Topic 05 Standards in Biomedical Informatics Part 1

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1 Topic 05 Standards in Biomedical Informatics Part 1 Kevin Robertson. MBA ACS-2816 Health Information Systems Winter 2019

2 Topic 5 Outline Standards Introduction Undertakings and Organizations Code Terminologies and Nomenclatures Data-Interchange Standards Final Thoughts on Standards Reading: Biomedical Informatics, 4 th Ed, Ch 7,

3 Two Questions Why do we need standards in health informatics? What are the relevant standards and how they apply within the field? 3

4 Topic 5 Outline Standards Introduction Undertakings and Organizations Code Terminologies and Nomenclatures Data-Interchange Standards Final Thoughts on Standards 4

5 The Idea of Standards Standards benefits Makes things work more easily & economically Standards comprises a set of rules and definitions that specify how to carry out a process or produce a product E.g. ASCII codes, C computer language 5

6 The Need for HI Standards When do we need standards? Excessive diversity creates inefficiencies or impedes effectiveness Do we have previous situation in healthcare? Pressure to reused data collected in a multitude of ways 6

7 The Need for HI Standards E.g. need for standardized identifiers Individuals e.g. MB Health ID Number E.g. need for coding patient data Not that easy due to data complexity How do we transfer data between systems? Messaging standards that use standards for patient identification & data encoding 7

8 Topic 5 Outline Standards Introduction Undertakings and Organizations Standards development process Standards organizations Code Terminologies and Nomenclatures Data-Interchange Standards Final Thoughts on Standards 8

9 Development Process Methods Ad hoc method E.g. DICOM standard for medical imaging De facto method E.g. PDF/word docs Government-mandate method E.g. Some insurance claims Consensus method Most common E.g. Health Level 7 9

10 Development Process Stages Identification stage There is a need for a standard Conceptualization stage Standard characteristics are defined. E.g. scope, format, role, etc. Discussion stage Outline is created that define content, identifying critical issues and timelines 10

11 Development Process Meetings Working Groups General Meeting 11 Figure source: Shortliffe et al, Biomedical Informatics, 3 rd Edition, Figure 7.1, p270

12 Development Process Stages Discussion stage (continue ) Production of a draft standard Open policy approach E.g. Open balloting process Several standard versions before maturity Backward compatibility issue Production of an implementation guide 12

13 Development Process Stages Early implementation stage Acceptance and rate of implementation important Relevance of influential entities, e.g. major vendors, government, marketplace, etc. Operation & maintenance stage Conformance document & testing issue Certification issue 13

14 Topic 5 Outline Standards Introduction Undertakings and Organizations Standards development process Standards organizations Code Terminologies and Nomenclatures Data-Interchange Standards Final Thoughts on Standards 14

15 Standards Organizations Sample ANSI American National Standards Institute It assists standards developers and users It represents US interests in international standardization An standards organization may be accredited by ANSI to publish American national standards E.g. HL7 is an ANSI Accredited Organization ANSI C 15

16 Standards Organizations Sample CEN TC 251 European Committee for Standardization, Technical Committee 251 Standards for healthcare informatics Working groups Information models Terminology Security, safety and quality Technology for interoperability It has had little vendor involvement 16

17 Standards Organizations Sample ISO TC 215 International Organization for Standardization, Technical Committee 215 Standards for healthcare informatics Working groups for some aspect of EHR WG 1 Data structure WG 4 Privacy & security, etc. Permits other bodies standards to move directly to become ISO standards E.g. ISO / IEEEE Infrared Wireless 17

18 Standards Organizations Sample ASTM American Society for Testing and Materials Largest nongovernment source of standards It is a ANSI charter member ASTM Committee E31 develops medical information standards 18

19 Standards Organizations Sample 19 Table source: Shortliffe et al, Biomedical Informatics, 3 rd Edition, Table 7.1, p275

20 Standards Organizations Sample HIMSS Health Care Information and Management Systems Society Health care industry organization It influences health care public policy and industry practices through advocacy, education and professional development 20

21 Standards Organizations Sample IHE Integrating the Healthcare Enterprise Fosters integration of health care information resources Sponsored by RSNA (Radiological Society of North America) and HIMSS It provides implementation profiles for the transactions used to communicate health data within the enterprise 21

22 Standards Organizations Sample NQF National Quality Forum Private, not-for-profit membership organization Focus on health care quality measurement and reporting NIST National Institute of Standards and Technology US Department of Commerce non-regulatory agency It provides measurement tools, manufacturing assistance, R&D support and quality guidelines, e.g. measurement reference standards for clinical labs 22

23 Standards Organizations Sample WEDI Workgroup for Electronic Data Interchange Fosters consensus, resources and education on issues affecting the acceptance of electronic commerce by the healthcare community Others Health Level Seven International HL7, Digital Imaging and Communication in Medicine DICOM See Table 7.1 textbook for additional groups 23

24 Topic 5 Outline Standards Introduction Undertakings and Organizations Code Terminologies and Nomenclatures Data-Interchange Standards Final Thoughts on Standards 24