Medications on FHIR - Draft

Project Scope Statement2015 Version

Release 1

HL7 Project Management OfficeProject Services Work Group

Point of Contact Name and Email:David Hamill (pmo@hl7.org)

Co-Chairs of Project Services Work Group: http://www.hl7.org/Special/committees/projectServices/leadership.cfm

Publication Date: January, 2015

URL to download document: http://www.hl7.org/permalink/?ProjectScopeStatement

For prior versions of this document refer to:

http://www.hl7.org/Special/committees/projectServices/docs.cfm

The objective of this document is to communicate the type of activities a group is undertaking to achieve specific objectives or to produce specific work products. It’s intended for projects to produce standards or Implementation Guides as well as infrastructure projects.

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Medications on FHIR - DraftTemplate Usage Information:

Replace Highlighted Courier New text with appropriate content. To use Track Changes, turn off “protection” by clicking on Tools > Unprotect Document; in Word 2010, select Review>Track

Changes For assistance in completing each section, refer to Appendix A. Information on the Project Approval Process is documented in Appendix B. For FAQs (Frequently Asked Questions), refer to Appendix C Submit template change requests to PMO@HL7.org

1. Project Name and ID

Click here to go to Appendix A for more information regarding this section.An ID will be assigned by Project Insight

Medications on FHIR Project ID:TSC Notification Informative/DSTU to Normative Date :

Check this box when the project proceeds from Informative to Normative or DSTU to Normative status. Forward to the TSC for notification, as this triggers American National Standards Institute (ANSI) Project Initiation Notification (PINS) submission.

2. Sponsoring Group(s) / Project TeamClick here to go to Appendix A for more information regarding this section.Primary Sponsor/Work Group (1 Mandatory) Mobile Health Work GroupCo-Sponsor Work Group(s) Pharmacy Work Group

Co-Sponsor Group Approval Date Co-Sponsor Approval Date CCYY-MM-DDIndicate the level of involvement that the co-sponsor will have for this project:

Request formal content review prior to ballotRequest periodic project updates. Specify period: Monthly, at WGMs, etc.Other Involvement. Specify details here: Enter other involvement here

Project Team:Project facilitator (1 Mandatory) Matthew Graham

Other interested parties and their roles

Mobile Health Co-Chairs: Gora Data, Matthew Graham, Nathan Botts, Harry Rhodes; Pharmacy Work Group Co-Chairs:

Multi-disciplinary project team (recommended)Modeling facilitator Enter a name here (or ask MnM for a name).Publishing facilitator With the exception of FHIR projects, mandatory

if balloting in the same cycle as project submission

Vocabulary facilitator Enter a name here (or ask Vocab for a name)Domain expert repBusiness requirement analystConformance facilitator (for IG projects)Other facilitators (SOA, etc)

Implementers (2 Mandatory for DSTU 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)2)

3. Project Definition3.a.Project Scope

Click here to go to Appendix A for more information regarding this section and FHIR project instructions.This project will focus on the development of a set of FHIR Profiles to support patient centered Medication Management and Administration. This project will create FHIR Profiles to promote standards based interoperability between Care Providers, Pharmacy Services and Mobile Applications. The project goal is to enable

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Medications on FHIR - Draftthe patient/ care giver to better adhere to medication administration as prescribed by their care team. Improved medication adherence will improve patient safety and quality of life while reducing the cost of healthcare.

Use Cases to be supported by FHIR profiles: Patient management of a list of care organization(s),

(patient identifiers, security authentication and authorizations). Patient request active list of medications. Patient request for new Medication Prescription be fill. Patient request for Medication Prescription Refill. Patient request for Medication Prescription Renewal. Patient management of prescription medications administration. Patient reminder to administer medication. Patient can generate a list of current Medications.

3.b.Project NeedClick here to go to Appendix A for more information regarding this section and FHIR project instructions.Patient centric medication administration is core to improving patient medication adherence. The proper and timely administration of medication as directed by a patient care team and coordination of pharmacy services is an issue of patient safety. It also poses a significant cost savings by avoiding visits to Emergency Care and unneeded hospitalizations. Patients taking more than 3 medications have a higher risk of poor medication adherence and possible drug to drug interactions.

Secondary, this project may likely be the first major use of FHIR Profiles as a core for Realm based interoperability. The project will provide an opportunity identify and exercise FHIR as an HL7 standards product line.

How to use FHIR tooling to manage profiles and extensions? How to develop FHIR as a realm specific standard for interoperability?

3.c.Success CriteriaClick here to go to Appendix A for more information regarding this section and FHIR project instructions.Develop a FHIR Profile supporting the use cases identified in the project scope.

3.d.Project RisksClick here to go to Appendix A for more information regarding this section.

Risk Description: Identify any known risks at this time.Impact: Critical Serious Significant Low

Likelihood: High Med Low

Risk Type: Requirements Resources Social-Political Technology

Risk To HL7: Internal to HL7 External to HL7

Mitigation Plan: Document the mitigation plan.Copy this entire table as needed to define multiple project risks.

3.e. Security RisksClick here to go to Appendix A for more information regarding this section.

Will this project produce executable(s), for example, schemas, transforms, stylesheets, executable program, etc. If so the project must review and document security risks.

Yes No Unknown

3.f. External DriversClick here to go to Appendix A for more information regarding this section.Describe any external schedules or calendars which may not be known outside of the project team that are driving target dates for this project.

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Medications on FHIR - Draft3.g.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).Click here for further information, FHIR project instructions, and an EXAMPLE

Target Date (in WGM or ballot cycle format, e.g.‘2010 Sept WGM’ or‘2010 Jan Ballot’)

Submit for DSTU Ballot (First Ballot Cycle) 2015 Oct BallotComplete DSTU Reconciliation 2016 Jan WGMSubmit for 2nd DSTU Ballot 2016 May BallotRequest DSTU Publication 2016 Sep WGMDSTU Period – 12 months 2016 Jan - 2017 JanSubmit for Normative Ballot 2017 May BallotComplete Normative Reconciliation 2017 Sep WGMSubmit Publication Request 2017 OctReceive ANSI Approval 2017 NovProject End Date 2017 DecFHIR Project Tasks:Resource and/or Profile proposals have been submitted and endorsed for development by FHIR Management Group (FMG)FHIR content ready for inclusion in FHIR DSTU ballotFHIR content passes DSTU ballot

3.h. Common Names / Keywords / AliasesClick here to go to Appendix A for more information regarding this section.

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.

3.i. LineageClick here to go to Appendix A for more information regarding this section.Not applicaple

3.j. Project RequirementsClick here to go to Appendix A for more information regarding this section.To support requirements traceability, enter the requirements known at this point in time of the project. If requirements are yet to be determined, enter the SPECIFIC URL where they will be documented.

3.k.Project DependenciesClick here to go to Appendix A for more information regarding this section.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.l. Project Document Repository LocationClick here to go to Appendix A for more information regarding this section.Enter the SPECIFIC URL where supporting project documents, deliverables, ballot reconciliation work and other project information will be kept. A template to create a Project Page on the HL7 Wiki is available at: http://wiki.hl7.org/index.php?title=Template:Project_Page.

3.m. Backwards CompatibilityAre the items being produced by this project backward compatible? Yes No Unknown N/A

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

If you check 'No' please explain the reason:

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Medications on FHIR - DraftIf desired, enter additional information regarding Backwards Compatibility.

3.n.External VocabulariesWill this project include/reference external vocabularies? Yes No Unknown N/AIf yes, please list the vocabularies:

4. Products Click here to go to Appendix A for more information regarding this section

Non Product Project- (Educ. Marketing, Elec. Services, etc.) V3 Domain Information Model (DIM / DMIM)Arden Syntax V3 Documents – Administrative (e.g. SPL)Clinical Context Object Workgroup (CCOW) V3 Documents – Clinical (e.g. CDA)Domain Analysis Model (DAM) V3 Documents - KnowledgeElectronic Health Record (EHR) Functional Profile V3 Foundation – RIMLogical Model V3 Foundation – Vocab Domains & Value SetsV2 Messages – Administrative V3 Messages - AdministrativeV2 Messages - Clinical V3 Messages - ClinicalV2 Messages - Departmental V3 Messages - DepartmentalV2 Messages – Infrastructure V3 Messages - InfrastructureFHIR Resources V3 Rules - GELLOFHIR Profiles V3 Services – Java Services (ITS Work Group)New/Modified/HL7 Policy/Procedure/Process V3 Services – Web Services (SOA)New Product DefinitionNew Product Family

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

5. Project Intent (check all that apply)Click here to go to Appendix A for more information regarding this section and FHIR project instructions.

Create new standardRevise current standard (see text box below)Reaffirmation of a standardNew/Modified HL7 Policy/Procedure/ProcessWithdraw an Informative DocumentN/A (Project not directly related to an HL7 Standard)

Supplement to a current standard

Implementation Guide (IG) will be created/modified

Project is adopting/endorsing an externally developed IG: Specify external organization in Sec. 6 below;Externally developed IG is to be (select one):Adopted - OR - Endorsed

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)Click here to go to Appendix A for more information regarding this section and FHIR project instructions.

Comment OnlyInformativeDSTU to Normative

Normative (no DSTU)Joint Ballot (with other SDOs or HL7 Work Groups)N/A (project won’t go through ballot)

If necessary, add any additional ballot information here. If artifacts will be jointly balloted with other HL7 Work Groups or other SDOs, list the other groups.

5.b.Joint Copyright Click here to go to Appendix A for more information regarding this sectionCheck 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 Collaboration2015 Release Page 5 of 7

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Medications on FHIR - DraftClick here to go to Appendix A for more information regarding this section and FHIR project instructions.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? Indicate % hereWas the content externally developed (Y/N)? If Yes, list developersDate of external content review by the ARB? Approval date CCYY-MM-DDIs this a hosted (externally funded) project? (not asking for amount just if funded)

Yes No

6.b.RealmClick here to go to Appendix A for guidelines regarding choosing Universal or Realm Specific.

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

U.S. Realm

6.c.Project Approval DatesClick here to go to Appendix A for more information regarding this section.Affiliate/US Realm Task Force Approval Date (for US Realm Specific Projects) USRTF Approval Date CCYY-MM-DDSponsoring Work Group Approval Date WG Approval Date CCYY-MM-DDSteering Division Approval Date SD Approval Date CCYY-MM-DD

PBS Metrics and Work Group Health Reviewed? (required for SD Approval) Yes NoFHIR Project: FHIR Management Group Approval Date FMG Approval Date CCYY-MM-DD

Technical Steering Committee Approval Date TSC Approval Date CCYY-MM-DDTSC has received a Copyright/Distribution Agreement (which contains the verbiage outlined within the SOU), signed by both parties.

Yes No

6.d.Stakeholders / Vendors / ProvidersClick here to go to Appendix A for more information regarding this section

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

Clinical and Public Health Laboratories Pharmaceutical Clinical and Public Health Laboratories Immunization Registries EHR, PHR Emergency Services Quality Reporting Agencies Equipment Local and State Departments of Health Regulatory Agency Health Care IT Medical Imaging Service Standards Development Organizations

(SDOs) Clinical Decision Support

Systems Healthcare Institutions (hospitals, long term

care, home care, mental health) Payors Lab Other (specify in text box below) Other (specify in text box below) HIS N/A N/A Other (specify below)

N/AOther: Indicate other stakeholders, vendors or providers not listed above.

6.e.Synchronization With Other SDOs / ProfilersClick here to go to Appendix A for more information regarding this section Check all SDO / Profilers which your project deliverable(s) are associated with.

ASC X12 CHA LOINC AHIP DICOM NCPDP ASTM GS1 NAACCR BioPharma Association (SAFE) IEEE Object Management Group (OMG) CEN/TC 251 IHE The Health Story Project CHCF IHTSDO WEDI CLSI ISO Other (specify below)

For standards and implementation guides (IG) being developed by this project, please indicate: - Similarities to standards or IGs from the checked SDO/Profilers - How they will be different - How overlaps will be coordinated with the checked SDO/Profilers

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Medications on FHIR - Draft - Why coordination is not needed with other SDOs/Profilers

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