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Health IT Strategic Framework

Framework for Strategic Action

Health care that is consumer centered and information rich requires a sustained set of strategic actions, embraced by both the public and private health sectors that need to be taken over many years.  Four major goals that will be pursued in realizing this vision for improved health care are:

  • Inform clinical practice;
  • Interconnect clinicians;
  • Personalize care; and
  • Improve population health.

The following framework describes each of these goals, along with strategies that will be followed to realize the goal and specific actions that pragmatically advance toward the goal.  As this framework evolves into a full strategic plan, goals and strategies will be updated and a variety of new specific actions will be implemented.

Inform clinical practice

Fundamental to the goal of improving care and making health care delivery more efficient is providing complete and useful patient information and knowledge to clinicians when and where they need it and in a manner linked to selection and ordering of tests or therapies for patients.  Information technology can enable this end-to-end approach to clinical decision making.  To do this, several needs must be met.

Information technology products that work within the unique environment of health care should be further innovated.  This is particularly true for the EHR, which has the potential to deliver substantial value but which relies on a unique relationship between a clinician and information technology.  Better information about the characteristics of EHRs will allow for a marketplace where clinicians will better understand their needs and the options available.  A stronger business case for EHRs among physician buyers is required to offset the disincentives for quality and efficiency in current reimbursement.  Furthermore, clinicians who care for underserved populations, including rural areas, require special consideration to ensure that they can make the requisite investments and encourage regional referral centers to similarly invest in compatible technology.

There following three strategies will enable realization of the goal of informing clinical practice:

  • Incentivize EHR adoption;
  • Reduce the risk of EHR investment; and
  • Promote EHR diffusion in rural and underserved areas.

Incentivize EHR adoption

There are high expectations about the benefits that will be derived from using electronic medical records, computerized order entry, and other components of the EHR.  Evidence is well documented that EHRs can improve patient health status (Kohn, 2000).  Several studies have demonstrated that EHRs can reduce errors and improve use of medical evidence (Kuperman, 2003; Bates et al, 1998; Balas et al, 2000).  There is a belief that EHRs will induce concomitant changes in workflow, in relationships between physicians and patients, and in process control that together will trigger subsequent waves of positive change, moving health care toward a more modern and consumer-driven model.

A large gap remains, however, between the promise of EHRs and the capacity and willingness of clinicians to use them.  Data from EHR adoption studies show only modest rates of EHR adoption by hospitals and physician groups.  Thirteen percent of hospitals in 2002 reported that they used EHRs (HIMSS 2002).  Physician office EHR use rates reported in 2002 ranged from 14% to a possible high of 28% of practices (Loomis et al, 2002; HIMSS, AstraZenca, 2002).  The most commonly cited barrier to implementation of EHRs is insufficient resources or a negative return on investment associated with its purchase, implementation, and operation.  Because of these concerns, the use of EHRs remains low, and forecasts do not show substantial trends in adoption over the next few years.

Many health system and physician decision makers believe that EHRs are bad financial investments, even if they are also business expenses made necessary by the mission of their organizations.  Despite the long-term benefits realized by patients, payers, purchasers, and society as a whole, physician groups and hospitals may be making rational economic decisions when they choose not to invest in EHRs.  Hospital and physician investments in EHRs are costly, pose substantial risks, and have few benefits for economic buyers, suggesting that EHR demand is low because the total cost of ownership (purchase price, plus implementation, plus maintenance, plus impact on operations) is unaffordably high.

Some of the concerns around EHR adoption are centered on cost because of the upfront investment needed for technology and infrastructure, and also because of the high costs of managing concomitant clinical and administrative changes.  These changes are risky because the implementations may not succeed, and also because the EHR-driven changes in workflow, communication, and decision making threatens physicians and could upset the delicate balance between physicians and hospitals, as well as among physicians themselves.  Some believe that EHRs deliver only a small fraction of their potential benefits because the fragmented and volume-based model of health care financing in the United States rewards physicians and hospitals for transactions rather than for patient health status and quality.

Current adoption of EHRs demonstrates that at least some organizations are realizing positive economic returns on EHR use, or that they do not require a positive return on investment to justify purchasing an EHR.  The latter organizations may place a high financial value on the quality or safety benefits to patients, essentially choosing to fund a positive externality in order to fulfill their mission, or they may derive a return from strategic positioning or market differentiation.  However, there are very few physician groups or hospitals in the United States able to sustain high capital expenses or operating losses over the long term simply because of mission or strategy.  For the rest, short-term finances will determine whether they invest in EHRs.

EHRs are a unique category of technology procured by physicians and health systems.  Like MRIs, for example, they collect a variety of data, summarize data with algorithms, store and communicate data, and present data in a manner meaningful to clinicians.  Both MRIs and EHRs provide information that supplements diagnostic decision making, refines choice of treatment, and supplements monitoring of patient progress over time.  Neither is useful or reliable without a physician's guidance and oversight.  Both can harm patients if overused, underused, or used improperly, or if they do not perform as promised, whether through malfunction, poor maintenance, or design defect.  Like MRIs, EHRs are very expensive to purchase and operate and have an extended payback period.  However, EHRs are different from an MRI machine, and nearly every other clinical technology, in one notable way:  EHRs evolved incrementally into clinical tools from their administrative office tool roots, and only recently has sufficient evidence of EHR benefit to patient health status been compiled.

Incentives that might induce EHR adoption or quality and other clinical benefits have been discussed for some time.  Incentives as a means of stimulating EHR adoption may overlook the technical, cultural, and operational barriers to EHR adoption and use.  Non-financial barriers should and are being addressed.  In addition, options for reducing the financial disincentives to EHR adoption could also be explored.  Options should meet at least the following four criteria:

  • Business case improvement.  Policy options should consider, in part, the economic expense borne by a hospital or physician when purchasing or using an EHR.
  • Compatibility with existing programs and regulations.  Policy options for EHR adoption should be compatible with or incrementally build on existing reimbursement and regulations.
  • Budget cost-effectiveness.  Policy options should be cost-effective and deliver the largest impact for the smallest expenditure.
  • Stakeholder alignment.  Policy options should align physicians, hospitals, and other stakeholders toward a common goal of improving quality and efficiency.

HHS will examine many potential policy options for incentivizing EHR adoption, including those that might require statutory or regulatory changes for full implementation.  Among these are the following:

    Regional grants and contracts.  HHS will further explore how grants and contracts could be made available to regions, states, or communities for EHR adoption and health information exchange.  In addition to stimulating EHR adoption, this mechanism could foster creation of local infrastructures that could support deployment of EHRs and oversee data exchange across settings of care.  This may improve the business case for EHR adoption by physicians and other health care providers and might direct some of this investment into regional organizations as well.  Up to five state and regional HIT demonstration projects will be funded by the Agency for Healthcare Research and Quality (AHRQ) in FY04, and an additional $50 million is in the FY05 budget request for HHS to continue the support of such projects.  This mechanism could align community stakeholders toward a common goal of health care improvement.

    Improve the availability of low-rate loans for EHR adoption.  The federal government could identify possible incentives for the banking and loan industry to provide low-rate loans to clinicians and providers that are investing in EHR adoption.  This could include reducing or removing impediments or barriers to providing such loans.

    Update federal physician self-referral and anti-kickback protections.  The physician self-referral prohibition and the anti-kickback statute provide important protection against fraud and abuse, assuring that taxpayer and beneficiary dollars are spent appropriately and preventing patient harm.  However, these statutes did not anticipate interoperable HIT that necessarily involves relationships among different providers. While the in-kind provision of EHRs, hardware, or support by hospitals and other providers or suppliers to physicians could accelerate physician adoption of EHRs, this action could face unintended conflicts with the physician self-referral prohibition and the anti-kickback statute in some circumstances.  HHS could explore safe harbors or exceptions to these laws that could accelerate EHR adoption without creating inappropriate conflicts of interest or potential for abuse.

    Pay for use of EHR.  There are two general approaches being explored to reimburse clinicians for the use of EHRs that are consistent with current Medicare law.  Under the physician fee schedule, CMS could consider payment for specific EHR uses though the use of new codes or modifiers based on the best estimate of the incremental, amortized costs actually incurred by physicians nationwide who use EHRs.  Demonstration projects could test alternative EHR payment methods, such as direct contracts with physicians, and determine whether certain EHRs functionalities or other capabilities could be incentivized.

    Pay-for-performance programs.  Pay-for-performance would reward clinicians for delivering the best quality of care, not the highest volume of care.  CMS, under its demonstration authority, has the ability to design, implement, and evaluate pay-for-performance programs, above and beyond those planned as a part of implementation of MMA.  It remains unclear how strongly pay-for-performance programs would accelerate EHR adoption, but the effect will likely be dependent on the program design and the inclusion of specific EHR criteria within the program.  If designed to enable the clinician to develop quality management capabilities before stringent performance accountability, pay-for-performance programs could enhance EHR adoption and also ensure realization of the quality and efficiency value it brings.

While further analysis and review is needed, it is possible that one or more of these mechanisms (or others) could be employed by HHS to stimulate EHR adoption.  These incentives could be aimed at institutions, clinicians, or both.  Clinicians are known to be reluctant to adopt EHRs, and hospitals report substantial barriers to EHR adoption that arise from physician resistance.  Despite their management depth, capital availability, and technology experience, hospitals are to some degree dependent on the general views of clinicians toward EHRs.  Therefore, incentives aimed at professionals might be helpful to EHR adoption in physicians' offices and other ambulatory care sites, but also in hospital and other institutional settings as well.

In order to better understand the value of these options from a societal and industry perspective, the Secretary of HHS will take immediate action and convene a Health Information Technology Leadership Panel, consisting of executives and leaders.  This panel will assess the costs and benefits of HIT to industry and society, and evaluate the urgency of investment in these tools.  These leaders will discuss the immediate steps for both the public and private sector to take with regard to HIT adoption.  The Health Information Technology Leadership Panel will deliver a report to the Secretary no later than Fall 2004.

In addition, HHS and OPM are participating in the recently formed National Alliance for Health Care Information Technology Advancement.  The Alliance is comprised of purchasers and payers representing almost 200 million covered persons.  It will work together to accomplish the following goals:

  • Identify financial and non-financial incentives that would lower some of the current barriers to HIT adoption and use, while recognizing potential cost implications for all stakeholders.
  • Explore avenues to share standardized data and contribution to electronic PHRs.
  • Build on the collaborations between all parties to support each other in the adoption and implementation of this initiative to advance the quality, safety, and efficiency of health care.

HHS will work closely with the Alliance during the next 90 days to identify specific strategic actions to meet these goals.

Beyond its role as a payer, the federal government operates large care delivery networks for active military, their families, and retirees through DoD, for eligible veterans through VA, and for American Indian/Alaska Native people through the Indian Health Service (IHS.)  As a purchaser of clinical services, the federal government contracts with private sector providers to deliver care to eligible beneficiaries.  For VA, these contracts are primarily in the area of nursing home and rehabilitative care.  The VA recognizes strong similarities between the use of incentives within contracting and those within reimbursement, so it will align its contract incentives with the reimbursement incentives as established by the private and public sectors.  IHS has begun leveraging its buying power with two major contractor reference laboratories to ensure that Health Level 7 (HL7) messaging standards are incorporated to ensure bi-directional electronic transfer of laboratory orders and results.  DoD continues to work closely with the health services and support contractors in the areas of privacy, security, and the trusted exchange of health information.  DoD will also solicit industry's input regarding potential contracting incentives.  DoD has already developed contract language to encourage the electronic reporting of health data and will consider using the electronic sharing of health data in future contract evaluation criteria.  The full VA report is included as Attachment 2 and the DoD report is included as Attachment 3.

As the nation's largest employer purchaser of health care benefits for more than 8 million people across the United States, the federal government has a strong interest in ensuring high-quality care for its employees and annuitants at a reasonable price.  OPM is exploring a variety of options to leverage its purchasing power to support EHR adoption by the providers and networks that deliver services to federal employees, annuitants, and their covered family members.  OPM will be strongly encouraging health plans to promote the early adoption of HIT.  The report from OPM is presented in Attachment 1.

Reduce risk of EHR investment

Clinicians who purchase an EHR and who attempt to change their clinical practices and office operations face a variety of risks that make this decision unduly challenging.  Implementation failure and partial use of EHRs are commonplace.  Even if EHRs are implemented, there is no guarantee that they will be used and therefore lead to value for clinicians, consumers, or payers.  Failed EHR implementation dissipates investment capital and leads to cynicism and fear among those who may want to bring their practices into a more modern era.

Implementation risks and the lack of value realization from EHRs limits growth and sustainability of the private market for health care information technology.  Both buyers and sellers can benefit from institutions and agents that support physician buyers when they deal with highly capitalized technology companies.  These institutions can mitigate the risk of EHR implementation failure and can also affect information asymmetry between clinicians and vendors when EHRs are being marketed.  This will result in more cost-effective EHR adoption, less risk-adverse buyers, and a faster-growing and more attractive market for investments in HIT.

There are many causes of the risks associated with EHR implementation.  One is that clinicians lack affordable and skilled support to assist in implementation and workflow change.  Clinicians need ongoing technical assistance on how to reorganize office workflow processes to integrate and utilize EHRs to improve the quality, safety, efficiency, and cost in managing care.  Support is needed for a wide variety of information tools, including registries, e-prescribing, e-labs, PHRs, and a fully integrated EHR.  However, since many physicians are in small practices that may lack capital and spend relatively small sums on EHRs, they cannot easily find these services.  ONCHIT will encourage private sector organizations to evaluate potential vehicles to provide this support on a cost-effective and trusted basis.

Another risk is faced in product selection.  EHRs and even specific components such as decision support software are unique among clinical tools in that they do not need to meet minimal standards to be used to deliver care.  To increase uptake of EHRs and reduce the risk of product implementation failure, the federal government is exploring ways to work with the private sector to develop minimal product standards for EHR functionality, interoperability, and security that will be tied to financial incentives.  A private-sector, ambulatory EHR certification task force is determining the feasibility of certification of EHR products based on functionality, security, and interoperability.  This task force will determine the governance structure for the certification entity that represents the various participants in EHR adoption.  It will also identify minimal requirements for portable, secure, and interoperable health information and develop mechanisms for evaluating products against these criteria.

Promote EHR diffusion in rural and underserved areas

A gap in EHR adoption between urban and rural practices has been documented.  Organizational size appears to influence EHR adoption (Lorence et al, 2002) in both inpatient and ambulatory settings.  Urban practices capture 30% more patient information electronically than do rural practices.  Interventions that increase overall EHR uptake may widen this gap unless protections are established for practices and hospitals in rural and other underserved areas.  This could result in divergent standards of care based on availability of EHR technology.

The federal government will explore how to address the barriers to EHR adoption in rural and underserved areas by using its buying power and specialized technology to improve the access to EHRs.  DoD and VA operate the largest health care delivery networks in the nation.  VA has significant experience in delivering care to rural and historically underserved veteran populations.  DoD has significant experience in delivering care in isolated conditions such as those encountered in wartime or overseas peacekeeping missions, which can be compared to the conditions in some rural health care environments.  Furthermore, the need for DoD to transport data to other facilities or providers may be similar to the situation with migrant workers.  As purchasers of health care delivery products and services, these departments have significant experience in developing health care information technology acquisition strategies, performance-based contracts, negotiated volume discounts, and contract management.  DoD and VA will draft templates of standard contract language for use nationally that will encourage industry to produce products and services that are scalable and applicable to the private sector.  When selecting potential contractors, acquisition selection criteria could be developed that favorably consider those companies that agree to provide products and services applicable to targeted communities such as rural and underserved areas.

To meet the existing business needs of reaching geographically distanced providers and consumers, the VA has become a leader in the field of telehealth and telemedicine.   's strategy for the expansion of telehealth could not take place without the presence of the VistA computerized patient record system. Within VA, there is a uniformity of opinion that the future of telehealth is within the context of a multimedia patient record.  The driver for these innovations in VA is not primarily technological; it is instead that technology is serving how VA meets the changing nature of the health needs of veterans.

VA is working with HHS to transfer HIT to the private sector.  CMS is funding and collaborating with VA and other key federal agencies on the development of a "VistA-Office EHR" version of the VistA system for potential use in clinics and physician offices.  An overriding goal of VistA-Office EHR is to stimulate the broader adoption and effective use of EHRs by making a robust, flexible EHR product available in the public domain.  The first version of VistA-Office EHR is expected to be available in 2005.  The system will be made available under the Freedom of Information Act, and may be used by commercial EHR vendors or installed directly by health care providers.  Further details of VA activities are reported in Attachment 2.

DoD has significant experience in delivering care in isolated conditions such as those encountered in wartime or overseas peacekeeping missions that can be compared to the conditions in some rural health care environments.  Examples of the technologies used in these conditions include:  telehealth for radiology, mental health, dermatology, dental, and pathology consultation; online PHRs for beneficiary use; bed regulation for disaster planning; basic patient encounter documentation; and pharmacy, radiology, and laboratory order entry and results retrieval for use in remote areas and small clinics.  The full DoD report is presented in Attachment 3.

IHS can provide another alternative for rural and safety net sites through the next generation of the Resource and Patient Management System (RPMS) EHR system.  Through support from AHRQ, the new RPMS will have an improved graphical-user interface that will significantly enhance the functionality of the system.  Since the IHS system is extensively used in small and rural communities, it has many features that would support its use in other safety net communities.  In addition, since the IHS provides care across the life continuum, much functionality for women and children are already available.

Interconnect clinicians

Without an interoperable infrastructure to allow for the secure movement of health information, the adoption and use of EHRs will not realize their full benefits.  Indeed, non-interoperable EHRs could actually impede access and harm care by protecting information silos and proprietary control over populations to limit mobility of patients.  Therefore, it is essential that EHRs are interoperable so that data are portable and can follow patients as they move through care settings.

An interoperable infrastructure requires coordinated and secure health information exchange, including the business, governance, and technical delivery mechanisms to support it; a set of intercommunication tools, and services for common architecture development; the diffusion of product standards into deployed products; privacy and security assurances; and connectivity infrastructure.  Development of this infrastructure is a vital national priority and will require vehicles that can support public and private sector investments.  An interoperability infrastructure will accelerate the adoption of EHRs, as well as their use in a way that benefits consumers, purchasers, and society as a whole.

The following three strategies for achieving the goal of interconnecting care are detailed below:

  • Foster regional collaborations;
  • Develop a national health information network; and
  • Coordinate federal health information systems.

Foster regional collaborations

The development, implementation, and application of secure health information exchange across care settings require a local leadership, oversight, fiduciary responsibility, and governance.  These regional health information organizations (RHIOs) are critical to health information exchange that reflects the health care priorities of a local area as well as the legitimacy and trustworthiness of this activity to clinicians and consumers.

While a few regions, states, or local areas have collaboratives that operate as governance entities, such as the Indiana Health Information Exchange, The Share Health Information Across Regional Entities project in Massachusetts, and the Santa Barbara County Care Data Exchange, there is no systematic basis for regional organization that can serve the nation's health information exchange goals.  These local or regional initiatives are under way and increasing in number, but they lack coordination, involve poorly funded early stage projects, are highly variable, and have not produced a sustainable business model for other regions.

The Foundation for eHealth Initiative's Connecting Communities for Better Health Program, based on a widely disseminated request for capabilities funded by the Health Resources and Services Administration, Office of the Advancement of Telehealth (HRSA/OAT), found that 134 community-based health information exchange projects across 42 states are developing varying types of organizational and operating models.

To create a more permanent and accountable infrastructure to support health information exchange, there is a need for a common approach to the formation and operation of RHIOs.  The government could help define a common set of practices by incorporating minimal performance requirements into its contracts with, or grants to, communities.  Another approach, commonly used in health care, is private sector accreditation to ensure that these organizations meet minimal standards.  Nongovernmental accreditation would serve a necessary oversight function without undue regulation or requirements.  HHS will explore how to ensure minimal standardization in conjunction with other federal agencies and the private sector.

Regardless of how RHIOs are overseen, the government can play an important role in supporting their formation. One role is to ensure that RHIOs are formed in the major market areas and, to the extent possible, in rural areas.  Currently, there are two HHS programs available to support RHIOs through grants and contracts.

First, AHRQ is funding State and Regional Health Information Exchange Demonstration Projects.  AHRQ will fund at least five state-level health information exchange projects to build on current state-level planning activities by providing crucial funding, technical assistance, and coordination. Further, the regional health information authorities will be piloted as critical aspects of the projects to build, operate, and sustain health information exchange.  AHRQ will announce the states that are awarded contracts in 2004.

The second HHS health information exchange program is through HRSA/OAT, which has a cooperative agreement with the Foundation for eHealth Initiative to administer contracts to support the Connecting Communities for Better Health (CCBH) Program totaling $2.3 million.  This program is providing seed funds and support to multi-stakeholder collaboratives within communities (both geographic and non-geographic) to implement RHIOs that can drive improvements in health care quality, safety, and efficiency.  The specific communities that will receive the funding through this program will be announced and recognized during the Secretarial Summit on July 21.

Develop a national health information network

Interoperable EHRs and health information exchange requires a set of common standards as well as intercommunication tools such as mobile authentication, Web services architecture, and security technologies.  Many of these technologies exist in other industries, but have not been adapted to the unique requirements of health information exchange.  A national health information network that can provide low-cost and secure data movement is needed, along with a public-private oversight or management function to ensure adherence to public policy objectives.

Such a technology should be nonproprietary, available for broad use, and shared within the public domain in a manner that is available to all.  It should be integrated with public health surveillance and response in accordance with existing statutory provisions, and deployed and operated in a secure, HIPAA-compliant and decentralized manner.  This national network will require an investment that is large and risky, and will require the coordinated efforts of many technology companies.

A key component of a national health information network is the development of technically sound and robustly specified interoperability standards and policies for diffusion into practice.  There has been considerable effort and progress achieved by HHS and other federal agencies with the adoption of standards across 20 domains by the Consolidated Health Informatics (CHI) initiative to allow for the electronic exchange of clinical health information across the federal government.  The National Library of Medicine (NLM), AHRQ, FDA, VA, and DoD have been collaborating to promote the adoption, mapping, and implementation of key vocabularies such as SNOMED CTÃ’ and RxNorm (a clinical drug vocabulary).  Additionally, the Public Health Information Network (PHIN) and National Electronic Disease Surveillance System (NEDSS) under the leadership of the CDC have made notable progress in the development of shared data models, data standards, and controlled vocabularies for electronic laboratory results reporting and health information exchange. With HHS support, HL7 has also created a functional model and standards for the EHR.

To begin the process of movement toward a national health information network, HHS is releasing a request for information (RFI) in the summer of 2004 inviting responses describing the requirements for private sector consortia that would form to plan, develop, and operate a health information network.  Members of the consortium would agree to participate in the governance structure of this privately financed consortium in an equitable manner.  The role that HHS could play in facilitating the work of the consortium and assisting in identifying the services that the consortium would provide will be explored, including the standards to which the health information network would adhere to in order to ensure that public policy goals are executed and that rapid adoption of interoperable EHRs is advanced.  The resulting national health information network will be coordinated and interoperable with the FHA.

Also, CMS will be proposing a regulation that will require the first set of widely adopted e-prescribing standards in preparation for the implementation of the new Medicare drug benefit in 2006.  When this regulation is final, Medicare Prescription Drug Plan (PDP) sponsors will be required to offer e-prescribing, which will significantly drive adoption across the United States.  Health plans and pharmacy benefit managers that are PDP sponsors could work with RHIOs, including physician offices, to implement private industry-certified, interoperable e-prescribing tools and to train and support clinicians.

A subsequent regulation will be proposed for additional standards necessary to realize the full value of e-prescribing, once these standards have been developed and tested in the health care system.  In parallel with this effort, FDA will work with the pharmaceutical industry to develop a structured product label that will use medication standards to enable electronic drug information to be available at the point of care when prescribing decisions are made.  Through collaboration with the NLM, electronic drug information called DailyMed will be disseminated free of charge to all information systems.

Future possible actions by the federal government include security technology transfer by the DoD.  The DoD has significant experience in developing and implementing common and unique infrastructure solutions that provide the foundation for all information exchange. DoD is exploring ways to share this experience with private-sector developers of interoperability solutions to the extent allowable under current law.  Potential areas of technology transfer include computing (e.g., computers, databases, and servers) and communication (networks, Internet connectivity, and security firewalls) infrastructure requirements, which serve as the backbone for exchanging secure information.

Coordinate federal health information systems

The federal government maintains a large variety of health information systems that support the delivery, management, reimbursement, monitoring, and other aspects of patient care.  There is a strong need to provide for interoperability and exchange of data through these systems so that federal systems are more efficient and cost-effective.  Additionally, federal health information systems will be coordinated and interoperable with the national health information network.  There have been early efforts to coordinate these systems through the FHA and the CHI, but there is more to be done.  The federal government operates at least three patient care information systems, multiple claims and reimbursement systems, and an undefined number of systems that collect and deliver information for federal agencies, or that store, analyze, or communicate this information elsewhere.  To facilitate the exchange of electronic health information, DoD and VA are finalizing a common architecture strategy consisting of standardized data, communications, security, and high-performance health information systems.  However, many systems still cannot communicate among themselves or provide a minimal amount of interoperability.

In the near future, a consortium of federal agencies that are involved in health information will make a renewed commitment to the FHA and CHI for the purpose of achieving internal interoperability.  This will be accomplished by refining a blueprint and an information architecture for the federal health enterprise.  The blueprint will serve as a common business reference point from which information technology investment decisions can be made.  The architecture will enable collaboration and data sharing across the government and with various organizations such as states and private entities that provide or need federal information.  The FHA initiative is the forum to forge unification of isolated architectures to develop common pathways of interoperability between government agencies.  Toward this end, FHA has committees on the EHR, food safety and surveillance, and interagency operability under way.  All resulting information architectures will adhere to the industry standards endorsed by the federal agencies as CHI standards.

The VA and DoD are also actively collaborating and cooperating on security standards, consistent with HIPAA security rule and other relevant laws, for the following services:  identification, authentication, accountability, data integrity, non-repudiation, confidentiality, and certification.  Confidentiality, security of information, and data integrity are fundamental requirements for the successful exchange of information and in the evolution of the EHR.

The VA and DoD Common Security Architecture will contain a framework for information assurance (information security and confidentiality) roles and behavior among information technology assets, and prescribe rules for interaction and interconnection.  This architecture must provide for the integrity, confidentiality, and authentication of electronic-protected health information (EPHI) as dictated by HIPAA.  It can serve as a basis for federal enterprise-wide health communications exchange.  The important work of these departments will be incorporated into the FHA, where both departments are leading members.

Personalize care

The ability to assemble and use information that is complete with respect to a specific person is an essential part of the application of information technology to health care and, in many ways, the fullest expression of interoperability.  Consumer-centric information helps individuals manage their own wellness and assists with their personal health care decisions.  This information could include consumer-specific health findings, health status monitoring tools, or customized prevention and self-care information. Such personalized care information could be adapted for diverse individual needs, cultural traditions, reading levels, or socioeconomic modulators of illness.  The ability to personalize care is a critical component of using health care information in a meaningful manner.

The universe of health information that may be accessed by consumers is enormous.  Tools to synthesize and customize this information are crucial for the discovery and presentation of relevant facts in the interest of a given consumer.  At present, most of an individual's personal health information is only accessible through a restricted set of channels, primarily his/her physician or health plan.  Enhancing the information available to consumers, making it more relevant or customized to their needs and linking this to treatment options, promises to improve the consumer's participation in care delivery.  This is particularly true for advances in genetics and genomics that will be key in many respects to personalizing health care.  Once equipped with the information about their health and health care choices, consumers will be empowered to co-manage their health and participate actively in decisions about their care.

Consumers are increasingly seeking customized and better information as a means of improving their health status.  Increasingly consumers are accessing health information via the Internet, and the number of health-related websites has increased.  Consumers are looking for information that is tailored to their illness or concerns, and want to know how advisories, treatment options, risks, or other information relate to themselves.  They also want to be able to share and discuss this information with their own health care clinicians.

Three strategies for achieving the goal of personalized care are detailed below:

  • Encourage use of (PHRs);
  • Enhance informed consumer choice; and
  • Promote use of telehealth systems.

Encourage use of PHRs

One rapidly emerging trend is the PHR, which maintains individual personal health information from a variety of health records, guidelines, and other tools useful to consumers.  While the specifications for the PHR and its relationship to EHRs have yet to be defined, the Connecting for Health Public Private Collaborative, involving the American Public as Partners work group, has identified techniques, standards, and policies to be employed by developers of PHRs to ensure that information can be exchanged between PHRs and other data sources for the patients' benefit.  The group has also recommended that demonstration projects should occur to implement these common practices.

The federal government has and will continue to use information technology as a central tool and vehicle to disseminate health information and knowledge to consumers.  Currently, HHS provides health information via the Web, and agencies customize information and interactive tools for different types of consumers, including the elderly.  For example, MedlinePlus, MedlinePlus en Espanol, healthfinderâ, CDC's consumer health information, and www.4woman.gov, the Office of Women's Health website, are experimenting with different methods of customizing personal health information.  In particular, the CDC's new Futures Initiative includes anticipated changes in the CDC's website that will allow for up-to-date prevention and disease information to be integrated into clinical care information systems to support just-in-time information delivery and reference.

An immediate step in improving consumers' access to personal and customized health information is CMS' Medicare Beneficiary Portal, which provides secure health information via the Internet.  This portal will be hosted by a private company under contract with CMS, and will enable authorized Medicare beneficiaries to have access to their information online or by calling 1-800-MEDICARE.  Initially the portal will provide access to fee-for-service claims information, which includes claims type, dates of service, and procedures.  The pilot test for the portal will be conducted for the residents of Indiana.  In the near term, CMS plans to expand the portal to include prevention information in the form of reminders to beneficiaries to schedule their Medicare-covered preventive health care services.  CMS also plans to work toward providing additional electronic health information tools to beneficiaries for their use in improving their health.

Enhance informed consumer choice

Unbiased information about the performance of health care providers empowers consumers to make informed choices about where and from whom to receive health care treatments.  Consumers should be informed about clinicians and institutions based on what the consumer values, including, but not limited to, the quality of care that the provider has historically delivered.  However, efforts to provide reliable and sufficiently risk-adjusted measures about health care provider performance have been significantly shaped and limited by the availability of robust clinical information.  Because of this, clinical performance is difficult to compare with certainty, and what is measurable is often not what is important in consumer choice.

CMS has taken a leadership role in promoting consumer choice by providing information about the performance of dialysis facilities, nursing homes, and home health agencies on its consumer-friendly www.medicare.gov website.  Since there was no regulation for hospital data reporting, a 10-measure starter set of performance data for heart attack, heart failure, and pneumonia has been voluntarily reported as part of the National Voluntary Hospital Reporting Initiative (NVHRI) since October 2003.  The NVHRI is collaborating with the American Hospital Association, the Federation of American Hospitals, the Association of American Medical Colleges, the AFL-CIO, JCAHO, and others.  In February 2005, this information will migrate to Hospital Compare on www.medicare.gov for consumers.  Content, displays, and formats are now being tested with consumers in order to make the information consumer friendly and understandable.

Promote use of telehealth systems

The use of telehealth can provide access to health services for consumers and clinicians in rural and underserved areas.  Telehealth is the delivery of health care services in cases where the participants are in different locations, and may even be separated in time.  Using various forms of telehealth, rural clinicians can, for example, examine a patient's inner ear from a remote location.  A patient in a rural emergency room can get the benefit of local care in addition to remote consultation with a specialist.  A clinician can review a radiology scan that was forwarded from a remote location.  A patient and nurse can interact during a video home visit, and the nurse can check vital signs and monitor medication compliance.  A patient and clinician can communicate by e-mail to make health care decisions without requiring the patient to be in the physician's office.  These forms of telehealth provide distance-based support to clinicians or to clinicians and patients.

Research studies have demonstrated the usability and cost savings of telehealth applications.  Medicare's reimbursement of telemedicine through the physician fee schedule started in January 1999 for several care providers, including physicians, physician assistants, nurse practitioners, clinical nurse specialists, nurse midwives, clinical psychologists, and clinical social workers as well as various types of procedures such as consultations, office visits, individual psychotherapy, and pharmacologic management.  Currently, there are certain limitations on the reimbursement requirements, including:  a) Only patients located in rural Health Professional Shortage Areas (HPSAs) and beneficiaries in counties not defined as a metropolitan statistical area (MSA) are eligible for telemedicine reimbursement;  b) there are fee-sharing challenges between primary care clinicians and specialists; and  c) licensed practicing nurses and registered nurses are not eligible for reimbursement under Medicare.

In order to fully use telemedicine as a means of improving care, the Joint Working Group on Telehealth (JWGT) provides a forum for federal agencies to coordinate telehealth program and policy development.  The JWGT membership includes representatives from every major cabinet agency involved in providing telehealth services, and is staffed by the Office for the Advancement of Telehealth, HRSA. Agencies and private-sector organizations share telehealth expertise and information, educate participants, and take actions to increase use of telehealth.  Additionally, HRSA has been a leader in promoting the advancement of telehealth systems, funding programs and demonstrations since 1988.

Improve population health

The improvement of population health requires timely, accurate, and detailed clinical information to allow for evaluation of health care delivery.  It may include reporting of critical findings to public health officials, clinical trials, and other research.  Feedback to clinicians is also important for improvements in care delivery.  However, collection of this information cannot impose an undue burden.  This is of particular importance as assumptions are made about the ability of EHRs to support a new echelon of information needs for research and surveillance.

Significant work has been done by the CDC and state public health agencies to identify and implement appropriate standards and establish practices that meet a broad array of different population health functions.  The benefits of information collection to support population health - quality measurement, patient safety, research and clinical trials, public health reporting, and biosurveillance - are apparent, but how and under what conditions these data should be collected are not.  While information required for population health needs to be captured by EHRs and exchanged with local, state, and federal government to the extent possible under current law, this has to proceed in a coherent and collaborative manner.

The following three strategies will achieve the goal of using HIT to improve the population's health status:

  • Unify public health surveillance architectures;
  • Streamline quality and health status monitoring; and
  • Accelerate discovery and dissemination.

Unify public health surveillance architectures

To reduce the risk to public health from hazards such as communicable diseases, unsafe imported foods, and terrorism, public health must detect threats soon after they occur, investigate the magnitude and nature of the threat, track who is sick, with whom they have been in contact, and where they were exposed to the disease or contaminated food.  Public health officials must also alert health care providers of a confirmed or potential threat and deliver relevant information, treatment guidelines, and interventions; support countermeasure and response administration, including treatment, prophylaxis, vaccination, and isolation; and monitor the response, determine if it was effective, and apply changes to improve outcomes.  Likewise, medical devices and other products need to be monitored by trained professionals who can ensure that the device is functioning properly and the desired functional result is achieved.

An interoperable surveillance system will allow exchange of information, consistent with current law, among provider organizations, organizations they contract with, and state and federal agencies.  The key challenge in harmonizing surveillance architectures is to identify solutions that meet the reporting needs required for each surveillance function yet which also work in a single integrated and cost-effective architecture.  The current legal framework for public health surveillance will guide short-term planning efforts to integrate architecture.  However, as longer-term planning is under way, HHS will explore business practices and certain types of secure information exchange for public health purposes.  These findings may require additional regulations to better protect public health.

HHS is exploring many actions to realize the goal of improving population health.  The following actions summarize the most important future efforts that could better unify architectures to improve surveillance.  The government-sponsored standards-setting processes, CHI and the FHA, will develop a unified and interoperable infrastructure to simplify the surveillance-related data exchange between government agencies and the health care delivery system.  This will result in consistent, real-time data feeds routed over common infrastructure to meet the needs of public health surveillance and response functions, and allow for a unified population-health approach that will deliver the best care in the most cost-effective manner.  As part of this, CDC will work to integrate local and state public health surveillance, alerting, knowledge management, and response functions using national information systems standards.  Public Health Informatics Network (PHIN) partnerships with the Department of Homeland Security have implemented HL7 lab result reporting for environmental monitoring in over 20 Laboratory Response Network Labs nationally.  Partnerships with the FDA are developing HL7 standard messages for food monitoring, and the FDA has also developed an HL7-based messaging standard to facilitate automated reporting of product-related adverse events from the EHR to improve the frequency and quality of reporting without inconveniencing the clinician or causing undue burdens on providers.  Similarly, the Environmental Protection Agency (EPA) has a mature surveillance system that will contribute substantially to the consolidated architecture.

CDC will also work with local and state public health partners that are involved with regional health information projects to ensure that important public health data is captured and transmitted, as appropriate, to CDC.  BioSense, a new program for accelerated early detection of bioterrorist or naturally occurring outbreaks, will work with AHRQ-funded state demonstration programs starting in 2004 to plan for the provision of health event data for use in detecting, localizing, and then investigating emerging disease events.  BioSense is now receiving standards-based health event data from DoD and VA health care facilities.

Streamline quality and health status monitoring

Aggregated and de-identified individual health care data have a critical role in monitoring population health status and clinical quality at the point of care.  These data can be used to detect and address quality variations, to enable consumer choice, and for many other functions.  They can support pay-for-performance programs and other means of rewarding outstanding quality.  When aggregated and analyzed, timely and detailed clinical data can improve care in a community or the whole nation by rationalizing the allocation of resources, steering new research, and enhancing clinician training.  Many different state and local organizations collect subsets of data for specific purposes and use them in different ways.  A streamlined quality-monitoring infrastructure will allow for a complete look at quality and other issues in real-time and at the point of care, while also minimizing intrusions and burdens imposed on clinicians.

Population health status monitoring can also benefit from widespread adoption of EHRs and PHRs.  CDC currently receives health status data from many sources, including population-based surveys, vital statistics, and administrative datasets.  EHRs and PHRs have the potential to supplement conventional reporting and monitoring through direct electronic data acquisition.

HHS has already shown progress in streamlining quality reporting.  CMS has developed, in conjunction with the American Medical Association's Consortium on Performance Improvement, a set of clinical quality measures for physician office-based care, which are now going through an expedited approval process at the National Quality Forum.  The measures are designed in such a way as to be collected by an EHR.  In addition, the IHS has developed specific software applications to facilitate the electronic tracking of patient, community, and population-based health indicators.  This software is linked to Healthy People 2010, as well as other national quality measure sets, and can be used by organizations that qualify for payments in performance-based programs.  The software application, as well as the specifications for it, are available to the public for review and re-use.

Accelerate research and dissemination of evidence

To improve human health, scientific discoveries must be translated into clinically useful products and applications.  Such discoveries typically begin in the laboratory, where scientists study the mechanisms and pathogenesis of a disease at a molecular or cellular level, and then progress to testing in animal models and eventually people.  This bench-to-bedside approach is critical to ensuring a fruitful return on the public's investment in research and in ensuring the safety and efficacy of future clinical therapies.  It is important, therefore, that the federal government use information technology to accelerate this process.

Information technology can be a key tool in enhancing the efficiency and effectiveness of the development of therapeutic agents and tools such as drugs, devices, and biologics.  Information technology can enhance the process of organizing and conducting trials, including protocol development, human subject protection review, participant recruitment, and site selection.  Information technology can also be promoted to optimize the safety of clinical studies, facilitating the timely reporting of safety data, as well as the sharing and analysis of data by the FDA, AHRQ, and the National Institutes of Health (NIH), and other agencies that may have oversight responsibilities.

NIH plans to develop NECTAR, which will link research sites and ultimately create a "national network of networks," in coordination with the national health information network, by which research information and findings will be shared and scientific collaborations facilitated.  NECTAR includes a research workflow model, a common lexicon of standard vocabularies to describe medical and scientific events, and analytical and dissemination tools.

FDA and NIH, together with the Clinical Data Interchange Standards Consortium (CDISC) - involving over 40 pharmaceutical companies and clinical research organizations - have developed a standard for representing observations made in clinical trials called the Study Data Tabulation Model (SDTM).  This model will facilitate the automation of the largely paper-based clinical research process, which will lead to greater efficiencies in industry and government-sponsored clinical research.  The first release of the model and associated implementation guide will be finalized prior to the July 21 Secretarial Summit and represents an important step by government, academia, and industry in working together to accelerate research through the use of standards and HIT.

The National Cancer Institute (NCI) has been piloting the Cancer Biomedical Informatics Grid (caBIG), and plans to implement it across 50 academic research centers supporting cancer research.  The informatics infrastructure connects teams of cancer and biomedical researchers to enable them to better develop and share tools and data in an open environment with common standards, creating a network that links individuals and national and international institutions.  caBIG is contributing standards-based applications from basic science in genomic and proteomics through those supporting clinical research to provide researchers with state-of-the-art tools to accelerate the discovery and development process.

In another effort to speed new research discoveries to the public, NCI and FDA are also working to facilitate a more cost-efficient flow of higher-quality clinical research data to FDA. As part of the caBIG effort, they will deploy a standards-based, electronic clinical research exchange to support regulatory submissions.  This infrastructure will allow secure transmission of clinical research information among sponsors, researchers, and the FDA.  This infrastructure is being developed through an open community process involving academia, government, and industry to address the opportunities of this technology to facilitate clinical research and the issues surrounding implementation.

Beyond using information tools to facilitate the research process, interoperable EHRs that can access national clinical decision support databases would also accelerate translation of research into practice through ready access to the latest clinical knowledge.  Real-time delivery of clinical information to clinicians at the point of care could improve clinical decisions at the time they are being made.  It would also allow for clinical alerts on medication recalls, as some large health plans have been able to do for some time, as well as new therapies and screening opportunities.  HHS agencies will work together in implementing the necessary actions to translate the evidence base into practice.

Last revised: July 26, 2004

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