HEALTHCARE DATA STANDARDS

What are Standards? They are critical components in the development and implementation of an electronic health record (EHR). Factors that Affect the Effectiveness Healthcare Delivery The ability of clinicians to assess critical health information when and where it is needed The ability to exchange health information across organizational and system boundaries A common set of rules and definitions A sociopolitical structure NEED FOR HEALTHCARE DATA STANDARDS Data Standards as applied

this process. Temporal and physical proximity of the communicators provided ample opportunity to clarify any ambiguity regarding the intended meaning of what was being communicated

in Healthcare: methods, protocols, terminologies, and specifications for the collection, exchange, storage, and retrieval of information associated with healthcare applications, including medical records, medications, radiological images, payment and reimbursement, medical devices and monitoring systems, and administrative processes (Washington Publishing Company, 1998).

Healthcare Delivery Today, it is far more complex. A single episode may frequently take place across multiple settings and involve numerous parties: patients and their social support system providers working directly and indirectly with patients administrators payers Information about patients and their case is used for: direct care process reimbursement research public health education policy development litigation What is the reason behind the use of ELECTRONIC INFORMATION and MANAGEMENT SYSTEMS in the healthcare domain? tremendous increase in the need for health information exchange However, while current IT is able to move and manipulate large amounts of data,

in Information Management, standards are further categorized as: 1. those that support the generic infrastructure not domain-specific examples: equipment specifications processor type network transmission protocols: Ethernet, token ring 2. those that support the exchange of information domain-specific typically involves the specification of data structures and content examples: message formats, core data sets 3. those that support activities and practices within a specific domain addresses the interpretation of that data as information example: professional practice guidelines. What is Healthcare? Fundamentally, it is a process of communication. Verbal communication between a patient and a healthcare provider characterized

it is not as proficient in dealing with ambiguity in the structure and semantic content of that data.

Data Standards They are an attempt to reduce the level of ambiguity in the communication of data so that actions taken based on the data are consistent with the actual meaning of the data. Generally used to describe those standards having to do with the structure and content of health information

Data: collections of unstructured, discrete entities (facts) that exist outside of any particular context. Information: interpreted data within a given context and given meaningful structure within that context. Knowledge: collection of information from various contexts that follows a

defined set of rules and provides the basis for informed action. Represent both data and their transformation into information Analysis generates knowledge, which is the foundation of professional practice standards.

HEALTHCARE DATA INTERCHANGE STANDARDS Data interchange standards, address, primarily, for the format of messages, that are exchange between: Computer systems Document architecture Clinical templates User interface Patient Data Linkage To achieve data compatibility between systems it is necessary to have prior agreement on the syntax of the messages to be exchanged. Message Format Standards

from bedside medical services such as found in: Intensive care unit Operating rooms Emergency department These data include physiologic parameter measurements and device settings The current activities includes efforts to develops standard that supports wireless technology the IEEE 802.xx suite of wireless networking standards, 802.11, 802.15, and 802.16 has stirred up developments in an otherwise sluggish communications market. The most widely known standard, 802.11, commonly referred as WI-FI.

Four broad classes of message format standards have merge in the health care sector: Medical device communications Digital imaging communications Administrative data exchange Clinical data exchange

WI-FI allows anyone with a computer and either a plug-in card or built-in circuitry to connect to the internet wirelessly through a myriad access points installed in offices,hotels,airports,convention, centers and even parks, among other locations.

The National Committee on Vital and Health Statistics (NCVHS)

the advisory committee established to make recommendations on health information policy to the department of health and human services (HHS) and congress.

ABBREVIATIONS: HIPPAA-health insurance portability and accountability PMRI-patient medical record information HL7-health level seven DICOM-digital imaging communications in medicine standard committee NCPDP-national council for prescription drug program IEEE-Institute of electrical and electronic engineers Institute of Electrical and Electronic Engineers (IEEE) The IEEE developed a series of standards known collectively as P1073 medical information(MIB) Which support real time, continuous,and comprehensive capture and communications of data

National Electrical Manufacturers Association (NEMA) The National Electrical Manufacturers Association (NEMA) in collaboration with the American college Radiologists (ACR) and others, the DICOM to develop a generic digital format and transfer protocol for medical images and image related information. The DICOM standard is the dominant international data interchange message format in biomedical imaging The joint NEMA/The European coordination committee of the radiological and electro medical industry/Japan industries association of radiological systems (COCIR/JIRA) security and privacy committee (SPC) has recently issued a white paper which provides a guide for vendors and users on how to protect medical information systems against: Viruses Trojan horses denial of service attack

internet worms related forms of so-called malicious software

Accredited Standards Committee X12N/Insurance Accredited standards committee (ASC)X12N has developed abroad range of electronic data interchange (EDI) standards to facilitate electronic business

transactions. Vision To be an innovative leader in the development of cross industry e-commerce standards that improve global business process interoperability and facilitate business information exchange. Mission To develop high quality e-commerce standards in an open consensus environment To drive the adoption and implementation of the standards we develop To promote and provide education about the standards we develop National Council for Prescription Drug Programs NCPDP is a not-for-profit, ANSI-accredited*, Standards Development Organization with over 1600 members representing virtually every sector of the pharmacy services industry. Our diverse membership provides leadership and healthcare business solutions through education and standards, created using the consensus building process. Develops standards for information processing for the pharmacy services sector of the health care industry Since the introduction of this standard in 1992,the retail pharmacy industry has moved to almost 100% electronic claims processing in real time. HL7 The major areas covered by the standard include medical orders, clinical observations, test results,admission,transfer,and discharge. The HL7 boards of directors recently approved the electronic health record system(EHR-S)functional model to move forward as a draft standard for trial use. This draft standard consists of four distinct sections including an EHR-S functional overview, direct care, supportive and information infrastructure. TERMINOLOGIES International Statistical Classification of Diseases and Related Health Problems: 9th Revision and Clinical Modifications Used in the heathcare industry and has been adopted for a number of purposes including data collection, quality-of-care analysis, resource utilization, and statistical reporting Internationally, ICD-9 is used for death

tabulation International Statistical Classification of Diseases and Related Health Problems: 10th revision The most recent revision of the ICD classification system for mortality and morbidity which is used worldwide Also encompasses nomenclature structures Current Procedural Terminology 4th Revision A listing of descriptive terms and codes for reporting medical services and procedures Contains modifiers, notes, and guidelines to facilitate correct usage Systematized Nomenclature of Human and Veterinary Medicine International, Clinical Terms A comprehensive classification system created for indexing human and veterinary medical vocabulary, including signs and symptoms, diagnoses, and procedures Logical Observation Identifiers Names and Codes (LOINC) Provides a set of universal names and numeric identifier codes for laboratory and clinical observations and measurements in a database structure Represents laboratory data in terms of names for tests and clinical observations Rx Norm Clinical drug nomenclature Provides standard names for clinical drugs (active ingredients + strength + dose form) and for dose forms as administered ANA has recognized the following languages: Omaha System Home Health Care Classification Patient Care Data Set Perioperative Nursing Data Elements SNOMED-CT International Classification for Nursing Practice ABC Codes LOINC North American Nursing Diagnosis Association Nursing Interventions Classification Nursing Outcome Classification Nursing management minimum data set Nursing minimum data set

 Unified Medical Language System Consists of a semantic network of relationships among the concepts recognized metathesaurus, and an information sources map of the various biomedical database referenced DATA CONTENT STANDARDS The Concept of a Minimum Data Set a minimum set of items with uniform definitions and categories concerning a specific aspect or dimension of the healthcare system which meets the essential needs of multiple users (Health Information Policy Council, 1983). Core Data Element

the Computer-Based Patient Record (ASTM E1384-96) American Society for Testing and Materials (ASTM) one of the largest SDOs in the world publishes over 9,000 standards covering all sectors in the economy. Committee E31 on HI developed a wide range of standards supporting electronic management of health information. E1384-96 Provides a framework vocabulary for the CPR content. Proposes a minimum essential content drawn from a developing annex of dictionary elements. Used in conjunction with ASTM E1633-95 (standard specification for coded values for the CPR). Continuity of Care Record (CCR) a core data set of the most relevant and timely facts about a patient's healthcare. To be prepared by a practitioner at the conclusion of a healthcare encounter in order to enable the next practitioner to readily access such information. It includes the following: Summary of the patient's health status (e.g. problems, medications, allergies) Basic information about insurance Advance directives Care documentation Care plan recommendation THE STANDARDS DEVELOPMENT PROCESS Standards are resource-intensive to develop and to implement different ways to do things Concept of a Secure Patient-Centered her Safeguards personal privacy Uses standardized medical terminology Eliminates danger of illegible handwriting and missing patient information Can be transferred as a patient's care requires over a secure communications infrastructure

a standard data element with uniform definition and coding convention to collect data on persons and on events or encounters (National Committee on Vital and Health Statistics, 1996). Serves as the building block for wellformed minimum data sets and may appear in several minimum data sets. Based on a recent survey of public and private sector efforts in the development of minimum data sets and core data elements, there are 17 such sets in use nationally (McCormick et al., 1997). Examples of Minimum, or Core, Data Sets currently in use:

Professional specialty groups: the best source for current information on minimum data set development efforts. Messaging format standards: ex. HL7 and ASC X12N

National Uniform Claim Committee Recommended Data Set for a Noninstitutional Claim NUCC organized in 1995 develops, promotes, and maintains a standard data set for use in noninstitutional claims and encounter information. Chaired by the American Medical Association member organizations: major public and private sector payers current data set forms the basis for the proposed noninstitutional claim and encounter standard proposed for national adoption under HIPAA. Standard Guide for Content and Structure of

3 Ways How Standards are Developed and Adopted 1. Proprietary Standards often developed quickly and are supported by available implementations and tools

although it can respond quickly to technologic changes, it can also result in a delay in the adaptation of new technologies 2. Legislated (Government-based) Standards Accepted by virtue of their being required regulation or in order to participate in large government-funded programs Developed to support particular government initiatives and not be as suitable for general, private sectors 3. Consensus-based Standards Have a wide variety of stakeholders Not tied in one specific system They tend to be robust and adaptable across a range of implementation. INTEGRATING THE HEALTHCARE ENTERPRISE An initiative that provides a detailed framework for implementing standards, filling the gap between standards and their implementation. STANDARDS COORDINATION EFFORTS Health Insurance Portability and Accountability Act The single most important advance in the adoption of national health data standards was the passage in 1996 of HIPAA. It has been estimated that, 26 cents of every dollar intended for healthcare is spent on administrative overhead The healthcare industry has been attempting to develop standards to allow these transactions to be accomplished electronically. At the request of the industry with bipartisan support, Congress included the administrative simplification provisions in the HIPAA signed into law August 21, 1996. These provisions could save up to $9 billion per year w/o reducing the amount/quality of healthcare services (Workgroup for Electronic Data Interchange [WEDI] 1993). To make saving in cost and administrative efficiency a reality, the law charges the US secretary of HHS with establishing standards for a broad range of health information. The law also require standards for security and confidentiality of health information. Civil and criminal penalties are prescribed for failure to use standards or wrongful disclosures of confidential information. The administrative simplification subtitle of the government has mandated health data standards on a national level.

The industry has made great progress over the past several years in its goal to achieve compliance and operationalize the HIPAA requirements.

National Committee on Vital and Health Statistics Subcommittee on Standards and Security The administrative simplification provisions also begin the process of addressing the broader standards issues of electronic-healthcare records in general. Section 263 of the administrative simplification provisions of HIPAA. These provisions state that NCVHS: Shall study the issues related to the adoption of uniform data standards for patient medical record information and electronic exchange of such information. Shall report to the secretary not later than four years after the date of the enactment of the Health Insurance Portability and Accountability Act of 1996 recommendations legislative proposals for standards and electronic exchange. NCVHS formed the CPR Workgroup The workgroup develops recommendations based on public hearings and input from informed stakeholders and domain experts

Six Major Areas of Interest: 1. Message format standards that contain PNRI 2. Medical terminology related to PMRI 3. Business case issues related to the development & implementation of uniform data standards for PMRI 4. National Healthcare Information Infrastructure (NHII)& integrity related to PMRI 5. Data quality, accountability, and integrity related to PMRI 6. Inconsistencies & contradictions among state laws that discourage or prevent the creation, storage or communication of PMRI in a consistent manner nationwide. The secretary of the U.S. Department of HHS, the CPR Workgroup stated that the lack of complete and comprehensive PMRI standards is a major constraint on the ability of our healthcare delivery system to enhance quality, manage cost and safeguard data. The committee has subsequently recommend to sets of PMRI standards including message formats and

terminologies. CONSOLIDATED HEALTH INFORMATICS Another federal project that has great potential for furthering health data standards is the consolidated health informatics(CHI)initiative coordinated by the U.S. Department of Defense, the U.S Department of VA,and the U.S. Department of HHS, Indian health service. The goal of this ambitious project is to develop and implement standard means of exchanging and managing health information across federal health providers. Although this project is focused solely on federal healthcare providers, three factors increase its general interest and impact: Size of population these organization serve Characteristics of the project Explicit effort FRAMEWORK STRATEGIC ACTION On April 27,2004,president Bush called for widespread adoption of interoperable EHRs within 10 years and established the position of national coordinator for health information technology. Secretary Tommy Thompson appointed David Brailer, MD, PhD to serve in this new position In fulfilling the requirements of the executive order,Dr.Brailer has submitted a report that outlines a framework for a strategic plan that will help the nation to realize anew vision for healthcare made possible through the use of information technology. THE BUSINESS VALLUE OF DATA STANDARDS Clearly the importance of data standards to enhancing the quality and efficiency of health care delivery is being recognized by our national leadership Having data standards for data interchange and information modeling will provide a mechanism against which is deployed system can be validated The most important concept to keep in mind when discussing the definition and use of data standards is predictability. Predictability associated with information exchange allows application developers to design and implement application architectures that can exploit expectations to allow for more efficient processing.