HI300 Unit 5: Standards for Electronic Data and Data Interchange – Discussion

 

Standard Development Organizations

 

 

 

Identify and research standard development organizations listed in the text on pp. 165–166. Select one of the organization’s websites and identify at least 3-4 facts about this organization and explain what it does.

Do not duplicate your classmates’ information. Note: You may explore the internet for recent articles about the organization and include this information as well.

 

When responding to your classmates describe similarities and differences between the organizations you researched.

Discussion responses should be strictly on topic, original with scholar references, and contribute to the quality of the discussion by making frequent informed references to lesson material.

 

NO PHARGIARISM!!

 

 

Below is the Chapter 4 reading for this assignment.

 

Standards for Electronic Data and Electronic Data Interchange

The original uniform data sets such as the UHDDS and the UACDS were created for use in paper-based (manual) health record systems. They were not designed to accommodate the data needs of the current healthcare delivery system or the demands of EHRs and clinical information systems.

Standards are needed in order for data to be easily, accurately, and securely communicated and exchanged electronically among various computer systems. This is referred to as interoperability. Without standards for interoperability, EHRs and the NHIN will not realize their full benefits (Thompson and Brailer 2004).

Many types of standards are being developed to support the EHR and health information exchange. Some involve defining record structure and content, others specify technical approaches for transmitting data, and still others provide rules for protecting the privacy and security of data.

Public and private organizations have been actively engaged in the process of developing healthcare informatics standards to support EHR development, interoperability, and information exchange. The federal government supports this work in a variety of ways. One example is the S&I Framework. According to Fridsma (2010 slide 4), the Framework “is the mechanism by which ONC will manage the implementation of specifications and the harmonization of existing health IT standards to promote interoperability nationwide.”
Definition of Data Standard for Electronic Data Exchange

Data standards provide the ability to record a certain data item in accordance with the agreed upon standard (Giannangelo 2007). Data content standards are “clear guidelines for the acceptable values for specified data fields” (Fenton et al. 2007). Data exchange standards are protocols that help ensure that data transmitted from one system to another remain comparable.

One of the purposes of HIPAA’s Administrative Simplification rules was to standardize information exchange and in August 2000, the Department of Health and Human Services (HHS) published regulations for electronic transactions. These regulations apply to transactions that occur among healthcare providers and healthcare plans and payers (Rode 2001). The long-term goal of the transaction standards is to allow providers and plans or payers to seamlessly transfer data back and forth with little intervention. To do this, HHS adopted the electronic transaction standards of ASC X12 Insurance Subcommittee (Accredited Standards Committee Health Care Task group [X12N]). The standards adopted for EDI are called ANSI ASC X12N.

The HIPAA standards also include code sets standards for the electronic exchange of health-related information. To illustrate how the adoption and utilization of standards for data representation and data exchange facilitates billing functions, consider the codes sets are data standards used to identify specific data elements such as the diagnosis on a claim. The compendium of data elements on the claim form make up a data set. In order to send the diagnosis and other items that make up the data set electronically, the healthcare provider uses the ASC X12N 837 messaging standard. The 837 specifies the format for each data element. For example, one specification for the format of the diagnosis would be that diagnosis codes have a maximum size of seven (7) characters.

A new version of the standard for electronic healthcare transactions (Version 5010 of the X12 standard) was approved in 2009 and implemented in 2012. This new version is essential to the use of ICD-10-CM and ICD-10-PCS codes that are slated for implementation in 2013.
Data Needs in an Electronic Environment

As discussed in chapter 16, healthcare organizations often have several different computer systems operating at the same time. For example, a hospital’s laboratory system might be entirely separate from its billing system. In fact, the various departments of large healthcare organizations often use different operating systems and are serviced by different vendors. In addition to operating multiple systems, it is an ongoing challenge to integrate information from legacy (older) systems operating on old platforms with state-of-the art information systems.

Healthcare organizations must integrate data that originate in various databases within facilities as well as in databases outside the facility. They also must be able to respond to requests to transfer data to other facilities, payers, accrediting and regulating agencies, quality improvement organizations, and other information users. These goals can only be accomplished when every database system is either operating on the same platform or using common standards.
Benefits of Data Exchange Standards

Healthcare informatics standards describe accepted methods for collecting, maintaining, and/or transferring healthcare data among computer systems. These standards are designed to provide a common language that makes it easy to:

    Exchange information
    Share information
    Communicate within and across disciplines and settings
    Integrate disparate data systems
    Compare information at a regional, national, and international level
    Link data in a secure environment

Having the ability to exchange, share, communicate, integrate, compare, and link data is important to healthcare delivery. These activities make possible important activities such as:

    Disease surveillance
    Health and healthcare population monitoring
    Outcomes research
    Decision making and policy development

The long-term vision is to enhance the comparability, quality, integrity, and utility of health information from a wide variety of public sources through uniform data policies and standards (NCVHS 2001). Thompson and Brailer (2004, 13) expressed the federal commitment to standards in their statement that “A key component of progress in interoperable health information is the development of technically sound and robustly specified interoperability standards and policies.” In 2010, states, eligible territories, and qualified State Designated Entities received awards from ONC to assist them in facilitating the secure exchange of health information in order to advance state-level health information exchange while moving toward nationwide interoperability. The ONC expects the funding to be used to increase connectivity, enable patient-centric information flow to improve the quality and efficiency of care, and ensure healthcare providers and hospitals meet national standards (ONC 2011b).

Many types of standards are necessary to implement EHRs and a health information technology infrastructure that supports connectivity, interoperability, and seamless data interchange. International, national, state and regional or local standards ensure communication and efficiency and minimization of duplication of effort along the continuum of healthcare. It is especially important to note that healthcare is provided locally and standards must be adopted at the local level to achieve the full benefit of an EHR.
American Recovery and Reinvestment Act

Officially known as the American Recovery and Reinvestment Act (ARRA P.L. 111-5) and Health Information Technology for Economic and Clinical Health Act (HITECH), the “Stimulus Law” was signed on February 17, 2009. ARRA provides $19.2 billion in spending on health IT. Title XIII of ARRA, given a subtitle, “Health Information Technology for Economic and Clinical Health Act (HITECH),” deals with many of the health information communication and technology provisions.
Office of National Coordinator

ARRA includes the statutory authorization of ONC, which makes ONC a permanent office under HHS (Asmonga 2009). Its charge is to help develop a national health IT infrastructure to improve the quality and efficiency of healthcare and the ability of consumers to manage their care and safety. ARRA stipulated $2 billion to ONC for use as follows (Asmonga 2009):

    $20 million: to advance healthcare information enterprise integration through technical standards analysis and establishment of conformance testing infrastructure to be done by the National Institute of Standards and Technology (NIST) and coordinated with ONC
    $300 million: to support regional or subnational efforts toward health information exchange
    Remaining funds: to the immediate implementation assistance to support:
        — Health IT architecture
        — Development and adoption of certified electronic health records (EHRs) for categories of healthcare providers not eligible for support under title XVIII or XIX of the Social Security Administration for the adoption of such records
        — Training on best practices to integrate health IT
        — Infrastructure and tools for the promotion of telemedicine
        — Promotion of the interoperability of clinical data repositories or registries
        — Promotion of technologies and best practices
        — Improvement and expansion of the use of health IT by public health departments

The ONC published a final rule establishing standards, implementation specifications, and certification criteria for the certification of EHR technology to support the achievement of meaningful use Stage 1 by eligible professionals and eligible hospitals under the Medicare and Medicaid EHR incentive programs in 2010. Stage 1 standards, which took effect in 2011, fall into three categories: content exchange, vocabulary, and privacy and security (ONC 2010). Transport standards were proposed but removed in the final rule. These standards will be discussed later in this chapter.
Health Information Technology (HIT) Policy Committee and HIT Standards Committee

Two official HHS advisory committees established as a result of ARRA are the HIT Policy Committee (HITPC) and the HIT Standards Committee (HITSC). The HIT Policy Committee provides recommendations to the National Coordinator on a policy framework for the development and adoption of a nationwide health information technology infrastructure that permits the electronic exchange and use of health information as is consistent with the Federal Health IT Strategic Plan and that includes recommendations on the areas in which standards, implementation specifications, and certification criteria are needed.

The HIT Standards Committee provides recommendations to the National Coordinator on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of adoption, consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed by the HIT Policy Committee.
Standards Development, Coordination, Testing, and Harmonization

Developing, coordinating, testing, and harmonizing healthcare standards is a complex process in which many organizations are involved. The following definitions provide further information on standards and harmonization (HITSP 2009):

The term standard … is a well-defined approach that supports a business process and:

    has been agreed upon by a group of experts
    has been publicly vetted
    provides rules, guidelines, or characteristics
    helps to ensure that materials, products, processes, and services are fit for their intended purpose
    is available in an accessible format
    is subject to an ongoing review and revision process.

    Harmonization is the name given to the effort by industry to replace the variety of product standards and other regulatory policies adopted by nations, in favor of uniform global standards. Usually used in the context of trade agreements, harmonization has recently been adopted by the United States government to refer to information technology standards.

Most standards are created through a voluntary consensus process that involves identifying the need for a standard, negotiating the content of the standard, and drafting a proposed standard. The final standard is published after undergoing a comment and revision period. This process facilitates wide adoption and improved utility. Figure 4.5 describes the standards value chain.
Figure 4.5. Standards value chain

Standards typically go through several stages in a process that can take three or more years. It begins with developers, who draft new standards or update existing ones. Profiling organizations select among applicable standards, combine the work of multiple developers, and create use scenarios for how to apply them. Typically, independent, neutral organizations test the standards, and implementers put them to work.

Advocates

Advocacy organizations influence and facilitate the value chain at every step. National governments are prominent standardization advocates, often sponsoring, funding, and staffing standards activities. Private-sector stakeholders include advocacy organizations such as health IT and finance advocates and software vendors, implementers, and users. Consumers also have a stake in standards, although they are underrepresented in standards advocacy.

Market Stakeholders

Software vendors, implementers, and users are economic stakeholders. They influence standards development and implementation through participation and funding. Their balance of interest is both strategic and tactical.

Source: Marshall 2009.

Organizations referred to as standards development organizations (SDOs) are involved with the creation or revisions of standards. HL7 and ASTM, for example, are both accredited SDOs. Table 4.1 provides a list of several organizations that are actively involved in developing standards for health-related information management.
Table 4.1. Standards development organizations

Resource
   

Description
   

Source

AIIM
   

AIIM is an ANSI (American National Standards Institute) accredited standards development organization. AIIM also holds the Secretariat for the ISO (International Organization for Standardization) committee focused on information management compliance issues, TC171.
   

http://www.aiim.org

Accredited Standards Committee (ASC) X12
   

ASC X12 is a designated committee under the Designated Standard Maintenance Organization (DSMO), which develops uniform standards for cross-industry exchange of business transactions through electronic data interchange (EDI) standards. ASC X12 is an ANSI-accredited standards development organization.
   

http://www.x12.org

American Dental Association (ADA)
   

The ADA is an ANSI-accredited standards developing organization that develops dental standards that promote safe and effective oral healthcare.
   

http://www.ada.org/275.aspx

ASTM International
   

Formerly the American Society for Testing and Materials, ASTM International is an ANSI-accredited standards development organization that develops standards for healthcare data security, standard record content, and protocols for exchange of laboratory data.
   

http://www.astm.org

European Committee for Standardization (CEN)
   

CEN contributes to the objectives of the European Union and European Economic Area with voluntary technical standards that promote free trade, the safety of workers and consumers, interoperability of networks, environmental protection, exploitation of research and development programs, and public procurement.
   

http://www.cenorm.be/cenorm/index.htm

Clinical and Laboratory Standards Institute (CLSI)
   

A global, nonprofit, standards development organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community. Its core business is the development of globally applicable voluntary consensus documents for healthcare testing.
   

http://www.clsi.org

Clinical Data Interchange Standards Consortium (CDISC)
   

CDISC is an open, multidisciplinary, nonprofit organization that has established worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development.
   

http://www.cdisc.org/

Designated Standard Maintenance Organization (DSMO)
   

The DSMO was established in the final HIPAA rule and is charged with maintaining the standards for electronic transactions, developing or modifying an adopted standard.
   

http://www.hipaa-dsmo.org

Health Industry Business Communications Council (HIBCC)
   

HIBCC is an industry-sponsored and supported nonprofit organization. As an ANSI-accredited organization, its primary function is to facilitate electronic communications by developing standards for information exchange among healthcare trading partners.
   

Home

Health Level 7 (HL7)
   

An ANSI-accredited standards development organization that develops messaging, data content, and document standards to support the exchange of clinical information.
   

http://www.hl7.org

Institute of Electrical and Electronic Engineers (IEEE)
   

A national organization that develops standards for hospital system interface transactions, including links between critical care bedside instruments and clinical information systems.
   

http://www.ieee.org

International Organization for Standardization (ISO)
   

ISO is a nongovernmental organization and network of national standards institutes from 157 countries.
   

http://www.iso.org/iso/en/ISOOnline.frontpage

National Council for Prescription Drug Programs (NCPDP)
   

A designated committee under the Designated Standard Maintenance Organization (DSMO) that specializes in developing standards for exchanging prescription and payment information.
   

http://www.ncpdp.org

National Information Standards Organization (NISO)
   

An ANSI-accredited, nonprofit association that identifies, develops, maintains, and publishes technical standards to manage information. NISO standards address areas of retrieval, re-purposing, storage, metadata, and preservation.
   

http://www.niso.org

National Uniform Billing Committee (NUBC)
   

A designated committee under the Designated Standard Maintenance Organization (DSMO) that is responsible for identifying data elements and designing the CMS-1500.
   

http://www.nubc.org

National Uniform Claim Committee (NUCC)
   

The national group that replaces the Uniform Claim Form Task Force in 1995 and developed a standard data set to be used in the transmission of noninstitutional provider claims to and from third-party payers.
   

http://www.nucc.org

Source: AHIMA 2007.

Private or government organizations involved in the development of healthcare informatics standards at a national or international level.

Because so many organizations are developing standards, there needs to be coordination. Therefore, some organizations play key roles in coordinating the efforts of other SDOs. The American National Standards Institute (ANSI) is one example. It coordinates the development of voluntary standards in a variety of industries, including healthcare. Most SDOs in the United States are members of ANSI. ISO coordinates international standards development. ANSI represents the United States at the ISO.

Some other projects that coordinate healthcare standards are the National Library of Medicine’s Unified Medical Language System (UMLS) and the USHIK.

The UMLS’s Metathesaurus is a centralized vocabulary database that includes more than a hundred vocabularies, classifications, and code sets. Source vocabularies found in the Metathesaurus include those designed for use in patient-record systems such as SNOMED CT as well as those used for healthcare billing such as ICD-9-CM. The code sets mandated for use in electronic administrative transactions in the United States under the provisions of HIPAA are found in the Metathesaurus with the exception of the National Drug Codes (NDC) which are available from the FDA.

The USHIK is a computer-based health metadata registry funded and directed by the AHRQ with CMS and the Veterans Administration as strategic inter-agency partners. It is populated with the data elements and information models of SDO and other healthcare organizations in such a way that public and private organizations can harmonize information formats with healthcare standards. The knowledge base also contains data element information for government initiatives supporting the use and implementation of data standards (for example, HIPAA) and the federal health architecture program.

ARRA called for ONC, in consultation with NIST, to recognize a program for the voluntary certification of health information technology as being in compliance with applicable certification criteria to meet defined meaningful use requirements. In collaboration with ONC, NIST has developed the necessary functional and conformance testing requirements, test cases, and test tools in support of the health IT certification program. The NIST is a non-regulatory agency of the U.S. Department of Commerce.

At present, one of the most challenging aspects of the standards movement is the area of standards harmonization. In 2011, the HITSC Clinical Quality Workgroup and Vocabulary Task Force were tasked with selecting the minimum number of vocabulary standards with the minimum number of values to meet the requirements of meaningful use stages 2 and 3. Content exchange standards are being reviewed as well with the same goal to harmonize HIT standards. It will take the cooperation and collaboration of many, especially the HIM profession, to harmonize HIT standards and implementation guides for the purpose of interoperability and health information exchange HIE.
Types of Standards

Many types of standards are necessary to implement EHRs and a health information technology infrastructure that supports connectivity, interoperability, and seamless data interchange. While progress with standards harmonization and consolidation has occurred, there are still hundreds of standards. Thus, it is impossible to discuss them all in this chapter. Those better-known standards HIM professionals may work with are addressed here. Other chapters, such as chapter 5 Clinical Vocabularies and Classification Systems, provide additional information on specific standards.
Record Structure and Content Standards

Structure and content standards establish and provide clear and uniform definitions of the data elements to be included in EHR systems. They specify the type of data to be collected in each data field and the attributes and values of each data field, all of which are captured in data dictionaries.
ASTM Standard E1384-02a 07

ASTM International is an SDO that develops standards for a variety of industries in the United States. The ASTM Technical Committee on Healthcare Informatics E31 is charged with the responsibility for developing standards related to the EHR. E31 works through subcommittees assigned to various aspects of this endeavor.

The ASTM Subcommittee E31.25 on Healthcare Data Management, Security, Confidentiality, and Privacy developed ASTM Standard E1384-02a 07. This standard identifies the content and structure for EHRs. The scope of this standard covers all types of healthcare services, including acute care hospitals, ambulatory care, skilled nursing facilities, home healthcare, and specialty environments. It applies to short-term contacts such as EDs and emergency medical care services as well as long-term care contacts.
HL7 EHR-S Functional Model and Standards

HL7 provides a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery, and evaluation of health services. It provides a reference list of functions that may be present in an EHR-S (http://www.HL7.org). Figure 4.6 shows the HL7 EHR-S Functional Model. HL7 developed the HL7 EHR-S Functional Model and Standards that address the content and structure of an EHR. The purpose of the functional model is to provide a foundation for common understanding of possible and useful functions of EHR systems.
Figure 4.6. ANSI/HL7 EHR System Functional Model, R1-2007
Content Exchange Standards

Content exchange standards complement record content and structure and vocabulary standards. These standards provide the rules, often called protocols, of how data are actually transmitted from one computer system to another. Content exchange standards supply the specifications for the format of data exchanges, thereby providing the ability to send and receive medical and administrative data in an understandable and usable manner across information systems.
CCR, CDA, and CCD

The CCR standard is a core data set of relevant current and past information about a patient’s health status and healthcare treatment. The CCR was created to help communicate that information from one provider to another for referral, transfer, or discharge of the patient or when the patient wishes to create a personal health record. Data from a CCR may also be incorporated into a personal health record. Because it utilizes XML codes, it enhances interoperability and allows its preparation, transmission, and viewing in multiple ways. The CCR is designed to be organized and transportable. It is sponsored by a consortium of healthcare organizations, practitioners, and other stakeholders. The CCR is the other content exchange option available for meeting the requirement for EHR Technology to be certified as being capable of electronically exchanging a patient summary record for stage 1.

HL7 is a SDO that provides standards, guidelines, and methodologies that make data exchange possible among hospitals, physician practices, and other types of provider systems. For example, the standards consist of rules for transmitting demographic data, orders, patient observations, laboratory results, history and physical observations, and findings. They also include message rules for appointment scheduling, referrals, problem list maintenance, and care plans.

The HL7 CDA provides an exchange model for clinical documents (such as discharge summaries and progress notes) and brings the healthcare industry closer to the realization of an EHR. The CDA standard makes documents machine-readable so that they can be easily processed electronically. It also makes documents human-readable so that they can be retrieved easily and used by the people who need them.

ASTM and HL7 negotiated a memorandum of understanding to bring ASTM’s CCR initiative into line with HL7’s EHR functionality and CDA standards. The CCD was developed as a collaborative effort between ASTM and HL7 to leverage CDA with the CCR specifications. As the use of the CCD increases, it is likely to become the common health information exchange (HIE) methodology between the EHR and PHR systems.
Institute of Electrical and Electronics Engineers 1073

The Institute of Electrical and Electronics Engineers (IEEE) 1073 provides for open-systems communications in healthcare applications, primarily between bedside medical devices and patient care information systems, optimized for the acute care setting. The IEEE 1073 series was adopted as a federal health information interoperability standard for electronic data exchange (ONC 2006).

The IEEE 1073 series of standards pertains to connectivity. The standard specifically addresses the requirement for two devices to automatically configure a connection for successful operation, independent of connection type. The standard defines a device-to-device internal messaging system that allows hospitals and other healthcare providers to achieve plug-and-play interoperability between medical instrumentation and electronic healthcare information systems, especially in a manner that is compatible with the acute care environment.
Digital Imaging and Communication in Medicine

Through a cooperative effort between the American College of Radiology and the National Electrical Manufacturers Association (ACR-NEMA), Digital Imaging and Communication in Medicine (DICOM) was originally created to permit the interchange of biomedical image wave forms and related information.

DICOM is used by most medical professions that use imaging within the healthcare industry, such as cardiology, dentistry, endoscopy, mammography, ophthalmology, and orthopedics. DICOM was adopted as the federal health information interoperability messaging standard for imaging in March 2003 (ONC 2006).
Vocabulary Standards

Vocabulary standards include vocabularies, code sets, and nomenclatures. These standards go hand in hand with other health informatics standards such as those for information modeling and metadata. Vocabulary standards establish common definitions for medical terms to encourage consistent descriptions of an individual’s condition in the health record. Having established standards for clinical data enables consistent definition of data elements. These systems are explored thoroughly in chapter 5.
Privacy and Security Standards

HIPAA mandated the adoption of privacy and security protection for identifiable health information. HIPAA privacy standards have been implemented throughout the healthcare industry to protect personal health information and define appropriate use and disclosure.

Security standards ensure that patient-identifiable health information remains confidential and protected from unauthorized disclosure, alteration, or destruction. Effective security standards are especially important in computer-based environments because patient information is accessible to many users in many locations. Many standards organizations—most notably, the ASTM and HL7—have developed security standards, but no single standard currently addresses all of the HIPAA provisions. Privacy is addressed in chapter 13 and security is addressed in chapter 17.
Check Your Understanding 4.2

    1. Which of the following best describes an SDO?
        A. Coordinates standards groups
        B. Develops standards
        C. Develops data sets
        D. Develops best practices
    2. Which of the following should be used to communicate information from one provider to another for referral, transfer, or discharge of the patient?
        A. CDA
        B. CCR
        C. HL7
        D. ORYX
    3. Which of the following was adopted as the federal health information interoperability messaging standard for imaging?
        A. DEED
        B. DICOM
        C. IEEE
        D. NHIN
    4. Which SDO develops messaging, data content, and document standards to support the exchange of clinical information?
        A. IEEE
        B. DSMO
        C. NUBC
        D. HL7
    5. Which of these standards is a standard for communication between bedside medical devices and patient care information systems?
        A. ASTM Standard E1384-02a 07
        B. LOINC
        C. HL7 CDA
        D. IEEE 1073
    6. One of the two official HHS advisory groups established as a result of ARRA responsible for making recommendations to the National Coordinator is:
        A. Certification Commission for Health Information Technology
        B. HL7
        C. HIT Policy Committee
        D. Accredited Standards Committee Health Care Task group
    7. Which standard assists in the sharing of information from one provider to another for patient care?
        A. ASTM CCR
        B. LOINC
        C. HL7 CDA
        D. DICOM
    8. What organization coordinates the efforts of other SDOs?
        A. ANSI
        B. HL7
        C. ASTM
        D. ARRA
    9. What type of standard establishes common definitions for medical terms?
        A. Content exchange
        B. Interoperability
        C. Record structure and content
        D. Vocabulary

Emerging Health Information Standards

The development of healthcare informatics standards is far from complete. The task is critically important to the development of EHR systems and, ultimately, to implementation of a national health information infrastructure. Leading standards groups are continuously working to reach consensus on a variety of standards, but many issues remain unresolved.
Extensible Markup Language (XML)

A key technology tool for enabling data sharing is called extensible markup language (XML). XML was developed as a universal language to facilitate the storage and transmission of data published on the Internet. Markup languages communicate electronic representations of paper documents to computers by inserting additional information into text (Sokolowski 1999).

For example, the CCR standard specifies XML coding that allows users to prepare, transmit, and view the CCR in multiple ways such as in a browser, as an element in a HL7 message, or CDA compliant document, or as a word processing document (ASTM 2009).

Another XML-based standard, the Structured Product Labeling (SPL), is a document markup standard approved by HL7 and adopted by Food and Drug Administration (FDA) as a mechanism for exchanging product information (FDA 2012).
Metadata Standards

AHIMA (2012) defines metadata as “Descriptive data that characterize other data to create a clearer understanding of their meaning and to achieve greater reliability and quality of information. Metadata consist of both indexing terms and attributes. Data about data: for example, creation date, date sent, date received, last access date, last modification date” (221). Metadata standards would be standards that support descriptive data that characterize other data to create a clearer understanding of their meaning and to achieve greater reliability and quality of information.

CDA documents are also encoded in XML. CDA is cited throughout an ONC advance notice of proposed rule making published on August 9, 2011. This notice solicited comments on metadata standards to support nationwide electronic health information exchange. Initial categories of metadata under consideration as a minimum set include patient identity, provenance, and privacy in association with a patient obtaining their summary care record from a health care provider (ONC 2011c). Following the notice, the ONC announced the launch of two pilot programs which will test the metadata standards. At the time of publication, a determination had not been made as to whether EHR technology should be capable of applying the metadata standards as part of EHR certification requirements supporting meaningful use under Stage 2 of the Medicare and Medicaid EHR Incentive programs.
Role of HIM Professional

As the domain experts in health record data content, HIM professionals have a large role to play in overseeing healthcare data sets and standards for their organizations. As paper disappears and electronic information environments appear, the HIM professional will be called upon to coordinate and manage the organization’s data requirements. HIM professionals have the opportunity to serve as leaders in healthcare organizations and in their professional community to ensure data content standards are identified, understood, implemented and managed. Specific aspects that fall to HIM professionals include (AHIMA 2008):

    Conducting a data content standards requirements analysis
    Developing a local data dictionary to support enterprise-wide interoperability
    Advancing the development of data content standards
    Contributing to domain knowledge by participating in relevant professional association work
    Contributing to the development and harmonization of industry and professional standards

Real-World Case

According to the American Academy of Family Physicians (AAFP), “Continuity of care is the process by which the patient and the physician are cooperatively involved in ongoing health care management toward the goal of high quality, cost-effective medical care” (AAFP 2010, paragraph 1). The CCR, an XML-based health data exchange standard, was created to help communicate summary health information from one provider to another for referral, transfer, or discharge of the patient. Microsoft introduced a personal health record platform that allows sharing of health information.

Microsoft’s HealthVault allows the user to gather, store, and share health information online. HealthVault supports the CCR and CCD standards for exchanging patient data. Not only can applications use the CCR standard to exchange data with HealthVault, but a user can extract and reconcile data from a CCR (Microsoft 2009). Microsoft’s partners include NewYork-Presbyterian Hospital, Health Partners, Kaiser Permanente, Aetna, Walgreens, among others.
Summary

According to Brandt (2000), “the vision is clear: a longitudinal, or lifetime, health record for each person that is computer-based, secure, readily accessible when needed, and linked across the continuum of care [is needed]. In reality, we are a long way from that model.” It is impossible to develop a longitudinal EHR that meets Brandt’s specifications without standards that guide its development. The complexity of technology, the variations in computer platforms from one system to the next, and the different (and sometimes conflicting) data needs of users demand flexible health data/information systems. The systems must be able to store volumes of data in a standardized format, communicate across vendor-specific systems, and keep data in a secure manner that protects individual privacy and information confidentiality.

The need for standardized data definitions was recognized in the 1960s, and the NCVHS took the lead in developing uniform minimum data sets for various sites of care. As technology has driven the development of the data/information systems, the early data sets have been supplemented with healthcare information standards that focus on EHR systems.

A number of standards-setting organizations have been involved in developing uniform definitions, data fields, and views for health record content and structure. Standards for developing record structure and content, content exchange, vocabulary, and privacy and security are being created and implemented. These standards are dynamic and in constant development by various groups.

Standards development generally takes place as a consensus-driven process among various interested parties. Implementation is often voluntary but may be mandated. However, many groups are involved in standards development and competition exists among those groups. One of the major efforts of the ONC is standards harmonization that consolidates standards into a useful and accepted set of national information technology standards.

Some data sets and standards have been incorporated into federal law and are thus required for use by affected healthcare organizations. For example, in 1983, when Section 1886(d) of the Social Security Act was enacted, UHDDS definitions were incorporated into the rules and regulations for implementing an inpatient prospective payment system based on diagnosis-related groups (DRGs). These definitions are still required for reporting inpatient data for reimbursement under the Medicare program.

HIPAA mandated incorporation of healthcare information standards into all electronic or computer-based health information systems. Of particular importance under HIPAA are transaction/messaging standards for communication of data across systems, privacy standards that protect individual privacy and confidentiality, and security standards that ensure that data are accessed only by those who have a specific right to access them. The rules and regulations for HIPAA are still in development, and, to date, the transaction, privacy, and security standards have been implemented. Other standards are still under development. For example, in 2005 HHS published a proposed rule to adopt of a suite of standards for the electronic health care claim attachment. A final rule was never published. However, the Affordable Care Act requires the final rule defining standards and operating rules for claim attachments be published no later than January 2014 with compliance no later than January 2016.

The selection of health information standards to support EHR adoption gained national support through recent federal initiatives aimed at developing a strategic plan to guide the nation’s implementation of interoperable health information technology in both the public and private sectors. The ONC has been given a mandate to advance the development, adoption, and implementation of healthcare information technology nationally through collaboration among public and private interests and to ensure that these standards are consistent with current efforts to set HIT standards for use by the federal government (Thompson and Brailer 2004). As a permanent office under HHS, the ONC oversees implementation plans for the provisions of the HITECH Act within ARRA. In 2010, the ONC published standards, implementation specifications, and certification criteria for the certification of EHR technology to support the achievement of meaningful use Stage 1 by eligible professionals and eligible hospitals under the Medicare and Medicaid EHR incentive programs. The final rule for Stage 2 is expected to be released in third quarter 2012 followed by Stage 3 some years later.

Work will continue on the development of healthcare informatics standards. It is a complex and dynamic task with constant activity in the development, modification, negotiation, and implementation process. The rapid growth of technology and the increasing need for healthcare data/information makes the task a daunting one. According to Fridsma (2011, paragraph 2) “ONC is identifying the vocabularies, the message, and the transport ‘building blocks’ that will enable interoperability. While vendors should be able to flexibly combine them to support interoperable HIE, these ‘building blocks’ need to be unambiguous and have very limited (or no) optionality.”
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Additional Resources

Health Information and Management Systems Society. 2009. The digital office. http://www.himss.org/digital_office/20091027_DigitalOffice_boldTitle.html

Health Level 7. 2009. http://HL7.org