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Clinical templates, Clinical templates, registries and registries and terminologies terminologies Angelo Rossi Mori Angelo Rossi Mori National Research Council, Rome - National Research Council, Rome - Italy Italy HL7 / Clinical Templates SIG & CEN / HL7 / Clinical Templates SIG & CEN / TC251 / WG II TC251 / WG II
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Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251

Mar 27, 2015

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Page 1: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

Clinical templates, Clinical templates,

registries and terminologiesregistries and terminologies

Angelo Rossi MoriAngelo Rossi MoriNational Research Council, Rome - ItalyNational Research Council, Rome - Italy

HL7 / Clinical Templates SIG & CEN / TC251 / WG IIHL7 / Clinical Templates SIG & CEN / TC251 / WG II

Page 2: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

ContentsContents

what is a clinical template ?what is a clinical template ?batteries, data sets, batteries, data sets, reusable fragments of messagesreusable fragments of messages

3 pillars for semantic interoperability3 pillars for semantic interoperabilityrepositories, templates, value domainsrepositories, templates, value domains

““HL7 light”: a complementary approachHL7 light”: a complementary approach– decentralisation of a registration processdecentralisation of a registration process– involvement of professionals and agenciesinvolvement of professionals and agencies– a common strategy for HL7 and CEN ?a common strategy for HL7 and CEN ?

Page 3: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

what is a template ?

too many legitimate

perspectives and options

Page 4: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

typology of templatestypology of templates 1/21/2

1.1. USAM tablesUSAM tables• e.g. role-link-rolee.g. role-link-role

2.2. ENCAPSULATION (terminology vs RIM)ENCAPSULATION (terminology vs RIM)• e.g. to describe style in messages e.g. to describe style in messages

3.3. BATTERY = set of “Acts” BATTERY = set of “Acts” • sets of observations (i.e. battery)sets of observations (i.e. battery)

(precise description for orders and payments)(precise description for orders and payments)• goals, outcomesgoals, outcomes• sets of procedures (e.g. clinical guidelines)sets of procedures (e.g. clinical guidelines)• data sets (e.g. from regulatory agencies) data sets (e.g. from regulatory agencies)

Page 5: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

typology of templatestypology of templates 2/22/2

4.4. CDA-L2 = set of sectionsCDA-L2 = set of sections• Clinical Document Architecture - level 2Clinical Document Architecture - level 2• expected shape of a document expected shape of a document

5.5. DICOM SR = set of sections, acts, materials, devices, …DICOM SR = set of sections, acts, materials, devices, …

6.6. MESSAGES = profiles, new messages ?MESSAGES = profiles, new messages ?• internal needs of an organizationinternal needs of an organization• needs of a specialty (e.g. cancer network)needs of a specialty (e.g. cancer network)• needs of agencies (e.g. Public Health reporting)needs of agencies (e.g. Public Health reporting)• needs of a region / country (e.g. xDT Germany)needs of a region / country (e.g. xDT Germany)

Page 6: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

sharing templates

need for registries ?

Page 7: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

emerging needs in HL7 ?emerging needs in HL7 ?

refine standard messages and documents refine standard messages and documents with “local” detailed constraints or refinements, with “local” detailed constraints or refinements, e.g. to satisfy the needs of e.g. to satisfy the needs of – sub-communities (diabetes, cancer, ESRD)sub-communities (diabetes, cancer, ESRD)– ad-hoc information flows (e.g. CDC, HCFA)ad-hoc information flows (e.g. CDC, HCFA)– regional or national information flowsregional or national information flows

• management of pathology networksmanagement of pathology networksregistries, clinical trials, sharing recordsregistries, clinical trials, sharing records

• secondary usessecondary usesreporting to authorities, statisticsreporting to authorities, statistics

Page 8: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

clinical templates: a real need ?clinical templates: a real need ?

is there a need to reduce combinatorial alternatives is there a need to reduce combinatorial alternatives and and impose a common “style”impose a common “style” ? ?

what is better achieved by what is better achieved by a-posteriori transformations ?a-posteriori transformations ?

is there a need for is there a need for controlcontrol over the process over the processthrough through registrationregistration and and support databasessupport databases ? ?(i.e. decentralise but avoid the chaos)(i.e. decentralise but avoid the chaos)

if communication is local, why HL7 shouldif communication is local, why HL7 shouldintroduce introduce internationalinternational rules or registries rules or registries ? ?

Page 9: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

my visionmy vision: need for registries: need for registries

if we want to share clinical templates if we want to share clinical templates across organizations,across organizations,components of templates must be registered.components of templates must be registered.

all names and labels used in templatesall names and labels used in templates1.1. should be stored in a registry should be stored in a registry 2.2. should be mapped to the RIM classesshould be mapped to the RIM classes3.3. should have a well defined “value set”should have a well defined “value set”

(how can we (how can we decentralizedecentralize the register ?) the register ?)

Page 10: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

3 pillars for real interoperability3 pillars for real interoperability

The optimal strategy is based on 3 pillars:The optimal strategy is based on 3 pillars:

1. data dictionaries and metadata registries,1. data dictionaries and metadata registries,

including appropriate “LOINC codes”including appropriate “LOINC codes”

2. clinical templates2. clinical templates

3. tables with enumerated value domains3. tables with enumerated value domains

they are complementarythey are complementary

all 3 pillars are needed to assure all 3 pillars are needed to assure a real a real semantic interoperabilitysemantic interoperability

Page 11: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

1. Metadata registries1. Metadata registries 1/21/2

A registry of data elements, betweenA registry of data elements, between• one thousandone thousand robust data elements robust data elements

i.e. the attributes in the i.e. the attributes in the RIMRIM• millionsmillions of user-created of user-created XML labelsXML labels

Specializations of the RIM:Specializations of the RIM:each data element should be explicitly each data element should be explicitly registered as a child/refinement of a RIM class,registered as a child/refinement of a RIM class,under control of the respective HL7-TCunder control of the respective HL7-TC

Page 12: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

1. Metadata registries 1. Metadata registries 2/22/2

Quick solution:Quick solution:

Collection of data sets and lists of XML tagsCollection of data sets and lists of XML tagswith either answer-list or ranges of valueswith either answer-list or ranges of values(e.g. see “names for observations” in LOINC;(e.g. see “names for observations” in LOINC;see also xDT/Germany, ASTM E1384)see also xDT/Germany, ASTM E1384)

Optimal solution:Optimal solution:

Integrated repository Integrated repository (e.g. ISO 11179)(e.g. ISO 11179)with uniform and comparative representation with uniform and comparative representation of data elements from all the sourcesof data elements from all the sources

Page 13: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

2. Clinical templates2. Clinical templates

to aggregate data elements from the repositoryto aggregate data elements from the repository(including the RIM) into meaningful fragments (including the RIM) into meaningful fragments

i.e. building blocks, i.e. building blocks, from predefined data elementsfrom predefined data elements,,to produce more detailed messages, betweento produce more detailed messages, between• hundredshundreds of balloted of balloted standard messagesstandard messages• millionsmillions of user-created of user-created DTD/schemasDTD/schemas

Templates (and the related data elements)Templates (and the related data elements)need a process for (local) registration need a process for (local) registration under the control of HL7 TCs under the control of HL7 TCs

a neutral language to represent templates ?a neutral language to represent templates ?

Page 14: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

3. Value domains3. Value domains

Thousands of explicit tables Thousands of explicit tables with enumerated value domainswith enumerated value domainsor numeric rangesor numeric ranges

admitted values for each data element admitted values for each data element in the context of a clinical templatein the context of a clinical template

"terminologies in context" "terminologies in context" coordinated by HL7 vocabulary TCcoordinated by HL7 vocabulary TC

(see the “context groups” in DICOM-SR) (see the “context groups” in DICOM-SR)

Page 15: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

HL7 light ?Open HL7 ?

a registration process

in addition to normal ballots

Page 16: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

““HL7 light” ?HL7 light” ?

fix by ballot the common framework (ISO ?), i.e.fix by ballot the common framework (ISO ?), i.e.– basic rules and development processesbasic rules and development processes– RIM and common templatesRIM and common templates– rules for registrationrules for registration

my vision: two different speeds + legacymy vision: two different speeds + legacy

1.1. ballot the general standards (as usual)ballot the general standards (as usual)2.2. control decentralisation of detailcontrol decentralisation of detail

– a registration process driven by HL7 usersa registration process driven by HL7 users3. legacy systems (Z-segment and adaptations)3. legacy systems (Z-segment and adaptations)

Page 17: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

1. Unified development process1. Unified development process

Uniform process, according toUniform process, according to HDFHDF (HL7, CEN) (HL7, CEN)the development framework allows to define the development framework allows to define the standard for a type of messages/documentsthe standard for a type of messages/documents– uniform measures for a vendor (level 7 !) uniform measures for a vendor (level 7 !)

to create, transport, parse, and visualizeto create, transport, parse, and visualizethe the instancesinstances of messages and documents of messages and documents• general methodsgeneral methods• same softwaresame software• common skillscommon skills• basic manuals and trainingbasic manuals and training

Page 18: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

2. Sharing pre-defined building blocks2. Sharing pre-defined building blocks

1. usual ballots in HL7 (RIM, messages, CMETs)1. usual ballots in HL7 (RIM, messages, CMETs)– the RIM (and the CEN-RIM)the RIM (and the CEN-RIM)– general-purpose messagesgeneral-purpose messages– basic clinical templates and CMETsbasic clinical templates and CMETs

2. HL7 Committees 2. HL7 Committees registerregister data elementsdata elements and “shared” clinical templates (LOINC + ?) and “shared” clinical templates (LOINC + ?)– data elements registered wrt the RIMdata elements registered wrt the RIM– related value domainsrelated value domains– useful clinical templatesuseful clinical templates

Page 19: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

( Not just a list … )( Not just a list … )

• harmonise data elements / XML tags harmonise data elements / XML tags across different systems/organisationsacross different systems/organisations

• facilitate users’ feedbackfacilitate users’ feedback into the process into the process by uniform collection of legacy usages by uniform collection of legacy usages

• facilitate mappingfacilitate mapping from legacy data elements of end-users from legacy data elements of end-users to registered data elements to registered data elements [similarly to RELMA for LOINC][similarly to RELMA for LOINC]

Page 20: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

3. Decentralise detailed content3. Decentralise detailed content

HL7 members HL7 members registerregister "local" clinical templates "local" clinical templates

define the content of define the content of theirtheir typical messages and typical messages and documents (i.e. documents (i.e. all and only the detailed all and only the detailed data elements needed and adequate for a taskdata elements needed and adequate for a task))– National affiliates (and CEN/TC251 ?)National affiliates (and CEN/TC251 ?)– US government agenciesUS government agencies– disease networks (e.g. cancer registries, ESRD)disease networks (e.g. cancer registries, ESRD)– member organisations member organisations – professional bodiesprofessional bodies

Page 21: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

the new SIG

a forum for discussion

and harmonization

Page 22: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

A new SIG on Clinical TemplatesA new SIG on Clinical Templates

to coordinate discussion across TC/SIGsto coordinate discussion across TC/SIGsand with external bodies and with external bodies • CEN, ASTM, DICOM, GEHR.org, ...CEN, ASTM, DICOM, GEHR.org, ...• XML schemas, bizTalk, ebXML, …XML schemas, bizTalk, ebXML, …

compare perspectives on:compare perspectives on:– real needsreal needs– use cases, purposes, target groupsuse cases, purposes, target groups– potential solutionspotential solutions

no production activities within the template SIGno production activities within the template SIG

Page 23: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

role of HL7 groups vs templates SIGrole of HL7 groups vs templates SIG

The SIG is made of members from other groupsThe SIG is made of members from other groups

each TC/SIG should produce its visioneach TC/SIG should produce its visionreal user needs, use cases, kind of templates,real user needs, use cases, kind of templates,examples and the future “production” activities.examples and the future “production” activities.

Role of the new SIG:Role of the new SIG:• clarify the perspective of each groupclarify the perspective of each group• discover similarities and differencesdiscover similarities and differences• comparative review of TCs’ visionscomparative review of TCs’ visions• strategic proposals to the HL7 Boardstrategic proposals to the HL7 Board

Page 24: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

who has a “real need” for templates ?

e.g. professional societies(see cardiologists in DICOM …)

• quality of reports (check list)(complete, understandable, processable)

• clinical databases• uniform data collection

(clinical trials, clinical registries)

are they aware ?what is the limit of “promotion” ?

Page 25: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

perceived by professional groups ?perceived by professional groups ?

groups that are currently workinggroups that are currently workingon on clinical data setsclinical data sets include: include:• DEEDS (CDC)DEEDS (CDC)• Am. Dental AssociationAm. Dental Association• Am. Ophtalmology AssociationAm. Ophtalmology Association• Am. Coll. Obstetrics and GynecologyAm. Coll. Obstetrics and Gynecology• Am. College of PediatricsAm. College of Pediatrics

(consistent structure across specialties (consistent structure across specialties would be in the best interest of medicine)would be in the best interest of medicine)

Page 26: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

filling in the gapfilling in the gap

““clinical templates” as a keywordclinical templates” as a keyword::

everything filling in the gap betweeneverything filling in the gap between• (slow) ballot-based process(slow) ballot-based process• Z-segments and local adaptationsZ-segments and local adaptations

including registry of data elements (LOINC+)including registry of data elements (LOINC+)and related vocabulariesand related vocabularies

““now that XML is available now that XML is available we don’t need HL7 anymore, right ?”we don’t need HL7 anymore, right ?”

Page 27: Clinical templates, registries and terminologies Angelo Rossi Mori National Research Council, Rome - Italy HL7 / Clinical Templates SIG & CEN / TC251 /

IssuesIssues

what is a clinical template ?what is a clinical template ?batteries, reusable fragments of messages,batteries, reusable fragments of messages,data sets, messages, data sets, messages, internal structure of documentsinternal structure of documents

3 pillars for semantic interoperability3 pillars for semantic interoperabilityrepositories, templates, value domainsrepositories, templates, value domains

HL7 light ?HL7 light ?– decentralisation of a registration processdecentralisation of a registration process– neutral representation of templatesneutral representation of templates– involvement of professionals and agenciesinvolvement of professionals and agencies

concrete needs, use cases, solutionsconcrete needs, use cases, solutionsvolunteers to prepare the January meetingvolunteers to prepare the January meeting