Health Care Information System Standards 1
Standards Development Process Four Methods (Hammond & Cimino, 2001) Ad hoc no formal adoption process De facto vendor or other has a very large segment of the market Government mandate Consensus volunteers from organizations come together to reach a formal agreement 2
Formal Standards Development Organizations International Organization for Standardization (ISO) www.iso.org American National Standards Institute (ANSI) www.ansi.org Standards Development Organizations (SDOs) ASTM International www.astm.org Health Level 7 www.hl7.org ANSI ASC X12 www.x12.org 3
ISO Facts Members are national standards bodies from many countries ANSI is the US national body member Oversees the flow of documentation and international approval of standards developed by its member bodies 4
ANSI Facts US member of ISO Accredits SDOs from a wide range of industries (including health care) Oversees work of SDOs Does NOT develop standards Publishes the 10,000+ standards developed by SDOs 5
SDOs Facts Must be accredited by ANSI Develops standards in accordance with ANSI criteria Can use the label Approved American National Standard 270+ ANSI-accredited SDOs representing many industries, including health care 6
Classification, Vocabulary and Terminology Standards To date no single vocabulary has emerged Common coding and classification systems ICD-9-CM ICD 10 DRGs 7
Classification, Vocabulary and Terminology Standards National Committee on Vital and Health Statistics identified a core set of patient medical record information (PMRI) terminology standards SNOMED CT LOINC Several federal drug terminology including RxNorm 8
SNOMED CT Systemized Nomenclature of Medicine Clinical Terms 340,000+ concepts with unique meanings 900,000+ English language descriptions or synonyms ~1.3 million semantic relationships Maps to other systems, such as ICD-9-CM, ICD-10, LOINC, and others 9
LOINC Logical Observation Identifiers Names and Codes Developed to facilitate the electronic transmission of laboratory results ~32,000 observational terms Applies to equivalent tests, not unique to companies 10
RxNorm RxNorm is a developing project within the National Library of Medicine Unified Medical Language System (UMLS) Purpose is to define a nonproprietary drug vocabulary 11
Data Interchange Standards Examples of Data Interchange standards that impact health care Health Level 7 standards (HL7) Digital Imaging and Communications in Medicine (DICOM) National Council for Prescription Drug Programs (NCPDP) ANSI X12N standards 12
HL7 HL7 is an ANSI-accredited SDO develops HL7 messaging standards to allow interoperability among health care applications Involved in other standards activities, but the messaging standard is referred to as HL7 13
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HL7 Other HL7 standards Clinical Context Management (CCM) specifications Arden Syntax for Medical Logic Systems Electronic Health Record functional model (discussed later) 15
DICOM American College of Radiology and the National Electrical Manufacturers Association published the first standard in 1985 Promotes communication of digital image information regardless of device manufacturer Works with picture archiving and communications systems (PACS) 16
Barriers and Challenges to the Adoption of E-health Standards
Background E-health: Cost-effective and secure use of ICT to support healthcare Benefits of e-health: o Improved clinical decisionmaking o Improved legibility o Reduction in medical errors o Availability of information at different locations o Cost reduction
Background Barriers to adoption: o Lack of interoperability o Cost of acquisition o Resistance to change o Security, privacy and confidentiality concerns o Lack of technical skills
Interoperability and e-health E-health interoperability: Ability of HISs to work together within and across organizational boundaries to facilitate effective delivery of healthcare for individuals and communities Interoperability is impossible without standardization Standard: an agreed-upon, repeatable way of doing something E-health standards are developed by standards development organizations (SDOs)
Overview of Standards Development Organizations
E-health standards landscape Several parallel standards development activities Literarily, 100s of e-health standards have been published ISO/TC 215 has published nearly 120 health informatics standards since its creation in 1998 Selecting appropriate set of interoperability standards can be daunting for a low resource country
E-health standards categories Identifier standards: enable unique identification of patients, health professionals and facilities (e.g. ISO / TS 22220:2011; ISO/TS 27527:2010) Messaging standards: specify the structure and format of exchanged messages (e.g. HL7 V2.X) Structure and content standards: specify the structure of data elements in EHRs and medical summaries (e.g. HL7/ASTM CCD) Clinical terminology standards: enable common description of medical terms to prevent ambiguity (e.g. ICD and LOINC codes) EHR standards: define the architecture of computerized medical records (e.g. ISO 18308:2011) Security and access control standards: enable secure transmission of healthcare information (e.g. ISO/TS 22600)
Why e-health standards adoption is slow
Limited participation in standards development ISO: HL7: IHTSDO: DICOM: Joint Initiative Council:
Limited health informatics expertise Contributing factors o Few health informatics courses o Health informatics generally not part of nursing and medical students training o Little or no short courses or training on e-health standards
Lack of foundational infrastructures Basic ICT infrastructures are limited Registries for patient and health professionals are absent Absence of common terminology services Lack of network connectivity to support secure exchange of health information
Little or no guidelines for implementation of standards Many of the published standards do not come with implementation guidelines Localization of standards are generally required to cater for domestic needs Some standards are not free
Overcoming the barriers Human resource capacity building through formal education and training; short courses and continuing education Prioritizing investments in foundational infrastructures to support secure health information exchange Active government participation in standardization through appropriate policies and legislations