Testimony

Thursday, April 6, 2006

Introduction
Chairwoman Johnson and Members of the Subcommittee, I am Dr. David Brailer, the National Coordinator for Health Information Technology. The Office of the National Coordinator for Health Information Technology is a component of the Department of Health and Human Services (HHS). Thank you for inviting me to testify today on health information technology activities underway in the Department.

Setting the Context
On April 27, 2004, the President signed Executive Order 13335 (EO) announcing his commitment to the promotion of health information technology (IT) to improve efficiency, reduce medical errors, improve quality of care, and provide better information for patients and physicians. In particular, the President called for widespread adoption of electronic health records (EHRs) within 10 years so that health information will follow patients throughout their care in a seamless and secure manner. Toward that vision, the EO directed the Secretary of HHS to establish within the Office of the Secretary the position of National Coordinator for Health Information Technology, with responsibilities for coordinating Federal health information technology (health IT) programs with those of relevant executive branch agencies, as well as coordinating with the private sector on their health IT efforts. On May 6, 2004, I was appointed to serve in this position.

• On July 21, 2004, during the Department�s Health IT Summit, we published the �Strategic Framework: The Decade of Health Information Technology: Delivering Consumer-centric and Information-rich Health Care,� (The Framework). The Framework outlined an approach toward nationwide implementation of interoperable EHRs and in it we identified four major goals. These goals are: 1) inform clinical practice by accelerating the use of EHRs, 2) interconnect clinicians so that they can exchange health information using advanced and secure electronic communication, 3) personalize care with consumer-based health records and better information for consumers, and 4) improve public health through advanced bio-surveillance methods and streamlined collection of data for quality measurement and research.

Building on the EO, The Framework, and input received from the public and private sectors, we have developed the clinical, business, and technical foundations for the HHS health IT strategy. Let me turn to some of those now.

The Clinical Foundation: Evidence of the Benefits of Health IT
We believe that health IT can save lives, improve care, and improve efficiency in our health system. Five years ago, the Institute of Medicine (IOM) estimated that as many as 44,000 to 98,000 deaths occur each year as the result of medical errors. Health IT, through applications such as computerized provider order entry can help reduce medical errors and improve quality. For example, studies have shown that adverse drug events have been reduced by as much as 70 to 80% by targeted programs, with a significant portion of the improvement stemming from the use of health IT.

Every primary care physician knows what a recent study in the Journal of the American Medical Association (JAMA) showed: that clinical information is frequently missing at the point of care, and that this missing information can be harmful to patients. That study also showed that clinical information was less likely to be missing in practices that had full electronic records systems. Patients know this too and are taking matters into their own hands. A recent survey by the Agency for Health Care Research and Quality (AHRQ) with the Kaiser Family Foundation and the Harvard School of Public Health found that nearly 1 in 3 people say that they or a family member have created their own set of medical records to ensure that their health care providers have all of their medical information.

Current analyses examining whether health IT will produce cost savings show mixed results. Some researchers estimate that savings from the implementation of health IT and corresponding changes in care processes could range anywhere from 7.5 to 30 percent of overall health care costs. These estimates are based in part on the reduction of obvious errors. For example, on average, a medical error is estimated to cost about $3,700 in 2003 dollars. But, these savings are not guaranteed through the simple acquisition of health IT. If poorly designed or implemented, health IT will not bring these benefits, and in some cases may even result in new medical errors and potential costs (Koppel et al. 2005).

Therefore, achieving cost savings requires a much more substantial transformation of care delivery that goes beyond simple error reduction and the use of health IT. Health IT must be combined with real process change in order to see meaningful improvements in our delivery system. It requires the industry to follow the best diagnostic and treatment practices everywhere in the nation. For example, cholesterol screenings can lead to early treatment, which in turn can reduce the risk for heart disease. Where that has been done, there have been substantial savings on cardiac expenditures. Studies also show that while most investments in health IT are made by providers, consumers and payers are most likely to reap the benefits and efficiencies from these investments.

Business Foundation: The Health IT Leadership Panel Report
Recognizing that the healthcare sector lags behind most other industries in its investment in IT, HHS employed a contractor, the Lewin Group, to convened a Health IT Leadership Panel to help understand how IT has transformed other industries and how, based upon their experiences, it can transform the health care industry.

The Leadership Panel was comprised of nine CEOs from leading companies that purchase large quantities of healthcare services for their employees and dependents and that do not operate in the healthcare business. These included CEOs from FedEx Corporation, General Motors, International Paper, Johnson Controls, Target Corporation, PepsiCo, Procter and Gamble, Wells Fargo, and Wal-Mart Stores. The business leaders were called upon to evaluate the need for investment in health information technology and the major roles for both the government and the private sector in achieving widespread adoption and implementation. Based upon their own experiences using IT to reengineer their individual businesses � and by extension, their industries � the Leadership Panel concluded that investment in interoperable health IT is urgent and vital to the broader U.S. economy due to rising health care demands and business interests.

As explained by the Lewin Group, The Leadership Panel unanimously agreed that the federal government must begin to drive change before the private sector would become fully engaged. Specifically, the Leadership Panel concluded:

• Potential benefits of health IT far outweigh manageable costs.
• Health IT needs a clear, broadly motivating vision and practical adoption strategy.
• The federal government should provide leadership, and industry will engage and follow.
• Lessons of adoption and success of IT in other industries should inform and enhance adoption of health IT.
• Among its multiple stakeholders, the consumer�including individual beneficiaries, patients, family members, and the public at large�is key to adoption of health IT and realizing its benefits.
• Stakeholder incentives must be aligned to foster health IT adoption.

The Leadership Panel identified as a key imperative that the Federal government should act as leader, catalyst, and convener of the nation�s health information technology effort. Private sector purchasers and health care organizations can and should collaborate alongside the federal government to drive adoption of health IT. In addition, The Leadership Panel members recognized that widespread health IT adoption may not succeed without buy-in from the public as health care consumer. Panelists suggested that the national health IT vision must be communicated clearly and directly to enlist consumer support for the widespread adoption of health IT.

The Technical Foundation: Public Input Solicited on Nationwide Network
HHS published a Request for Information (RFI) in November 2004 that solicited public input about whether and how a Nationwide Health Information Network (NHIN) could be developed. This RFI asked key questions to guide our understanding around the organization and business framework, legal and regulatory issues, management and operational considerations, standards and policies for interoperability, and other considerations.

We received over 500 responses to the RFI. These responses have yielded one of the richest and most descriptive collections of thoughts on interoperability and health information exchange that has likely ever been assembled in the U.S. As such, it has set the foundation for actionable steps designed to meet the President�s goal.

Among the many opinions expressed by those supporting the development of a NHIN, the following concepts emerged:

• A NHIN should be a decentralized architecture built using the Internet, linked by uniform communications and a software framework of open standards and policies.
• A NHIN should reflect the interests of all stakeholders.
• A governance entity composed of public and private stakeholders should oversee the determination of standards and policies.
• A NHIN should provide sufficient safeguards to protect the privacy of personal health information.
• Incentives may be needed to accelerate the deployment and adoption of a NHIN.
• Existing technologies, federal leadership, and certification of EHRs will be the critical enablers of a NHIN.
• Key challenges to developing and adopting a NHIN included: the need for additional and better refined standards; addressing privacy concerns; accurately verifying patients� identity; and addressing discordant inter- and intra-state laws regarding health information exchange.

Key Actions
Building on these steps, two critical challenges to realizing the President�s vision for health IT are being addressed: a) interoperability and the secure portability of health information, and b) electronic health record (EHR) adoption. Interoperability and portability of health information using information technology are essential to achieving the industry transformation goals sought by the President. Further, the gap in EHR adoption between large hospitals and small hospitals, between large and small physician practices, and among other healthcare providers must be addressed. This adoption gap has the potential to shift the market in favor of large players who can afford these technologies, and can create differential health treatments and quality, resulting in a quality gap.

To address these challenges, HHS is focusing on several key actions: harmonizing health information standards; promoting the certification of health IT products to assure consistency with standards; addressing variations in privacy and security policies that can pose challenges to interoperability; and developing a prototype, nationwide, Internet-based architecture for sharing of electronic health information. These efforts are inter-related, and a new federal advisory committee, the American Health Information Community (the Community), will make recommendations regarding the government�s role in responding to these challenges.

American Health Information Community
On July 14, 2005, Secretary Leavitt announced the formation of a national public-private collaboration, the American Health Information Community, a public-private body formed pursuant to the Federal Advisory Committee Act. The Community has been formed to facilitate the transition to electronic health records in a smooth, market-led way. The Community is providing input and recommendations to the Secretary on use of common standards and how interoperability among EHRs can be achieved while assuring that the privacy and security of those records are protected. On September 13, 2005, Secretary Mike Leavitt named the Community�s 17 members, including nine members from the public sector and eight members from the private sector.

At its November 29, 2005 meeting, the Community formed workgroups that will make recommendations for specific achievable near-term results in the following areas:

• Biosurveillance - Enable the transfer of standardized and anonymized health data from the point of health care delivery to authorized public health agencies within 24 hours of its collection.
• Consumer Empowerment - Make available a consumer-directed and secure electronic record of health care registration information and a medication history for patients.
• Chronic Care - Allow the widespread use of secure messaging, as appropriate, as a means of communication between doctors and patients about care delivery.
• Electronic Health Records - Create an electronic health record that includes laboratory results and interpretations, that is standardized, widely available and secure. These workgroups will make recommendations at the May 16 meeting of the Community.

In addition to the formation of the Community, HHS has issued contracts, the outputs of which will serve as inputs for the Community�s consideration. Specifically, these contracts focus on the following major areas:

Standards Harmonization
HHS awarded a contract to the American National Standards Institute, a non-profit organization that administers and coordinates the U.S. voluntary standardization activities, to convene the Health Information Technology Standards Panel (HITSP). The HITSP brings together U.S. standards development organizations and other stakeholders. The HITSP is developing and implementing a harmonization process for achieving a widely accepted and useful set of health IT standards that will support interoperability among health care software applications, particularly EHRs.

Today, the standards-setting process is fragmented and lacks coordination and specificity, resulting in overlapping standards and gaps in standards that need to be filled. We envision a process where standards are identified and developed around real-world scenarios � i.e., around use cases or breakthroughs. A �use case� is a technology term to describe how we can focus standardization efforts on specific areas that demonstrate clinical and business value. As of March 2006 we have three common use cases for the standards harmonization process and which will be used in the other contracts discussed below. In May 2006, the HITSP will have proposed "named standards" for the three use cases. After the named standards are recommended to the Community, the HITSP will begin the development of interoperability specifications for each.

Compliance Certification
HHS awarded a contract to the Certification Commission for Health Information Technology (CCHIT) to develop criteria and evaluation processes for certifying EHRs and the infrastructure or network components through which they interoperate. CCHIT is a private, non-profit organization established to develop an efficient, credible, and sustainable mechanism for certifying health care information technology products. The contract, currently scheduled for a three-year period, will address three areas of certification: ambulatory electronic health records, inpatient electronic health records, and the infrastructure components through which they could interoperate.

The CCHIT has made significant progress toward the certification of ambulatory electronic health records. In February 2006, CCHIT began using its final criteria to conduct ambulatory electronic health record certification pilot tests and will be accepting applications for operational certification in April 2006 [note that we are now in April 2006, so this might need some clarification], with the goal of having certified electronic health record products in the marketplace as early as June 2006. Certification will help buyers of HIT determine whether products meet minimum requirements, which include functionality and interoperability.

NHIN Architecture
HHS has awarded contracts totaling $18.6 million to four consortia of health care and health information technology organizations to develop prototype architectures for the Nationwide Health Information Network (NHIN). The four consortia will move the nation toward the President�s goal of personal electronic health records by creating uniform architecture for health care information. The NHIN architecture will be coordinated with the work of the Federal Health Architecture and other interrelated infrastructure projects. The goal is to develop real solutions for nationwide health information exchange by stimulating the market through a collaborative process and the development of network functions. In June 2006, the contractors will submit proposed architecture requirements for the NHIN's to HHS and a public meeting will be held to review them.

Security and privacy
HHS awarded a contract to RTI International in association with the National Governors Association Center for Best Practices. Through this contract, stakeholders, including consumers, within and across up to 40 states will assess variations in organization-level business policies and State laws that affect health information exchange; identify and propose practical solutions for addressing such variation that will comply with privacy and security requirements in applicable Federal and State laws; and develop detailed plans to implement identified solutions.

All State and territory governors have been invited to submit a proposal for participation. Proposals for participation were due March 1, 2006, and are presently being reviewed. States and territories that receive an award will be required to undertake certain activities that include: examining privacy and security policies and business practices regarding electronic health information exchange; convening and working closely with a wide range of stakeholders in the State, including consumers, to identify best practices, barriers and solutions; and developing an implementation plan for solutions to address organization-level business practices and State laws that affect privacy and security practices for interoperable health information exchange.

In the next six months, state consortia will produce an interim assessment of current privacy and security variations. To do this, state subcontractors will form collaborative workgroups to define this preliminary landscape. State solutions and implementation plans under this contract will be finalized in early 2007.

EHR Adoption Study
To assess progress toward the President�s goal for EHR adoption, we must be able to measure the rate of adoption across relevant care settings. To date, several health care surveys have queried health care providers such as individual physicians, physician group practices, community health centers, and hospitals on their use of EHRs in an effort to estimate an overall �EHR adoption rate.� These surveys indicate an adoption gap; however, the surveys and what they have measured have varied. These variations occur from survey factors such as the type of entity, geography, provider size, type of health information technology deployed, how an EHR is defined, the survey sampling frame methodology (e.g., the source list of physicians), and survey data collection method (i.e., phone interview, mail questionnaire, internet questionnaire, etc.).

Due to the variations in the purpose and approach, these surveys have yielded varying methods of EHR adoption measurement. In particular, no single approach yields a reliable and robust long-term indicator of the adoption of interoperable EHRs that could be used for (1) bench marking progress towards meeting the President�s EHR goal and (2) informing Federal policy decisions that would catalyze progress towards reaching this goal. Therefore, HHS awarded a contract to the George Washington University and Massachusetts General Hospital Harvard Institute for Health Policy to support the Health IT Adoption Initiative. The new initiative is aimed at better characterizing and measuring the state of EHR adoption and determining the effectiveness of policies to accelerate adoption of EHRs and interoperability.

Federal Health Architecture
Now that HHS has established an infrastructure to address standards harmonization, compliance certification, nationwide health information network architecture, security and privacy, and EHR adoption measurement through its contracts, there is a need to gain the Federal perspective in these and other Federal health information technology areas. To accomplish this, we are looking to the Federal Health Architecture (FHA), an OMB line of business, established on March 22, 2004 and managed by ONC to create interoperability and increase efficiency within the public sector. To better meet the President�s health IT goals, FHA as of March 2006 has been realigned to provide the federal perspective using the processes created within ONC to ensure that interoperability exists within and between the public and private sector. FHA will achieve this refined vision by providing input into the established infrastructure and guidance for implementation within the public sector. Moving forward, FHA will be representing and coordinating the federal activities in all matters relating to the President's health IT plan.

Conclusion
Thank you for the opportunity to update you on the progress we are making in the area of health information technology. HHS, under Secretary Leavitt�s leadership, is giving the highest priority to fulfilling the President�s commitment to promote widespread adoption of interoperable electronic health records, and it is a privilege to be a part of this transformation.

This concludes my prepared statement. I would be pleased to answer any questions.

Last Revised: April 6, 2006

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