Studies published by the Institute of Medicine and other organizations have indicated that fragmented, disorganized, and inaccessible clinical information adversely affects the quality of health care and compromises patient safety. In addition, long-standing problems with medical errors and inefficiencies increase costs for health care delivery in the United States. With health care spending in 2004 reaching almost $1.9 trillion, or 16 percent, of the gross domestic product, concerns about the costs of health care continue. As we reported last year, many policy makers, industry experts, and medical practitioners contend that the U.S. health care system is in a crisis. Health IT provides a promising solution to help improve patient safety and reduce inefficiencies. The expanded use of health IT has great potential to improve the quality of care, bolster the preparedness of our public health infrastructure, and save money on administrative costs. As we reported in 2003, technologies such as electronic health records and bar coding of certain human drug and biological product labels have been shown to save money and reduce medical errors. Health care organizations reported that IT contributed other benefits, such as shorter hospital stays, faster communication of test results, improved management of chronic diseases, and improved accuracy in capturing charges associated with diagnostic and procedure codes. Over the past several years, a growing number of communities have established health information exchange organizations that allow multiple health care providers, such as physicians, clinical laboratories, and emergency rooms to share patients’ electronic health information. Most of these organizations are in either the planning or early implementation phases of establishing electronic health information exchange. 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. Seven major federal health care programs, such as the Centers for Medicare and Medicaid Services (CMS), DOD’s TRICARE, VA’s Veterans Health Administration, and HHS’s Indian Health Service, provide or fund health care services to approximately 115 million Americans. 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. The programs and number of citizens who receive health care services from the federal government and the cost of these services are summarized in appendix II. 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 recommended that HHS develop the detailed plans and milestones needed to ensure that its goals are met, and HHS agreed with our recommendation. 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 the framework for strategic action. We described the formation of a public-private advisory body—the American Health Information Community—to advise HHS on achieving interoperability for health information exchange and four breakthrough areas the community identified—consumer empowerment, chronic care, biosurveillance, and electronic health records. Additionally, we reported that, in late 2005, HHS’s Office of the National Coordinator for Health IT awarded $42 million in contracts to address a range of issues important for developing a robust health IT infrastructure. In October 2006, HHS’s Office of the National Coordinator for Health IT awarded an additional contract to form a state-level electronic health alliance and address challenges to health information exchange, including privacy and security issues. HHS intends to use the results of the contracts and recommendations from the National Committee on Vital and Health Statistics and the American Health Information Community proceedings to define the future direction of a national strategy. The contracts are described in appendix III. 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. It includes a specific objective for safeguarding consumer privacy and protecting against risks along with two 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. According to officials with the Office of the National Coordinator, the framework will continue to evolve as the office works with other federal agencies to further refine its goals, objectives, and strategies, which are described in appendix IV. While HHS continues to refine the goals and strategies of its framework for a national health IT strategy, it has not yet defined the detailed plans and milestones needed to ensure that its goals are met, as we previously recommended. As the use of electronic health information exchange increases, so does the need to protect personal health information from inappropriate disclosure. The capacity of health information exchange organizations to store and manage a large amount of electronic health information increases the risk that a breach in security could expose the personal health information of numerous individuals. According to results of a study conducted for AARP in February 2006, Americans are concerned about the risks introduced by the use of electronic health information systems but also support the creation of a nationwide health information network. A 2005 Harris survey showed that 70 percent of Americans are concerned that an electronic medical record system could lead to sensitive medical information being exposed because of weak security, and 69 percent are concerned that such a system would lead to more personal health information being shared without patients’ knowledge. While information technology can provide the means to protect the privacy of electronically stored and exchanged health information, the increased risk of inappropriate access and disclosure raises the level of importance for adequate privacy protections and security mechanisms to be implemented in health information exchange systems. A number of federal statutes were enacted between 1970 and the early 1990s to protect individual privacy. For the most part, the inclusion of medical records in these laws was incidental to a more general purpose of protecting individual privacy in certain specified contexts. For example, the Privacy Act of 1974 was enacted to regulate the collection, maintenance, use, and dissemination of personal information by federal government agencies. It prohibits disclosure of records held by a federal agency or its contractors in a system of records without the consent or request of the individual to whom the information pertains unless the disclosure is permitted by the Privacy Act or its regulations. The Privacy Act specifically includes medical history in its definition of a record. Likewise, the Social Security Act requires the Secretary of HHS to protect beneficiaries’ records and information transmitted to or obtained by or from HHS or the Social Security Administration. Descriptions of these and other federal laws that protect health information are provided in appendix V. Federal health care reform initiatives of the early- to mid-1990s were, in part, inspired 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. 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 provides for the protection of certain health information held by covered entities, defined under regulations implementing HIPAA as health plans that provide or pay for the medical care of individuals, health care providers that electronically transmit health information in connection with any of the specific transactions regulated by the statute, and health care clearinghouses that receive health information from other entities and process or facilitate the processing of that information into standard or nonstandard format for those entities. HIPAA requires the Secretary of HHS to promulgate regulatory standards to protect the privacy of certain personal health information. “Health information” is defined by the statute as any information in any medium that is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse and relates to the past, present, or future physical or mental health condition of an individual, provision of health care of an individual, or payment for the provision of health care of an individual. HIPAA also requires 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. Finally, most, if not all, states have statutes that in varying degrees protect the privacy of personal health information. HIPAA recognizes this and specifically provides that regulations implementing HIPAA 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, HIPAA 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. The Privacy Rule governs the use and disclosure of protected health information, which is generally defined as individually identifiable health information that is held or transmitted in any form or medium by a covered entity. The Privacy Rule regulates covered entities’ use and disclosure of protected health information. In general, a covered entity may not use or disclose an individual’s protected health information without the individual’s authorization. However, uses and disclosures without an individual’s authorization are permitted in specified situations, such as for treatment, payment, and health care operations and public health purposes. In addition, the Privacy Rule requires that a covered entity make reasonable efforts to use, disclose, or request only the minimum necessary protected health information to accomplish the intended purpose, with certain exceptions such as for disclosures for treatment and uses and disclosures required by law. Most covered entities must provide notice of their privacy practices. Such notice is required to contain specific elements that are set out in the regulations. Those elements include (1) a description of the uses and disclosures of protected health information the covered entity may make; (2) a statement of the covered entity’s duty with regard to the information, including protecting the individual’s privacy; (3) the individual’s rights with respect to the information, including, for example, the right to complain to HHS if he or she believes the information has been handled in violation of the law; and (4) a contact from whom individuals may obtain further information about the covered entity’s privacy policies. A covered entity is also required to account for certain disclosures of an individual’s protected health information and to provide such an accounting to those individuals on request. In general, a covered entity must account for disclosures of protected health information made for purposes other than for treatment, payment, and health care operations, such as for public health or law enforcement purposes. HIPAA’s Privacy Rule reflects basic privacy principles for ensuring the protection of personal health information. Table 1 summarizes these principles. Subsequent to the issuance of the Privacy Rule, the Secretary issued the HIPAA 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 Security Rule includes administrative, physical, and technical safeguards and specific implementation instructions, some of which are required and, therefore, must be implemented by covered entities. Other implementation specifications are “addressable” and under certain conditions permit covered entities to use reasonable and appropriate alternative steps. Covered entities are required to develop policies and procedures for both required and addressable specifications. The privacy and security rules require covered entities to include provisions in contracts with business associates that mandate that business associates implement appropriate privacy and security protections. A business associate is any person or entity that performs on behalf of a covered entity any function or activity involving the use or disclosure of protected health information. The rules require covered entities to obtain through formal agreement satisfactory assurances that their business associates will appropriately safeguard protected health information. The Security Rule also contains specific requirements for business associate contracts and requires that covered entities maintain compliance policies and procedures in written form. However, covered entities are generally not liable for privacy violations of their business associates, and the Secretary of HHS does not have direct enforcement authority over business associates. 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 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 and identify techniques and standards for securing health information. 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. In summer 2006, the privacy and security solutions contractor selected 33 states and Puerto Rico 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 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 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 privacy principles for use and disclosure and security. The standards harmonization contract is intended to identify, among other things, security mechanisms that affect consumers’ ability to establish and manage permissions and access rights, along with consent for authorized and secure exchange, viewing, and querying of their medical information between designated caregivers and other health professionals. In May 2006, the contractor for HHS’s standards harmonization contract selected initial standards that are intended to provide security mechanisms. The initial security standards were made available for stakeholder and public comment in August and September, and the contractor’s panel voted on final standards that were presented to AHIC in October 2006. AHIC accepted the panel’s report and forwarded it to the Secretary for approval. HHS’s Nationwide Health Information Network contract requires four selected contractors to develop proposals for a nationwide health information architecture and prototypes of a nationwide health information network. The prototypes are to address privacy and security solutions, such as user authentication and access control, for interoperable health information exchange. In June 2006, HHS held its first nationwide health information network forum, at which more than 1,000 functional requirements were proposed, including nearly 180 security requirements for ensuring the privacy and confidentiality of health information exchanged within a nationwide network. The proposed functional requirements were analyzed and refined by NCVHS, and on October 30, 2006, the committee approved a draft of minimum functional requirements for the Nationwide Health Information Network, and sent it to HHS for approval. In January 2007, the four contractors are to deliver and demonstrate functional prototypes that are deployed within and across three or more health care markets and operated with live health care data using the same technology for information exchange in all three markets. HHS’s Compliance Certification Process for Health IT contract is intended to identify certification criteria for electronic health records, including security criteria. In May 2006, the Certification Commission for Health IT, which was awarded the contract, finalized initial certification criteria for ambulatory electronic health records including 32 security criteria that address components of the security principle, such as controls for limiting access to personal health information, methods for authenticating users before granting access to information, and requirements for auditing access to patients’ health records. To date, 35 electronic health records products have been certified based on these criteria. The commission is currently defining its next phase of certification criteria for inpatient electronic health records. 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, Health Information Technology Standards Panel, and other HHS partners. In October 2006, the committee recommended to the Secretary of HHS that HIPAA privacy rules be extended to include other forms of health information not managed by covered entities. 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. AHIC, a committee that provides input and recommendations to HHS on nationwide health IT, formed the Confidentiality, Privacy, and Security Workgroup in July 2006 to frame the privacy and security policy issues relevant to all breakthrough areas 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 privacy principle. According to the cochairs of the work group, the members are developing work plans for completing tasks, including the definition of privacy and security policies for all of AHIC’s breakthrough areas. The work group intends to address other key 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 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. Table 2 describes HHS’s current privacy-related initiatives and the key HIPAA privacy principles that they are intended to address. HHS has taken steps to identify solutions for 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. 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. 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 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 therefore 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, nor has it 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 increased use of information technology to exchange electronic health information introduces challenges to protecting individuals’ personal health information. Key challenges are 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 3 summarizes these challenges. 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. Differing interpretations and applications of the privacy protection requirements of HIPAA and other privacy laws further complicate the ability of health information organizations to exchange data and to determine liability and enforce sanctions in cases of breach of confidentiality. Differing legal requirements for protecting health information introduce challenges to the ability to share health information among multiple stakeholders that may not be covered to the same extent by HIPAA’s privacy and security rules. Providers that are members of health information organizations are typically covered by the privacy and security requirements of HIPAA, but the information exchange organizations that provide the technology and infrastructure to conduct information exchange generally are not covered entities. Rather, they are usually thought of as business associates that are contractually bound through agreements with covered entities to provide protections to the health information that they manage but are not directly covered by the HIPAA privacy and security rules. An official with one health information exchange organization stated that he found it hard to determine if his organization was a covered entity or a business associate. In some cases, according to an official with a health information privacy professional association, health information exchange organizations may not even be business associates as defined by HIPAA. The differences between or uncertainty regarding the extent of federal privacy protection required of various organizations may affect providers’ willingness to exchange patients’ health information if they do not believe it will be protected to the same extent they protect it themselves. In June 2006, NCVHS recommended that, if necessary, HHS amend the HIPAA Privacy Rule to increase the responsibility of covered entities to control the practices of business associates. The need to reconcile differences in varying state laws’ privacy protection requirements introduces another widely acknowledged challenge to ensuring the privacy protection of health information exchanged on a nationwide basis. As health information exchange officials in states with strong privacy protections consider exchanging health information with organizations in other states, they will need to determine the extent to which they could share health information with organizations in states that have less stringent or no state-level laws and policies. For example, an official with one health information exchange organization described its state’s privacy laws as being much more stringent than federal requirements, while a health information exchange official in another state told us that HIPAA’s privacy requirements are the only laws that apply to the information exchanged by its organization. In this case, according to the official with the first organization, it would share more health information with providers in its own state than it would with providers in the other state because the other state’s less stringent privacy protection laws would not provide a sufficient level of protection. 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. Organizations also described another challenge associated with understanding and resolving legal and policy requirements for protecting electronic health information exchanged among multiple and diverse organizations. Differing interpretations and applications of the HIPAA privacy and security rules by providers and health information exchange organizations can result in disagreement about the data that can be exchanged and with whom the data can be shared. An official with one health information exchange described differing applications of HIPAA’s security requirements that affect the way systems are administered and hinder the exchange of health information. For example, to protect individuals’ information from inappropriate disclosure, the organization requires that the systems’ list of users be forwarded to managers so that they can review roles and access rights at least annually. HIPAA’s requirements do not specify protections at this level of granularity, so other organizations may not require this level of activity. This can create disagreements between organizations about the data that can be exchanged and with whom data can be shared if one organization does not administer access rights as strictly as another. Health information exchange organizations described difficulties with determining liability and enforcing sanctions in cases of confidentiality breaches. As the number of health information exchange organizations increases and information is shared on a widespread basis, determination of liability for improper disclosure of information will become more important but also more difficult. For example, the Markle Foundation described problems with tracing the source of a privacy violation and determining the responsible entity. Without such information, it becomes very difficult, if not impossible, to enforce sanctions for violations and breaches of confidentiality. 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. According to VA officials, the agency’s ability to ensure appropriate disclosure is further complicated by the fact that the Veterans’ Benefits Act prevents disclosure of certain information, such as information related to HIV infection, sickle cell anemia, and substance abuse, which must be removed from individuals’ health records before the requested information is disclosed. Additionally, VA’s current manual process for determining the legal authority for disclosures and the minimum amount of information authorized to be disclosed is difficult to automate because of the complexity of various privacy laws and regulations. Organizations also described issues with obtaining individuals’ authorization and consent for uses and disclosures of personal health information. For example, health information exchange organizations may provide individuals with the ability to either opt in or opt out of electronic health information exchange. The opt-in approach requires that health care providers obtain the explicit permission of individuals before allowing their information to be shared with other providers. Without this permission, an individual’s personal health information would not be accessible. The opt- out approach presumes that an individual’s personal health information is available to authorized persons, but any individual may elect to not participate. Another approach taken by health information organizations simply notifies individuals that their information will be exchanged with providers throughout the organization’s network. Several organizations described difficulties with determining the best way to allow individuals to participate in and consent to electronic health information exchange. While the opt-in approach increases individual autonomy, it is more administratively burdensome than the opt-out approach and may result in fewer individuals participating in health information exchange. The opt-out approach is easier, less costly, and may result in greater participation in health information exchange, but does not provide the autonomy that the opt-in approach does. The notification approach is the simplest to administer but provides individuals no choice regarding participation in the organization’s data exchange. In June 2006, NCVHS recommended to the Secretary of HHS that the department monitor the development of opt-in and opt-out approaches; consider local, regional, and provider variations of consent options; collect evidence on the health, economic, social, and other implications of opt-in and opt-out approaches; and continue an open, transparent, and public process to evaluate whether a national policy on opting in or opting out is appropriate. Organizations also described the need to effectively educate consumers so that they understand the extent to which their consent or authorization to use and disclose health information applies. For example, one organization stated that a request made to limit use and disclosure at one facility in a network may not apply to other facilities within the same network, but consumers may assume the limitations do apply to all facilities and not take steps to limit disclosure in those other facilities. 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. Several organizations described challenges with ensuring that individuals have access to and the ability to amend their own health information and with ensuring that amendments are made and tracked throughout their information exchange organizations. Officials with HHS’s Indian Health Service described a challenge with ensuring that individuals’ amendments to their own health information are properly made and tracked. Additionally, as individuals amend their health information, HIPAA requires that covered entities make reasonable efforts to notify or alert and send the corrected information to certain providers and other persons that previously received the individuals’ information. Meeting this requirement was described as a challenge by officials with VA, and it is expected to become more prevalent as the numbers of organizations exchanging health information increases. Officials with DOD described difficulties with ensuring that individuals’ amendments to health information are distributed across multiple facilities within its network of medical facilities. The department is addressing this problem through the implementation of electronic health records and information management tools that track requests for amendments and their status. Additionally, an official with a professional association described the need to educate consumers to ensure that they understand their rights to request access to and amendments of their own health information to ensure that it is correct. Organizations described the adequate implementation of security measures as another challenge that must be overcome to protect health information. For example, health information exchange organizations described difficulties with determining and implementing adequate techniques for authenticating requesters of health information, such as the use of passwords and security tokens. User authentication will become more difficult as health information exchange expands across multiple organizations that employ different techniques. 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. Implementing proper access controls, particularly role-based access controls, was also cited as a challenge to determining the information to which requesters may have access. Several organizations stated that maintaining adequate audit trails for monitoring access to health information is difficult but is necessary to ensure that information is adequately protected. Organizations described problems introduced by the need to protect health information stored on portable devices and data transmitted between business partners. The use of laptops and other portable media by health information exchange employees presents a challenge to organizations since the data stored on these media should be encrypted to be secure. The VA is also faced with limitations related to the need to encrypt electronic health information shared with its business partners. According to VA officials, the agency and its business partners’ solutions must be compatible in order to share the encrypted data, and VA’s deployment of encryption solutions is limited. Encryption of data can be challenging, as organizations often must implement hardware and complex software technology to achieve adequate protection. As the use of health IT and the exchange of electronic health information increases, concerns about the protection of personal health information exchanged electronically within a nationwide health information network have also increased. HHS and its Office of the National Coordinator for Health IT have initiated activities that, collectively, are intended to address aspects of key privacy principles. While progress has been made through the various initiatives, HHS has not yet defined an approach and milestones for integrating its efforts, resolving differences and inconsistencies between them, and fully addressing key privacy principles. As the use of health IT and electronic information exchange networks expands, health information exchange organizations are faced with challenges to ensuring the protection of health information, including understanding and resolving legal and policy issues, ensuring that the minimum information necessary is disclosed only to those entities authorized to request the information, ensuring individuals’ rights to request access and amendments to health information, and implementing adequate security measures. These challenges are expected to become more prevalent as more information is exchanged and as electronic health information exchange expands to a nationwide basis. HHS’s current initiatives are intended to address many of these challenges. However, without a clearly defined approach that establishes milestones for integrating its efforts and fully addresses key privacy principles and these 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. We recommend 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; and (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. We received written comments on a draft of this report from HHS’s Assistant Secretary for Legislation. The Assistant Secretary disagreed with our recommendation. Throughout the comments, the Assistant Secretary 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. We acknowledge in our report that HHS has established a strategic objective to protect consumer privacy along with 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 from health information. Our report also acknowledges the key efforts that HHS has initiated to address this objective, and HHS’s comments describe these and additional state and federal efforts. HHS stated that the department has made significant progress in integrating these efforts. While progress has been made initiating these efforts, much work remains before they are completed and the outcomes of the various efforts are integrated. Thus, we recommended that HHS define and implement a comprehensive privacy approach that includes milestones for integration, identifies the entity responsible for integrating the outcomes of its privacy-related initiatives, addresses key privacy principles, and ensures that challenges are addressed in order to meet the department’s objective to protect the privacy of health information exchanged within a nationwide health information network. 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 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. Milestones are especially important considering the need for HHS to integrate and coordinate the many deliverables of its numerous ongoing and remaining activities. We agree that it is important for HHS to continue to actively involve both public and private sector health care stakeholders in its processes. 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 any 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. HHS also disagreed with our conclusion that without a clearly defined privacy approach, it is likely that HHS’s objective to protect personal health information will not be met. We believe that an overall approach is needed to integrate the various efforts, provide assurance that HHS’s initiatives continue to address key privacy principles (as we illustrate in table 2 of the report), and to ensure that key challenges faced by health information exchange stakeholders are effectively addressed. HHS also provided technical comments that we have incorporated into the report as appropriate. HHS’s written comments are reproduced in appendix VI. In written comments, the Secretary of VA 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. VA also provided technical comments that we have incorporated into the report as appropriate. VA’s written comments are reproduced in appendix VII. DOD chose not to comment on a draft of this report. As agreed with your offices, unless you publicly announce its contents earlier, we plan no further distribution of this report until 30 days from the date on the report. At that time, we will send copies of the report to other Chairmen and Ranking Minority Members of other Senate and House committees and subcommittees that have authorization and oversight responsibilities for health information technology. We will also send copies of the report to the Secretaries of Defense, Health and Human Services, and Veterans Affairs. Copies of this report will also be made available at no charge on our Web site at www.gao.gov. If you have any questions on matters discussed in this report, please contact me at (202) 512-6240 or David Powner at (202) 512-9286, or by e- mail at koontzl@gao.gov or pownerd@gao.gov. Contact points for our offices of Congressional Relations and Public Affairs may be found on the last page of this report. Other contacts and key contributors to this report are listed in appendix VIII. The objectives of our review were to describe the steps the Department of Health and Human Services (HHS) is taking to ensure privacy protection as part of the national health information technology (IT) strategy and identify challenges associated with meeting requirements for protecting personal health information within a nationwide health information network. To address our first objective, we analyzed information that we collected from agency documentation and through discussions with officials with HHS components and advisory committees that play major roles in supporting HHS’s efforts to develop and implement a national strategy for health IT, including activities intended to ensure the protection of electronic health information exchanged within a nationwide health information network. Specifically, we reviewed and assessed privacy- related plans and documentation describing HHS’s efforts to ensure privacy protection from HHS’s Office of the National Coordinator for Health IT, Office for Civil Rights, Centers for Medicare and Medicaid Services and its Office for E-Health Standards and Services, and the Office of the Assistant Secretary for Planning and Evaluation. We also held discussions with and collected information from the American Health Information Community and the National Committee on Vital and Health Statistics, the Secretary’s two primary advisory committees for health IT. We reviewed information from the Office of the National Coordinator for Health IT on the description and status of its plans to address health information privacy as part of its national health IT strategy. We identified recommendations that the American Health Information Community and the National Committee for Vital and Health Statistics made to the Secretary of Health and Human Services regarding protecting the privacy of electronic health information. We also reviewed documentation about the scope and status of privacy-related work currently planned or being conducted under several of the Office of the National Coordinator’s health IT contracts that support its efforts to develop and implement a national health IT strategy. We reviewed procedures for enforcing privacy and security laws related to the protection of health information (i.e., the Health Information Portability and Accountability Act privacy and security rules) from the Office for Civil Rights and the Office of E-Health Standards and Services. We also reviewed involvement by HHS’s Agency for Healthcare Research and Quality, the National Institutes of Health, the Health Resources and Services Administration, the Substance Abuse and Mental Health Services Administration, and the Centers for Disease Control and Prevention in initiatives to ensure privacy protection related to the electronic exchange of health information within a nationwide health information network. We mapped the HHS privacy-related activities we identified to key privacy principles in the HIPAA Privacy Rule. We identified HHS activities that addressed specific aspects of these principles to describe the extent to which HHS’s privacy-related initiatives are intended to address key privacy principles. To address the second objective, we analyzed documentation from and held discussions with officials from the federal agencies that provide health care services—the Departments of Defense and Veterans Affairs and the Indian Health Service—and representatives from selected state-level health information exchange organizations. We selected these organizations by conducting literature research and consulting with HHS and recognized health IT professional associations to identify existing health information exchange organizations. We initially identified more than 40 organizations and then conducted screening interviews to narrow the universe to 7 state- level health information exchange organizations that were actively exchanging health information electronically. To ensure that we identified challenges introduced by both federal privacy protection requirements and requirements that are more stringent than existing federal protections, we included states that do not have state laws that supersede federal requirements and states with privacy laws that are more stringent than federal laws. We selected state-level health information organizations from California, Florida, Indiana, Louisiana, Massachusetts, North Carolina, and Utah. We also included a telehealth network from Nebraska and a community health center network from Florida to ensure that we identified any privacy-related challenges unique to their health care IT environments. During interviews, we asked the health information exchange organizations to provide examples of challenges associated with protecting the privacy of health information that they encountered with the implementation of electronic health information exchange networks, along with challenges that they anticipated would be introduced by the nationwide health information exchange being proposed by HHS. We also held discussions with HHS officials with the Agency for Healthcare Research and Quality, the National Institutes of Health, the Health Resources and Services Administration, the Substance Abuse and Mental Health Services Administration, and the Centers for Disease Control and Prevention to collect examples of challenges those organizations and their stakeholders face in attempting to address federal privacy and security requirements. To gain further insight into the challenges organizations face in protecting privacy while exchanging electronic health information, we contacted representatives from nationally recognized health IT professional organizations. We held discussions with officials from the American Health Information Management Association, the American Medical Informatics Association, the eHealth Initiative, the Healthcare Information and Management Systems Society, the Markle Foundation, and the Public Health Informatics Institute to discuss challenges these organizations faced that are associated with protecting electronic health information. We also gathered relevant information about the challenges in protecting privacy within health information exchange from officials with the Health Privacy Project, the Vanderbilt Center for Better Health, Kaiser Permanente, and NHII Advisors, a health information consulting firm. We reviewed and analyzed the information provided by the health information exchange organizations, federal health care providers, and professional associations to identify key challenges associated with the electronic exchange of personal health information throughout the health care industry. To characterize the challenges that we identified, we analyzed the specific examples of challenges and categorized them into four broad areas of challenges—understanding and resolving legal and policy issues, ensuring appropriate disclosures of health information, ensuring individuals’ rights to access and amend health information, and implementing adequate security measures for protecting health information. We conducted our work from December 2005 through November 2006 in the Washington, D.C., area in accordance with generally accepted government auditing standards. The following table includes the major federal programs that provide health care services for U.S. citizens, the number of beneficiaries for each program, and the cost of each program for 2004. The following table describes key health IT contracts awarded by the HHS Office of the National Coordinator for Health IT. The following table describes the Office of the National Coordinators’ current goals, objectives, and strategies and indicates which strategies are initiated, which are under active discussion, and which require future consideration. There are several federal statutes that protect personal health information. HIPAA provides the most extensive and specific protection. However, other federal statutes, although not always focused specifically on health information, nonetheless have the effect of protecting personal health information in specific situations. This table presents an outline of selected federal laws that protect personal health information. In addition to those named above, Mirko J. Dolak, Amanda C. Gill, Nancy E. Glover, M. Saad Khan, Charles F. Roney, Sylvia L. Shanks, Sushmita L. Srikanth, Teresa F. Tucker, and Morgan F. Walts made key contributions to this report.

Summary: The expanding implementation of health information technology (IT) and electronic health information exchange networks raises concerns regarding the extent to which the privacy of individuals' electronic health information is protected. 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 describe HHS's efforts to ensure privacy as part of its national strategy and to identify challenges associated with protecting electronic personal health information. To do this, GAO assessed relevant HHS privacy-related initiatives and analyzed information from health information organizations. 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.