HL 7 RIM An Incoherent Standard Barry Smith

HL 7 RIM: An Incoherent Standard Barry Smith and Werner Ceusters ORG Ontology Research Group University at Buffalo http: //org. buffalo. edu http: //ifomis. org http: //hl 7 -watch. blogspot. com 1

Severe problems with HL 7 RIM http: //ontology. buffalo. edu/smith – – – FMA GO + other OBO Ontologies Fu. GO SNOMED CT UMLS Semantic Network NCI Thesaurus ICF (International Classification of Functioning, Disability and Health) ISO Terminology Standards SCo. P IPAP Algorithm SNODENT http: //hl 7 -watch. blogspot. com 2

Not e. g. with HL 7 Clinical Document Architecture http: //ontology. buffalo. edu/smith – – – FMA GO + other OBO Ontologies Fu. GO SNOMED CT UMLS Semantic Network NCI Thesaurus ICF (International Classification of Functioning, Disability and Health) ISO Terminology Standards SCo. P IPAP Algorithm SNODENT http: //hl 7 -watch. blogspot. com 3

The hype “HL 7 V 3 is the standard of choice for countries and their initiatives to create national EHR and EHR data exchange standards. . . Significant V 3 national implementations exist in many countries, e. g. in the UK (e. g. the English NHS), the Netherlands, Canada, Mexico, Germany and Croatia. ” (R. Spronk) http: //hl 7 -watch. blogspot. com 4

The reality “None of the implementations have a national scope” (R. Spronk) Even local working implementations are hard to find (in spite of claims, e. g. by Oracle) Standard response: ‘set to go live in 6 months’ http: //hl 7 -watch. blogspot. com 5

The hype The RIM is “credible, clear, comprehensive, concise, and consistent” It is “universally applicable” and “extremely stable” http: //hl 7 -watch. blogspot. com 6

The reality • HL 7 V 3 documentation is 542, 458 KB, divided into 7, 573 files • remains subject to frequent revisions • The RIM documentation is especially difficult to understand • is marked by sloppy and unexplained technical uses of terms such as ‘act’, ‘Act’, ‘Acts’, ‘action’, ‘Act. Class’ ‘Act-instance’, ‘Act-object’ http: //hl 7 -watch. blogspot. com 7

from HL 7 email forum “I am. . . frightened when I contemplate the number of potential V 3 ers who. . . simply are turned away by the difficulty of accessing the product. “Some of them attend V 3 tutorials which explain V 3 as the hugely complex process of creating a message and are turned off. [They] simply do not have the stamina, patience, endurance, time, or brain-cells to understand enough for them to feel comfortable contributing to debates / listservs, etc. , so they remain silent. ” http: //hl 7 -watch. blogspot. com 8

Gunther: HL 7 is “the data standard for biomedical informatics” http: //aurora. regenstrief. org/~schadow/ HL 7 The. Data. Standard. For. Biomedical. Informatics. ppt http: //hl 7 -watch. blogspot. com 9

Are definitions like this a good basis for achieving semantic interoperability in the biomedical domain? Living. Subject Definition: A subtype of Entity representing an organism or complex animal, alive or not. http: //hl 7 -watch. blogspot. com 10

Person (from HL 7 Glossary) • Definition: A Living Subject representing single human being [sic] who is uniquely identifiable through one or more legal documents http: //hl 7 -watch. blogspot. com 11

The RIM’s normative specifications • are supposed to guarantee consistent messaging across all health-care institutions – solving the problems of inconsistency in HL 7 V 2 • yet the HL 7 organization has not even succeeded in making its own V 3 Glossary conform to the RIM’s normative specifications • after 10+ years http: //hl 7 -watch. blogspot. com 12

Gunther (p. 151) On the one hand, the RIM is to ‘establish semantic interoperability across a vast and growing number of subject domains (e. g. laboratory, clinical health record data, . . . public health, clinical research, etc. )’ http: //hl 7 -watch. blogspot. com 13

Gunther (p. 153 f. ) On the other hand, ‘Imperfections and inconsistencies in the HL 7 documentation exist’ ‘inconsistency and ambiguity are deeply unavoidable in constructing a collaborative volunteer-based standard, which brings together a wide range of people from different backgrounds. . ’ http: //hl 7 -watch. blogspot. com 14

Gunther (p. 154) ‘As different people edit parts of the specification, inconsistencies in form and quality may emerge; as some ambiguities are clarified, other previous systematic ideas may be corrupted; and well-meant glossary entities may cause confusion. ’ http: //hl 7 -watch. blogspot. com 15

So: On the one hand the RIM is to facilitate agreement on consistent meanings across the entire range of clinical domains. On the other hand the RIM’s own collaborating authors cannot reach agreement even amongst themselves. Yet still the resultant inconsistent ‘normative’ recommendations are approved by HL 7 ballot http: //hl 7 -watch. blogspot. com 16

Gunther (p. 151) The RIM ‘defines the grammar of a language for information in healthcare’. ‘All data is in a form in which Entities (people, places, things: NOUNS) are related in Roles (RELATORS) to other Entities, and through their participations (PREPOSITIONS) interact in Acts (VERBS). ’ http: //hl 7 -watch. blogspot. com 17

Problems of scope • Act = intentional action No processes (verby items) outside Act • How can the RIM deal with disease processes, drug interactions, traffic accidents? http: //hl 7 -watch. blogspot. com 18

Problems of scope • Entity = persons, places, organizations, material No things (nouny items) outside Entity • How can the RIM deal with wounds, fractures, bodily organs, biomolecules? How can the RIM deal with diseases? http: //hl 7 -watch. blogspot. com 19

Diseases in the RIM. . . are not Acts. . . are not Entities. . . are not Roles, Participations, Role-Links. . . So what are they? • Answer: they are Acts of Observation A case of pneumonia is an Act of Observation of a case of pneumonia http: //hl 7 -watch. blogspot. com 20

Mayo on ‘Act’ as “intentional action” • Is a snake bite or bee sting an intentional action? • Is a knife stabbing an intentional action? • Is a car accident an intentional action? • When a child swallows the contents of a bottle of poison is that an intentional action? http: //informatics. mayo. edu/wiki/index. php/Intentionality_of_Act_and_the_Future_ 21 of_Observations http: //hl 7 -watch. blogspot. com

The RIM has no coherent criteria for deciding • For this reason, HL 7 dialects are formed – and the RIM does not do its job. One health information system might conceive snakebites and gunshots as Procedures. Another might classify them with diseases, and so treat them as Observations. • If basic categories cannot be agreed upon for common phenomena like snakebites, then the RIM is in serious trouble. http: //hl 7 -watch. blogspot. com 22

The methodology does not impede the formation of local dialects In the UK, the $ 35 bn. NHS National Program “Connecting for Health” has applied the RIM rigorously, using all the normative elements, and it discovered that it needed to create dialects of its own to make the V 3 -based system work for its purposes (it still does not work) http: //hl 7 -watch. blogspot. com 23

HL 7’s Clinical Genomics Standard Specifications an individual allele as an Act of Observation Why is Act of Observation used for biomolecules but not for pharmaceutical products? Gunther: because biomolecules ‘are in the process of being discovered. ’ http: //hl 7 -watch. blogspot. com 24

HL 7: Items in reality about which we have information that is known a priori are identified as Entities Items in reality about which we are still discovering information are identified as Acts of Observation. Gunther: ‘ What seems like an arbitrary split . . . is in fact the practical thing to do’ – it helps us to avoid ‘frequent modifications’ http: //hl 7 -watch. blogspot. com 25

Lessons for the Future Establish standards only after thorough pilot testing Encourage criticism and open discussion Create clear documentation under expert supervision Avoid attempting to impose untested systems like the RIM across entire nations from the top down http: //hl 7 -watch. blogspot. com 26

What’s gone wrong? • People of good will are making mistakes because of insufficient concern for clarity and consistency • International standards are built in uncontrolled fashion • Money is wasted on megasystems that cannot be used http: //hl 7 -watch. blogspot. com 27

What should be done? Extend the RIM to allow adequate treatment of all the types of entity relevant to information exchange in biomedicine, including: non-intentional processes, diseases, infections, biomolecules, etc. http: //hl 7 -watch. blogspot. com 28

Gunther: ‘A complete and integrated ontology of everything would certainly be nice to have; however, we think it is impractical and dangerous to force such a model into being independently of the RIM. The moment such a model gained traction people would then expect that the RIM reflect that other model. Why should there be two models, if in the end one is to reflect the other? Instead, a single model of real world objects should suffice, but must contain well-defined features for informationmanagement functions. ’ http: //hl 7 -watch. blogspot. com 29

Gunther (paraphrased): HL 7 has created a clunky ontology which is full of gaps which force strange and arbitrary seeming choices; however, it would be impractical and dangerous to complete it to create a more coherent framework. The single HL 7 model must suffice, even with its strange rules for information-management functions which make the documentation so difficult to understand. http: //hl 7 -watch. blogspot. com 30

Conclusion: Are there practical consequences? Are there consequences for health IT? The hours (days, months) of software developers attempting to create HL 7 V 3 based applications work not only cost money (sometimes large amounts of money). They also reinforce scepticism on the part of potential users of health IT systems http: //hl 7 -watch. blogspot. com 31

Conclusion: Are there practical consequences? Are there consequences of clunky standards for the quality of patient care? Let us hope not http: //hl 7 -watch. blogspot. com 32