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Template Usage Information:

  1. Project Name and ID



Enter the name of the project here: Multiple Chronic Conditions (MCC) Dynamic Electronic Care Planning and Management FHIR IG

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.


 

No

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

 

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
(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)

CDS?

Learning Health System (FHIR Plan Definition and FHIR Clinical Guidelines?

Indicate the level of involvement that the co-sponsor will have for this project:
 Request formal content review prior to ballot
 Request periodic project updates. Specify periodat WGMs
 Other Involvement. Specify details here: 

Interested Parties:

  • CIMI
  • CBCP
  • Public Health
  • O&O
  • EHR

2.c. Project Team

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

Project facilitator (1Mandatory)

Gay Dolin

Other interested parties and their roles

PC (Care Plan Team) - Patient-Centered Care Planning 
Learning Health Systems - Care Team Member Roles
CIMI - Modeling for profiled resources and care team
CBCP - Consent/Privacy&Security; where consent might fit into the use cases
OO - Referral Orders and Tracking (mechanisms to do closed-loop referrals)
CIC - Registry Usage of the information (confirm data element content is valuable and appropriate for secondary use)
CQI - Quality Measure usage of the information (confirm the element content is valuable and appropriate for quality measure uses)
CDS - Clinical Decision Support
Patient Empowerment

     Modeling facilitator

Jerry Goodnough/ Gay Dolin, others?

     Publishing facilitator

Jerry Goodnough, others

     Vocabulary facilitator

Gay Dolin

Susan Matney?

Rob Hausam?  

     Domain expert rep

Jenna Norton

     Business requirement analyst

Evelyn Gallego

     Conformance facilitator (for IG projects)

Gay Dolin/ Jerry Goodnough/others

     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) AHRQ ACTION III Networks https://www.ahrq.gov/research/findings/factsheets/translating/action3/actionIIIpartners.html

2)AHRQ ACTION III Networks https://www.ahrq.gov/research/findings/factsheets/translating/action3/actionIIIpartners.html

3. Project Definition

3.a. Project Scope

Initiated by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the multiple chronic conditions (MCC) Dynamic electronic care (eCare) Plan Project aims to develop, test, and pilot an interoperable eCare plan that will facilitate aggregation and sharing of critical patient-centered data across home, community, clinic, and research-based settings for persons with MCC, including chronic kidney disease (CKD), type 2 diabetes mellitus (T2DM), cardiovascular disease (CVD), and pain with opioid use disorder (OUD). The MCC Dyanic eCare Plan Project will:

  1. Identify use cases to support the documentation and exchange of MCC eCare plan data within EHRs and related systems;
  2. Identify, develop and prioritize the necessary MCC data elements and clinical terminology standards, clinical information models (CIM), and FHIR mappings that will enable the standardized transfer of data across health settings;
  3. Develop and test an open-source clinician facing SMART on FHIR dynamic eCare plan application for managing persons with MCC; leveraging work done in previous FHIR Connectathon Care Planning and management tracks, FHIR Plan Definition and FHIR Clinical Guidelines; and
  4. Develop, test, and ballot an HL7® Fast Health Interoperability Resource (FHIR®) Implementation Guide based on the defined use cases and MCC data elements.

3.b. Project Need

More than 25% of Americans have MCC, accounting for more than 65% of U.S. health care spending. These individuals have complex health needs handled by diverse providers, across multiple settings of care. As a result, their care is often fragmented, poorly coordinated and inefficient. Therefore, data aggregation is particularly important and challenging for people with MCC. These challenges will increasingly strain the U.S. health system, with the aging of the US population. Projections suggest numbers of adults aged 65 and older will more than double and numbers of those aged 85 and older will triple by 2050. 

Care plans are a prominent part of multifaceted, care coordination interventions that reduce mortality and hospitalizations and improve disease management and satisfaction. In addition, proactive care planning promotes person-centeredness, improves outcomes, and reduces the cost of care. By design, care plans take a patient-centered approach, both by making comprehensive health data available across providers and settings and through the incorporation of data elements that have not traditionally been included in health IT systems (e.g., social determinants of health [SDH], patient health and life goals, patient preferences). While Care Plans have been developed, they remain paper-based in many U.S. healthcare settings and are not standardized and interoperable across care settings when electronic. While care plans focused on a single disease or condition are unlikely to be tenable for patients with MCC or their providers, existing care plans infrequently address individuals with MCC. The development of care plans based on structured data has been proposed as a method for enabling electronic systems to pull together and share data elements automatically and dynamically. Such aggregated data would not only provide actionable information to identify and achieve health and wellness goals for individuals with MCC, but also would reduce missingness and improve quality of point-of-care data for use in pragmatic research. 

The Fast Healthcare Interoperability Resources (FHIR) specification is an open-source standard for exchanging healthcare information electronically based on emerging industry approaches. The FHIR workflow specification includes a CarePlan request resource that may facilitate the transfer of data for an e-care plan across healthcare settings. SMART (https://smarthealthit.org/) and SMART on FHIR standards include open specifications to integrate applications with health IT systems and may enable the development of an e-care plan application that can integrate with a variety of electronic health record (EHR) systems. 

3.c. Security Risks

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. 

No




3.d. External Drivers


National Institutes of Health (NIH) Statement of Work Requirements and Timelines.

3.e. Project Objectives / Deliverables / Target Dates

Clinical Information Model Analysis Mapping and definition (to existing profiles and resources)March 2020
Value Set Definitions June 2020
Care Planning, Plan Definition and Clinical Guidelines Framework for MCC eCare PlanJune 2020
Draft IG (non -balloted, ready for testing)

September 2020

SMART on FHIR App v1.0 (ready for testing)

September 2020

Connectathon 1

September 2020

Connectathon 2January 2021
Connectathon 3May 2021
Connectathon 4Sept 2021
Connectathon 5January 2022
Connectathon 6May 2022

Submit for STU ballot

Target Date:

September 2022

Complete STU Reconciliation

February 2023

Request STU PublicationFebruary 2023
STU Publication DateMay 2023?

Submit for Normative Ballot

September 2025

Complete Normative Reconciliation

February 2026

Submit Publication Request

March 2026

February 2024Example: STU Period – 24 months


Example: Submit for Normative Ballot


Example: Complete Normative Reconciliation


Example: Submit Publication Request


Example: Receive ANSI Approval


Project End Date (all objectives have been met)

Enter Project End Date


3.f.   Common Names / Keywords / Aliases


eCare Plan, Dynamic Care Plan, Multiple Chronic Condition Care Plan, Shared Care Plan, Comprehensive Care Plan


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:

3.h. Project Dependencies



3.i.   HL7-Managed Project Document Repository Location

Multiple Chronic Conditions (MCC) eCare Plan

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
HTTP://Multiple Chronic Conditions (MCC) eCare Plan


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, ICD10, CPT, RxNorm, CPT


4. Products (check all that apply)



Arden Syntax


V2 Messages – Administrative

x

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)


V3 Documents – Clinical (e.g. CDA)

x

FHIR Profiles (enter FHIR product version below)


V3 Documents - Knowledge

x

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?

4 + (??)


5. Project Intent (check all that apply)



Create new standard


Supplement to a current standard

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:
-    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)

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

No


6. Project Logistics

6.a. External Project Collaboration


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:

Joint initiative with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the Agency for Healthcare Research and Quality (AHRQ), and the Assistant Secretary for Planning and Evaluation (ASPE).

https://ecareplan.ahrq.gov/

https://www.niddk.nih.gov/health-information/communication-programs/nkdep/working-groups/health-information-technology/development-electronic-ckd-care-plan

How much content for this project is already developed?

Requirements and content data elements only

10%

Was the content externally developed ? :

NA

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

Yes

No


6.b. Realm


Universal 

- OR -

 

Realm Specific



 

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

US

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

 X 

Pharmaceutical

  

Clinical and Public Health Laboratories

X  

Immunization Registries

X  

EHR, PHR

  

Emergency Services

X  

Quality Reporting Agencies

X  

Equipment

  

Local and State Departments of Health

X  

Regulatory Agency

 X 

Health Care IT

  

Medical Imaging Service

X  

Standards Development Organizations (SDOs)

 X 

Clinical Decision Support Systems

 X 

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

X  

Payors

  

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:

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

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

USRSC 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

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