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HL7 Working Group Meeting MinutesAtlanta, September 2009

Electronic Health Record Work GroupWorking Group Meeting Minutes

Atlanta, Georgia September 21 – 25, 2009

Attendees: See file below for entire meeting attendance

Monday September 21, 2009Q1

Plenary Session


Plenary Session


IntroductionsOverview of Week’s Work

1. Goalsa. Working toward EHR-S Functional Model Release 2b. Introduction to the SAEAF Methodology

2. Reminder to vote: CoChair Electionsa. Voting is open until Tuesday, end of day, since this is the Plenary Meeting

3. Agenda Review4. Project Updates


Agenda Item #1: EHR-S Functional Model R2 (Don Mon)

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o Pairing of system to system certification – another dimension not certified today.EHRS to EHRS EHRS to PHRPHR to PHRPHR to EHRS

o EHRS R2 is needed to meet the commitment to ISOo Identify Enhancements/requirements slide

Design Principles: Compatibility

Need to fix relationship betweenFM’s and profiles?Functional and modular profiles?

EHR-SFM

EHR-SFM

PHR-SFM

PHR-SFM

LTCProf.LTCProf.

RMESProf.

RMESProf.

EHR-PHR HIE

Prof.

EHR-PHR HIE

Prof.

Provider-Based

PHR Prof.

Provider-Based

PHR Prof.

o Overview: inputs to Release 2 slide

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….….

Overview: Inputs to Release 2

Vital Rptg.Vital Rptg.

RM & ESRM & ES

Beh. HealthBeh. Health

LTCLTC

EHR-SProfilesEHR-S

Profiles

Other Industry InitiativesOther Industry Initiatives

Privacy,Security,

Confi-dentiality

Privacy,Security,

Confi-dentiality

HealthInfo

Exchange

HealthInfo

Exchange

….….

Data Use

• Fraud Mgt• Quality• Rev Cycle

Data Use

• Fraud Mgt• Quality• Rev Cycle

Certifi-cation

(CCHIT,Q-Rec)

Certifi-cation

(CCHIT,Q-Rec)

EHR-S FMRelease 2

EHR-S FMRelease 2

Others?Others?

AlignmentAlignment

LifecycleLifecycleSOASOA

R1Adjustments,

Enhance-ments

R1Adjustments,

Enhance-mentsInterop

ModelInteropModel

Inter-national

Stds(ISO TC215, ISO 20514,

ISO DISCEN 18308,

13606)

Inter-national

Stds(ISO TC215, ISO 20514,

ISO DISCEN 18308,

13606)

Provider BasedProvider Based

PHR-SFM &

Profiles

PHR-SFM &

Profiles

o Legal interoperability (Jeremy Thorpe, England)o Privacy Architecture (Canada Health Infoway)o Meaningful Use criteria defined by CMS (ARRA) in 2010o Certification Criteria defined by HHS later in 2009o ISO standards 18308 and 13606o Review of R2 development worksheet using most recent model

spreadsheeto What Forms is R 1.1 available in?

PDFWord (cleaned up)Word with track changesExcel (Helen Stevens has moved R.1.1 to Excel)There was discussion regarding the need for R.1.1 to be produced in XML – the cochairs will discuss this further.

Agenda Item #2: Voting Items (Pat) A. Acceptance of Minutes the May Working Group Meeting

The working group minutes were posted 2 weeks after the conclusion of the May meeting. The motion was made and seconded to accept the minutes as written:

Vote: 13 approved8 abstentions0 negative

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B. Acceptance of the Electronic Health Record Work Group Governance and Operations Manual (GOM)This document has been under review during working group meetings over the past 2 years. The major changes to the document include:

1. the replacement of ‘technical committee’ with ‘work group’ to be aligned with the HL7 corporate changes and

2. the update of required lead times of document availability prior to voting on such.

The document will now go into an annual review cycle.

The motion was made and seconded to accept the GOM: Vote: 7 approved

9 abstentions0 negative

Tuesday September 22, 2009Q1

Agenda Item #1 Canadian eHealth Blueprint 2015 (Sasha Bojicic, Hl7 Canada)Functional Support for Patients Access to Quality Care and Relevance to EHRS FM R2

Sasha presented the progress and experiences of the eHealth BluePrint for Canada.

o Infoway has approved funding for 276 projects across Canada as of 20081231; 156 projects have been completed and/or are being implemented.

o Projects are based on the “EHRS Blueprint”, which is an enterprise architecture for achieving standards-based interoperability.

o The Blueprint uses HL7 V3.o Canada took advantage of the fact that EHR-S FM was being promoted

through ISO to provide comments that would ready the EHR-S FM for use

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in Canada (to inform vendors of Canada’s requirements, to develop profiles, and to certify vendors’ systems).


Agenda Item #1 Overview and Discussion of SAEAF (Charlie Mead)

Charlie Mead from ArB reviewed the HL7 direction for an architecture and discussed high level components of SAEAF. The NCI project using the EHRS FM R1.1 and SAEAF was reviewed. There are other projects that will involve SAEAF and this work group including:

a. EHRS FM R2 and the Interoperability Models using SAEAF as a basisb. Project for Ambulatory Oncology Care Functional Profilec.

o There is currently a high-profile NCI Project to build a reference implantation of an ambulatory EHR.

o Functional semantics are based on the EHR-S FM. To build a ballotable “Ambulatory Oncology Care Functional Profile” (CA-EHR Project). (To be approved by the TSC, ArB, and HL7 Board.) Project members: Paul and Christine, headed by Charlie Mead.

o HL7 has hired a technical editor (specifically) to develop a SAEAF Handbook.

o Enterprise Architecture is not about technology; it is about Governance.o The Dynamic Model is the early version of the Behavioral Framework.o SAEAF places governance-touchpoints in multiple, key places in the

development of a healthcare specification.o SAEAF makes explicit all (implicit) assumptions that are routinely made

from the beginning of standards-specification process, through to the final implementation of a given standard.

o John Zachman has written “Mass Customization in Quantities of One” http://en.wikipedia.org/wiki/Zachman_Framework

o SAEAF does not regard the enterprise architecture itself (particularly), rather, it regards those aspects of enterprise architecture that deal with the interoperability (i.e., the interactions) between enterprises.

o RM-ODP (Reference Model for Open Distributed Processing) or Zachman could have been chosen; RMODP was selected as being “good enough” in which to develop the SAEAF framework.

o Proposed EHR WG Project: Combining EHR-S FM Release 2, IM, CA-EHR Project using the SAEAF approach.

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http://en.wikipedia.org/wiki/Zachman_Framework


The 4 way SAEAF ‘cube’:

Topic Specification

Enterprise/Business viewpoint

Information viewpoint

Computational viewpoint

Engineering viewpoint

ConceptualPlatform-Independent (logical)Platform-specific

Resources for further information: https://wiki.nci.nih.gov/display/CTMS/COPPA Core Services https://wiki.nci.nih.gov/display/CTMS/Accessing_Services


Agenda Item #1 Healthcare SOA Reference Architecture (aka EHR System Design Reference Model EHR-SD RM)

Joint meeting of 4 work groups: Government Projects, SOA, EHR, PHER

o HL7 Project Schedule:o 2008 developed Healthcare SOA Reference Architecture (H-SOA-

RA) in September 2008.o Oct 2009: H-SOA-RA version 2.0o Sept 2011: To be balloted as a normative standard

o Nancy Orvis is pleased to report that the VA and DoD’s clinicians have begun to recognize the value that the EHR-S FM has as a foundation for designing VA and DoD systems.

o The EHR-SD RM team mapped the AHIC use-case’s functional statements to EHR-S FM functional statements, and also used the See Also links to indentify functional dependencies. An informational model could then be defined that met the needs of each set of functional requirements’ service components.

o The EHR-S FM currently exists as a PDF, WORD document, and an Excel spreadsheet. Steve has recently ported the EHR-S FM to the Enterprise Architecture tool.

o Google search on “HHS Use Cases” to get to the website.o HIAL: transfer protocols and messaging transportation

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https://wiki.nci.nih.gov/display/CTMS/Accessing_Services

https://wiki.nci.nih.gov/display/CTMS/COPPA%20Core%20Services


o Privacy/security – auditing logging, interoperabilityo How does V3 and interoperability work together?o Standards between PHRs and providers – see that as a standard that

needs to be addressed. Not all providers talk in V3 ---many talk in terms of V2. How does that transformation from V2 to V3 work.

o Registry of providers and applicationso Use of HIAL to support much of the message brokering. o Point of service from the specific domainso Appointment brokeringo Use of RCRIM information with the EHR SD RM Prototypeo Dependencies in the FM were most helpful (See Also)o HITSP/SC115 HL7 messaging: transport plus privacy/securityo EHRS would help define the functions; use as candidate serviceso Ported to the enterprise architect tool.o What should be balloted in 2010o HL7 V3 messages may be a gap. Need either a volunteer or funding to do

the V3 messaging part.o HITSP 2.51 in the USo What is the difference between the HITSP model and dynamic modeling

at HL7. HITSP is a behavioral model: Use case and UML. This is the same as is being requested by SAEAF.

o HITSP is specifying informattion exchnage requirements and data requirements.

o C32 summary with HL7 transport (EBXL) o Communication between applications is what brings valueso DOD and VA (bidirectional health exchange) (far advanced beyond

HITSP)o Service aware framework is very important to this work. o EHR is the conceptual model for SAEAFo HITSP is filling in the concept between concept and System. (Steve)


Agenda Item #1 Diabetes Data Strategy Project (Don Mon) o Desire to have data within the EHRS and the ARRA interest in quality and

efficiencyo Data collection for quality can be a huge burden o Desire to collect data once and repurpose many timeso Overlap in Uses of Clinical Data

Quality measurement & Patient Safety Clinical Decission support

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Public and Population Helath Reimbusement management Clinical Data Research

o National Quality Forum – Quality data set (Crystal Kallem). Quality framework has been defined. The value set has been in the process of being defined in HITSP

o HL7 SD Health Quality format leveraging the logic and meta data to support. Data element at the quality measure level. Data type at the measure level

o How would we get this out of the EHR? This would have to be atomic data.

o Diabetes Data Strategy (prototype) Group of organizations coming together to take a look at the

‘Research feather’ Optimally would take care of 4 of these feathers Looking for commonality and variations across the model

o Need a process to do the harmonization of the data elementso Tool to harmonize data sets and data definitions

Way to identify the requirements of this tool. USHIKB US Health Information Knowledge Base CADSR Cancer Data Standards Repository PHIN VADs Public Health information Vocabulary

o CCD is good for identifying the data elements ---- but the variation continues to exist.

o AHIMA, NQF and CDISC will meet on Thursday.o Should the output go into an API or onto a Terminology Server? o There will be a requirements development process.

Clear specifications so we know what we need to do. Cdisc may have been promised some funding

o Model proof of concept in two ways: DAM/RIM UsingInteroperability Model approach

o Artifact standpoint ---- document in a DAM ----- DCM -----EHRS FM

Agenda Item #2 Update/Planning for Interoperability Work Group Projects (Gary Dickinson)

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o Interopable records at the unit of record level. CDAR2 met 51 of 56 requirements.

Profile against the interoperability model.o Implementation Guide for CDA R2o Simplification Strategy

Has not been formailized into a balloted item.o Now using the AHIC use cases to apply to simplification strategyo Projects identified in Face to Face meeting in California

US HIT Policy Committee – Notable Recommendations Certification and Adoption

US HIT Standards Committee Recommendations Information Exchange

o Core informaiton exchange requirements includes interoperability , privacy and security

o Use of a structured, single container for all exchangeo EHR Interop Projects

o Joint Initiative Councilo ISO TC215 New Work Item proposal (NWIP)o Standards convergence to promote EHR interoperabilityo 26 capabilities are identified, work underway to reduce this to

one (CAP119)o 2013 Target : structured content with a single container (using

CDA as the container) o EHR-S FM R2 and Interoperability mergero EHRS FM R2 Record Synchronization across disparate

systems and architectureo HL7 Records Mgt/Evidentiaryo Is CDA R2/Re the Persistent Record Object (container)o HL7 Diabetes Use Case

Should this be derived from an activity diagram. Quality Reporting Use Case (out of HITSC)

Based on 2011 Meaningful Use Criteria

Wednesday September 23, 2009Q1

Agenda Item #1 Joint Meeting: Security, Structured Documents and EHR

Discussion of the Role Based Access (Security) and Privacy Consent Directiv (CBCC) ballots.Discussion of the project scope statement for Structured documents for the Security Domain Analysis Model

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o Tied the Functional Model to Securityo Perform with constraining attributeso HL7 work in this area is also part of HITSB and the access controlo What they wanted to express in terms of roles, may need to come back to

the HER Work Groupo Bernd – 28 member countries

Roles, functional roles technical and bound to work flow Many legislations

o Mike - ANSI standard permission/operation on an object RIM

o DAM for Security will ballot in Januaryo Education in RBAC – in Januaryo Move from narrative descriptions to formal descriptionso Role based author identityo Audits – where in your planning

AAA with SOA providing support for authorization framework functional models

Privacy and security management alignment RIM based expressions for auditing RFC3881 going into the ISO area. Pursuing the vocabularies Work item in auditing ISO27799 JIC Security is part of an architectural design – SAEAF is the

right direction Should we showcase?

2008: demonstration with HITSP at RSA. Vendor demonstration of implementing attributes

October 2008: London HIMSS – RBAC and OASIS profiles

o Policies – who manages these---where do they goo Need: Information Model at a Global level; Interoperability at record level o Wanted to leverage SNOMED with their ballot, but found that it would not

be viable. So they tied the RBAC (Role-Based-Access-Control) to the EHR-S FM.

o Needed a framework for expressing policies.o The HL7 RBAC work was accepted by HHS’ HITSP.o The Security WG tied its work to the EHR-S FM, so if Security receives

comments that impact the EHR-S FM, the EHR WG will be informed.o Calvin Beebe: What about Authentication, authorization, and audit

requirements?o Mike Davis: The Security WG is collaborating with SOA WG on the

SAEAF models.

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o Mike Davis: In the U.S. at the OASIS conference and at the HIMSS conference, vendors demonstrated the use of security and privacy RBAC standards and OASIS profiles. The challenge is for the entire set of policies to be used in a policy-engine.

o Richard Dixon-Hughes: There’s so much activity regarding RBAC, but there is little awareness of the other related standards, activities, and issues around the world. What is being done in HL7 to view the larger picture?

o Mike: We are on a broad variety of lists, organizations, etc, but also rely on others to inform us so that we can harmonize. Fortunately, the number of security experts is both relatively small and relatively active; these experts are involved in multiple organizations’ work groups.

o Privacy Consent Directive Format project scope statement: The Security WG needs to be more fully informed of the PSS. The Structured Documents Work Group is planning to co-sponsor the PSS with the Community-Based Collaborative Care (CBCC).

o Mike Davis: It is very important each Privacy Policy is aligned with Security’s ability to implement that Privacy Policy.


Joint Meeting: Public Health Emergency Response (PHER), Patient Care and EHR

Agenda Item #1 Update on Vital Records Functional Profile: Michelle Williams and Hetty Khan

o The PC Work Group reviewed some of the projects they are focusing on.o Vital Records Functional Profile – presented by Michelle Williamson and

Hetty Khano PHDSC Ad Hoc Task Force on EHR-Public Health, 2004o Goal: to provide Public Health perspective to the evaluation of the

EHR-S FM.o Goal: to demonstrate the benefits of an organized interaction

between the public health and clinical heath care.o White Papero http://www.phdsc.org/health_

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http://www.phdsc.org/health_


Agenda Item #2 Public Health and use of the EHR-S FM: Anna Orlova

o Re-evaluation of HL7 EHR-S FM from Public Health perspective. Why?o EHR-S FM has undergone a series of enhancements

o Project outcomes:o Development of a Public Health Functional Profile (or Profiles)o Identification of the need for an independent HL7 Public Health

Functional Modelo Participants:

Previous PHDSC Project team members New stakeholders

o Project website: www.phdsc.org o Beth Acker: Today’s presentations reveal the fact that there is an acute

downstream need to use of EHR data.o HITSP, IHE, and HL7 are all currently working on the Data Element

requirements for Public Health. What might be the best way to work together??

o There are a number of databases, which if combined and normalized might bring value: Cabig, caehr, nci, asco, naaccr, American college of surgeons, nccn (national cancer care network), ACP


Agenda Item #1 Vital Records Profile – Issues discussion/resolution and building toward R2 (Hetty Khan and Michelle Williamson)

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http://www.phdsc.org/


o There is concern within the agency regarding moving to an electronic system. There are agency concerns with data owndership and concerns about the quality of data available from the EHR system. At this point there is more trust in the paper process than in an electronic process. There is a request to limit the US Realm Vital Records profile to a restricted amount of data.

o After discussion, it was suggested to:a. Resubmit the scope statement for the US Realm Vital Records Profile

as a derived profile with the restrictions imposed.b. Submit a new universal project scope statement as much of the work

that will not be in the US Realm profile could be of value to the international community.

o Michelle read the “NCHS/DVS Position Statement for Vital Records Project”

Data must have a high degree of quality.A demonstration project will be necessary to verify that the quality of the data is sufficiently high and as such have requested the profile be limited to those items that are to be part of a pilot without reference to future items that might be included.


Agenda Item #1 Using Certified EHRs: Describing a US experience and discussing the applicability to the International Community (Kim Harris-Salamone, PhD; Executive Director, HIT, Health Services Advisory GroupGora Datta; chairman and CEO CAL2cAL Corporation

Presentation:

o Quality Reporting is performed by a QIO (Quality Improvement Organization).o There is one QIO for each state and territory of the United States.o Goal: Help authorities on the west coast make better use of their EHR

systems.o CMS’ goal is to receive higher quality reports from EHRs.

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ThursdaySeptember 24, 2009Q1

Agenda Item #1 Interoperability Model and EHRS-FM R2 (Gary Dickinson)

Gary provided a general overview of the models on which his work group has been developing.

o What do you mean by data in the model? attributes, relationships, set of operations

o HITSP as USHIK = the elements that have been selected in the US realm for the functions

o Stephen – Pt care is doing DCM work. Do we expect that our output would be consumed by them

o Data interoperability levelo Set of principles that can be derivedo Diabetes Data Project – Two prototypes: DAM/ DCM and the

Interoperability model o UML is HL7 preferred approacho Action Record entries comprised of attributeso Health Record is comprised of ActRecords or instanceso Health Record is part of an EHR or part of a PHR?o Has nothing to do with whether or not data has been vetted.o Need to review RM&ES part of this model need to be in that profile e.g.

characteristics related to legal.o Steve – sees this as an informative referenceo Meta model added into an instantiated functional modelo Gary – Clauses H through L may belong in the modelo Could be a list in IN??o The proposal that SAEAF is showingo Business enterprise is orthoganal to engineering, technology, etc.o Uneasy about integrating into existing FM (Steve)o HITSP view of records management – you would follow these processes

and that makes sense. o Does this occur within the EHR only or only on transporto Robert Stegwee: The interoperability req of an EHRS are imbeddedin the

specifications of the EHRo Difficult balance of the requirements incorporated into the EHRS FM and

how much is left by reference in another place.o How much interop spec has to be carried forward in R2?o Steve Hufnagel: Gary’s group is interoperability---not privacy and security.

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o Data at rest – In a trusted environment, one would not have to do audit and traceability

o Data in motion - HITSP agrees on DIMo Question: Is the EHR Interoperability Model orthogonal with the DAM and

DCM?o End to End o Point to pointo If it were a single clinician system: should he be forced to bear the

expense for his auditing of recordso Suggestion to change Yes/No to SHALL/SHOULD/MAY in the lifecycle

modelo Single isolated system----IF you have an isolated system and you need to

connect to a larger infrastucture, THEN you must…….o Holland (Robert) – legal requirement to keep records of those items that

are medically relevant Not directly linked to the financial side

o Australia (Richard) - legal requirement to keep recordso Japan (Phillip) – legal requirement to keep recordso Japan (Myhoko) – must keep for 5 years legally, and many keep beyondo Canada (Sasha) – depends on jurisdiction or province.o US (Harry) – Practice briefo Add a conformance criteria on the amending actor – o Go through the process and find where it fits and add that in the

descriptiono Add columns to the right of the R2 model to identify something as DIM,

DAR, Medical/legal responsibilityo *****In the overview discuss, DIM, DAR, Data is Use and Data Disposal

o DCM, DAM, Interoperability Model, and how they relate.o DAR, DIM and medical legal requirements Where do they fit,

where do they overlap

ThursdaySeptember 24, 2009Q2

Agenda Topic #1 Review of RM&ES profile and EHRS R2

The quarter was spend in review of functions/criteria in the RM&ES profile and applicability to R2

The next Working Group Meeting will be held in Scottsdale Arizona, January 17-22, 2009.

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