts in 2005 intended to  advance the nationwide exchange of health information—Privacy  and Security Solutions for Interoperable Health Information  Exchange, Standards Harmonization Process for Health IT,  Nationwide Health Information Network Prototypes, and  Compliance Certification Process for Health IT. These contracts  include requirements for developing solutions that comply with  federal privacy requirements. The contract for privacy and security  solutions is intended to specifically address privacy and security  policies and practices that affect nationwide health information  exchange.
HHS’s contract for privacy and security solutions is intended to  provide a nationwide synthesis of information to inform privacy and  security policymaking at federal, state, and local levels and the  Nationwide Health Information Network prototype solutions for  supporting health information exchange across the nation. In  summer 2006, the privacy and security solutions contractor selected  34 states and territories as locations in which to perform  assessments of organization-level privacy- and security-related  policies and practices that affect interoperable electronic health  information exchange and their bases, including laws and  regulations. The contractor is supporting the states and territories  as they (1) assess variations in organization-level business policies  and state laws that affect health information exchange, (2) identify  and propose solutions while preserving the privacy and security  requirements of applicable federal and state laws, and (3) develop  detailed plans to implement solutions.
The privacy and security solutions contractor is to develop a  nationwide report that synthesizes and summarizes the variations  identified, the proposed solutions, and the steps that states and  territories are taking to implement their solutions. It is also to  deliver an interim report to address policies and practices followed  in nine domains of interest: (1) user and entity authentication, (2)  authorization and access controls, (3) patient and provider  identification to match identities, (4) information transmission  security or exchange protocols (encryption, etc.), (5) information  protections to prevent improper modification of records, (6)  information audits that record and monitor the activity of health  information systems, (7) administrative or physical security  safeguards required to implement a comprehensive security  platform for health IT, (8) state law restrictions about information  types and classes and the solutions by which electronic personal  health information can be viewed and exchanged, and (9)  information use and disclosure policies that arise as health care  entities share clinical health information electronically. These  domains of interest address the use and disclosure and security  privacy principles.

		The National Committee on Vital and Health Statistics Made Recommendations for Addressing Privacy and Security within a Nationwide Health Information Network

In June 2006, NCVHS, a key national health information advisory  committee, presented to the Secretary of HHS a report  recommending actions regarding privacy and confidentiality in the  Nationwide Health Information Network. The recommendations  cover topics that are, according to the committee, central to  challenges for protecting health information privacy in a national  health information exchange environment. The recommendations  address aspects of key privacy principles including (1) the role of  individuals in making decisions about the use of their personal  health information, (2) policies for controlling disclosures across a  nationwide health information network, (3) regulatory issues such  as jurisdiction and enforcement, (4) use of information by non- health care entities, and (5) establishing and maintaining the public  trust that is needed to ensure the success of a nationwide health  information network. The recommendations are being evaluated by  the AHIC work groups, the Certification Commission for Health IT,  the Health Information Technology Standards Panel, and other HHS  partners.
In October 2006, the committee recommended that HIPAA privacy  protections be extended beyond the current definition of covered  entities to include other entities that handle personal health  information. It also called on HHS to create policies and procedures  to accurately match patients with their health records and to require  functionality that allows patient or physician privacy preferences to  follow records regardless of location. The committee intends to  continue to update and refine its recommendations as the  architecture and requirements of the network advance.

		The American Health Information Community’s Confidentiality, Privacy, and Security Workgroup Is to Develop Recommendations to Establish a Privacy Policy Framework

AHIC, a commission that provides input and recommendations to  HHS on nationwide health IT, formed the Confidentiality, Privacy,  and Security Workgroup in July 2006 to frame privacy and security  policy issues and to solicit broad public input to identify viable  options or processes to address these issues. The  recommendations to be developed by this work group are intended  to establish an initial policy framework and address issues including  methods of patient identification, methods of authentication,  mechanisms to ensure data integrity, methods for controlling access  to personal health information, policies for breaches of personal  health information confidentiality, guidelines and processes to  determine appropriate secondary uses of data, and a scope of work  for a long-term independent advisory body on privacy and security  policies.
The work group has defined two initial work areas—identity  proofing and user authentication—as initial steps necessary to  protect confidentiality and security. These two work areas address  the security principle. Last month, the work group presented  recommendations on performing patient identity proofing to AHIC.  The work group intends to address other key privacy principles,  including, but not limited to maintaining data integrity and control  of access. It plans to address policies for breaches of confidentiality  and guidelines and processes for determining appropriate secondary  uses of health information, an aspect of the use and disclosure  privacy principle.

		HHS’s Collective Initiatives Are Intended to Address Aspects of Key Privacy Principles, but an Overall Approach for Addressing Privacy Has Not Been Defined

HHS has taken steps intended to address aspects of key privacy  principles through its contracts and with advice and  recommendations from its two key health IT advisory committees.  For example, the privacy and security solutions contract is intended  to address all the key privacy principles in HIPAA. Additionally, the  uses and disclosures principle is to be further addressed through the  advisory committees’ recommendations and guidance. The security  principle is to be addressed through the definition of functional  requirements for a nationwide health information network, the  definition of security criteria for certifying electronic health record  products, the identification of information exchange standards, and  recommendations from the advisory committees regarding, among  other things, methods to establish and confirm a person’s identity.  The committees have also made recommendations for addressing  authorization for uses and disclosure of health information and  intend to develop guidelines for determining appropriate secondary  uses of data.
HHS has made some progress toward protecting personal health  information through its various privacy-related initiatives. For  example, during the past 2 years, HHS has defined initial criteria and  procedures for certifying electronic health records, resulting in the  certification of 35 IT vendor products. In January 2007, HHS  contractors presented 4 initial prototypes of a Nationwide Health  Information Network (NHIN). However, the other contracts have  not yet produced final results. For example, the privacy and security  solutions contractor has not yet reported its assessment of state and  organizational policy variations. This report is due on March 31,  2007. Additionally, HHS has not accepted or agreed to implement  the recommendations made in June 2006 by the NCVHS, and the  AHIC Privacy, Security, and Confidentiality Workgroup is in the very  early stages of efforts that are intended to result in privacy policies  for nationwide health information exchange.
HHS is in the early phases of identifying solutions for safeguarding  personal health information exchanged through a nationwide health  information network and has not yet defined an approach for  integrating its various efforts or for fully addressing key privacy  principles. For example, milestones for integrating the results of its  various privacy-related initiatives and resolving differences and  inconsistencies have not been defined, and it has not been  determined which entity participating in HHS’s privacy-related  activities is responsible for integrating these various initiatives and  the extent to which their results will address key privacy principles.  Until HHS defines an integration approach and milestones for  completing these steps, its overall approach for ensuring the privacy  and protection of personal health information exchanged  throughout a nationwide network will remain unclear.

	The Health Care Industry Faces Challenges in Protecting Electronic Health Information

The increased use of information technology to exchange electronic  health information introduces challenges to protecting individuals’  personal health information. In our report, we identify and  summarize key challenges described by health information  exchange organizations: understanding and resolving legal and  policy issues, particularly those resulting from varying state laws  and policies; ensuring appropriate disclosures of the minimum  amount of health information needed; ensuring individuals’ rights to  request access to and amendments of health information to ensure it  is correct; and implementing adequate security measures for  protecting health information. Table 2 summarizes these challenges.
Understanding and Resolving Legal and Policy Issues  Health information exchange organizations bring together multiple  and diverse health care providers, including physicians, pharmacies,  hospitals, and clinics that may be subject to varying legal and policy  requirements for protecting health information. As health  information exchange expands across state lines, organizations are  challenged with understanding and resolving data-sharing issues  introduced by varying state privacy laws. HHS recognized that  sharing health information among entities in states with varying  laws introduces challenges and intends to identify variations in state  laws that affect privacy and security practices through the privacy  and security solutions contract that it awarded in 2005.
Several organizations described issues associated with ensuring  appropriate disclosure, such as determining the minimum data  necessary that can be disclosed in order for requesters to  accomplish the intended purposes for the use of the health  information. For example, dieticians and health claims processors  do not need access to complete health records, whereas treating  physicians generally do. Organizations also described issues with  obtaining individuals’ authorization and consent for uses and  disclosures of personal health information and difficulties with  determining the best way to allow individuals to participate in and  consent to electronic health information exchange. In June 2006,  NCVHS recommended to the Secretary of HHS that the department  monitor the development of different approaches and continue an  open, transparent, and public process to evaluate whether a national  policy on this issue would be appropriate.
Ensuring Individuals’ Rights to Request Access and  Amendments to Health Information to Ensure It Is Correct  As the exchange of personal health information expands to include  multiple providers and as individuals’ health records include  increasing amounts of information from many sources, keeping  track of the origin of specific data and ensuring that incorrect  information is corrected and removed from future health  information exchange could become increasingly difficult.  Additionally, as health information is amended, HIPAA rules require  that covered entities make reasonable efforts to notify certain  providers and other persons that previously received the individuals’  information. The challenges associated with meeting this  requirement are expected to become more prevalent as the numbers  of organizations exchanging health information increases.
Implementing Adequate Security Measures for Protecting  Health Information  Adequate implementation of security measures is another challenge  that health information exchange providers must overcome to  ensure that health information is adequately protected as health  information exchange expands. For example, user authentication  will become more difficult when multiple organizations that employ  different techniques exchange information. The AHIC  Confidentiality, Privacy, and Security Workgroup recognized this  difficulty and identified user authentication as one of its initial work  areas for protecting confidentiality and security.

	Implementation of GAO Recommendations Should Help Ensure that HHS’S Goal to Protect Personal Health Information is Met

To increase the likelihood that HHS will meet its strategic goal to  protect personal health information, we recommend in our report  that the Secretary of Health and Human Services define and  implement an overall approach for protecting health information as  part of the strategic plan called for by the President. This approach  should:   1.  Identify milestones and the entity responsible for integrating the  outcomes of its privacy-related initiatives, including the results  of its four health IT contracts and recommendations from the  NCVHS and AHIC advisory committees.  2.  Ensure that key privacy principles in HIPAA are fully addressed.   3.  Address key challenges associated with legal and policy issues,  disclosure of personal health information, individuals’ rights to  request access and amendments to health information, and  security measures for protecting health information within a  nationwide exchange of health information.
In commenting on a draft of our report, HHS disagreed with our  recommendation and referred to “the department’s comprehensive  and integrated approach for ensuring the privacy and security of  health information within nationwide health information exchange.”  However, an overall approach for integrating the department’s  various privacy-related initiatives has not been fully defined and  implemented. While progress has been made initiating these efforts,  much work remains before they are completed and the outcomes of  the various efforts are integrated. HHS specifically disagreed with  the need to identify milestones and stated that tightly scripted  milestones would impede HHS’s processes and preclude  stakeholder dialogue on the direction of important policy matters.  We disagree and believe that milestones are important for setting  targets for implementation and for informing stakeholders of HHS’s  plans and goals for protecting personal health information as part of  its efforts to achieve nationwide implementation of health IT.
HHS did not comment on the need to identify an entity responsible  for the integration of the department’s privacy-related initiatives,  nor did it provide information regarding an effort to assign  responsibility for this important activity. HHS neither agreed nor  disagreed that its approach should address privacy principles and  challenges, but stated that the department plans to continue to work  toward addressing privacy principles in HIPAA and that our report  appropriately highlights efforts to address challenges encountered  during electronic health information exchange. HHS stated that the  department is committed to ensuring that health information is  protected as part of its efforts to achieve nationwide health  information exchange.
In written comments, the Secretary of Veterans Affairs concurred  with our findings, conclusions, and recommendation to the  Secretary of HHS and commended our efforts to highlight methods  for ensuring the privacy of electronic health information. The  Department of Defense chose not to comment on a draft of the  report.
In summary, concerns about the protection of personal health  information exchanged electronically within a nationwide health  information network have increased as the use of health IT and the  exchange of electronic health information have also increased. HHS  and its Office of the National Coordinator for Health IT have  initiated activities that, collectively, are intended to protect health  information and address aspects of key privacy principles. While  progress continues to be made through the various initiatives, it  becomes increasingly important that HHS define a comprehensive  approach and milestones for integrating its efforts, resolve  differences and inconsistencies among them, fully address key  privacy principles, ensure that recommendations from its advisory  committees are effectively implemented, and sequence the  implementation of key activities appropriately.
HHS’s current initiatives are intended to address many of the  challenges that organizations face as the exchange of electronic  health information expands. However, without a clearly defined  approach that establishes milestones for integrating efforts and fully  addresses key privacy principles and the related challenges, it is  likely that HHS’s goal to safeguard personal health information as  part of its national strategy for health IT will not be met.
Mr. Chairman, Senator Voinovich, and members of the  subcommittee, this concludes our statement. We will be happy to  answer any questions that you or members of the subcommittee  may have at this time.

	Contacts and Acknowledgments

If you have any questions on matters discussed in this testimony,  please contact Linda Koontz at (202) 512-6240 or David Powner at  (202) 512-9286, or by e-mail at koontzl@gao.gov or  pownerd@gao.gov. Other key contributors to this testimony include  Mirko J. Dolak, Amanda C. Gill, Nancy E. Glover, M. Saad Khan,  David F. Plocher, Charles F. Roney, Sylvia L. Shanks, Sushmita L.  Srikanth, Teresa F. Tucker, and Morgan F. Walts.

Summary:
Why GAO Did This Study

In April 2004, President Bush called for the Department of Health and Human Services (HHS) to develop and implement a strategic plan to guide the nationwide implementation of health IT. The plan is to recommend methods to ensure the privacy of electronic health information. GAO was asked to summarize its report that is being released today. The report describes the steps HHS is taking to ensure privacy protection as part of its national health IT strategy and identifies challenges associated with protecting electronic health information exchanged within a nationwide health information network.

What GAO Found

HHS and its Office of the National Coordinator for Health IT have initiated actions to identify solutions for protecting personal health information through several contracts and with two health information advisory committees. For example, in late 2005, HHS awarded several health IT contracts that include requirements for addressing the privacy of personal health information exchanged within a nationwide health information exchange network. Its privacy and security solutions contractor is to assess the organization-level privacy- and security-related policies, practices, laws, and regulations that affect interoperable health information exchange. Additionally, in June 2006, the National Committee on Vital and Health Statistics made recommendations to the Secretary of HHS on protecting the privacy of personal health information within a nationwide health information network and in August 2006, the American Health Information Community convened a work group to address privacy and security policy issues for nationwide health information exchange. While these activities are intended to address aspects of key principles for protecting the privacy of health information, HHS is in the early stages of its efforts and has therefore not yet defined an overall approach for integrating its various privacy-related initiatives and addressing key privacy principles, nor has it defined milestones for integrating the results of these activities. GAO identified key challenges associated with protecting electronic personal health information in four areas.