Do you remember the first time you visited the doctors office and they had either a desktop computer or laptop for use in the exam room. Perhaps the nurse entered your blood pressure, temperature, and reason for visiting the doctor into a template especially designed for this type of information. It probably was not too long ago that this started happening at your doctors' office, since the Health Information Portability and Accountability Act (HIPAA) of 1996 mandated that all healthcare providers with more than ten employees must go digital by the year 2003.
The only problem was that HIPAA did not set standards for sharing this health information in a digital format. This caused an extended thirteen yearlong battle in which numerous fly-by-night electronics companies jostled each other to position themselves to be the one to set the standard that would be adopted by the federal government.
This researcher does not intend to give the reader the idea that this is an exhaustive study based on technical data or medical details. But rather, in this paper it will be asserted that there is a need for standardization, and explore some of the benefits that will result from adopting standards, such as reducing the cost of implementation, fraud and abuse abatement, and explore how the historic medical practices of misuse, underuse, and overuse can be eliminated and replaced by Evidence Based Medicine Practices derived from electronic health records systems.
1. Standardization
In the late 1970's the personal computer was simply an emerging technology for which the healthcare industry had not yet seen a use for in the clinical or hospital setting. At that time life in general and especially the medical arena was much less complicated. Health Maintenance Organization and Managed care had not been invented yet. When you went to the doctor it was on a fee-for-service basis wherein you received a bill for the doctor's services and submitted it to your health insurance company for reimbursement. There was minimal dabbling in medicine by the federal government with the use of regulations. In fact it was forbidden to regulate any aspect of insurance by the McCarran-Ferguson Act.
The increasing complexity of life that we have seen in the last couple of decades is mirrored, if not proportionally exaggerated in the healthcare industry. It is due in large part to this same personal computer. The ability to digitalize all sorts of data has led to the creation of the internet, enabling physicians as well as patients to absorb a wealth of heretofore unavailable medical information.
As Dr. Andrew Schuman, professor of pediatrics at Dartmouth Medical School, states in his article for Contemporary Pediatrics,
"Perhaps the most significant technological change, slow in coming, has been the transition to the electronic medical record. Lack of standards and high implementation costs continue to make physicians reluctant to adopt
an electronic medical record system, despite the many advantages of
having one."
Schuman goes on to discuss the fact that no matter how advanced medicine appears to be, only a small portion of medical practice is founded in evidence. The rest is primarily delivered because of observation alone, not from any scientifically derived clinical trials data.
There are many voices joining this repetitive chorus attributing the lag of implementation of EHR's to the lack of standards. In a national survey published in the 2007 volume of Health Affairs, Bates, Ebell and Zach, leave no doubt that clinicians and hospital administrators alike are united in their "wait-and-see" attitude of adoption, because of the virtual vacuum that exists in the area of standardization. Not only do they lament the lack of technical cohesion, but display disgust at the apparent lack of even the most basic of standards, such as the definition of terms.
Some progress is being made in this area. As Margaret Amatayakul plainly defines for us in her 2009 article in Healthcare Financial Management Journal, "EHR vs. EMR; what's in a name?" The definition of EMR is, "an electronic record of health-related information on an individual which is managed by authorized clinicians and other staff within one healthcare organization." This is differentiated from EHR by the simple fact EMR is used within one organization, whereas the electronic Health record is managed "across more than one healthcare organization" (Amatayakul).
The article goes on to define the more obscure terms PHR, personal health record as being controlled by only the individual, and HIE, a health information exchange as "… the electronic movement of health related information among organizations according to nationally recognized standards", which at the time of publication were still non-existent.
From these definitions it can be surmised that the primary barrier to establishing a national Health Information Exchange is the necessity of adoption of standards for the interoperability of diverse electronic health records systems.
Other significant barriers to the adoption of EHR's that have been identified by the governmental Agency for Healthcare Research and Quality include the high cost and insufficient ROI , underestimation of the capabilities for change in an organization, a failure to redesign processes and the workflow of a clinic to incorporate these new advances in technology. Not the least of these barriers to implementation are three very telling concerns: if a clinic adopts a system will it become obsolete, are current market systems meeting the needs of the individuals, the patients, that they are meant to be helping, and concerns regarding negative unintended consequences of adding yet another layer of technology onto the American healthcare system.
Drug production organizations have excelled at collecting and analyzing vast and complex data required for clinical trials, while complying with the detailed regulations at many levels. The result, unfortunately, is robust data management at the study level--creating silos of data, most in different data formats, and using different coding schema. To move beyond clinical trials data and study focused analysis, an organization needs to start at the top to implement an approach to enterprise-wide management of internal and external information.
Lynette Ferrara a research principal in emerging practices at the applied research arm for CSC's Global Healthcare Sector states in her article, "Information as a strategic asset," …When all these changes and technologies are put into place, information becomes a strategic asset that takes time, cost, and risk out of clinical EHR implementation. Two major technology-related challenges today are the lack of data standards and the limited adoption of EHRs in physician practices." (2009)
"Real-world health care data in the form of administrative claims data, lab data, electronic medical records, and the longitudinal electronic health record (EHR) have important roles to play. In de-identified forms, these data can be incorporated into standard practice to support all stages of research, development, and post market support. Protected health information accessed through models involving patient consent will play an important role too in areas such as personalized medicine and outcomes management" (Ferrara).
The elements that are creating the need for and breaking down the barriers to making the necessary changes to implementing standards of interoperability are many and varied. For example, the escalating drug development costs, and public demand for safe and effective medications, as well as the recent push by the federal government to solve the data interoperability and technology adoption issues are providing a favorable environment for clinical trial innovations supported by health intelligence.
But changes are coming that will help address both these obstacles. Publication of the Clinical Data Acquisition Standard Harmonization (CDASH) by CDISC--the Clinical Data Interchange Standards Consortium--is an important step toward standardizing clinical research data capture. The recently enacted Health Information Technology for Economic and Clinical Health (HITECH) Act will set EHR data and interoperability standards starting this year. HITECH has the potential to significantly improve EHR adoption by providing financial incentives for implementing applications that support data exchanges.
2. Reducing the cost of Implementing Standardization
Electronic Health Records Systems can facilitate workflow and improve the quality of patient care and patient safety as indicated by the "Evidence Based Practice" study done by the National Alliance for Health Information Technology (NAHIT), completed in 2007. Despite these benefits, widespread adoption of EHR's in the United States is low.
DesRoches, et al, conducted a recent survey for the New England Journal of Medicine (July 3rd, 2008), indicated that only 4% of ambulatory physician practices reported having extensive, fully functioning electronic records systems, and 13% reported having only the most basic of systems.
Thankfully an educational and information dissemination entity was established as a way to make Healthcare Facilities aware of the benefits and implementation structure that is available to them. This entity is known as The Office of the National Coordinator for Health Information Technology (ONC)
The ONC is at the forefront of the Obama administration's health IT efforts and is a resource to the entire health system to support the adoption of health information technology and the promotion of nationwide health information exchange to improve health care. ONC is organizationally located within the Office of the Secretary for the U.S. Department of Health and Human Services (HHS).
Although the ONC is the principal Federal entity charged with coordination of nationwide efforts to implement and use the most advanced health information technology and the electronic exchange of health information. The position of National Coordinator was created in 2004, through an Executive Order, and legislatively mandated in the Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009.
The ONC's primary mandated mission is to promote development of a nationwide HIT infrastructure that allows for electronic use and exchange of information that: Ensures secure and protected patient health information, improves health care quality, reduces health care costs, informs medical decisions at the time/place of care, includes meaningful public input in infrastructure development, improves coordination of care and information among hospitals, labs, physicians, etc., improves public health activities and facilitates early identification/rapid response to public health emergencies, facilitates health and clinical research, promotes early detection, prevention, and management of chronic diseases, promotes a more effective marketplace and improves efforts to reduce health disparities.
Additional weight of recent legislative actions gives credence to this notion that the patients, as well as the Healthcare system, will see untold benefits from implementing the standardized EHR.
The American Recovery and Reinvestment Act of 2009 (Recovery Act) authorizes the Centers for Medicare & Medicaid Services (CMS) to provide reimbursement incentives for eligible professionals and hospitals who are successful in becoming "meaningful users" of certified electronic health record (EHR) technology.
Meaningful Use Notice of Proposed Rule Making (NPRM) - Criteria established for Medicare and Medicaid participating providers and hospitals to receive incentives for using electronic health records (EHRs) in a meaningful manner, which includes, but is not limited to, electronically capturing health information in a coded format, using that information to track key clinical conditions, communicating that information to help coordinate care, and initiating the reporting of clinical quality measures and public health information.
Providers and patients must be confident that the electronic health information technology (health IT) products and systems they use are secure, can maintain data confidentiality, can work with other systems to share information, and can perform a set of well-defined functions.
To this end, an Interim Final Rule (IFR) on an initial set of standards, implementation specifications, and certification criteria for adoption by the HHS Secretary was issued on December 30, 2009, with a request for comments. This Interim Final Rule represents the first step in an incremental approach to adopting standards, implementation specifications, and certification criteria to enhance the interoperability, functionality, utility, and security of health IT and to support its meaningful use.
The certification criteria adopted in this initial set establishes the required capabilities and related standards that certified electronic health record EHR technology managers will need to include in order to, at a minimum, support the achievement of the proposed meaningful use Stage 1 (beginning in 2011) by eligible professionals and eligible hospitals under the Medicare and Medicaid EHR incentive programs.
Health and Human Services Secretary Kathleen Sebelius and Labor Secretary Hilda Solis today announced a total of nearly $1 billion in Recovery Act awards to help health care providers advance the adoption and meaningful use of health information technology (HIT) and train workers for the health care jobs of the future.
These awards will help make health IT available to over 100,000 hospitals and primary care physicians by 2014 and train thousands of people for careers in health care and information technology. This Recovery Act investment will help grow the emerging health IT industry which is expected to support tens of thousands of jobs ranging from nurses and pharmacy techs to IT technicians and trainers (Sebelius).
The over $750 million in Health and Human Services grant awards Secretary Sebelius announced are part of a federal initiative to build capacity to enable widespread meaningful use of health IT. This assistance at the state and regional level will facilitate health care providers' efforts to adopt and use electronic health records (EHRs) in a meaningful manner that has the potential to improve the quality and efficiency of health care for all Americans.
Of the over $750 million investment, $386 million will go to 40 states and qualified State Designated Entities (SDEs) to facilitate health information exchange (HIE) at the state level, while $375 million will go to an initial 32 non-profit organizations to support the development of regional extension centers (RECs) that will aid health professionals as they work to implement and use health information technology.
With additional HIE and REC awards to be announced in the near future, RECs are expected to provide outreach and support services to at least 100,000 primary care providers and hospitals within two years.
"Health information technology can make our health care system more efficient and improve the quality of care we all receive," said Secretary of Health and Human Services Kathleen Sebelius. "These grant awards, the first of their kind, will help develop our electronic infrastructure and give doctors and other health care providers the support they need as they adopt this powerful technology."
The more than $225 million in Department of Labor grant awards Secretary Solis of the DOL announced will be used to train 15,000 people in job skills needed to access careers in health care, IT and other high growth fields. Through existing partnerships with local employers, the recipients of these grants have already identified roughly 10,000 job openings for skilled workers that likely will become available in the next two years in areas like nursing, pharmacy technology and health information technology. The grants will fund 55 separate training programs in 30 states to help train people for secure, well-paid health jobs and meet the growing employment demand for health workers.
Employment services will be available via the Department of Labor's local One Stop Career Centers, and training will be offered at community colleges and other local education providers.
"The Recovery Act's investments are making a positive difference in the lives of America's working families," said Secretary of Labor Hilda L. Solis. "The investments announced today will ensure thousands of workers across the nation can receive high-quality training and employment services, which will lead to good jobs in healthcare and other industries offering career-track employment and good pay and benefits."
The HHS and DOL awards are part of an overall $100 billion investment in science, innovation and technology the Administration is making through the Recovery Act to spur domestic job creation in growing industries and lay a long-term foundation for economic growth. In addition to the 10,000 jobs the DOL grantees expect to fill with freshly trained workers, the health IT extension centers are expected to hire over 3,000 technology workers nationwide in the months ahead.
Overall, the Administration investments in health IT and training will help significantly expand an emerging industry expected to support tens of thousands of secure, well-paid jobs nationwide. The aforementioned plethora of benefits will soon induce those clinical, and larger, healthcare facilities that are still dragging their feet, to get on board and join the Health Information Technology bandwagon, which is certainly the wave of the future.
3. Benefits of Standardization
