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Accenture

The evolving needs of the healthcare industry — especially for EHR implementation — demand uniformmessaging standards and consistent use of those standards.

Connectivity is important both to patient safety and costeffectiveness in healthcare. Keeping costs down through compatibility of new IT systems — workstations, CT scanners, MR imagers, film digitizers, shared archives, laser printers and host computers and mainframes made by multiple vendors and located at one site or many sites — can be greatly enhanced through a single clinical messaging standard.

When clinical information can be exchanged among various IT systems — within a hospital and among external health providers, public health entities and even insurance plans — the corresponding medical information, diagnoses and images are captured and communicated sooner, physicians reach diagnoses sooner and treatment decisions can be made more quickly. In the future, even individual patients may be able to request, receive and manage their own personal health information via the Internet using secure messaging standards. In a restricted way, this is already happening today.

The goal is clear: a fully integrated healthcare system that allows secure transfer of personal health information within the United States or abroad. The U.K., Canada, Australia, Finland and other countries are well on their way to implementing their own set of EHR applications and data integration standards. Surely this country should also be a leader in healthcare information technology.

While the federal government has recognized the need for messaging standards to enable improved levels of interoperability and data comparability, progress toward widespread use remains difficult. One of the U.S. government’s goals is to accelerate adoption of EHR standards such as Health Level 7 (HL7), that will facilitate implementation of an interconnected electronic health information infrastructure nationwide.

Collecting and Moving Clinical Data In the Organization

Collecting patients’ clinical and demographic information starts the moment they first schedule an appointment, which is where the challenge of working with various messaging standards becomes evident. Figure 1 is a summary of the types of information that can come together at a patient’s physician office via other physicians, payers, reference labs, diagnostic centers and hospital records — every one in a differing format. It illustrates the complexity of getting to a compatible EHR.

This is a partial listing of possible IT system types that identifies some of the different information sources — all with mostly incompatible message standards or differing implementations of those messaging standards for each information source. In short, the data and the supportive process must “match” at both the source and destination computer systems.

Outside of healthcare, automating a process — such as ordering an airline ticket over the Internet — is based on an industry-standard, intuitive information sequence familiar to anyone with a PC. However, little true standardization is actually deployed on any level within the fragmented healthcare industry. Placing a prescription order, receiving lab test results, billing for a patient visit or referral to a specialist — communications become an exercise in risk management. Especially alarming is that a typical hospital runs dozens of different computer systems. Large academic institutions may have more than 100 online systems.

Because almost every provider organization relies on off-theshelf software solutions, an open and profitable market for thirdparty vendors of healthcare applications has resulted in the U.S. and most other countries. This market consists of a number of relatively small vendors that are mostly unique to the healthcare market and a few recognizable “big brands,” such as Siemens and General Electric. By and large, these software solutions are extremely configurable to the wide variety of processes that exist across the industry. Similarly all interfaces are also configured to match the exact data and process being supported for every computer interconnection in every organization.

Going Beyond the Organization

Until now we have limited our considerations to a single organization. However, there are two different theaters for messaging standards: 1) moving data inside an organization (inter-organizational), and 2) moving data back and forth among separate locations and organizations. The seemingly simple process of transferring diagnosis or allergy information from a hospital to a specialist can quickly expose the weakness of the system.

Once EHRs are transferred to other facilities or organizations — or even other countries — the technical challenges become more complex. True plug-and-play standards are far more important, as there is neither the time nor the resources to both match data and the process across organizational boundaries.

HIPAA — This 1996 federal set of regulations that is still being deployed covers communications between providers and payers as well as federal laws protecting the privacy of health information and the security measures necessary to ensure that privacy. HIPAA also includes provisions that require the Health and Human Services (HHS) department to identify and adopt national standards for electronic healthcare transactions, while integrating crucial protocols to protect individual privacy. These standards include the Accredited Standards Committee X12 standard, the National Council for Prescription Drug Program standard and the HL7 standard.

Electronic Prescribing and EHR — The Medicare Modernization Act of 2003 (MMA) requires the Secretary of HHS to promote and secure the adoption of electronic prescribing by 2010 as defined in the act. Unlike HIPAA, MMA is very specific in its definition of the relatively technical concept of electronic prescribing. MMA requires that electronic prescribing systems contain a subset of what we expect in an EHR or electronic medical record (EMR) system. In short, MMA requires what we might call a “light” version of EHR by 2010 — significantly earlier than the president’s goal of 2014.

Modes of Messaging

There are several variations in the style and content of messaging standards. Some of these differences result from the needs of different business and clinical purposes. Others result from a growing awareness of user requirements, improvements in modeling methods and increasingly rigorous efforts to define the implementation issues.

Because they deal with arbitrary processes and a seemingly unlimited amount of data, messaging standards applications are very complex. Variations in standards specifications are inevitable; however, implementation guides with a common style of documentation and more consistent content can ease understanding and implementation of messaging standards.

There are two general ways that healthcare information is typically communicated between computer systems:

• Unsolicited Update — Unsolicited updates are messages that are “pushed” from a source computer system as the result of a pre-specified event. This type of event-driven messaging is what is most typically used between computer systems inside of provider organizations.
• Query Response — Similar to accessing your financial records over an ATM, a query response is initiated by the user. Query response messages are a coupling of two messages. The first message makes a request of data specified in a query. The second message is a coupled response to the query that contains the request information or possibly an explanation of why the data can’t be sent.

Role of the NCVHS in Recommending Standards

The National Committee on Vital and Health Statistics (NCVHS) is the public advisory body to the secretary of HHS and was directed by the HIPAA law to make recommendations of specific national standards for electronic clinical messaging formats.

In a letter to the secretary of HHS, the subcommittee stated that “standards for EHR are important because they will facilitate significant improvements in the quality of patient care, promote patient safety, control rising healthcare costs, enhance the productivity of clinical research and strengthen the nation’s ability to identify and respond to healthcare emergencies. They are critical for a National Health Information Infrastructure.”

The subcommittee recently recommended that HHS make the standards voluntary by outlining industry use of standards rather than creating new regulations. It also suggested HHS use its leading healthcare market position to accelerate the development, adoption and coordination of EHR standards.

Because HHS has been so slow in promoting the implementation of further standards, committee members believe that making clinical standards voluntary — but using HHS and other government agencies as early adopters — may result in widespread adoption faster than mandates, contrary to the national mandate for standardized electronic transactions authorized under HIPAA.

HHS has enormous influence in the healthcare industry.With control over Medicare, Indian Health Service and other health programs, and joint authority with states over Medicaid, HHS is by far the largest healthcare payer in the nation. Other federal agencies, especially the Departments of Defense and Veterans Affairs, are among the largest providers of healthcare in the nation.

To harmonize the various EHR message format standards, the NCVHS Subcommittee recommends that standards developing organizations (SDOs) share data elements and definitions with the U.S. Health Information Knowledgebase, a data registry. The subcommittee’s proposal also gives a glimpse of its future work to standardize clinical data: “NCVHS has limited its EHR recommendations to message format standards. The committee plans to further investigate medical terminologies and code sets and will also consider EHR standards for clinical documents and the content and structure of patient records.”

Messaging and Data Standards — The current list of SDOs and different messaging standards proposals are summarized below. In addition, there are various data vocabulary standards, such as LOINC (Logical Observation Identifiers, Names and Codes) — codes used as universal identifiers for laboratory and other clinical transactions that facilitate the exchange and pooling of results, such as blood hemoglobin, serum potassium or vital signs, for clinical care, outcomes management and research. The different terminologies also add to the complexity of standards, such as the American College of Pathologists’ SNOMED Clinical Terms (SNOMED CT). This terminology provides a common language to enable a consistent way of capturing, sharing and aggregating health data across specialties and sites of care. Some applications for SNOMED CT include EMR, ICU monitoring, clinical decision support, medical research studies, clinical trials, computerized physician order entry, disease surveillance, image indexing and consumer health information services.

EHR/EMR — For purposes of discussion in this article, an EHR contains information about a patient’s health and is used to communicate a patient’s health status to a physician or other caregiver. EHR Systems (or EHRS) is developing into a formal standard definition by HL7’s EHR Technical Committee and its published normative EHR standard. EHRS support the creation and communication of an EHR. EMR is a similar (and overlapping) term used to describe a more formal definition of an electronic collection of patient information and the processes surrounding the collection and use of that data. It can also extend to a specific (state-by-state defined) legal definition. In general, EMR (like EHR) systems are computer systems that both hold the EMR and are used by a physician to document and retrieve information about the patient in the normal course of providing care. At this point in time, the terms EHR and EMR are sometimes difficult to distinguish and many users of the terms do not really distinguish a distinct different meaning to the terms.

Electronic Prescribing — Already noted earlier, electronic prescribing, as set forth by the MMA, requires electronic prescribing systems to feature items such as a patient’s medication history, allergies and other information, such as diagnosis, problem lists and laboratory results.

Major Standards Organizations

There are several SDOs accredited by the American National Standards Institute (ANSI) that operate in the U.S. healthcare arena, and in some cases, in other countries as well. SDOs produce standards (also called specifications or protocols) for specific healthcare areas such as pharmacy, medical devices, imaging or insurance (claims processing) transactions.

Following is an overview of the major SDOs in use in the U.S.:

Health Level Seven (HL7) — Provides standards for management and integration of data supporting clinical patient care and healthcare services. HL7 endeavors “specifically, to create flexible, cost-effective approaches, standards, guidelines, methodologies, and related services for interoperability between healthcare information systems.” It is unique in encompassing “the interface requirements of the entire health care organization” rather than focusing on the messaging requirements of a single department.

• Version 2 — This messaging standard (Application Protocol for Electronic Data Exchange in Healthcare Environments) from HL7 is the most widely implemented standard for healthcare information in the world and seen as the “workhorse” of data exchange in healthcare. Later versions (such as the current 2.5) have evolved and feature enhanced functionalities over earlier versions as well as support for newer syntax coding technologies such as XML.
• Version 3 — Similar to V2.x in functionality, V3 is a standard for exchanging messages among information systems that implement healthcare applications. However, V3 is a more robust standard based on a formal development methodology that includes the use of modeling both for data (a reference information model) and processes (use case scenarios). It uses rigorous analytic and message-building techniques and incorporates more trigger events and message formats while also greatly reducing options. Unlike V2, the Version 3 standard is definite and testable, and provides the ability to certify vendors’ conformance. Version 3 uses an object-oriented development methodology and a Reference Information Model to create messages.

  - Reference Information Model (RIM) — This cornerstone of V3 is a large model language and pictorial representation of the clinical data (domains), and identifies the life cycle of events that a message or groups of related messages will carry. Shared between the domains, the RIM is the model for all domains to create their messages.

  - HL7 Methodology — The HL7 Development Framework is the methodology for the development of HL7 Version 3 and its messages.

  - Vocabulary Standards — The vocabulary standards vary by the data item in a message. Standards are chosen by HL7 and the NCVHS. They make use of established standards when they exist for the data item (e.g., ICD for a diagnosis); when possible, non-health specific data are coded from standards established by organizations such as the UN’s ISO (e.g., race and religion).

Clinical Document Architecture (CDA) — Previously known as the patient record architecture, CDA provides an exchange model for clinical documents (such as discharge summaries and progress notes), and is an important step toward implementation of EHRs. The CDA standard makes documents both machine-readable and human-readable to enable easy retrieval and readability for users while at the same time managing the integrity and attestability of the specific collection of data contained in the document.

Digital Imaging and Communications in Medicine (DICOM) — A standards committee of the American College of Radiology and the National Electrical Manufacturers Association (ACR/NEMA) that supports DICOM, an industry standard for the transmission of a wide range of medical images (in radiology, cardiology, pathology and dentistry). DICOM enables digital communication between diagnostic and therapeutic equipment and systems from various manufacturers.

National Council of Prescription Drug Programs (NCPDP) — Has defined a standard for sending drug prescription information from pharmacies to payers for prescription management service and for receiving approval and payment information — all at close to real time. The council is currently working on standards for adverse drug reactions and utilization review and mapping of their prescription “script” standards to HL7s in-hospital pharmacy order messages.

Clinical Data Interchange Standards Consortium (CDISC) — Leads development of standard data models that improve process efficiency while supporting the scientific nature of clinical research, particularly the end-to-end data flow of clinical trials, from the source(s) into an operational database, through analysis to regulatory submission. The relevant data sources vary among patient records (e.g., case-report-form data), clinical laboratory data, data from contract research organizations, shared data between companies with corporate mergers or development partners, and other sources.

X12N — A transaction standard of the ANSI-accredited Standards Committee X12’s insurance subgroup (N) that is also part of the Transactions and Code Sets Rule specified by HIPAA. The X12N standards include transactions for claims/ encounters, attachments, enrollment, disenrollment, eligibility, payment/remittance advice, premium payments, first report of injury, claim status, referral certification/authorization and coordination of benefits.

American Society for Testing and Materials (ASTM) — One of the largest voluntary standards development organizations in the world, ASTM develops technical standards for materials, products, systems and services. The ASTM Committee E31 on Healthcare Informatics develops standards related to the architecture, content, storage, security, confidentiality, functionality and communication of information used within healthcare and healthcare decision making, including patient-specific information and knowledge. Specific to EHR, ASTM has been developing the continuity of care record to ensure the portability of patients’ clinical data between settings of care.

American Dental Association (ADA) — Provides the HIPAA standards similar to X12 but specifically related to the dental industry and payers of dental services.

American National Standards Institute (ANSI) — Active in both national and international standardization, ANSI itself does not develop standards, but provides the framework of rules and accreditation of standards that SDOs develop. The Institute ensures that access to the standards process, including an appeals mechanism, is made available to anyone directly or materially affected by a standard under development. ANSI’s involvement in EHR is through the standards organizations that are accredited by ANSI. ANSI also sponsors the Health Information Standards Board to provide a forum for coordinating the activities of the multiple ANSI-accredited healthcare standards groups.

Integrating the Healthcare Enterprise (IHE) — An initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 to address specific clinical needs in support of optimal patient care. Systems developed in accordance with IHE standards-based implementation guides communicate with one another better, are easier to implement and enable healthcare providers to use information more effectively.

Electronic Health Record Vendor Association (EHRVA) — A trade association of EHR vendors that supports and promotes national efforts to create interoperable EHRs in hospital and ambulatory care settings. Its chief objective is to promote a rapid adoption of EHR to help improve the quality of patient care and the productivity of the healthcare system.

Healthcare Information and Management Systems Society (HIMSS) — The healthcare industry’s membership organization; it advances healthcare public policy and industry practices through its advocacy, educational and professional development initiatives. These promote information and management system contributions that help improve patient care. HIMSS supports EHRVA by providing staff to assist with meetings and conference calls, as well as to provide guidance relative to trade association operations.

Summary

EHR messaging standards are key to enabling efficiency gains and improved service across the U.S. healthcare industry. However, the complexity of reliably moving data and processes among IT systems continues to resist a useful solution. The NCVHS, the main advisor to HHS, sees voluntary adoption of EHR standards as more efficient than new regulations. This includes a call to the major SDOs to share data elements (such as messaging and EHRS standards, and electronic prescribing) to accelerate and enhance the development of an integrated healthcare system that allows secure transfer of personal health information.

As an independent and trusted advisor to many healthcare institutions and SDOs, Accenture is an experienced facilitator of IT solutions for the healthcare industry.We see the increased involvement of the U.S. government — through the NCVHS — as a necessary prerequisite for the development and adoption of a messaging standard.