Actividades en Health Level Seven con respecto a Soporte a la Toma de Decisiones Clínicas

Robert A. Jenders, MD, MS, FACP, FACMICientífico, Biblioteca Nacional de MedicinaInstitutos Nacionalesde la Salud (EE UU)

Jornadas Universitarias de Sistemas de Información en SaludHIBA

el 7 de diciembre 2010

Institutos Nacionalesde la Salud (EE UU)

Profesor de Medicina, Universidad de Georgetown

Jefe, Comité de Soporte a la Toma de Decisiones Clínicas, HL7

“Outline”

HL7 HIMSS CCHIT Arden RIM HSSP SOA DSS SNOMED ICD9 HCPCS NIC NOC NDC RxNorm SQL GEM ProFORMA ASTM CCR CDA CCD EDIFACT LOINC CPT NANDA CDA CCD EDIFACT LOINC CPT NANDA BIRADS DICOM ICPC UMLS CEN HITSP HISB ANSI ISO CTS AHIC ONC CHI NCVHS HIPAA NDF-RT HUGN CDISC ASC ICPC NCPDP IHE

Overview

• Standardization: How? What?

• HL7 as SDO

• HL7 CDS standards – Arden– GELLO– HQMF– vMR– Order Set– Infobutton– Decision Support Services

Standardization Process

• Development

• Too Much Development: Harmonization & Selection

• Conformance: Certification

Standards Development: Key Methods

• De facto: Think Redmond, WA

• Government– Use of regulatory and financial power to force – Use of regulatory and financial power to force

development

• Ad hoc: Consortia, etc– DICOM

• Standards Development Organization(SDO)

Standards Development: SDOs

• ASC X12: Accredited Standards Committee– General EDI (e.g., CICA for XML exchange)

• ASTM (E31): American Society for Testing and MaterialsMaterials– GEM, CCR– And many more

• CDISC: Clinical Data Interchange Standards Consortium – Clinical trials reporting

Standards Development: SDOs

• CEN (TC 251): Comité Européen de Normalisation

• Health Level Seven: Messaging standard (v2.x, v3), CDA, CCD (with ASTM), GELLO, Arden Syntax, CDA, CCD (with ASTM), GELLO, Arden Syntax, DSS, RIM, EHR Functional Model/Specification– Partnering with Object Management Group(OMG)

in Healthcare Services Specification Project (HSSP)

• IHTSDO: International Health Terminology Standards Development Organization – SNOMED CT

Standards Development:Other Organizations

• AMA : American Medical Association (CPT-4)

• WHO (OMS): ICD-9, ICD-10

• UN/CEFACT: Center for Trade Administration and Electronic Business– UN/EDIFACT (Electronic Data Interchange For

Administration Commerce and Transport)

• IEEE: Institute of Electrical and Electronics Engineers– Medical Information Bus

Standards Development:Other Organizations

• WICC : WONCA (World Organization of National Colleges, Academies = World Organization of Family Doctors) International Classification Committee – ICPC (International Classification of Primary Care)– ICPC (International Classification of Primary Care)

• NCPDP: National Council of Prescription Drug Plans– SCRIPT (Rx transmission standard)– And many more…

SDO Process: HL7

• North America with 20+ international affiliates• Subdivided into technical committees that work on

standards– Conference calls + thrice annual meetings– Conference calls + thrice annual meetings

• Mostly volunteer workers (400 attendees/meeting)• Heavily consensus-based, multilayer voting approval

process• Certification of adherence to process by external

authority that charters SDO (e.g., ANSI)

HL7 Structure: Clinical Decision Support

• Clinical Decision Support Work Group (Jenders, Del Fiol, Kawamoto, Strasberg) – Contribute to RIM, inform CDS aspects of other

HL7 work, develop overall decision support system model

– Related to Arden Syntax Work Group– Related to Arden Syntax Work Group

HL7 Structure: Clinical Decision Support

• Interactions with other groups: EHR Work Group, Patient Care Work Group, etc

• Coordination via the Technical Steering Committee:• Coordination via the Technical Steering Committee:– Structure and Semantic Design– Foundation and Technology– Domain Experts– Technical and Support Services

HL7 CDS: External Relationships

• HITSP– Coordinate development of work products that

fulfill HITSP use cases– Examples: Order set standard, Infobutton

standard, guideline formalism

• OMG– DSS

• ONC– CDS Collaboratory

HL7 Contacts

• http://www.hl7.org– Co-chair names/contact information– Mission statements– Meeting minutes– Meeting minutes– Official standards

Standardization Process: Harmonization & Selection

• Problems– Too many standards (and maybe SDOs) in some

domains: Vendors, HCOs don’t know which one to use

– Overlapping content– Need for local specialization– Need for local specialization

• May not be easy to accommodate

• Example: Terminology– SNOMED, ICD-9, LOINC, ICPC, etc

• Addressing the challenge: Selection and harmonization

Standards Selection: CHI• Consolidated Health Informatics initiative = health care

portion of eGov– Select from potentially overlapping standards

• Coalition of HHS (CMS, NLM, AHRQ, etc), DoD, VA, GSA, SSA, NIST + others– Will influence others wanting to do business with these – Will influence others wanting to do business with these

agencies

• Endorsed common standards (3/2003)– HL7: messages– NCPDP: ordering from pharmacies– IEEE 1073: Medical Information Bus (devices)– DICOM: imaging– LOINC: laboratory, vital signs

Standards Selection: Other Units

• NCVHS: Acting under its HIPAA authority to define standards for electronic transactions in 2000– IEEE 1073, NCPDP SCRIPT, HL7 v2.x and some v3– Amended in 2002– Further amendments under consideration now– Further amendments under consideration now

• ONC: Stimulate and coordinate standards work

• IHE : Interconnecting the Healthcare Enterprise– “Connectathons” using conformance profiles,

helping to define system interactions

Standardization: Harmonization

• AHIC (American Health Information Community) : Advise HHS about HIT– Use cases for standards that influence their

developmentdevelopment

• Healthcare Information Technology Standards Panel(formed by ANSI in 2005): Develop a process for identifying standards

Standardization: Certification Commission for Health Information

Technology

• Workgroups: Inpatient, ambulatory, emergency department, health information networks, foundation

• Expert panels: Advise on security, interoperability, etc• Process• Process

– Identify relevant standards to assure proper operation of health IT in these domains and timelines for compliance

– Create a vetting process to assess an application’s compliance with standards

Standardization Process: Summary

• Creation: SDOs and others

• Selection and Harmonization: CHI, NCVHS, AHIC, HITSPHITSP

• Certification: CCHIT

What is CDS?

• CDS = “Providing clinicians or patients with clinical knowledge and patient-related information, intelligently filtered or presented at appropriate times, to enhance patient care”

• CDS Intervention = “Delivering one or specific pieces of clinical information ( knowledgeand/or data) to an individual, at a specific time and place, to address a clinical objective.”

Osheroff JA, Pifer EA, Teich JM, Sittig DF, Jenders RA. Improving Outcomes with Clinical Decision Support: An Implementers’ Guide. HIMSS, 2005. http://www.himss.org/cdsworkbook

Aspects of Standardization

• Messaging: Format, terminology– Enable interoperability

• Function: Services• Function: Services

• Structure: Knowledge representation– Enable sharing + reuse

• Clinical practice: Guidelines

CDSS: Key Architectural Elements

• Data capture/display/storage– EMR – Central data repository

• Controlled, structured vocabulary

• Knowledge representation + knowledge acquisition

• Clinical event monitor: integrate the pieces for many different uses (clinical, research, administrative)

HL7 Standards

• v2.x, v3 messaging

• CDA: Structured documents

• SPL: Structured product labels

• CCOW: Desktop interoperability

• EHR Functional Model & Specification

HL7 Messaging (v2.x)

MSH|^~\&|EPIC|EPICADT|SMS|SMSADT|199912271408|CHARRIS|ADT^A04|1817457|D|2.5|

PID||0493575^^^2^ID 1 |454721||DOE^JOHN^^^^|DOE^JOHN^^^^|19480203|M||B|254 MYSTREET AVE^^MYTOWN^OH^44123^USA |254 MYSTREET AVE^^MYTOWN^OH^44123^USA ||(216)123-4567|||M|NON|400003403~1129086|

NK1||ROE^MARIE^^^^|SPO||(216)123-4567||EC|||||||||||||||||||||||||||PV1||O|168 ~219~C~PMA^^^^^^^^^||||277^ALLEN

MYLASTNAME^BONNIE^^^^|||||||||| ||2688684|||||||||||||||||||||||||199912271408||||||002376853

HL7 CDS Standards

• Current (or DSTU)– Arden Syntax– GELLO– HQMF– HQMF– Infobutton– DSS

• Proposed(in progress)– Virtual Medical Record (vMR)– Order Set

Arden Syntax

• ASTM v1 1992, HL7 v2 1999, v2.1 (ANSI) 2002, v2.5 2005, v2.6 2007, v2.7 2008. Adopted by several major vendors

• Hybrid of production rule and procedural formalisms– Rich with temporal operators common in clinical

decision-making• Unit of representation = Medical Logic Module (MLM)

– Enough logic + data to make a single decision– Generate alerts/reminders– Ideal: Writable and readable (verifiable) by

clinicians

Jenders RA, Dasgupta B. Challenges in implementing a knowledge editor for the Arden Syntax: knowledge base maintenance and standardization of database linkages. Proc AMIA Symp 2002;:355-359.

maintenance:slotname: slot-body;;slotname: slot-body;;...

library:

MLM - Structure

library:slotname: slot-body;;...

knowledge:slotname: slot-body;;...

end:

maintenance:

title: Admission Screen for Acute Coronary Artery Disease;;filename: ACUTE_CAD_1;;version: 1.09;;institution: Columbia-Presbyterian Medical Center;;author: Robert Jenders, MD, MS (jenders@cucis.cis.columbia.edu);;specialist: Alan Simon, MD (ads5@columbia.edu);;date: 1996-01-24;;

MLM Example

date: 1996-01-24;;validation: research;;

library:

purpose: To notify investigators of the admission of a patientwhose admission diagnosis suggests acute coronary arterydisease. IRB number 7205;;

explanation: ;;keywords: ;;citations: ;;

knowledge:

type: data-driven;;

data:admission := event {'32511','32467'; '32511','32472'};inpatient_case := read last {'evoking','dam'="GYDAPMP",'constraints'=" I***";

"HCASE";"K"}; /* note blank as first constraint char */email_dest := destination {'email','name'= "rra2@columbia.edu"};

MLM p. 2

'name'= "rra2@columbia.edu"};diagnosis_text := read {'evoking','dam'="GYDAPMP"; "HDIAGNOS"; "HDIAGTXT"};target_diagnoses := ("MI","R/O MI","MYOCARDIAL INFARCTION","CARDIOGENIC SHOCK","CHEST PAIN","CP","ANGINA","CHEST PAIN NOS","INTERMED CORONARY SYND","UNSTABLE ANGINA","CAD","ANGINA PECTORIS NOS","CHR ISCHEMIC HRT DIS NEC","RULE OUT MI","R/O MYOCARDIAL INFARCTION","ACUTE MI","SUBENDO INFARCT","UNSTABLE ANGINA/MI","ANGINA PECTORIS","CORONARY ARTERY DISEASE");

mrn := read last {'pcodes'="now mrn "};patient_name := read last {'dam'="GYDAPMP"; "HPBASIC"; "HNAME"};location := read last {'dam'="GYDAPMP"; "HLOC"; "HLOCNURS"};

;;

evoke: admission;;logic:if inpatient_case is null thenconclude false;

endif;if any (diagnosis_text are in target_diagnoses) thenconclude true;

elseconclude false;

endif;

MLM p. 3

endif;;;action:write "ACUTE CAD ADMISSION NOTICE" ||

"\n\nPatient Name: " || patient_name ||"\nMRN: " || mrn ||"\nLocation: " || location ||"\nAdmission Diagnosis: " || diagnosis_text ||"\n\n\n" || patient_name || " " || mrn || " " || location

at email_dest;;;

end:

Arden Syntax: Recent Changes

• v2.5– Objects (via a “dot” operator; no methods)– OpenURL for links– Optional XML schema for MLM representation

• v2.6– UNICODE support– Time-of-day, day-of-week operators– Localization: Add resources category & localized

operator = facilitate country/language-specific output

Arden Syntax: Recent Changes

• v2.7– Allow assignment to nested object attributes +

specific list (array) elements– Enhanced object initialization: Pre-population of – Enhanced object initialization: Pre-population of

object attributes

• 10/2010– Fuzzy Arden: Inclusion of fuzzy logic operators– Discussion of use in CLABSI project

Arden Syntax: Fuzzy Examples

• AfuzzyTime := today fuzzified by 1 day;

• simple := 2009-10-10 fuzzified by 12 hours;

• complex := fuzzy set (2009-10-10,0), (2009-10-11,1), (2009-11-10,1), (2009-11-11,0);

GELLO = Common Expression Language

• Executable language for expressing logical rules and queries in clinical decision support applications

• Provides a standard interface to medical record systems and other data/knowledge sources systems and other data/knowledge sources

– Based on OMG OCL

• GELLO expressions:

– Extract and manipulate data

– Construct decision criteria, abstractions, formulae

GELLO = Common Expression Language

• Purpose: Share queries and logical expressions– Query data (READ)– Logically manipulate data (IF-THEN, etc)

• Initial rationale : Stepping stone to a RIM-compliant • Initial rationale : Stepping stone to a RIM-compliant guideline formalism

• Initial version : ANSI standard release 1 = May, 2005

Ogunyemi O, Zeng Q, Boxwala A. Object-oriented guideline expression language (GELLO) specification: Brigham and Women’s Hospital, Harvard Medical School, 2002. Decision Systems Group Technical Report DSG-TR-2002-001.

GELLO: Examples

� QueriesObservation.select(coded_concept=’03245’)

Observation.selectSorted(coded_concept=“C0428279”)

� Expressions� Expressions� The variables calcium and phosphate are not null

calcium.notEmpty() and phosphate.notEmpty()

� The patient has renal failure and the product of calcium and phosphate exceeds a threshold signifying osteodystrophy

renal_failure and calcium_phosphate_product > threshold_for_osteodystrophy

GELLO: Status

• 2005: R1

• 2006– Tool release by Medical Objects (Australia)– Demonstration project: e-Prescribing prior – Demonstration project: e-Prescribing prior

authorization rules

GELLO: Status

• 2007– Authoring tool release by InferMed (UK).– Demonstration projects

• Possible: Clinical trial• Australia (Medical Objects + Haematology • Australia (Medical Objects + Haematology

Society + Leukaemia Society of Australia): Guideline representation in a GLIF context

• 2009: R2

• 10/2010: No additional work. Consideration for use in CLABSI project

Ancillary Work Product:HQMF DSTU

• Increasing mandates for clinical performance measurement– Pay for performance– CMS: No payment for hospital-acquired conditions– Competitive measurement: hospitalcompare.gov– Competitive measurement: hospitalcompare.gov

• Implementation of quality indicators (QIs) can be costly– Need to translate published QI to computable form– Need to collect digital data in structured format– Otherwise, paper-based collection is time- and

resource-intensive

Quality Indicators: Sample ACOVE QIs

• IF a vulnerable elder has had a myocardial infarction, THEN he or she should be offered a beta blocker unless there is a contraindication

• IF an ambulatory vulnerable elder has an osteoporotic fracture diagnosed, THEN physical therapy or an fracture diagnosed, THEN physical therapy or an exercise program should be offered within 3 months

• IF a vulnerable elder is taking warfarin for atrial fibrillation, THEN an INR should be checked at least every 6 weeks

HQMF

HQMF• 9/2009: Passed DSTU ballot 9/2009

• 10/2010– Discussed use in representing CLABSI algorithms

• Possible use in conjunction with GELLO or Arden to represent the calculations in quality measuresmeasures

– Part of an overall solution for measuring/documenting quality:

• Possible work to publish NQF Quality Data Set (QDS) as a separate standard

Work Product:Proposed Virtual Medical Record (vMR)

Standard

• Definition: Data model and implementation guide, based on the HL7 v3 RIM format, for representing clinical information inputs and outputs to/from clinical decision support services– Initial focus: Support POC chronic disease

managementmanagement

• Functionality : Clinical information systems use a standard model to represent data communicated with a clinical decision support system

• Status 10/2010: Passed I1 ballots (v2 IG; v3 DAM; v3 DAM for GELLO) 5/2010. Work in progress.

Work Product:Proposed Order Set Standard

• An order set is a functional grouping of orders in support of a protocol that is derived from evidence based best practice guidelines.– Order sets have a purpose.– Order sets have a purpose.– Order sets may contain conditional logic.– Some items in an order set may be fully specified,

others may have more optionality.– Order sets may be part of a larger care plan.

Order Sets

• In Scope– Create a structural and functional model to

communicate order set content between content authors and those who will use the content.authors and those who will use the content.

• Out of Scope– The result of this project will NOT be a standard for

messaging orders at the point of care.

Order Sets: Layers

• I – Publish, Distribute and Track: Metadata for authoring, maintenance and dissemination by professional standards organizations

• II - Import : Full text order set content permits localization and use within vendor EHR: Order tests, treatments and and use within vendor EHR: Order tests, treatments and procedures, set Goals, record Observations

• III – Presentation management: Organize and restrict order session content for maximum clinical utility

• IV - Manage as knowledge: Coded standards-based order content supports manipulation of order sets, order segments and order items by guideline decision support engine

Order Sets: Structure

• Order set = header + body• Header: Attributes

– Ownership– Authorship– Maintenance– Maintenance– Scope of Use– Related Order Sets (Nesting)– Description– Supporting Evidence– Use Cases– Authorship Milestones– Context for Use

Order Sets: Status

• September, 2008: Passed DSTU ballot– Had previously failed ballots because of disputes

over the data model

• 10/2010– Regrouped: Finalize requirements for publication– Continuing work toward publication

Infobutton Standard

• Standard mechanism to express and communicate EHR context

• HL7 v3 standard– Messages

• Infobutton request• Infobutton response(under development)• Infobutton response(under development)

– Implementations• XML and URL-based• SOA (under development)

• Standard terminologies– RxNorm, LOINC, SNOMED -CT, MeSH– “Free-text” is an option to allow faster adoption

Infobutton

ElectronicHealth i

Resource 1HL7

Infobutton

Infobuttonrequest

Infobuttonrequest

HealthRecord

i

Resource 3

Resource 2HL7

HL7

InfobuttonManagerHL7

HTML

Infobutton: Example

<mainSearchCriteria><value code="428"codeSystem="2.16.840.1.113883.6.103"displayName=“Heart Failure"/>displayName=“Heart Failure"/>

</mainSearchCriteria>

http://www.e-resource.com/api?mainSearchCriteria.v.c=428&mainSearchCriteria.v.cs=2.16.840.1.113883.6.103&mainSearchCriteria.v.dn=Heart Failure

Infobutton: Status

• 10/2010– Passed DSTU ballot– Ballot Reconciliation: Implementation guide for

using infobuttons in the context of the DSS standardusing infobuttons in the context of the DSS standard

Decision Support Services (DSS) Standard

• Business purpose – To facilitate implementation and maintenance of

clinical decision support (CDS) applications

• Functionality– Evaluates patient data using knowledge modules – Evaluates patient data using knowledge modules

and returns machine-interpretable conclusions

• History– Based on service interface of CDS Web service

developed at Duke (SEBASTIAN)– Project initiated in 10/2005 by HL7 Clinical Decision

Support WG in collaboration with HL7 SOA WG

DSS: Architecture

Decision Service Client

1. Evaluate Patient1. Evaluate PatientModules to use, required dataModules to use, required data

Patient-specific evaluation resultsPatient-specific evaluation results

2. Find Knowledge Modules2. Find Knowledge ModulesSearch criteriaSearch criteria

Modules meeting criteriaModules meeting criteriaDecision Support Service Service Client

3. Describe Knowledge Module3. Describe Knowledge ModuleModule of interestModule of interest

Description of moduleDescription of module

4. Get Data Requirements4. Get Data RequirementsModules of interestModules of interest

Data requirementsData requirements

DSS: Status

• DSS SFM approved in 9/06 as HL7 DSTU

• Available at http://www.hl7.org/v3ballot2009jan/html/ infrastructure/dss/dss.htminfrastructure/dss/dss.htm

• DSS profiles being developed for several domains (Infobutton, immunization CDS, clinical genomics CDS)

• 10/2010: Reviewed ballot for IG for use with Infobutton standard

Summary

• HIT standardization = Elaborate process involving many aspects of interoperability

• HL7 = Key SDO with a suite of standardds• HL7 = Key SDO with a suite of standardds

• Numerous HL7 CDS standards in use and evolving: Arden, GELLO, HQMF, Order Set, vMR, Infobutton, DSS

¡Gracias!

• Fernán González Bernaldo de Quirós

• Departamento de Informática en Salud, HIBA

jenders@nih.govhttp://csb.nlm.nih.gov/csbhome/staff/jenders.php