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  1. International Patient Summary (IPS) IG



Enter the name of the project here: International Patient Summary (IPS) IG

Project ID: 1525

Complete this section for all “Direct to Normative” ballot projects and when a project proceeds from “Informative to Normative” or “STU to Normative”.

Forward PSS to the TSC (via tscpm@HL7.org); this triggers American National Standards Institute (ANSI) Project Initiation Notification (PINS) submission.

 

TSC Notification:  Informative/STU to Normative 

Date:  Submission date

 

- or -                     Direct to Normative (no STU) (includes reaffirmations)       

 

Identify ISO, IEC or ISO/IEC standard to be adopted in text box below

Enter info here if an ISO, IEC, or ISO/IEC Standard is to be adopted as an American National Standard; Enter the designation of the standard(s) to be adopted:

Includes text from ISO, IEC or ISO/IEC standard: Check here if this standard includes excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption.


 

No

Select the unit of measure used in the standard; if no measurements are in the standard, select N/A

 


 


Metric

 


 

Investigative Project (aka PSS-Lite)

Date : 

Check this box when the project is investigative or exploratory in nature, which allows limited project scope definition. Sections 1-Project Name, 2-Sponsoring Group(s)/Project Team, 3a-Project Scope, 3b-Project Need, 3e-Project Objectives/Deliverables/Target Dates, 3i-Project Document Repository, 6b-[Realm, if known], and 6d-[applicable Approval Dates] are required for Investigative Project. Investigative Project specific instructions are highlighted in yellow. An investigative project must advance in two WGM cycles, requiring a full scope statement. Otherwise the project will be closed.

2. Sponsoring Group(s) / Project Team

2.a. Primary Sponsor/Work Group

Primary Sponsor/Work Group
(1 (And Only 1) Allowed)

Patient Care

2.b. Co-sponsor Work Group(s)

Co-sponsor Work Group(s):

(Enter co-sponsor approval dates in Section 6.d Project Approval Dates)

Electronic Health Records
Structured Documents

Indicate the level of involvement that the co-sponsor will have for this project:

 Request formal content review prior to ballot
X Request periodic project updates. Specify periodAt WGMs

 Other Involvement. Specify details here: 

Co-sponsor Work Group(s):

(Enter co-sponsor approval dates in Section 6.d Project Approval Dates)

Electronic Health Records
Structured Documents


2.c. Project Team

All names should have confirmed their role in the project prior to submission to the TSC.

Project facilitator (1Mandatory)

Robert Hausam, MD (rob@hausamconsulting.com)
Giorgio Cangioli (giorgio.cangioli@gmail.com)

Other interested parties and their roles

ISO TC215 POC

Mr Edward Terhune: ISO TC215 secretariat, JIC Secretariat

(eterhune@ansi.org)

Sequoia

Didi Davis: IHE International Board Member, IHE International Testing & Tools Committee (ddavis@sequoiaproject.org)

JIC

Michael Nusbaum: JIC Chair (michael@mhnusbaum.com)

Clinical Interoperablity Council WG

Anita Walden: WG co-chair

(anita.walden@duke.edu)

Emergency Care WG

Laura Heermann Langford: WG co-chair

(Laura.Heermann@imail.org)

Public Health WG

Joginder Madra: WG co-chair

(hl7@madraconsulting.com)

Orders & Observations WG

Hans Buitendijk: WG co-chair

(hans.buitendijk@cerner.com)

Vocabulary WG

Robert Hausam: WG Co-Chair

(rob@hausamconsulting.com)

Mobile Health WG

Frank Ploeg: Member

(r.f.ploeg@umcg.nl)

SNOMED International

Jane Millar

CEN TC251

Steven Kay

HTA

Heather Grain

Pharmacy WG

Christof Gessner

Multi-disciplinary project team (recommended)


     Modeling facilitator

Kai Heitmann (CDA)

     Publishing facilitator

Kai Heitmann (CDA), Rob Hausam (FHIR)

     Vocabulary facilitator

Rob Hausam

     Domain expert rep

Francois Macary, Christof Gessner

     Business requirement analyst

Catherine Chronaki, George Dixon, Gary Dickinson, Giorgio Cangioli

     Conformance facilitator (for IG projects)


     Other facilitators (SOA, etc)




Implementers (2Mandatory for STU projects)

FHIR Project Note: The implementer requirement will be handled by the “balloting” project.  Therefore work groups do not fill out the above section.  However, feel free to list implementers specific to your work group’s resources if you know of any.

1) openNCP

https://openncp.atlassian.net/wiki/display/ncp/OpenNCP+Community+Home

2) GNOMON
http://www.gnomon.com.gr/

3. Project Definition

3.a. Project Scope


Describe the project; include what is expected to be accomplished/delivered along with specified features and functions. Include whether the deliverable(s) are universal, realm specific or applicable to various realms. Be sure to spell out all acronyms as these are carried forward to the NIB (Notice of Intent to Ballot) for ballot announcements..

The goal of this project is to refine and maintain CDA R2 and FHIR  implementation guides and the associated artifacts (e.g. resource profiles) for the International Patient Summary, extending its current scope.  

This project continues and supersedes the prior HL7 IPS project (#1087). 

The IPS project has successfully collaborated with CEN/TC 251 delivering two STU Implementation Guides (the HL7 CDA R2 IPS IG and the HL7 FHIR IPS IG) that implement the CEN EN 17269 specification.  These guides are referred to, in turn, by the CEN TS 17288 standard.

This new HL7 IPS project takes in account the inputs and the lessons learned by the current CEN/HL7 IPS and the Trillium II (http://trillium2.eu) projects:

  • The IPS has been initially conceived as a document designed for a well specified purpose (emergency and unplanned care), but there are now expectations of broader use of the IPS components (FHIR profiles; CDA templates) as a core data set for additionally identified use cases.
  • The cross-border services capability with its conditional requirements is an added value of the IPS; but the IPS is expected to be used also in other national, regional and local contexts.
  • There are several outstanding requests for adding content for new clinical domains (e.g. dental, mental health, child health) and new information (e.g. provenance; risks; ….) to the IPS.
  • There are opportunities for extending the collaboration with other SDOs (e.g. SNOMED CT; ISO)
  • There are opportunities for enriching the IPS ecosystem with additional artifacts and products (e.g. FHIR Logical Models).
  • The IPS needs a continuous maintenance process, implementing the eStandards principles of co-creation-governance-alignment (see http://estandards-project.eu/)

Therefore:

  1. The revised IPS project will no longer be limited to the "IPS document" (the subject of the current project); but it will also develop and continuously maintain a library of IPS data blocks (the individual CDA templates or FHIR profiles that the IPS document is composed of).
    1. In fact, if the IPS document is a HL7 FHIR or CDA document that serves a well-known and specified scope, the IPS data blocks define a minimal, non-exhaustive, specialty-agnostic and condition-independent data set that might be reused beyond the IPS document scope. This library of data blocks will be expressed in term of HL7 FHIR profiles and HL7 CDA templates.
  2. The revised IPS project will identify, evaluate, select, develop and maintain all the HL7 products and artifacts to be included in the IPS standard ecosystem (e.g. FHIR logical models) and it will evaluate the need for the inclusion of new domains or information:
    1. involving the appropriate domain specific HL7 WGs;
    2. cooperating with other SDOs to keep consistency in the ecosystem with the artifacts produced by the other SDOs;
    3. interacting with the main stakeholders (e.g. eHDSI; Argonaut) to capture their needs and evaluations.

It is proposed to have a continuous maintenance process for the assigned products.  The intent, in fact, is to work on the two implementation guides (CDA and FHIR) subject to continuous revision lifecycles, whose content and included artifacts will be moved from STU to Normative.

3.b. Project Need


This information is required by ANSI for all ballots. Briefly explain the reason behind the need for this project. This may be related to legislative requirements, industry need, or similar justifications.
.

The creation of this project stems from 2 sources:

  • The need for increased patient empowerment and the promotion of individual and community health in a global environment.
  • The need for an innovative ecosystem of eHealth/Health IT that supports the electronic exchange of human- and machine-readable health, clinical, medical and management information to advance the health of individuals and communities.

3.c. Security Risks


Will this project produce executable(s), for example, schemas, transforms, style sheets, executable program, etc.  If so the project must review and document security risks. Refer to the Cookbook for Security Considerations for additional guidance, including sample spreadsheets that may be used to conduct the security risk assessment. 


Yes


No

X

Unknown

The use of validation scripts or tools presents security considerations that must be addressed.  The extent to which this will be required, and at what levels, is unknown at present.  See the HL7 Security WG Cookbook for Security Considerations (http://wiki.hl7.org/index.php?title=Cookbook_for_Security_Considerations) for further discussion.

3.d. External Drivers


Describe any external schedules or calendars which may not be known outside of the project team that are driving target dates for this project..

Coordination among SDOs (HL7, CEN/TC 251, JIC , SNOMED Int., ISO/TC215 and possible others) and with initiatives on Patient Summary (e.g. Trillium II).

EU Dependencies:

  • Alignment with the EU standardization/identification process, at least for cross border exchange of data.
  • Patient Summary guidelines will be revised by the eHealth Network.

3.e. Project Objectives / Deliverables / Target Dates

Within each row, enter the explicit work product(s) / objective(s).  Indicate their target date at the right in WGM/Ballot Cycle format.  Include the project end date as the last objective (for standards projects, the end date will be the projected ANSI approval date). 

Target Date(in WGM or ballot cycle format, e.g.

‘2017 Sept WGM’ or

‘2017 Jan Ballot’)

Enter objective/deliverable here.

All planned ballots and their target dates should be included

The example below is a "STU to Normative" path

Enter Target Date

Complete evaluation of the alignment of the current FHIR IPS balloted IG and the Argonaut specifications2019 April
STU1 publication2019 April

Submit revisions to the IG based on the Argonaut evaluation and implementation experience for STU Ballot

2019 Sep Ballot

Complete revised IG STU ballot reconciliation

2019 December

Request STU2 Publication

2019 December

STU2 Period – 12 months

2019 July - 2020 June

Incorporate additional content requests and feedback from STU2 and submit for Normative Ballot

2020 Sep Ballot

Complete Normative Reconciliation

2021 Jan WGM

Submit Publication Request

2021 Feb

Example: Receive ANSI Approval

2021 Dec

Project End Date (all objectives have been met)

Note:  For PSS-Lite/Investigative Project, End date must be no more than two WGM cycles, e.g. project initiated at January WGM must complete investigation by September WGM.

2021 Dec


3.f.   Common Names / Keywords / Aliases


What common name does your group use to refer to the product(s) produced?  What alternative names, aliases and keywords does your group use to refer to the product(s) that will be produced?  Some examples: C-CDA, LRI, eDOS.  

  • IPS
  • INTERPAS (former name)

3.g. Lineage


If your project creates a Post-Release 1 version; indicate the name of the prior product and if it is supplanting, replacing or coexisting with a previous release:

This project replaces the IPS FHIR IG STU 1; IPS CDA R2 IG STU 1.

3.h. Project Dependencies


Enter any dependencies or the name & Project Insight ID of project(s) that this project is dependent upon to achieve its objectives:
 

Projects and their Project Insight IDs can be found via http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?ref=common


3.i.   HL7-Managed Project Document Repository Location


Projects must adhere to the TSC's guidelines (which were approved on 2016-04-04 and summarized in Appendix A).

A template to create a Project Page on the HL7 Wiki is available at: http://wiki.hl7.org/index.php?title=Template:Project_Page.

Enter the SPECIFIC URL of the HL7-MANAGED SITE where supporting project documents, deliverables, ballot reconciliation work and other project information will be kept

https://github.com/HL7/fhir-ips

International Patient Summary


3.j.   Backwards Compatibility


Are the items being produced by this project backward compatible?


Yes


No


Unknown

X

N/A

If you check 'Yes' please indicate the earliest prior release and/or version to which the compatibility applies:


For V3, are you using the current data types? 

(Refer to TSC position statement on new projects using R2B for more information on the current V3 data types)


Yes


No


Unknown

X

N/A



If you check no, please explain the reason:

If desired, enter additional information regarding Backwards Compatibility.


3.k. External Vocabularies


Will this project include/reference external vocabularies?

X

Yes


No


Unknown


N/A

If Yes, please enter the vocabularies: SNOMED CT, LOINC, UCUM, EDQM (others TBD)


4. Products (check all that apply)



Arden Syntax


V2 Messages – Administrative


Clinical Information Modeling Initiative (CIMI)


V2 Messages - Clinical


Clinical Context Object Workgroup (CCOW)


V2 Messages - Departmental


Domain Analysis Model (DAM)


V2 Messages – Infrastructure


Electronic Health Record (EHR) Functional Profile


V3 Domain Information Model (DIM / DMIM)

X

FHIR Extensions


V3 Documents – Administrative (e.g. SPL)

X

FHIR Implementation Guide (enter FHIR product version below)

X

V3 Documents – Clinical (e.g. CDA)

X

FHIR Profiles (enter FHIR product version below)


V3 Documents - Knowledge


FHIR Resources


V3 Foundation – RIM


Guidance (e.g. Companion Guide, Cookbook, etc)


V3 Foundation – Vocab Domains & Value Sets


Logical Model


V3 Messages - Administrative


New/Modified/HL7 Policy/Procedure/Process


V3 Messages - Clinical


New Product Definition (please define below)


V3 Messages - Departmental


New Product Family (please define below)


V3 Messages - Infrastructure


Non Product Project - (Educ. Marketing, Elec. Services, etc.)


V3 Rules - GELLO


White Paper


V3 Services – Java Services (ITS Work Group)


Creating/Using a tool not listed in the HL7 Tool Inventory


V3 Services – Web Services (SOA)

If you checked New Product Definition or New Product Family, please define below:


For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

R4 (update to R5 when available)


5. Project Intent (check all that apply)



X

Create new standard



Supplement to a current standard

X

Revise current standard (see text box below)


X

Implementation Guide (IG) will be created/modified


Reaffirmation of a standard



Project is adopting/endorsing an externally developed IG:


New/Modified HL7 Policy/Procedure/Process



Specify external organization in Sec. 6 below;





Externally developed IG is to be (select one):


White Paper (select one):



Adopted  - OR -


Endorsed



Balloted Informative OR


Non-balloted WG White Paper



N/A  (Project not directly related to an HL7 Standard)











If revising a current standard, indicate the following:


-    Name of the standard being revised:HL7 CDA® R2 Implementation Guide International Patient Summary, Release 1
-    Date it was published (or request for publication, or ANSI designation date)10/25/2018
-    Rationale for revisionTo maintain close alignment with the IPS FHIR IG going forward (including updates subsequent to the Argonaut evaluation and future ballots).
-    The relationship between the new standard and the current standard (is it designed to replace the current standard, a supplement to the current standard, etc.)The FHIR IPS IGs is conceptually aligned with the CDA IPS IG and we intend to maintain this as closely as reasonably possible going forward, including with the possibility of having both IGs based on a common logical model (expected to be a FHIR logical model).


5.a. Ballot Type (check all that apply)



Comment (aka Comment-Only)



Joint Ballot (with other SDOs)


Informative



N/A  (project won’t go through ballot)

X

STU to Normative     - OR -


Normative (no STU)











If necessary, add any additional ballot information here.  If artifacts will be jointly balloted with other SDOs, list the other groups.



5.b. Joint Copyright

Check this box if you will be pursuing a joint copyright.  Note that when this box is checked, a Joint Copyright Letter of Agreement must be submitted to the TSC in order for the PSS to receive TSC approval.

Joint Copyrighted Material will be produced?



Yes

X

No


6. Project Logistics

6.a. External Project Collaboration

This project is a cooperative action plan between a global group of SDOs, experts and stakeholders, across the public, private and academic sectors.

Collaborations:

  • SDOs: CEN/TC 251, SNOMED Int., ISO/TC 215 
  • Governments: United States (via ONC) and European Commission (via CEN and CEN TC251)
  • European HL7 Affiliates (via ESAB and HL7 International Foundation / European Office)

COORDINATION WITH SDOs:

Because of the international nature of this initiative, coordination with global and regional SDOs is crucial.  It is expected that the project will be submitted to the Joint Initiative Council (JIC) in ISO with HL7 as the lead SDO and ISO TC215 as the secondary SDO.

Collaborating parties will have access to all project materials.

Existing content will be reviewed and evaluated for applicability as the project proceeds.

Include SDOs or other external entities you are collaborating with, including government agencies as well as any industry outreach.  Indicate the nature and status of the Memorandum of Understanding (MOU) if applicable.

For projects that have some of their content already developed:

How much content for this project is already developed?


Was the content externally developed ? :

N

Is this a hosted (externally funded) project?  (not asking for amount just if funded)


Yes

N

No


6.b. Realm


X

Universal 

- OR -


Realm Specific




 

Check here if this standard balloted or was previously approved as realm specific standard

Enter “U.S.” or name of HL7 affiliate(s) here.  Provide explanation/justification of realm selection. For projects producing deliverables applicable to multiple realms, document those details here. 

For Investigative projects, indicate if the project is planned to be Realm Specific or Universal, if known. Work Groups are encouraged designating project a Universal project initially, and discover which Realms can contribute to the work effort during the discovery phase of the project. Note: This status is subject to change during the investigative process.



6.c. Stakeholders / Vendors / Providers

This section must be completed for projects containing items expected to be ANSI approved, as it is an ANSI requirement for all ballots

 

Stakeholders

 

Vendors

 

Providers


 

Clinical and Public Health Laboratories

 
 

Pharmaceutical


 
 

Clinical and Public Health Laboratories

X
 
 

Immunization Registries

X
 
 

EHR, PHR

X
 
 

Emergency Services


 
 

Quality Reporting Agencies


 
 

Equipment

 
 

Local and State Departments of Health

X
 
 

Regulatory Agency

 X
 

Health Care IT

 X
 

Medical Imaging Service

X
 
 

Standards Development Organizations (SDOs)

 X
 

Clinical Decision Support Systems

 X
 

Healthcare Institutions (hospitals, long term care, home care, mental health)


 
 

Payors

X
 
 

Lab

 
 

Other (specify in text box below)


Other (specify in text box below)


 
 

HIS


 
 

N/A


 
 

N/A


 
 

Other (specify below)


 

 



 
 

N/A

 

 


Other:  Indicate other stakeholders, vendors or providers not listed above.










6.d. Project Approval Dates

Click here to go to HL7 Project Scope Statement Instructions#Appendix A for more information regarding this section.
Approvals are by simple majority vote of the approving body

Sponsoring Work Group Approval Date:

PCWG Approval Date

2019-03-25

Administrative review – in parallel with Work Group Approval

Co-Sponsor Group Approval Date


EHR WG Approval Date
SDWG Approval Date

2019-03-26
2019-04-04

Family Management Group Approval Date(s)

CIMI Projects: CIMI Management Group

CIMI MG Approval Date

CDA Projects: CDA Management Group

CDA MG Approval Date

2019-04-04

FHIR Projects: FHIR Management Group

FMG Approval Date

2019-03-27

V2/Publishing Projects: V2 Management Group

V2 MG Approval Date

US Realm Projects: US Realm Steering Committee Approval
(Email WG approved PSS to: tscpm@HL7.org)

USRSC Approval Date

Affiliate Specific Projects: Affiliate Approval Date

Affiliate Approval Date

Submit PSS to Steering Division after all of the above approvals are received

Steering Division (of Primary Sponsor WG) Approval Date:

SD Approval Date CCYY-MM-DD

2019-04-07

Last PBS Metrics Score:

 Green

 Yellow

 Red

PBS Metrics Reviewed? (required for SD Approval if not green)

 Yes

 No

ARB and Steering Division approval may be in parallel

Architectural Review Board Approval Date:

(required for externally developed content)

ARB Approval Date

TSC Approval

If applicable, TSC has received a Joint Copyright/Distribution Agreement (containing the verbiage outlined within the SOU),
signed by both parties.

Yes

No

 N/A


Technical Steering Committee Approval Date:
(Email SD WG approved PSS to: tscpm@HL7.org)

TSC Approval Date