Do not launch ANY of the links while your are in create or edit mode. There is a good chance all of your work will be gone.
Template Usage Information:
- Submit template change requests to PMO@HL7.org
- For Reaffirmations, please refer to the FAQ in Hl7 Project Scope Statement Instructions for a list of which sections and fields should be completed
International Patient Summary (IPS)
Enter the name of the project here: International Patient Summary (IPS)
|Project ID:||An ID will be assigned by Project Insight|
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.
Select the unit of measure used in the standard; if no measurements are in the standard, select N/A
Investigative Project (aka PSS-Lite)
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
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
|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 period||At WGMs|
|Other Involvement. Specify details here:|
2.c. Project Team
All names should have confirmed their role in the project prior to submission to the TSC.
Project facilitator (1Mandatory)
Other interested parties and their roles
ISO TC215 POC
Mr Edward Terhune: ISO TC215 secretariat, JIC Secretariat
Didi Davis: IHE International Board Member, IHE International Testing & Tools Committee (firstname.lastname@example.org)
Michael Nusbaum: JIC Chair (email@example.com)
Clinical Interoperablity Council WG
Anita Walden: WG co-chair
Emergency Care WG
Laura Heermann Langford: WG co-chair
Public Health WG
Joginder Madra: WG co-chair
Orders & Observations WG
Hans Buitendijk: WG co-chair
Robert Hausam: WG Co-Chair
Healthcare Standards Integration WG
Laura Heermann Langford: WG co-chair
Mobile Health WG
Frank Ploeg: Member
Multi-disciplinary project team (recommended)
Kai Heitmann (CDA)
Kai Heitmann (CDA), Rob Hausam (FHIR)
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.
|3) ONC (Inferno)?|
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
international 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)
which developed HL7 CDA R2 and HL7 FHIR IGs.
Project that 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 .
HL7 IPS IGs These guides are referred, 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
. In brief:
- 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/)
- The revised IPS project will not be anymore limited to the "IPS document" (subject of the current project); but it will develop and continuously maintain also a library of IPS data blocks (the IPS document is composed of).
- 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 defines a set of minimal, non-exhaustive, specialty-agnostic and condition-independent set of data; that might be reused beyond the IPS document scope. This library will be expressed in term of HL7 FHIR profiles and HL7 CDA templates.
- It 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 needs for the inclusion of new domains or information:
- involving the appropriate domain specific HL7 WGs;
- cooperating with other SDOs to keep the ecosystem consistency with the artifacts produced by the other SDOs;
- interacting with the main stakeholders (e.g. eHDSI; Argonaut) to capture their needs and evaluations.
It is proposed a continuous maintenance process for the assigned products.
The intent is in fact to work on 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.
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..
across among SDOs (HL7, CEN/TC 251, JIC , SNOMED Int., ISO/TC215 and possible others) and with initiatives on Patient Summary (e.g. Trillium II). Coordination with related standardization initiatives on Patient Summary, including the JIC Patient Summary Standards Set.
- Alignment with 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 specifications||2019 April|
|STU1 publication||2019 Feb|
Submit revisions to the IG based on the Argonaut evaluation for STU Ballot
2019 Sep Ballot
Complete revised IG STU Reconciliation
Request STU Publication
STU Period – 12 months
2019 July - 2020 June
Incorporate additional content requests and feedback from STU and submit for Normative Ballot
2020 Sep Ballot
Complete Normative Reconciliation
2021 Jan WGM
Submit Publication Request
Example: Receive ANSI Approval
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.
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.
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
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.|
3.j. Backwards Compatibility
Are the items being produced by this project backward compatible?
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)
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?
If Yes, please enter the vocabularies: SNOMED CT, LOINC, UCUM, EDQM (others TBD)
4. Products (check all that apply)
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)
V3 Documents – Administrative (e.g. SPL)
FHIR Implementation Guide (enter FHIR product version below)
V3 Documents – Clinical (e.g. CDA)
FHIR Profiles (enter FHIR product version below)
V3 Documents - Knowledge
V3 Foundation – RIM
Guidance (e.g. Companion Guide, Cookbook, etc)
V3 Foundation – Vocab Domains & Value Sets
V3 Messages - Administrative
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
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)
Create new standard
Supplement to a current standard
Revise current standard (see text box below)
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 -
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:|
|- Date it was published (or request for publication, or ANSI designation date)|
|- Rationale for revision|
|- 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.)|
5.a. Ballot Type (check all that apply)
Comment (aka Comment-Only)
Joint Ballot (with other SDOs)
N/A (project won’t go through ballot)
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?
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.
- 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. The project will be submitted to the JIC with HL7 as the lead SDO and ISO TC215 as the secondary SDO. (is this still true ?)
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 ? :
Is this a hosted (externally funded) project? (not asking for amount just if funded)
- OR -
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
Clinical and Public Health Laboratories
Clinical and Public Health Laboratories
Quality Reporting Agencies
Local and State Departments of Health
Health Care IT
Medical Imaging Service
Standards Development Organizations (SDOs)
Clinical Decision Support Systems
Healthcare Institutions (hospitals, long term care, home care, mental health)
Other (specify in text box below)
Other (specify in text box below)
Other (specify below)
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:
WG Approval Date
Administrative review – in parallel with Work Group Approval
Co-Sponsor Group Approval Date
List each Co-Sponsor and their Approval Date
Family Management Group Approval Date(s)
CIMI Projects: CIMI Management Group
CIMI MG Approval Date
CDA Projects: CDA Management Group
CDA MG Approval Date
FHIR Projects: FHIR Management Group
FMG Approval Date
V2/Publishing Projects: V2 Management Group
V2 MG Approval Date
US Realm Projects: US Realm Steering Committee Approval
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
ARB and Steering Division approval may be in parallel
Architectural Review Board Approval Date:
(required for externally developed content)
ARB Approval Date
If applicable, TSC has received a Joint Copyright/Distribution Agreement (containing the verbiage outlined within the SOU),
Technical Steering Committee Approval Date:
TSC Approval Date