hl7 ehr work group€¦ · • ehr wg ballots, publishes phr-s fm at iso (16527) • work begins on...

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HL7 EHR Work Group

HIMSS 2015 - Chicago Presented by: Gary Dickinson Director, Healthcare Standards, CentriHealth Co-Chair, HL7 EHR Work Group Co-Facilitator, HL7 EHR Interoperability WG Lead, S&I Simplification WG [email protected]


Consensus Standards “A standard is a technical expression of how

to make a product safe, efficient, and compatible with others”

“A standard is established by consensus and provides rules, guidelines, or characteristics for activities or their results.”

http://standardsboostbusiness.org



Conformity Assessment “Product problems… are frequently not due

to inadequacy of the standard, but rather conformance to the standard. Testing, inspection, and auditing of products and management systems is as important as the standard in ensuring that products and systems are safe and perform as expected.”




Vital ANSI Principles Open to all interested parties

No barriers to participation

Consensus-based approval process Transparent Balanced Responsive to Comments

Deliberative in Reconciliation Open to Appeal


Standards Adoption Voluntary

Consumer demand Competitive demand

Voluntary but Regulation Bound US: Meaningful Use 1/2/3

Mandatory By force of legislation and/or regulation US: HIPAA International: Many examples


Benefits of Standardization Relies on broad industry-wide input (collective wisdom) Offers potential to improve performance, quality, safety,

reliability of entire product categories Enhances consistency, uniformity, reduces redundancy Improves interoperability and compatibility of products Increases speed of development Decreases development costs and installation costs

Reduced development lead times (with specification in hand) Allows incorporation of previously standardized technology

and terminology


Benefits of Standardization Decreases time to market Makes competitive products comparable Helps identify gaps in existing or planned products Opens market access

Products made in one country suitable elsewhere Improves sales advantage

Customers/Users prefer standards-based products


Benefits of Participation Roles

Lead SME groups Draft, develop standards specifications Review, comment, ballot

Provides INFLUENCE in development of specification content

Offers early awareness and “insider” knowledge Ballot and pre-publication drafts

Has advantage whether competitors are standards-savvy or not


Health Level Seven (HL7) http://www.hl7.org Standards Development Organization Formed in 1987 Accredited by the American National Standards

Institute (ANSI) http://www.ansi.org

Focus: US and International 30+ Active International Affiliates

Member of Joint Initiative Council (JIC) Collaborative with ISO TC215, CEN TC251, IHTSDO,

DICOM, CDISC, GS1, IHE

http://www.hl7.org

http://www.ansi.org


HL7 EHR Work Group

Products ISO/HL7 10781 EHR System Functional Model

Release 2 (2014 HL7, 2015 ISO/CEN) ISO/HL7 16527 PHR System Functional Model

Release 1 (2014 HL7, 2015 ISO) HL7 EHR Interoperability Model DSTU (2007) HL7 EHR Lifecycle Model DSTU (2008) HL7 EHR Records Management/Evidentiary Support

Functional Profile (2009) HL7 Meaningful Use Functional Profile (2015) HL7 Fast Health Interoperability Resources (FHIR)

Record Lifecycle Event (RLE) Implementation Guide (2015)


HL7 EHR Work Group

Current Activities EHR-S FM – Release 3 in development

Mapping data requirements to FHIR resources PHR-S FM – Release 2 in development

Aligned with EHR-S FM Release 2 Records Management/Evidentiary Support (RM-ES)

RM-ES Functional Profile Release 2 in development EHR System Usability

Functional Profile in development EHR Interoperability

ISO 21089, Trusted End-to-End Information Flows, revision Functional Model Tooling Support FHIR Record Lifecycle Event Implementation Guide

Fast Health Interoperability Resources, DSTU 2, in ballot Vocabulary Alignment – EHR, Security, CBCC


EHR and PHR Electronic Health Record (EHR):

Supports Provider (Individual and/or Organization) Legal record Data: organizational, administrative, financial, clinical Data retention: defined by regulations, laws, best

practices, organizational guidelines Personal Health Record (PHR):

Supports Patient (typically Individual) Not a legal record Could span a lifetime (or beyond for genetic research) Data: personal, clinical Data Retention: specified by PHR Account Holder


HL7 EHR Work Group

Functional Model Scope Defines a standardized model of the functions that may be present in

EHR and PHR Systems. Makes no distinction regarding implementation Does not address whether the EHR-S is a system-of-systems or a single

system providing the functions required by the users. Makes no statement about which technology is used – Is “product”

agnostic Is comprised of “Functions” (e.g. “Manage Medications List”) and

associated “Conformance Criteria” (e.g. “The system SHOULD provide the ability to update a medication order directly from the medication list.”)

Includes “Core” health and healthcare functionality, typically provided by

applications that manage electronic health information. Associated generic application-level capabilities that are often provided by

middleware or other infrastructure components. Supports research needs by ensuring data is available to researchers. Follows required protocols for privacy, confidentiality, and security


….

Inputs to EHR-S FM Release 2

Vital Rptg.

RM & ES

Beh. Health

LTC

EHR-S Profiles

Other Industry Initiatives

Privacy, Security,

Confi- dentiality

Health Info

Exchange

….

Data Use • Fraud Mgt • Quality • Rev Cycle

Certifi- cation (CCHIT, Q-Rec)

EHR-S FM Release 2

Others?

UC Alignment

EHR Lifecycle SOA R1

Adjustments, Enhancements EHR

Interoperability Model

Inter- national

Standards (ISO TC215, ISO 20514,

18308, 13606)

Provider Based

PHR-S FM &

Profiles


EHRS FM to Testing EHRS/PHRS Functional Model Broad Range of Functions, Conformance Criteria

Functional Profile Select Functions and Conformance Criteria, tailored to Specific Use Domain, Care Setting, Service, Specialty

Certification Profile Select Certification Criteria (e.g., CCHIT Road Map 2005-2011)

Test Procedure Detailed Script, Test Steps


Conformance to the Functional Model An EHR or PHR system does not directly conform

to the Functional Model Rather it conforms to one or more Functional

Profiles

EHR-S FM, PHR-S FM Functional Profiles


ISO/HL7 10781 EHR-S FM Release 2 Functional Profiles


Meaningful Use

Functional Profile Bridge between EHRS FM and MU 1 and 2 Working back

From ONC/NIST Test Procedure, Test Steps To EHRS FM Functions, Conformance Criteria

Thus, both MU System Certification Criteria and HL7 MU FP resolve to same Test Procedure

VALUE ADD: Allows dual certification – MU (US), ISO/HL7 10781 (International) Without extra work


HL7 EHR Work Group

Timeline 2001 • HL7 EHR Work Group Formed 2003 • HL7 approached by HIMSS, VA, ASPE, RWJ to draft, ballot and

publish “Functional Model” for EHR Systems 2004 • HL7 balloting complete

• EHRS FM published as Draft Standard for Trial Use • CCHIT is formed by HIMSS, AHIMA, NAHIT (AHA)

2005 • CCHIT initiates certification of EHR Systems, substantially referencing HL7 EHRS FM conformance criteria

2007 • HL7 ballots, publishes EHRS FM Release 1 • EHR WG ballots, publishes EHR Interoperability Model DSTU

2008 • HL7 ballots, publishes Personal Health Record System Functional Model DSTU

• HL7 ballots, publishes EHR Lifecycle Model DSTU 2009 • HL7, ISO TC215 and CEN TC251 jointly ballot and publish ISO/HL7

10781 EHRS FM, Release 1.1


HL7 EHR Work Group

Timeline, con’t 2010 • HL7 ballots, publishes Records Management/Evidentiary Support (RM-

ES) Functional Profile (FP), Release 1 2011-2012

• EHR WG updates EHR-S FM and drafts Release 2, incorporating R1/R1.1 based Functional Profiles, CCHIT criteria, RM-ES, EHR Interoperability and Lifecycle Models and other input

• EHR WG updates PHRS FM and drafts Release 1 • Tooling support for EHR-S FM R2 development, balloting and

publication 2013-2014

• EHR WG ballots, publishes both EHR/PHR SFMs at HL7 • Tooling support for EHR-S FP R2 development, balloting and

publication 2015 • EHR WG ballots, publishes EHR-S FM at ISO/CEN (10781)

• EHR WG ballots, publishes PHR-S FM at ISO (16527) • Work begins on FM Framework for next Releases • Meaningful Use FP balloted and published • FHIR Record Lifecycle Events Implementation Guide in ballot


EHR-S FM R2

Translations

Dutch (new) William and Anneke Goosen [email protected]

French (new) Francois Macary [email protected] Italian (new) Stephano Lotti [email protected]

Japanese (update) Noriko Inaoka, PhD Hideshige Hasegawa

[email protected] [email protected]

Portuguese (update) Beatriz Leao [email protected]

Spanish (update) José Manuel Castañeda Casas [email protected]


Looking Forward Functional Model Framework

EHRS FM R3 PHRS FM R2 Others: Public Health, Lab…

Tool-based (Enterprise Architect) Functional Models Functional Profiles


EHR-S FM and PHR-S FM Tooling Support Phase 1 – Complete

Manage (capture, maintain, render) function list entries: names, descriptions, examples, conformance criteria

Maintain rules, validity checks Allow multiple views Manage ballot reconciliation, updates and publication Output/Publish for ballot/final: .pdf, .xlsx, .html, .eap

Phase 2 – Complete Create and update EHRS FM-based Functional Profiles

Phase 3 – Ready to Start Capture PHRS FM Release 1 Build Functional Model Framework Support Language Translation


Certification – Then and Now 2005-2011

CCHIT EHRS certification program encompasses ambulatory, inpatient and various specialties

2009 Meaningful Use (HITECH Act) passed 2010 ONC publishes MU Stage 1 EHRS Certification Standards

• ONC declares “MU 1 is floor” • CCHIT continues Premium Certification

2011 MU Stage 1 underway 2012 ONC Publishes MU Stage 2 Criteria

• ONC declares “MU 2 is floor” • CCHIT drops Premium Certification

2014 MU Stage 2 underway 2014 ONC Signals Supplemental EHR System Certification beyond MU

• Behavioral Health, Long Term Care 2015 MU Stage 3 – CMS/ONC NPRM Issued


MU Certified EHR Systems EHRS Type Stage 1

2011* Stage 2 2014*

Ambulatory All 3816 1232 Complete EHRS 1957 573

Inpatient All 1232 1028 Complete EHRS 372 71

* Certifications Posted as of 12 April 2015


Basics

Record Entry and FHIR Resources An EHR System manages a persistent EHR

comprising Record Entries for One or more provider organizations, One or more individual practitioners, and Many patients

An EHR comprises Many Record Entry instances

A Record Entry instance may comprise One or more FHIR Resource instance(s) With signature bindings


EHR Record Lifecycle/Lifespan

Dimensions of End-to-End Flow Record Lifespan 1. Within Single System

Starting at point of origination, in Source System Starting at point of receipt, in Receiving System Ending at point of deletion

2. Across Multiple Systems Starting at point of origination, in Source System Traversing one or more Points of Exchange Ending at point of deletion, in each System


Record Lifespan Start Intervening Record Lifecycle Events (0 to many) End

Source System (1) Originate/Retain Record Entry

(2) Amend (3) Translate (25,4) Verify, Attest (5) View/Access (6) Output/Report (7) Disclose (8) Transmit (10) De-Identify (11) Pseudo-nymize (12) Re-Identify (13) Extract (14,15) Archive, Restore (17,18) Deprecate/Retract, Re-Activate (19,20) Merge, Unmerge (21,22) Link, Unlink (23,24) Place, Remove Legal Hold (26,27) Encrypt, Decrypt

(16) Destroy

Receiving System (9) Receive/Retain Record Entry

(16) Destroy

Record Lifespan – End-to-End Within Single System


Record Lifespan Start Intervening Record Lifecycle Events (1 to many) End

Source/Sending System

Poi

nt o

f Exc

hang

e

Receiving System

(1) Originate/Retain Record Entry

… (6) Output/Report (7) Disclose (8) Transmit

(9) Receive/Retain (5) View/Access (6) Output/Report (13) Extract …

(16) Destroy

Record Lifespan – End-to-End

Across Multiple Systems

Repeated at each point of exchange…


http://www.hl7.org/fhir FHIR Clinical Resources

As of 12 Mar 2015

http://www.hl7.org/fhir



http://www.hl7.org/fhir FHIR Administrative Resources

As of 12 Mar 2015




http://www.hl7.org/fhir FHIR Financial Resources

As of 12 Mar 2015




http://www.hl7.org/fhir FHIR Infrastructure Resources

As of 12 Mar 2015




Requirements Are Fulfilled by… ISO/HL7 10781 EHR-S FM R2 Record Infrastructure (RI) 24(+3) Record Lifecycle Events

Implementable FHIR Resources

Basic Lifecycle Event • AuditEvent

Provenance Lifecycle Event when Record Entry content is originated or updated

• AuditEvent • Provenance • Other new/updated resource(s) corresponding to Action Taken

Resources may also be indivisibly and immutably bound by one or more digital signatures in a Record Entry.

Now Underway Mapping to FHIR


Pre Event State Resource @ Event Post Event State

AuditEvent Ad

ded

Even

t Ev

iden

ce

Ret

aine

d Pr

e Ed

ition

U

nalte

red

Adde

d N

ew

Editi

on

Sign

ed a

s Au

thor

Sign

ed a

s Sy

stem

[none] 1 Originate/Retain X X Opt X

[Record Entry as persisted,

indivisible and immutable since

previous Lifecycle Event]

2 Amend X X X Opt X 3 Translate X X X X 4 Attest X X X X 5 Access/View X 6 Output/Report X X 7 Disclose X X 8 Transmit X X 9 Receive/Retain X X

EHR-S FM Record Lifecycle

Pre/Post Events 1-9

+ Provenance



AuditEvent Ad

ded

Even

t Ev

iden

ce

Ret

aine

d Pr

e Ed

ition

U

nalte

red

Adde

d N

ew

Editi

on

Sign

ed a

s Au

thor

Sign

ed a

s Sy

stem




10 De-Identify X X X X 11 Pseudonymize X 12 Re-Identify X 13 Extract X X X X 14 Archive X 15 Restore X 16 Destroy/Delete X [none] 17 Deprecate X 18 Re-Activate X


Pre/Post Events 10-18

+ Provenance



AuditEvent Ad

ded

Even

t Ev

iden

ce

Ret

aine

d Pr

e Ed

ition

U

nalte

red

Adde

d N

ew

Editi

on

Sign

ed a

s Au

thor

Sign

ed a

s Sy

stem




19 Merge X X X 20 Unmerge X 21 Link X 22 Unlink X 23 Add Legal Hold X 24 Remove Legal Hold X 25 Verify (new event) X 26 Encrypt (new event) X X ? 27 Decrypt (new event) X X ?


Pre/Post Events 19-27

+ Provenance


ISO/HL7 10781 EHR-S FM – Sample Conformance Criteria

Originate/Retain Record Entry With Event Evidence (RI.1.1.1.1)

At Lifecycle Event Occurrence (RI.1.1.1)

Fulfilled by FHIR Resource Implementation Lifecycle Event Metadata (who, what, when, where, why)

Others to consider


Action Roles Record Entry Roles • Subject • Performer • Witness

• Record Target • Author • Recorder (Enterer?) • Verifier • Attester • Informant • Source/Copy From

Individuals have specific…

Action and Record Entry Roles


Action Metadata Record Entry Metadata

Who

Action Subject (Patient) Johnny Walker Role: Subject

Entry Subject (Patient) Johnny Walker Role: Record Target

Action Organization Bay City Medical Center Action Practitioner/Performer Doctor Sally Smith Role: Performer

Entry Source – Author or Scribe Nurse Janice Jones Role: Recorder

Entry Source – System/Device Erstwhile EHR/Device XX123456

Example – Medication Order

Action and Record Entry Metadata


Action Metadata Record Entry Metadata

What Action Taken Medication Order for Ambien 20mg PRN

Entry Origination/Retention evidenced by AuditEvent Provenance + FHIR Resources related to Medication Order MedicationPrescription, et al

When

Action Date/Time 22 Aug 2014 @ 1800

Entry Date/Time 22 Aug 2014 @ 1810

Action Duration 3 Minutes

Where Action Physical Location Ward/Room B/12

Entry Location – IP Address 255.255.255.1

Why Action Reason/Purpose To Induce Sleep

Entry Reason/Purpose <none entered>

Example – Medication Order

Action and Record Entry Metadata


EHR-S FM Record Infrastructure (RI) – Lifecycle Events Plus… More Evidentiary Metadata

Lifecycle Event

Orig

inat

e R

etai

n

Am

end

Atte

st

Tran

slat

e

Record Entry Unique ID X Record Entry Content: Data, Document, Artifact ID(s) X X Digital Signature(s) – Individual(s) X Digital Signature – Acting System/Device Any/All Corresponding/linked Record Entry(ies) X X Pointer to Pre-Event Entry, if any: pre update/translation X X Pointer to Post-Event Entry, if any: post update/translation X X Amendment and/or Translation Sequence X X Identity and version of Translation Tool(s), if any X


EHR-S FM Record Infrastructure (RI) – Lifecycle Events Plus… More Evidentiary Metadata

Lifecycle Event

Orig

inat

e R

etai

n

Am

end

Atte

st

Dis

clos

e Tr

ansm

it

Source of Copied Content: if copy/paste, template or boilerplate X X

Event is Known Disclosure Indicator X Permissions associated with Record Entry Content X X X Entries in Event Transaction, if multiple Set of Entries:

• Accessed/Viewed • Transmitted • Received • Extracted • Archived/Restored • Destroyed/Deleted • On/Off Legal Hold …


FHIR Resources

Car

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Med

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0+

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s…

13 March 2015 44

Abstract Metadata Attributes for Action Taken Who What When Where Why

A Potential Solution for Action Metadata Abstract Attributes


HL7 EHR WG Weekly Teleconferences


Want to Know More?

Join HL7, review the HL7 web site www.HL7.org ; Work Groups; Electronic Health Records http://www.HL7.org/Special/committees/ehr/index.cfm

Subscribe to HL7 EHR WG list serve http://www.HL7.org/special/committees/list_sub.cfm?list=ehr

Download and review Functional Profiles Attend open public sessions

No HL7 membership required

http://www.hl7.org/Special/committees/ehr/index.cfm

http://www.hl7.org/special/committees/list_sub.cfm?list=ehr


HL7 EHR Work Group Contacts

For questions or additional information HL7 EHR Work Group Co-Chairs

Gary Dickinson ([email protected]) Reed Gelzer, MD ([email protected]) Mark Janczewski, MD ([email protected]) John Ritter ([email protected]) Pat Van Dyke, RN ([email protected]) Diana Warner ([email protected])

mailto:[email protected]






hl7 ehr work group€¦ · • ehr wg ballots, publishes phr-s fm at iso (16527) • work begins on...

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