Question

What is the overall information systems operations health and future within the organization?

Answer 1

Information and Communications Systems: The Backbone of the Health Care Delivery System

The preceding chapter describes an array of systems-engineering tools and associated techniques for analyzing, designing, controlling, and improving health care delivery processes and systems. This chapter is focused on the application of information and communications technologies to the delivery of safe, effective, timely, patient-centered, efficient, and equitable health care, a review of progress toward the establishment of a National Health Information Infrastructure (NHII), and a description of the tasks that lie ahead. The committee highlights the complementary nature of information/ communications technologies and systems engineering.

THE CENTRALITY OF INFORMATION TO HEALTH CARE DELIVERY

Information and information exchange are crucial to the delivery of care on all levels of the health care delivery system—the patient, the care team, the health care organization, and the encompassing political-economic environment. To diagnose and treat individual patients effectively, individual care providers and care teams must have access to at least three major types of clinical information—the patient's health record, the rapidly changing medical-evidence base, and provider orders guiding the process of patient care. In addition, they need information on patient preferences and values and important administrative information, such as the status and availability of supporting resources (personnel, hospital beds, etc.).

To integrate these critical information streams, they will also need training/education, decision-support, information-management, and communications tools. For individual patients to participate as informed, “controlling” partners in the design and administration of their own care, they must also have access to much the same kind of information and education, decision-support, and communications tools—in a “patient-accessible/usable” form.

At the organizational level, hospitals and clinics need clinical, financial, and administrative data/information to measure, assess, control, and improve the quality and productivity of their operations. At the environmental level, federal/state funding and regulatory agencies and research institutions need information on the health status of populations and the quality and productivity/performance of care providers and organizations to execute regulatory oversight, protect and advance the public health (surveillance/monitoring), evaluate new forms of care, accelerate research, and disseminate new medical knowledge/evidence.

As discussed, information and information exchange are also critical to the tactical and strategic applications of systems-engineering tools at all four levels of the system, especially for strategic applications of enterprise-management tools and risk analysis and management tools at the organizational and environmental levels.

The Information Technology Deficit and Its Proximate Causes

Although information gathering, processing, communication, and management are essential to health care delivery, the health care sector as a whole has historically trailed far behind most other industries in investments in information/ communications technologies. Moreover, most health care-related information/communications technologies investments to date have been concentrated on the administrative side of the business, rather than on clinical care. As a result of this prolonged underinvestment, little overall progress has been made toward meeting the information needs of patients, providers, hospitals, clinics, and the broad regulatory, financial, and research environment in which they operate. A number of localized efforts have been made to develop and implement electronic patient records and other clinical applications of information/communications technologies since the 1960s, but little progress has been made in closing the gap.

Many factors have contributed to the information/ communications technology deficit: (1) the atomistic structure of the industry (the prevalence of relatively undercapitalized small businesses/provider groups); (2) payment/reimbursement regimes and the lack of transparency in the market for health care services, both of which have discouraged private-sector investment in information/communications systems; (3) historical weaknesses in the managerial culture for health care; (4) cultural and organizational barriers related to the hierarchical nature and rigid division of labor in health professions; and (5) the relative technical/functional immaturity (until very recently) of available commercial clinical information/communications systems.

FROM ELECTRONIC MEDICAL RECORDS TO A NATIONAL HEALTH INFORMATION INFRASTRUCTURE

The idea of transforming paper medical records into electronic medical records (EMRs) was first considered in the mid-1960s, when early prototype systems were developed. A number of large integrated health care provider organizations were early adopters of EMR systems, including Massachusetts General Hospital (COSTAR) in the 1960s, Indiana University Medical School (Regenstrief Medical Record System) in the early 1970s, and others. However, there was little diffusion of these systems in the next two decades. In 1991 and 1997, IOM issued reports documenting the magnitude and implications of the large information-technology gap in U.S. health care and called for the adoption of EMRs as a first, critical step in moving health care delivery toward information/communications-technology-supported improvements in quality performance achieved in other industries.

Building on these studies, a series of reports by IOM, the National Committee on Vital and Health Statistics (NCVHS), and other organizations in the past five years have documented the profound negative impact of the information/ communications technology deficit on patient safety, the number of medical errors, and the quality and cost of care; every one of these reports calls for the development of a comprehensive health care information infrastructure (e.g., NHII) to help close the gap.

In Information for Health: A Strategy for Building the National Health Information Infrastructure, NCVHS described the NHII as both infrastructure and a defined set of components linked explicitly to health care delivery processes (NCVHS, 2001). IOM (2004) summarized the NCVHS definition as follows:

The NHII is defined as “a set of technologies, standards, applications, systems, values, and laws that support all facets of individual health, health care, and public health”… It encompasses an information network based on Internet protocols, common standards, timely knowledge transfer, and transparent government processes with the capability for information flows across three dimensions: (1) personal health, to support individuals in their own wellness and health care decision making; (2) health care providers, to ensure access to complete and accurate patient data around the clock and to clinical decision support systems; and (3) public health, to address and track public health concerns and health education campaigns.

This stream of reports from IOM, NCVHS, and others catalyzed a number of actions in the private and public sectors intended to lay the groundwork for and build momentum toward realization of the NHII. Inspired by the 1999 IOM report, To Err Is Human, the Leapfrog Group for Patient Safety, a coalition of large companies established expressly for the purpose of using their market power as major purchasers of health care to encourage care providers to improve the safety, quality, and efficiency of health care. The Leapfrog Group called on all health care provider organizations serving Leapfrog members' employees to use information/communications systems (EMRs and computerized physician order entry [CPOE] systems in particular) (see paper by Milstein in this volume).

In April 2004, progress toward an NHII was given new impetus when President Bush called for national implementation of EMRs and announced the creation of the Office of the National Coordinator for Health Information Technology (ONCHIT) in the U.S. Department of Health and Human Services (DHHS); Dr. David Brailer was appointed the first national coordinator. In July, DHHS released a report outlining a 10-year plan to build an NHII, including the creation of electronic health records (EHRs), for all Americans. In November 2004, ONCHIT issued a Request for Information (RFI) for a National Health Information Network (NHIN), soliciting proposals for ways to advance interoperability and standards. As of early 2005, ONCHIT had received more than 500 responses from a wide variety of organizations and collaboratives.

One of the respondents to the RFI, the Interoperability Consortium, an alliance of eight information-technology systems vendors (Accenture, Cisco, CSC, Hewlett-Packard, IBM, Intel, Microsoft, and Oracle), describes the current challenges to interoperability:

Dozens of communities and innovative networks across America have begun implementing information exchange solutions—yet they are following no common pathway, no uniform standards, and have established no basis for eventual information exchange among them or with the important national information networks already in existence. A common framework is needed to guide and maximize the value of the enthusiastic efforts already in the field.

In its preliminary blueprint for NHIN, the Interoperability Consortium (2005) stresses that the NHIN must be part of an agenda for the comprehensive transformation of health care delivery:

The NHIN should be approached as an IT-enabled clinical transformation initiative that fuses technology and process reengineering in order to achieve its stated objectives of improving quality and decreasing costs. Performance metrics must be established to monitor progress, and incentives should be aligned (and periodically adjusted) to reward actual benefit realization. Conversely, the costs attached to supporting and monitoring the effectiveness of this transformation agenda should be included in the NHIN's total cost of ownership.

To meet these requirements, the NHII/NHIN must be a secure, reliable, and adaptable national infrastructure capable of connecting and supporting highly distributed, varied, independently managed, multi-tiered, intra-institutional, clinical information/communications technology systems and applications. This infrastructure would vastly expand the information gathering, exchange, processing, and application capabilities of stakeholders at all four levels of the health care system.

The Promise of a National Health Information Infrastructure

The NHII would provide a platform for the application of a wide range of proven and emerging information/ communications technologies that could have a dramatic impact on health care processes and outcomes. The following discussion explores the promise of an NHII for each level of the health care delivery system.

Patient Level

At the patient level, progress toward an NHII would greatly empower individual patients to assume a much more active, controlling role in decision making and in implementing their own health care (i.e., applications that could help bring about a shift from hospital/clinic-based, clinician-directed care to home-based, clinician-guided self-care). The foundations for this shift have been laid by the emergence of the Internet and the World Wide Web, which have provided patients with unprecedented access to information (albeit of mixed quality) and made possible more continuous, asynchronous communication between patients and care providers.

Progress in systems interoperability and data standards is likely to advance the development of patient remote access to self-care educational tools, individual patient health records, and health care provider and insurer services (scheduling, billing, etc.) (see papers by Gustafson and Halamka in this volume). In time, the NHII would also provide a platform for the implementation of new information/communications systems, such as wireless integrated microsystems (WIMS, sensors combined with microelectronics and wireless interfaces), which would enable the remote capture and continuous communication of a patient's physiological data to care professionals, thereby increasing the likelihood of the timely diagnosis and treatment of illnesses.

An improvement in patients' ability to assume greater control and responsibility for care decisions enabled by information/communications technologies would also advance many of IOM's six aims for patient-centered, quality health care. Information/communications technology systems would give patients access to timely, effective, and convenient care; improve patient compliance with guidance/treatment protocols, including preventive measures; and enable continuous, or at least much more frequent, monitoring of patient conditions by care professionals/care teams. Greater compliance with clinicians' guidance—preventive or palliative—and more timely intervention in case of illness would not only benefit the health of the patient but would also reduce the costs of caring for the patient over time.

Care Team Level

At the care team level, progress toward an NHII would accelerate the development, diffusion, and use of a broad spectrum of information/communications technologies to help care providers capture, tap into, and integrate critical information streams for patient-centered care—the patient's health record, information on the patient's preferences and values, the evolving medical-evidence base, the status of clinical orders, administrative information, and a range of process/system performance data—essentially all of the data and information necessary to diagnose and prescribe treatment, as well as to analyze, control, and optimize the performance of the delivery system and subsystems.

Over the past decade, several core clinical applications have been developed to support the clinical information needs of frontline care teams. These include, EHR systems linking various information resources related to clinical care; CPOE systems, through which physicians enter orders for tests, drugs, and other procedures; decision-support tools that draw on clinical-data repositories, and databases that collect and store patient care information from diverse data sources.

Although the utility and functionality of these first-generation core clinical applications have been severely limited by the absence of comprehensive clinical information systems throughout much of the health care delivery system, progress toward the NHII would lead to the development and implementation of next-generation clinical applications that are more fully integrated and capable of translating clinicians' orders into dynamic, automated execution routines, as well as tracking and notifying clinicians of the status of their patients automatically. These applications could lead to changes in the role of the care team and individual care professionals, enabling them to spend less time executing and verifying the execution of orders and more time focusing on healing relationships with individual patients. Implementation of these technologies would also facilitate continuous learning in the care delivery system.

Organizational Level

At the level of the organization, steps toward an NHII would greatly facilitate the capture, integration, and analysis of clinical, administrative, and financial data for measuring and improving the quality, patient-centeredness, and efficiency of health care.Integration is essential to the application of data-intensive systems tools for systems design, analysis, and control. Beginning in the 1980s, a select group of health care provider organizations and networks began the integration process by adding clinical-department systems to their billing and administrative systems. It is worth noting that most of these forerunner, integrated systems were used by organizations with corporate-type structures and management (e.g., the Mayo Clinic, Kaiser-Permanente, Veterans Health Administration, and others with salaried physicians and wholly owned hospitals and ancillary functions). Only in the last decade have leading hospitals and integrated institutions begun to leverage their information systems by adapting and deploying systems-engineering tools and techniques to analyze, control, and optimize aspects of their operations.

As NHII (and interoperability and data-interchange standards in particular) advances, more and more health care organizations would be able integrate their clinical, administrative, and financial information systems internally, as well as link their systems with those of insurers, vendors, regulatory bodies, and other elements of the extended health care delivery enterprise. This capacity, in turn, would enable provider organizations to make more extensive global or strategic use of data/information-intensive systems-engineering tools, such as enterprise management, financial engineering for risk management, and knowledge discovery in databases.

Environmental Level

The NHII would lead to significant improvements on the environmental level of the health care delivery system. With advances in interoperability standards and other tools and technologies, the NHII would enable connectivity both within and across levels of the delivery system. This, in turn, would facilitate the aggregation and more timely exchange of useful data between and among providers at the organizational level and elements/stakeholder organizations at the environmental level (i.e., public and private payer organizations [insurers, employers], regulatory bodies, and the research community).

A functioning NHII could provide a rich pool of data to support regulation and oversight of the health care delivery system, population health surveillance, and the continuing development of the clinical knowledge/research database. For example, the NHII could accelerate the flow of health care quality data from providers to the Center for Medicare and Medicaid Services and private insurers, data on evidence-based-medicine trials to the Agency for Healthcare Research and Quality, data on infectious diseases and bio-hazards to the Centers for Disease Control, and data on post-introduction adverse drug events to the Food and Drug Administration (FDA).

NHII could also accelerate the interfacing of the expanding genomic and phenotypic (clinical) knowledge databases. The application of high-level systems-engineering tools (risk analysis) to these massive linked data sets could support significant advances in “predictive medicine”—mathematical and statistical techniques to identify and treat high-risk patients and to personalize treatment strategies.

Although much of the information/communications technology necessary for the realization of NHII exists today, and will certainly improve in the decade ahead, there will be many challenges to putting it in place. Very serious privacy concerns must be addressed, as well as training issues at all levels of the health care system. There are also serious challenges associated with making information/communications systems reliable enough to ensure that records are not lost. Ensuring reliability will require a very large-scale distributed computing system.

Paper-based systems are still the norm at most hospitals, which are all but “drowning” in paperwork. Clearly, it will take a national effort to develop an infrastructure capable of connecting, integrating, and supporting diverse information systems and applications at facilities nationwide. Although individual functions might still vary from facility to facility, the operating framework used for storing records and the protocols by which information is passed between locations and systems must be standardized.

Indeed, interoperability among diverse information/ communications systems and messaging standards will be critical to the realization of an information/communications technology-enabled health care system, a programmable system with the capacity for mass customization to meet the needs of individual patients. At every level of the health care system, the focus should be on the patient, and the goal should be to ensure effective interactions between the patient and doctor or health care delivery team. Developing such a system in the coming decade is not an option. It is an absolute necessity for achieving the IOM vision of a patient-centered, high quality health care system.

The remainder of this chapter is divided into two sections. The first focuses on the current status of major components of the emerging NHII, identifies technical challenges and opportunities, identifies economic and cultural/organizational barriers to implementation, and provides recommendations for building on current momentum. The second focuses on emerging technologies based on wireless communications and microelectronic systems that have the potential to radically change the structure of the health care delivery system and advance the patient-centeredness and quality performance of the system. Although the widespread implementation of emerging technologies represents a longer term agenda than upgrading and/or diffusing existing clinical information/communications technology applications, the NHII has a 10-year time horizon for realization that can accommodate the incorporation of new technologies. Above all, the implementation of NHII must be part of a comprehensive transformation of health care delivery.

FOUNDATIONS OF A NATIONAL HEALTH INFORMATION INFRASTRUCTURE

The components of a national health information infrastructure can be divided into three interrelated categories: (1) health care data standards and technical infrastructure; (2) core clinical applications, including EHRs, CPOE systems, digital sources of medical knowledge, and decision-support tools; and (3) information/communications systems.

Health Care Data Standards and Technical Infrastructure

If health care data are standardized, they become understandable to all users. The IOM report (2004), Patient Safety, considered three key groups of standards:

• Data interchange formats are standard formats for electronically encoding data elements (including sequencing and error handling). Interchange standards can also include document architectures for structuring data elements as they are exchanged and information models that define relationships among data elements in a message.

• Terminologies are the medical terms and concepts used to describe, classify, and code the data elements and data-expression languages and syntax that describe relationships among the terms/concepts.

• Knowledge representation refers to standard methods of electronically representing medical literature, clinical guidelines, and other information required for computerized decision support.

For each group of standards, IOM identified critical challenges and described ongoing efforts led and/or funded by the federal government to address them. In the area of data-interchange formats, in which engineering has played an important role, a number of mature standards, recently endorsed by the secretary of DHHS, address some of the required domains:

• administrative data (the X12 standard of the Accrediting Standards Committee, Subcommittee on Insurance, Working Group 12)

• clinical data (Health Level 7)

• medical images (digital imaging and communications in medicine [DICOM])

• prescription data (National Council for Prescription Drug Programs [NCPDP] Script)

• medical device data (Institute for Electrical and Electronics Engineers [IEEE] Standard 1073)

In its data standards “action plan,” IOM called for the rapid development of the next version (version 3.0) of the Health Level 7 clinical-data standards “to support increased interoperability of systems and comparability of clinical data, as well as patient safety,” and underscored the need for “implementation guides and conformance testing/ certification procedures…to insure consistent application of the standards in commercial systems” (IOM, 2004).

In the area of medical terminologies, IOM called for the identification of a “core group of well-integrated, non-redundant clinical terminologies…needed to serve as the backbone of clinical information and patient safety systems.” With respect to knowledge representation, IOM identified a need for standards “for the representation of clinical guidelines and the implementation of automated triggers”.

To accelerate the development and adoption of health care data standards, IOM recommended a significant increase in the technical and material support provided by the federal government to ongoing public-private partnerships in this area (IOM, 2004). IOM also put forward a six-point federal government “work plan.”¹ As noted above, the establishment of ONCHIT and the subsequent RFI were focused on interoperability and standards for an NHIN, demonstrating the urgency of the clinical information/communications technology challenge at the national level and the need for renewed efforts to engage the private sector in developing solutions.

To ensure that the emerging NHII can support next-generation clinical information systems and applications, it is critical that research on advanced interface standards and protocols continue apace and that standards-related issues concerning the protection of data integrity, controlled access to data, data security, and the integration of large-scale wireless communications be addressed early on. There is also a pressing need for low-cost tools for standardizing new and legacy digital data without disrupting the clinical work flow (PITAC, 2004). Other industries that had to accommodate conflicting standards (e.g., computer networks and computer graphic design) used translators to allow the best standard to emerge. Stable funding for research in all of these areas will be essential.

These challenges are neither new nor unique to health care. Indeed, engineers, computer scientists, and researchers and practitioners in other disciplines have been working on them for more than a decade to meet the needs of financial services, telecommunications, and national defense. Much of this work has been supported by federal research and mission agencies (NITRD, 2004). Cross-sector research and learning in the area of information/communications technology standards among federal agencies, health care insurers, and health care providers represents a potentially vast source of knowledge and advancement. To realize this potential, the President's Information Technology Advisory Council has called for increased coordination of federally supported research and development related to standards, computer infrastructure, privacy issues, security issues, and other topics relevant to health care through the Networking and Information Technology R&D (NITRD) Program, an 11-agency program that includes NSF, National Institutes of Health, Agency for Health Care Research and Quality, National Institute of Standards and Technology, Defense Advanced Research Projects Agency, U.S. Department of Energy, and others.

Core Clinical Applications

Clinical information systems provide a mechanism for sharing data collected from various sources (e.g., EHRs in care settings that may include personal health record systems maintained by patients or their representatives). Data become available to clinical information systems via direct entry at the point of care, off-line entry through abstraction from other media, such as handwritten notes, and data collected by other systems, such as laboratory systems or monitoring devices. The data can take many forms—including free text, coded data, speech, document imaging, clinical imaging (e.g., x-rays), and video. In the following section, four core components of clinical information systems are described: (1) EHRs; (2) CPOE systems; (3) digital sources of medical evidence; and (4) decision-support tools. These descriptions are followed by a discussion of human/ information systems interface design and software dependability issues.

Electronic Health Records

The electronic capture of patient-specific clinical information is critical to many health care information/ communications technology applications. Attention has been focused in the creation of EHRs since the 1960s, and in 1991, IOM set forth a vision and issued a call for nationwide implementation of computer-based patient records that would be paperless and instantly available throughout the health care system in forms readily understandable to physicians and other providers at point of care and specialists, perhaps in a different location. However, the rate of progress toward realizing this vision has been glacial.

Only a fraction of hospitals have implemented comprehensive EHR systems, although many have made progress in certain areas, such as computerized reporting of laboratory results (Brailer, 2003). Rates of adoption of EHR systems are higher in ambulatory care settings—probably about 5 to 10 percent of physician's offices—but these systems vary greatly in content and functionality (IOM, 2004). Although some cases of failed EHR systems have been documented, many more examples show cost savings and quality improvements yielded by EHR systems.

EHRs have been instituted in health care settings in the public and private sectors, and a few communities and systems have implemented secure systems for the exchange of data among providers, suppliers, patients, and other authorized users. Among these are the Veterans Health Administration , Mayo Clinic, New England Healthcare Electronic Data Interchange Network, Indiana Network for Patient Care, Santa Barbara County Care Data Exchange, Patient Safety Institute's National Benefit Trust Network, and the Markle Foundation Healthcare Collaborative Network .