Electronic Health Records - Market Landscape

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Electronic Health Records Market Landscape Research Proposal
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BACKGROUND
A medical record is a confidential record that is kept for each patient by a healthcare professional or organization. It contains the patient’s personal details (such as name, address, date of birth), a summary of the patient’s medical history, and documentation of each event, including symptoms, diagnosis, treatment, and outcome. Relevant documents and correspondence are also included. Traditionally, each healthcare provider involved in a patient’s care has kept an independent record, usually paper-based. The main purpose of the medical record is to provide a summary of a person’s contact with a healthcare provider and the treatment provided in order to ensure appropriate healthcare. Information from medical records also provides the essential data for monitoring patient care, conducting clinical audits, and assessing patterns of care and service delivery. Integration of technology affords a great opportunity to leverage the value of medical records while incorporating the efficiency of newer electronic data management methodologies.1 The Value of Medical Records There is a longstanding research practice of combing medical records to glean information that could provide clues about the onset and progression of disease and to improve disease management and outcomes. In the past, paper medical records studies have been used to:         monitor the health of the population and detect emerging health problems; identify populations at high risk for disease; determine the effectiveness of treatment(s); assess and quantify prognoses; assess the usefulness of diagnostic tests and screening programs; influence policy through cost-effectiveness analysis; support administrative functions; and monitor the adequacy of care.

Electronic health record (EHR) is a computerized patient-centric history of an individual’s health care record that includes data from the multiple sources of care that the patient has used. Generally, EHR refers to the combination of the medical record created by the medical care system and personal health information. Because they are interoperable (can be accessed across networks by computers using a variety of operating systems and software), they can be accessed at any authorized point of care.2 The potential value of medical records data to clinical research could be magnified by the computing power associated with a system of digitized, or electronic, medical records. The application of information technology to patient records offers the promise of new knowledge that can be obtained only by integrating and analyzing data extracted from hundreds if not thousands of patient records, including medical history, physical examination, diagnoses, diagnostic tests, medical images, administrative data (claims, billing, outcomes), clinical information, environmental profiles, and genetic analyses, combined with new findings from molecular and genomics research. As institutions struggle with the adoption and implementation of EHR systems, it is crucial that they consider the needs of and seek the advice of the research community. Payers and consumers are increasingly including the results of patient surveys in performance measures used for payment, public reporting, and improvement. A fully functional electronic healthcare information system would enable physicians to contact patients directly, to solicit patient feedback related to specific conditions, and to compile actionable feedback to the practice.3

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Having electronic health information about the entire population of patients served by a given practice or provider enables queries about groups of patients who suffer from a specific condition, are eligible for specific preventive measures, or are currently taking specific medications. Among other things, this population-based view enhances the ability of the practice to identify and work with patients to manage specific risk factors or combinations of risk factors. It also can detect patterns of potentially related adverse events and enable patients at risk to be quickly and correctly notified. Outreach, patient education, and notification about particular risks are made possible by this kind of system. For this to happen, we must be able to “disassemble” the information in electronic health records and then “reassemble” it in various ways.4 US Healthcare Initiatives The potential of EHR to strengthen the health care system and improve quality of care has garnered nationwide attention. Now more than ever, physicians need information about implementing EHRs as the American Recovery and Reinvestment Act (ARRA) begins offering financial incentives for physicians to implement EHR (Figure 1). Successfully implementing health information technology into an office practice can bring improvements in both quality of patient care and practice profitability. Using properly designed databases and powerful computers, informatics can provide a view of the relationships between health and illness and unwrap the mysteries of human variation.5 Figure 1: The US Government Has Put Billions Behind Health Information Technology

Source: Centers for Medicare & Medicaid Services, Office of Management and Budget

In 2004, President George W. Bush launched an initiative to make electronic health records available to most Americans by 2014. This was followed by an August 2006 executive order calling for federal programs to lead the way with HIT adoption, along with financial and quality transparency. Recent Federal legislation has charted a new path forward. The Health Information Technology for Economic and Clinical Health (HITECH) Act, a part of ARRA of 2009, authorized expenditures of at least $20 billion under the U.S. Health and Human Services Department (HHS) to promote the adoption and use of EHR technologies that would ideally be connected through a national health information network. Hospitals and physicians who make “meaningful use” of interoperable EHRs can qualify for extra payments through Medicare and Medicaid.6
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Responsibility for developing policies that implement the overall HITECH Act lies primarily with the Office of the National Coordinator for Health Information Technology (ONC). In this role, ONC works closely with the Center for Medicare and Medicaid Services (CMS), which is responsible for promulgating policies that relate to Medicare and Medicaid payment for “meaningful use” of EHRs under HITECH. Meaningful use specifically requires that organizations leverage EHRs to capture health information; use health information for continuous quality improvement; and use integrated decision support functions to improve quality, safety and efficiency in real time. ONC and CMS recently released final rules to implement the first phase of the HITECH Act, which begins in 2011. The 3 ONC rule specifies the standards, implementation specifications and other criteria for EHR systems and technologies to be certified under HITECH and thus eligible for the Acts incentive programs while the CMS rule specifies how hospitals, physicians, and other eligible professionals must demonstrate their meaningful use of these technologies in order to receive Medicare and Medicaid payment incentives.5,6 Depending on the amount of Medicare services provided, physicians who accept Medicare patients could earn up to $44,000 in incentives over five years. The Medicaid incentive program will be administered by the states, and has a more complex funding schedule based on EMR costs. Physicians can receive a one-time incentive payment for 85 percent of the allowable cost for the purchase and implementation of a certified EHR in the first year. The legislation does not penalize Medicaid physicians for failing to adopt a certified technology. Unlike Medicare penalties, no reductions in Medicaid payments are to be made if the physician does not adopt EHR technology. Both sets of rules strongly indicate that standards and criteria for achieving meaningful use of EHRs will grow more rigorous in subsequent phases (2013 and 2015) as the technology continues to evolve and providers gain experience and sophistication in its use. This funding enables the Centers for Medicare and Medicaid Services and the Office for Civil Rights to carry out mandated audits and make modifications in case and document management systems. The law also grants state attorneys general authority to file suit on behalf of a state’s citizens and increases monetary penalties for violations of certain provisions to a maximum of $1,500,000 per year for each identical violation.5,6 In a report to the President on healthcare IT, the President’s Council of Advisors of Science and Technology (PCAST) suggested that the Chief Technology Officer of the United States, in coordination with the Office of Management and Budget and HHS, develop within 12 months [of December 2010] a set of metrics that measure progress toward an a operational, universal, national health IT infrastructure.5 They emphasized focusing these metrics on operational progress, as distinct from research, prototype, and pilot efforts, to enable a more accurate continuing assessment of whether Federal efforts in health IT, including both executive initiatives and legislative mandates, are in fact supportive of the President’s goal of increasing the quality, and decreasing the cost, of healthcare (Figure 2).

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The Three Forces Shaping the Evolution of Healthcare
Figure 2: The Three Forces Shaping the Value Demonstrating Evolution of Healthcare
molecular medicine and personalized medicine

access, cost and quality of care

proficient use of information (e.health)
Source: George Poste

The Physicians’ Perspective In cooperation with the Robert Wood Johnson Foundation, the New England Journal of Medicine conducted a study in 2008 to determine national electronic medical record (EMR) adoption rates, satisfaction with chosen systems, anticipated barriers to adoption, and perceived effect on quality of care (Figure 3). The survey drew 2,758 responses. At the time of the survey, seventeen percent (17%) of the physicians surveyed used EMRs in their office practices, and twenty-six percent (26%) planned to acquire EMRs in the next two years. Those who had adopted EMRs had had successful experiences. The physicians overwhelmingly reported the following as the most important features of EMRs. Collectively, all of these improvements reflect positive changes in patient care and practice operations.7 Figure 3: Most Important EMR Features

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Source: Texas Medical Association Overall, the survey results describe a physician community that now favors the adoption of EMRs:  Physicians who are using EMRs in their offices can cite concrete benefits to their office operations and quality of patient care. Among the adopting physicians, 93 percent (93%) report that they are satisfied with a fully functional system that includes order entry capabilities and clinical decision support. Eighty-eight percent (88%) who utilize a more basic EMR system indicate that they are satisfied.

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While physicians believe that EMRs are beneficial to their practice, a concern across the board is cost. A large majority of respondents reported an overall positive effect on their practice with the use of their EMR system.

More relevant to the individual physician, perhaps, is the need for change in the following four areas, areas in which the application of HIT will be noticeably beneficial: patient safety, quality improvement, pay-for-performance reimbursement, and improved practice efficiency. As physician income continues to decline, controlling practice costs is becoming a critical issue for physicians in office practice. Medical practices that use HIT potentially can gain the same type of cost savings that information technology has long been creating in other businesses through the substitution of technology for manual work. With EMRs, clinical staff no longer needs to pull charts for every patient visit, every patient phone call, or every request for a prescription renewal, and no one has to search for lost charts. One study of a number of family practices that installed HIT systems found that the combination of more accurate coding and additional office visits (due to increased efficiencies) generated an additional $23,000 per physician in annual revenue. The cost recovery and subsequent improvement in practice profitability result from a series of process improvements that EMR capabilities facilitate.  A combination of template-based documentation and expert coding advice increases the use of higher-level codes because physicians and coders are more confident of their ability to demonstrate the appropriateness of their code selections. The elimination of paper records leads to numerous efficiencies that flow to a practice’s bottom line. The time spent pulling paper records for every patient visit, telephone call, or request for a prescription renewal is virtually eliminated. There are no more lost records. Medical record supply costs also are eliminated. The office space used to store medical records can be eliminated or put to profitable use. The number of nonclinical employees can be reduced, or alternatively, each staff person’s responsibilities can be shifted to support a practice’s ability to handle an increased patient load. The ability to run a profitable satellite office is greatly increased through the availability of EMRs over a practice’s network, which eliminates the need for faxing records back and forth.

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EHR Challenges The EHR is still in a developmental phase, and it will be several years before it will be possible to determine the effect that the EHR will have on medical practices and patients. In the meantime, vendors and large consulting firms try to scale down their traditional big EHR methodologies for smaller institutions, but all too often the packaging, pricing and resource requirements remain beyond the reach of community hospitals. The traditional behemoth EHR implementation model is clearly out of step with the needs of today’s small-to mid-sized healthcare delivery systems. Solution platforms for EHRs should be highly customized for each hospital’s environment so caregivers can use all available, necessary data and functionality at the point of care. This ensures large health systems and community hospitals alike are well positioned for maximum clinical and financial benefit from their electronic records projects because they carry out every step of their implementations with clear, concise project plans.1,2

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EHR systems have the capability to serve as a broadly enabling research infrastructure that facilitates and promotes the sharing and reuse of data from the patient care process and that channels the results of clinical research back into the hands of patients and practitioners, where it can create the greatest benefit. The greatest challenge to using the EHR for research is the reliability and validity of the data in the record. The bottom line is that data are as reliable as the patient gives and the user enters. Although clinical data generally are valid, there may be mistakes or omissions.3 In addition, although billing codes are considered part of the record, they are the least useful and reliable data elements for researchers and therefore almost meaningless for most clinical research. At some point soon, a critical mass may be reached in EHR adoption that will help accelerate substantially greater progress in standardization. This must occur in tandem with efforts to integrate multiple databases for data mining. Standards for security and confidentiality also are needed, as is the consistent use of messaging standards and a universal language for the exchange of health data. An extensible markup language, where individual pieces of data can be tagged with context-setting metadata, is a straightforward solution and is superior to other proposed architectures.1,2 In light of the much-needed overhaul of CMS’s antiquated IT infrastructure, it is important not to replace one inflexible architecture with another. Fortunately, CMS now has new leadership, with the appointment of an administrator. A solid technical plan, with the necessary resources, is required for success. A common infrastructure for locating and assembling individual elements of a patient’s records, via secure tagged “data element access services” (DEAS) allows for a sophisticated, fine-grained model of implementing strong privacy controls (including honoring patient-controlled privacy preferences where applicable) and strong security protection. Importantly, this approach does not require any national database of healthcare records; the records themselves can remain in their original locations. Distinct DEAS could be operated by care delivery networks, by states or voluntary grouping of states, with possibly a national DEAS for use by Medicare providers. DEAS should be interoperable and intercommunicating, so that a single authorized query can locate a patient’s records, across multiple DEAS.3,4 E-Health Innovations The state of health IT today can be summarized as a mix of “the good, the bad, and the ugly.” This diversity, and especially the fact that perhaps eighty percent (80%) of physicians still do not use electronic records at all, except possibly for billing functions, creates a dilemma. Given the difficulty of bringing the healthcare system forward into the computer age, should we focus on small incremental steps? Or, having seen the remarkable adoption rates and advances of Internet-based technologies in other sectors, should we push for a more radical advance that risk leaving some providers behind? Fortunately, there is a bridge between these two extremes. It is the fact that the Internet-based technologies create a platform for “disruptive innovation,” meaning innovations that upset the status quo and can broadly expand markets. Cloud-based technologies and EHRs are potential examples of disruptive technologies in health IT. These types of technologies might allow the eighty percent (80%) of physicians who are non-digital to leapfrog some of the existing limitations of EHR systems directly into more modern technologies. Indeed this is precisely what we want to happen, and it is a direction in which ONC and CMS could concentrate their efforts.7

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Some aspects of the new health IT infrastructure will enable new, competitive, entrepreneurial markets. Some other aspects are “public goods” and will require government leadership. The benefits of health IT affect, and are affected by, other aspects of healthcare reform, especially payment models. Other models, such as Geisinger Health System, are testing the power of information technology to improve patient care through the use of online interactive selfassessment.3 It is conceivable that such an approach could be modified and easily adapted for research purposes. A further class of applications might help users compile and aggregate population-level data on health outcomes, physician performance, or population health. These applications could be geared toward provider organizations, insurance companies, public-health companies, and researchers, broadly defined. Likewise, the development of customized algorithms and pattern recognition systems will aid researchers while simultaneously providing physicians with smart clinical decision-support tools.4 Other technology innovations include applications that provide physicians with mobile access to electronic health records via iPhone™, iPad™, iPod® Touch, BlackBerry® or Android® smartphones. Physicians can also dictate clinical notes, document calls and send messages through their smartphone. This innovation encourages increased productivity, improved levels of care, and connectivity to critical patient data whenever and wherever they need it.7 Paper-to-Electronic Health Record Transition The successful transition from a paper- to electronic-based practice begins with developing an understanding of system functionality (what HIT actually does), analyzing a practice’s readiness to manage a new operating system, and preparing staff for this major change. With hundreds of EHR products, the marketplace offers a robust choice, and selecting the right system depends heavily on assessing the practice’s needs. The efficiency benefits of an EHR derive from these changes that occur in practices as they move from paper to electronic:      The reduction in expenses associated with the management of paper records; Significantly more efficient and accurate coding and billing of claims as a result of templatebased documentation; Redesign of workflow so that practice staff can become more productive users of the practice’s HIT system; Real-time access to a patient records from multiple computers and locations, including remote access beyond the office, without physically retrieving a paper chart; and Multiple people simultaneously accessing a single patient record from multiple locations, improving work flow in some situations.

Current health care publications highlight an increased national interest in EHRs and personal health records. These forms of Health IT are ways to help resolve multiple issues within the health care system. With decreasing physician reimbursement, increasing overall costs of health care, and an increasingly uninsured and underinsured population, the dialogue is shifting from simply managing costs to include quality improvement. Improved health IT can directly affect, and improve, clinical encounters between doctor and patient, healthcare organizations, clinical research, and the monitoring of public health. The clinical research community sees enormous potential in the ability of researchers to access and analyze the clinical information contained in millions of medical and personal health records. With appropriate privacy and human subjects protection safeguards in place, this capability could speed the discovery of new therapies beyond anything imaginable today.
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To better understand the landscape of EHR system adoption and evaluate the challenges and opportunities involved in developing research uses of this vast resource, Harrison Hayes will conduct a broad overview and characterization of current efforts to promote EHRs and their potential research use, and to assess what is needed to optimize the creation and use of such databases for research purposes. This analysis rests on the premise that as the healthcare system addresses the challenges of widespread adoption of electronic patient record systems, research capacity should be a part of the architecture.

REFERENCES
1. “Top Technology Innovations.” Health Data Management. July 2010. 2. “Think Research: Using Electronic Medical Records to Bridge Patient Care and Research.” FasterCures. 2005. 3. “How Electronic Records are Driving New Storage Challenges for Hospitals.” Forrester Research, Inc. January 2010. 4. “Transforming Health Innovation Area Projects.” MITRE. 2011. 5. “Report to the President Realizing Full Potential of Health Information Technology to Improve Healthcare for Americans: The Path Forward.” Executive Office of the President; President’s Council of Advisors of Science and Technology. December 2010. 6. Agrawal R, Johnson C. “Securing Electronic Health Records without Impeding the Flow of Information.” IBM Alamaden Research Center. 7. Marcus DD, Lubrano J, Murray J. “Electronic Medical Record: Impelementation Guide.” 2nd ed. Texas Medical Association. 2009.

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