Health Information Technology: HHS is Continuing Efforts to Define Its National Strategy
Published: 2006-09-01T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: As GAO and others have reported, the use of information technology (IT) has enormous potential to improve the quality of health care and is critical to improving the performance of the U.S. health care system. Given the federal government's role in providing health care in the U.S., it has been urged to take a leadership role in driving change to improve the quality and effectiveness of health care, including the adoption of IT. In April 2004, President Bush called for 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. A National Coordinator within the Department of Health and Human Services (HHS) was appointed in May 2004 and released a framework for strategic action two months later. In May 2005, GAO recommended that HHS establish detailed plans and milestones for each phase of the framework and take steps to ensure that its plans are followed and milestones are met. GAO was asked to identify progress made by HHS toward the development and implementation of a national health IT strategy. To do this, GAO reviewed prior reports and agency documents on the current status of relevant HHS activities.
section_title: What GAO Found
paragraphs: In late 2005, to help define the future direction of a national strategy, HHS awarded several health IT contracts and formed the American Health Information Community, a federal advisory committee made up of health care stakeholders from both the public and private sectors. Through the work of these contracts and the community, HHS and its Office of the National Coordinator for Health IT have made progress in five major areas associated with the President's goal of nationwide implementation of health IT. These activities and others are being used by the Office of the National Coordinator for Health IT to continue its efforts to complete a national strategy to guide the nationwide implementation of interoperable health IT. Since the release of its initial framework in 2004, the office has defined objectives and high-level strategies for accomplishing its goals. Although HHS agreed with GAO's prior recommendations and has made progress in these areas, it still lacks detailed plans, milestones, and performance measures for meeting the President's goals.

section_title: Letter
paragraphs: I am pleased to be here today to comment on federal efforts to  advance the use of information technology (IT) for health care  delivery and public health. As we and others have reported, the use  of IT has enormous potential to improve the quality of health care  and is critical to improving the performance of the U.S. health care  system.
Recognizing the potential value of IT in public and private health  care systems, the federal government has been working to promote  the nationwide use of health IT. In April 2004, President Bush called  for 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 the Department of Health and Human Services  (HHS). The National Coordinator’s responsibilities include the  development and implementation of a strategic plan to guide the  nationwide implementation of interoperable health IT in both the  public and private sectors.
At your request, today we will discuss progress made by HHS and its  Office of the National Coordinator for Health IT toward the  development and implementation of a national health IT strategy. In  preparing this statement, we reviewed agency documents on the  current status of HHS’s activities related to a national health IT  strategy and supplemented our analysis with interviews of agency  officials. We also summarized prior GAO reports. Our work was  performed in accordance with generally accepted auditing  standards.
subsections: section_title: Background
paragraphs: Studies published by the Institute of Medicine and others 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. For example, a 1,951-bed teaching hospital  reported that it realized about $8.6 million in annual savings by  replacing outpatient paper medical charts with electronic medical  records. This hospital also reported saving more than $2.8 million  annually by replacing its manual process for managing medical  records with an electronic process to provide access to laboratory  results and reports. Health care organizations also 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. However, according to HHS,  only a small number of U.S. health care providers have fully adopted  health IT due to significant financial, technical, cultural, and legal  barriers such as a lack of access to capital, a lack of data standards,  and resistance from health care providers.
subsections: section_title: Federal Government’s Role in Health Care
paragraphs: 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 Medicare and Medicaid, provide 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. Table 1 summarizes the programs and number of citizens  who receive health care services from the federal government and  the cost of these services.
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 an 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. The  National Coordinator’s responsibilities include the development and  implementation of a strategic plan to guide the nationwide  implementation of interoperable health IT in both the public and  private sectors. The first National Coordinator was appointed in  May 2004, and two months later HHS released The Decade of Health  Information Technology: Delivering Consumer-centric and  Information-rich Health Care—Framework for Strategic Action,  the first step toward the development of a national strategy. The  framework described goals for achieving nationwide  interoperability of health IT and actions to be taken by both the  public and private sectors to implement a strategy. Just last week,  President Bush issued an executive order calling for federal health  care programs and their providers, plans, and insurers to use IT  interoperability standards recognized by HHS.
section_title: Need for a National Strategy and Greater Interoperability
paragraphs: In the summer of 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. Last year, we reported that HHS, through the Office  of the National Coordinator for Health IT, had taken a number of  actions toward accelerating the use of IT to transform the health  care industry. To further accelerate the adoption of interoperable  health information systems, we recommended that HHS establish  detailed plans and milestones for meeting the goals of its framework  for strategic action and take steps to ensure that those plans are  followed and milestones are met. The department agreed with our  recommendation.
We also reported in June 2005 that challenges associated with major  public health IT initiatives still need to be overcome to strengthen  the IT that supports the public health infrastructure. Federal  agencies face many challenges in their efforts to improve the public  health infrastructure, including (1) the integration of current  initiatives into a national health IT strategy and federal architecture  to reduce the risk of duplicative efforts, (2) development and  adoption of consistent standards to encourage interoperability, (3)  coordination of initiatives with state and local agencies to improve  the public health infrastructure, and (4) overcoming federal IT  management weaknesses to improve progress on IT initiatives. To  address these challenges, we recommended that HHS align federal  public health initiatives with the national health IT strategy and  federal health architecture, coordinate with state and local public  health agencies, and continue federal actions to encourage the  development and adoption of data standards.
Last September, we testified about the importance of defining and  implementing data and communication standards to speed the  adoption of interoperable IT in the health care industry. Hurricane  Katrina highlighted the need for interoperable electronic health  records as thousands of people were separated from their health  care providers and their paper medical records were lost. As we  have noted, standards are critical to enabling this interoperability.  Although federal leadership has been established to accelerate the  use of IT in health care, we testified that several actions were still  needed to position HHS to further define and implement relevant  standards. Otherwise, the health care industry will continue to be  plagued with incompatible systems that are incapable of exchanging  medical information that is critical to delivering care and responding  to public health emergencies.
In March 2006, we testified before this subcommittee on HHS’s  continued efforts to move forward with its mission to guide the  nationwide implementation of interoperable health IT in the public  and private health care sectors. We identified several steps taken by  the department, such as the establishment of the organizational  structure and management team for the Office of the National  Coordinator for Health IT under the Office of the Secretary and the  formation of a public-private advisory body—the American Health  Information Community—to advise HHS on achieving  interoperability for health information exchange. The community,  which is co-chaired by the Secretary of HHS and the former National  Coordinator for Health IT, identified four breakthrough areas — consumer empowerment, chronic care, biosurveillance, and  electronic health records—and formed workgroups intended to  make recommendations for actions in these areas that will produce  tangible results within a one-year period. Subsequently, in May 2006  the workgroups presented 28 recommendations to the American  Health Information Community that address standards, privacy and  security, and data-sharing issues.
We also reported in March 2006 that HHS—through the Office of  the National Coordinator for Health IT— awarded $42 million in  contracts that address a range of issues important for developing a  robust health IT infrastructure, such as an increasing number of  health care providers adopting electronic health records, definitions  of health information standards being developed, architectural  definitions for a national network, and the development and  implementation of privacy and security policies. HHS intends to use  the results of the contracts and recommendations from the  American Health Information Community proceedings to define the  future direction of a national strategy. In March, the National  Coordinator told us that he intended to release a strategic plan with  detailed plans and milestones later this year. The contracts are  described in table 2.
section_title: HHS Is Continuing Efforts to Advance the Nationwide Implementation of Health IT and Complete a National Strategy
paragraphs: HHS and its Office of the National Coordinator for Health IT have  made progress through the work of the American Health  Information Community and several contracts in five major areas:  (1) advancing the use of electronic health records, (2) establishing  standards to facilitate the exchange of patient data, (3) defining  requirements for the development of prototypes of the Nationwide  Health Information Network, (4) incorporating privacy and security  policy, practices, and standards into the national strategy, and (5)  integrating public health into nationwide health information  exchange.
These activities and others are being used by the Office of the  National Coordinator for Health IT to continue its efforts to  complete a national strategy to guide the nationwide  implementation of interoperable health IT. Since the release of its  initial framework in 2004, the office has taken additional steps to  define a complete national strategy, building on its earlier work.  However, while HHS has made progress in these areas, it still lacks  detailed plans, milestones, and performance measures for meeting  the President’s goals.
subsections: section_title: HHS Is Advancing the Use of Electronic Health Records
paragraphs: HHS has made progress toward advancing the adoption of  electronic health records by defining initial certification criteria for  ambulatory electronic health records. The Certification Committee  for Health IT, which was awarded the Compliance Certification  Process for Health IT contract, finalized functionality, security, and  reliability certification criteria for ambulatory electronic health  records in May 2006 and described interoperability criteria for  future certification requirements. The committee subsequently  certified 22 vendors’ electronic health records products in July. Its  next phase is to define and recommend certification criteria for  inpatient electronic health records. The committee plans to publish  these criteria for public comment during the last quarter of 2006,  with certification beginning in the second quarter of 2007.
Additionally, the Nationwide Health Information Network contracts  have thus far resulted in the identification of draft functional  requirements for incorporating lab results and patient information,  such as medical history and insurance information, into electronic  health records. The requirements were presented to the Secretary of  HHS in June 2006, and an initial set of requirements for the  Nationwide Health Information Network are expected to be issued  in September 2006.
In our March 2006 testimony, we described the Gulf Coast  Electronic Digital Health Recovery contract, which was awarded by  HHS to promote the use of electronic health records to rebuild  medical records for patients in the Gulf Coast region affected by  hurricanes last year. The outcomes of the contract are expected to  coordinate planning for the recovery of digital health information in  cases of emergencies or disasters and to develop a prototype of  health information sharing and electronic health records support.  The contract established a task force of local and national experts to  help area providers turn to electronic medical records as they  rebuild medical records for their patients.
section_title: HHS Has Initiated Steps to Establish Health IT Standards
paragraphs: HHS awarded its Standards Harmonization Process for Health IT  contract to ANSI. The contract is supported by ANSI’s Health IT  Standards Panel, a collaborative partnership between the public and  private sector. This effort integrates standards previously identified  by the Consolidated Health Informatics and other federal  initiatives. To date, the panel has selected 90 interoperability  standards for areas such as electronic health records and public  health detection and reporting. The selected standards specifically  address components of the breakthrough areas defined by the  American Health Information Community and were produced by  accepted standards organizations. The Nationwide Health  Information Network functional requirements also incorporate  standards defined through the work of the Standards Harmonization  Process for Health IT contract. The selected standards are currently  being reviewed for acceptance by the Secretary.
HHS has also involved the Department of Commerce’s National  Institute for Standards and Technology (NIST) with HHS’s work to  implement health IT standards through its standards harmonization  contract. HHS’s standards harmonization contractor is required to  maximize the use of existing processes and collaborate with NIST  where appropriate, including consideration of outputs from the  standards harmonization process as Federal Information Processing  Standards relevant to federal agencies. NIST’s issuance of Federal  Information Processing Standards for health IT is to be aligned with  recommendations from public and private sector coordination  efforts through the American Health Information Community, as  accepted by the Secretary of HHS. The Federal Information  Processing Standards are to be consistent with the standards  adopted by the harmonization contract to enable the alignment of  federal and private sector standards and widespread interoperability  among health IT systems, particularly electronic health records  systems.
section_title: HHS Has Begun to Define Requirements for the Development of Prototypes for the Nationwide Health Information Network
paragraphs: HHS’s Nationwide Health Information Network contracts are  intended to provide architectures and prototypes of national  networks based on the breakthrough areas defined by the American  Health Information Community. HHS awarded contracts for  developing these architectures and prototypes to four contractors.  The contractors are to deliver final operating plans and prototypes  of a national network that demonstrates health information  exchange across multiple markets in November 2006.
In late June 2006, HHS held its first Nationwide Health Information  Network forum. More than 1000 functional requirements for a  Nationwide Health Information Network were presented for  discussion and public input. The requirements addressed general  Nationwide Health Information Network infrastructure needs and  the breakthrough areas defined by the American Health Information  Community. The requirements are being reviewed by the National  Committee for Vital and Health Statistics, which is expected to  release its approved requirements by September 2006.
section_title: HHS Is Taking Steps to Incorporate Privacy and Security Policies, Practices, and Standards into Its National Strategy
paragraphs: HHS, through its contracts and recommendations from the  American Health Information Community and the National  Committee for Vital and Health Statistics, has initiated several  actions to address privacy and security issues associated with the  nationwide exchange of health information. In May 2006, 22 states  subcontracted under HHS’s privacy and security contract to perform  assessments of the impact of organization-level business policies  and state laws on security and privacy practices and the degree to  which they pose challenges to interoperable health information  exchange. In August 2006, 11 more states and Puerto Rico were  added to the scope of the contract. The outcomes of the contract are  to provide a nationwide synthesis of information to inform privacy  and security policy making at federal, state, and local levels.
In addition, the standards selected through the standards  harmonization contract include those that are applicable to the  consumer empowerment breakthrough area, specifically privacy  and confidentiality. Its initial standards are intended to allow  consumers the ability to establish and manage permissions and  access rights, along with informed consent for authorized and  secure exchange, viewing, and querying of their medical information  between designated caregivers and other health professionals.  Additionally, the proposed functional requirements for the  Nationwide Health Information Network include security  requirements that are needed for ensuring the privacy and  confidentiality of health information.
In May 2006, several of the American Health Information  Community workgroups recommended the formation of an  additional workgroup comprised of privacy, security, clinical, and  technology experts from each of the other American Health  Information Community workgroups. The Confidentiality, Privacy,  and Security Workgroup was formed in July to frame the privacy  and security policy issues relevant to all breakthrough areas and  solicit broad public input to identify viable options or processes to  address these issues. The recommendations developed by this  workgroup 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 workgroup convened last month.
In June 2006, the National Committee on Vital and Health Statistics  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. Specifically, they address (1) the role of  individuals in making decisions about the use of their personal  health information, (2) policies for controlling disclosures across a  national 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 national health information  network. The recommendations are being evaluated by the  American Health Information Community workgroups, the  Certification Commission for Health IT, Health Information  Technology Standards Panel, and other HHS partners. The  committee intends to continue to update and refine its  recommendations as the architecture and requirements of the  network advance.
section_title: HHS Is Continuing to Address Public Health Integration
paragraphs: To help promote the integration of public health data into a  nationwide health information exchange, the American Health  Information Community’s biosurveillance workgroup made  recommendations in May 2006 intended to help the simultaneous  flow of clinical care data to and among local, state, and federal  biosurveillance programs. The community recommended that HHS  develop sample data-use agreements and implementation guidance  to facilitate the sharing of data from health care providers to public  health agencies. The workgroup also recommended that HHS, in  collaboration with privacy experts, state and local governmental  public health agencies, and clinical care partners, develop materials  to educate the public about the information that is used for  biosurveillance including the benefits to the public’s health,  improved national security, and the protection of patient  confidentiality by September 30, 2006.
Information exchange standards for sharing clinical health  information (e.g., emergency department visit data and lab results)  with public health are included in the 90 standards recently  recommended as a result of HHS’s standards harmonization  contract. The standards are intended to enable the transmission of  essential ambulatory care and emergency department visit,  utilization, and lab result data from electronic health care delivery  and public health systems in standardized and anonymized format  to authorized public health agencies within less than one day. In  addition to advancing the use of electronic health records, the Gulf  Coast contract is intended to help support public health emergency  response by fostering the availability of field-level electronic health  records to clinicians responding to disasters.
section_title: HHS Is Continuing Efforts to Complete and Implement a National Strategy for Health IT
paragraphs: As called for by the President’s executive order in April 2004, the  national coordinator’s office is continuing its efforts to complete a  national strategy for health IT. Since we testified in March 2006, the  office has worked to evolve the initial framework and, with  guidance from the American Health Information Community, has  revised and refined the goals and strategies identified in the initial  framework. The new draft framework—The Office of the National  Coordinator: Goals, Objectives, and Strategies—provides high-level  strategies for meeting the President’s goal for the adoption of  interoperable health IT and is to be used to develop internal  performance measures for the office’s activities.
The framework identifies objectives for accomplishing each of four  goals, along with 32 high-level strategies for meeting the objectives.  The Office of the National Coordinator has identified and prioritized  the 32 strategies for accomplishing the framework’s goals and has  initiated 10 of them, which are supported by the contracts that HHS  awarded in fall 2005. Table 3 illustrates the framework’s goals,  objectives, and strategies and identifies the 10 strategies that have  been initiated.
The Office of the National Coordinator has prioritized the remaining  22 strategies defined in its framework. Six strategies are under  active consideration, and the remaining 16 require future discussion.  According to officials with the office, the strategies were prioritized  based on guidance and direction from the American Health  Information Community. The Office of the National Coordinator  expects the framework to continue to evolve through collaboration  among the Office of the National Coordinator and its partners, such  as other federal agencies and the American Health Information  Community, and as additional activities are completed through the  contracts.
While HHS has taken additional steps toward completing a national  strategy and has initiated specific activities defined by its strategic  framework, it still lacks the detailed plans, milestones, and  performance measures needed to ensure that its goals are met.  While the National Coordinator acknowledged the need for more  detailed plans for its various initiatives and told us in March that  HHS intended to release a strategic plan with detailed plans and  milestones later this year, current officials with the office could not  tell us when detailed plans and milestones would be defined. Given  the complexity of the tasks at hand and the many activities to be  completed, a national strategy that defines detailed plans,  milestones, and performance measures is essential. Without it, HHS  risks not meeting the President’s goal for health IT.
In summary, Mr. Chairman, our work shows that HHS is continuing  its efforts to help transform the use of IT in the health care industry.  However, much work remains. While HHS, through the Office of the  National Coordinator for Health IT and the American Health  Information Community, has initiated specific actions for  supporting the goals of a national strategy, detailed plans and  milestones for completing the various initiatives and performance  measures for tracking progress have not been developed. Until these  plans, milestones, and performance measures are completed, it  remains unclear specifically how the President’s goal will be met  and what the interim expectations are for achieving widespread  adoption of interoperable electronic health records by 2014.
Mr. Chairman, this concludes my statement. I would be pleased to  answer any questions that you or other Members of the  Subcommittee may have at this time.
section_title: Contacts and Acknowledgments
paragraphs: If you should have any questions about this statement, please  contact me at (202) 512-9286 or by e-mail at pownerd@gao.gov.  Other individuals who made key contributions to this statement are  Amanda C. Gill, Nancy E. Glover, M. Saad Khan, and Teresa F.  Tucker.
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