Top Ten Electronic Health Record System Expectations/Requirements: Beyond ‘Meaningful Use’

Much industry attention and hype surrounds the incentive payments made available to providers under the HITECH portion of the American Recovery and Reinvestment Act of 2009 for implementing an Electronic Health Record (EHR) system. Eligible institutions and providers now search for software and service partners to help them find the quickest path to the incentive dollars and avoid future penalties. Some vendors even make "Meaningful Use" certification guarantees part of their marketing campaigns. The Interim Final Rule (IFR) published by the Office of the National Coordinator (ONC) is the benchmark for achieving compliance and securing eligibility for incentive payments.

There is more to EHRs than obtaining "certified" deployments, receiving government incentive payments, or replacing paper records with electronic versions. In this "Top Ten," the Epstein Becker Green Connected Health Practice presents four expectations for EHRs and six EHR system requirements beyond the specifications of Meaningful Use.

Expectations for EHRs

1. EHRs will serve as the prerequisite foundation for the modernization of health care information technology systems. Health care information technology systems and processes feed data into a health record or consume information obtained from it. Without an EHR infrastructure, ancillary systems that enable the practice of evidence-based medicine, improve the quality of care delivered consistently and measurably, and reduce the overall cost of health care through data-based decision making won't be possible. Clinical software applications will rely heavily on the EHR, thus, increasing the impact of an electronic version of a health record well beyond its paper counterparts that document but do not directly enable health care delivery. EHRs also will serve as a data repository for financial and administrative process improvement and cost reduction.

2. Government and private sector organizations will rely on EHRs for monitoring quality, efficiency, and safety of care. Participants in the health care system are busy making preparations for the time when an interoperable electronic health information system readily delivers the secure, seamless access to any patient's health record. This vision is the primary driver for the formation of the ONC, the incentive payments authorized under HITECH, and, ultimately, a mandate for accelerated information technology adoption in health care. Also, the Centers for Medicare and Medicaid (CMS) will continue to monitor EHRs for fraud and abuse detection, a $54 billion problem in 2009, and the Agency for Health care Research and Quality (AHRQ), will depend on access to EHRs to help measure care quality improvements, track patient safety results, and serve as a comparative effectiveness data source for exploring alternative treatment protocols that may be less expensive and yet provide equal or better results. Other government agencies, employers, private insurers, states, and organizations have indicated their desire to leverage EHRs for eligibility determination, occupational health assessments, remote home monitoring chronic care services, and many other requirements that need patient-specific information.

3. EHRs will network with their medical device counterparts. The common perception of EHR software is that, like Microsoft Office or any other general purpose software tool, it adds value to a business and runs on a computer. Medical devices typically conjure up images of a MRI machine or an implantable cardiac defibrillator. However, the two worlds of health information technology software and medical devices are increasingly converging as part of a bigger system called "Connected Health." Sophisticated medical devices (i.e., devices having some kind of advanced electronics or the ability to store data and display results) are essentially specialized computers with software, sensors, and actuators to translate between the physical and digital worlds. Caregivers will rely increasingly on EHRs to be the linchpins for patient monitoring data, captured by a medical device used at home or inside the hospital, to assist them in delivering safe and effective care. The EHR will likely be updated in real-time by many different devices used to deliver care, which will change much of the original nature and use of electronic records. No longer just a place to document and store historical data, the EHR will become a vital, active participant in the delivery of care.

4. EHRs will play important roles in the research of new diseases and treatments. "Connected Health" means all aspects of health care are united by common and consistent network access from different participants in different locations, for different reasons. As mentioned above, the EHR will be relied upon heavily for informatics, public policy decisions, quality reporting, and business purposes simultaneously. Specific to improving care and patient outcomes, however, is the distinct advantage of making data available for biomedical research and drug development consistent with security and privacy requirements (described later). Leading research institutions, academic medical centers, and biopharmaceutical sponsors have begun using the ability to extract anonymized patient data and recruit clinical trial participants from information stored in EHRs to aid in the research of new diseases and treatments. In the future, the promise of "Personalized Medicine" could be proven by directly observing the outcome of patients using a particular prescribed treatment and other information available in their EHR.

EHR System Requirements

5. An EHR must be designated to serve as the system-of-record (SOR) for a patient's health profile. A SOR is an information storage system that is the authoritative data source for a given data element or piece of information. Input from storage systems goes into a SOR, and the resulting data is re-processed for potential use as output for other systems. Any discrepancies between systems need to be resolved by only one serving as a SOR for that information. This process is hard to achieve within the boundaries of a distinct business entity, and even harder when patient-specific data may be shared across many different entities and for many varied reasons (e.g., proof of eligibility, care delivery, drug interaction profile, claims history, etc.). Erroneous or incomplete data will amplify mistakes and bad decisions. Deployment of a reliable and accurate system of record architecture across the entire network of EHRs must be done in order to help avoid data accuracy problems.

6. EHRs must be interoperable with other EHRs, regardless of technology, location, and source. The formation of secure and interoperable EHRs is a worthy goal, but, in reality, achieving it will be very difficult. This is exemplified by the recent letter from the College of Health Information Management Executives (CHIME) to the ONC. The letter states that the Meaningful Use IFR contained data transmission and encryption requirements that were too onerous for organizations to adhere to within the targeted timeframe. The CHIME organization requested both additional time and modifications to the rule as it pertained to compliance with Meaningful Use. The organization certainly has valid arguments for its position. To enable an interoperable network of EHRs, common standards for data transmission, encryption for security, and identification methods associated with particular elements of data and unique patient identifiers must be worked out. The lack of verified, interoperable standards remains the single biggest obstacle to overcome on the way to networked health care information.

7. EHRs must be adept at understanding different terminologies and classifications. According to the American Health Information Management Association, there are currently more than 25 unique classifications and clinical terminologies that can be used to represent health data within an EHR. Efforts are underway to reduce and harmonize the different vocabularies, syntax, and context used for each purpose, but clinical care and secondary uses of data (such as disease classification, payment, and public health reporting) will not be able to settle on a single standard nomenclature. This complicates interoperability, since none of the terminologies and classifications are static entities; CPT, SNOMED-CT, LOINC, and other clinically oriented coding systems continuously add new procedure codes; and the US is faced with the added burden of transitioning from ICD-9 disease classification to ICD-10. There is a proposal from CMS to freeze ICD-10 codes between now and 2013, the deadline required by HIPAA for the industry adoption of ICD-10. Automated mapping, or "crosswalks," do help, but the terminologies and classifications issue remains understated as a challenge to successful EHR deployment.

8. EHRs must be trusted and secure. If patients and providers do not possess a reasonable sense of trust in the security of their most sensitive health information, the desired objective -- interoperable access to data to gain insight from analysis and make informed, data-driven decisions -- will not be achieved. User trust is vital. Privacy, a close cousin to security, must also be guarded, as consumers would like control over who is authorized to access their information, for what reason, and when.

9. EHR types, despite differences, must not interfere with the goal of interoperability. Electronic medical records inside a hospital serve as the legal records of the services provided to its patients, while other forms of electronic health information are intended to be shared across a variety of sources, including, in the case of personal health records, direct data input by the patient. EHRs that are shared across health information exchanges and through standardized transaction definitions, as envisioned in HITECH, contain elements from medical records, e-prescribing networks, laboratory, and radiology results, and physician ambulatory health records. The distinctions and nuances of these data sources will always be important, but they must not impede sharing and interoperability across a network of connected records.

10. EHRs must reject 'technologic determinism.' Drexel University College of Science Technology Professor Dr. Scot Silverstein represents a growing cadre of trained experts in both medicine and informatics who are concerned about the safety of health care delivery in the future Connected Health system. He rejects the "technologic determinism" theory, which the current hype surrounding EHRs tends to espouse. Under the theory, technological innovation causes social change, rather than enabling or responding to the need for change. Thus, the practice of medicine and improvement of health care delivery could be automated by EHRs and software, rather than better enabling health care professionals to do their job through reliable clinical software tools and access to any patient's unique health record from the network. Dr. Silverstein believes that medicine will remain an art and science practiced by trained physicians and clinicians, not by IT people; EHR technology must avoid being viewed as a technical panacea or an automated replacement for professional judgment. Health information technology holds tremendous promise for facilitating better care, putting valuable tools in the hands of knowledgeable and trained physicians, and providing greater interaction and collaboration with patients who can be more participative in their own health and well-being. EHRs will not substitute for expert care.

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This "Life Sciences Top Ten" was authored by Dane Stout of The Anson Group. The author thanks Epstein Becker Green attorney Robert Hudock, who has written extensively on health privacy and security issues, for his contributions. For additional information about the issues discussed in this "Life Sciences Top Ten," please contact the author or contributor, or the Epstein Becker Green attorney who regularly handles your legal matters.