HL7 Project Scope Statement s13

/ Health Level Seven®, International
2013.1 Project Scope Statement

1. Project Name and ID

Data Access Framework (DAF) FHIR Profile / Project ID:
TSC Notification Informative/DSTU to FHIR Date : 8/29/2014

1. Sponsoring Group(s) / Project Team

Primary Sponsor/Work Group (1 Mandatory) / Infrastructure and Messaging
Co-sponsor Work Group(s) / Structured Documents (SD)
Other Interested Party(s) / Conformance Guidance for Implementation and Testing (CGIT)
Orders and Observations (O&O)
Templates
OO guidance indicates that the HL7 WGs that own various FHIR Resources should be treated as interested parties (keep informed and use as SME as needed) unless DAF requires changes to resource/profile
Project Team:
Project facilitator (1 Mandatory) / John Feikema ()
Other interested parties and their roles / The Office of the National Coordinator for Health IT (ONC) Standards Interoperability (S&I) Framework POCs: Mera Choi ()
Integrating the Healthcare Enterprise (IHE) PCC POCs. Keith Boone()
Multi-disciplinary project team (recommended)
Modeling facilitator / Dragon (Nagesh) Bashyam (),
Brett Marquard ()
Publishing facilitator / Lloyd McKenzie ()
Vocabulary facilitator
Domain expert rep
Business requirement analyst / Dragon (Nagesh) Bashyam ()
Conformance facilitator (for IG projects) / Lloyd McKenzie ()
ONC S&I Support Team / Angelique Cortez ()
Ed Larsen ()
Gayathri Jayawardena ()
S&I Community
Other facilitators (SOA, SAIF)
Implementers (2 Mandatory for DSTU projects):
1) ONC Standards Implementation and Testing Environment (SITE)
2) Other Pilot recruitment activities currently in progress

2. Project Definition

2.a. Project Scope

This project aims to create Fast Healthcare Interoperability Resources (FHIR) Profiles for access to discrete Meaningful Use Stage 2 data as FHIR resource instances. It is not the intention of this project to create new FHIR resource or content profile, but work with resource profile owners if necessary. The project intends to use the defined FHIR security methods. This project will not create a profile for document access since this is covered by the Integrating Healthcare Enterprise Mobile access to Health Documents (IHE MHDv2).
Artifacts to be produced as part of this project include:
1. Define profiles on selected FHIR resources that define additional search criteria for retrieving those resources.
2. Define a Conformance Resource instance that defines expected system behavior on server side and/or client side for DAF conformant systems. Project expects one for client, and one for servers.
3. Create profiles on selected FHIR resources identifying minimum data and corresponding constraints and value sets for query response. This activity may overlap with C-CDA on FHIR activities to some extent. See notes below on coordination with C-CDA on FHIR project.
4. Define a DAF implementation guide that organizes and provides context for the above artifacts.
Coordination with C-CDA on FHIR project:
This project will coordinate with the C-CDA on FHIR project to minimize duplicate profiles on common resources. An additional profile will only be created if the C-CDA profile doesn’t already exist for the resource, or the C-CDA profile doesn’t include required data elements in a current resource to support DAF. Coordination with the C-CDA on FHIR will be done by engagement with the work groups responsible for key resources. Where multiple profiles are required on the same resource, common data elements will be kept in alignment; Where different profiles require different scope in near term, additional work will be done in future to bring back into alignment.
The DAF Profile(s) will build from the existing work of the Standards & Interoperability (S&I) Data Access Framework (DAF) Initiative.

2.b. Project Need

The nation is reaching a critical mass of Health IT systems (EHRs, Data Warehouses etc.) that comply with data and vocabulary standards. The wide deployment of Health IT systems has created unique opportunities for providers, provider support teams, healthcare professionals and organizations etc. to access and use the patient data that is already collected during clinical workflows. While the Health IT systems provide many access paths through their pre-defined interactions between a user and the system, they are limited in their support for data queries, APIs, or services to access data sets as needed. Where Health IT systems provide data access, they likely do not use industry standard access methods. Increasing support for this class of data access, using industry standards, would enable other applications to expand the ability of users to create value out of their data without having to rely on the predefined access paths. Allowing access to this data can enable a provider to further analyze the collected data to understand a patient’s overall health, the health of a provider’s collective patient population, and use the data to power innovative new applications and tools to take better care of patients and populations.
The Data Access Framework (DAF) is standardizing how data can be accessed within an organization from disparate systems (called as Local DAF) and how data can be accessed from external organizations (called as Targeted DAF). Further DAF addresses both document access and discrete data element with granularity resembling FHIR resources. For Document access, DAF has adopted IHE XCA based protocols for SOAP, IHE MHDv2 for RESTful access which is based on FHIR. For discrete data element based access DAF is pursuing FHIR which is resulting in this PSS.
DAF Discrete Data Element Access:
DAF has developed a list of data elements starting from Meaningful Use Stage 2 which are expected to be retrieved using queries. These data elements include problems, medications, allergies, patient demographics among others. DAF will be specifying the Query parameters that must be supported for each FHIR resource representing the data elements. In addition DAF may constrain cardinality and vocabularies on FHIR resources being returned as part of the Query Result.
Over 80% of the DAF data element needs are covered in the existing FHIR DSTU. So rather than wait for C-CDA on FHIR or other projects creating resource profiles, DAF intends to use existing FHIR DSTU and will focus on the 80% of the data elements available. The remaining 20% we expect to be added as part of the next version of FHIR DSTU and we will adopt then as they get added. The DAF profile is focused on constraining cardinality and vocabulary, is not planning on creating new extensions for data element purposes. The key reason why DAF would like to proceed on this project is to start getting pilots underway on FHIR using the DAF profiles to gather feedback and gain useful experience implementing these profiles in the real-world as soon as possible. These lessons learned will inform the ONC organization to determine various aspects of FHIR such as maturity, ease of implementation, effectiveness, policy frameworks and other aspects necessary for large scale adoption by the industry.

2.c. Success Criteria

· Create balloted implementation guides for DAF pilots
· Deliver balloted guides(s) with changes from pilots incorporated to ONC for potential inclusion in regulations
· Proliferation and use of implementation guides for DAF FHIR Profile(s)
· Additional request to build profiles beyond the initial DAF Data Elements

2.d. Project Objectives / Deliverables / Target Dates

Objective / Target Date
Complete analysis, design, draft specification work on FHIR Profiles for DAF / 2014 Oct
Submit for Draft for Comment / 2014 December
Submit for DSTU / 2015 March
Ballot Comments Reconciliation / 2015 May
DSTU Period – 24 months / 2015 June

2.e. Project Requirements

URL where requirements will be documented: http://wiki.siframework.org/Data+Access+Framework+Homepage
Basis for mapping: DAF Data Elements xlsx at http://siframework.us4.list-manage1.com/track/click?u=b2d816b0f651c7c47d0722c23&id=47f3759ef1&e=d4f42db4da

2.f. Project Risks

Risk Description / Building FHIR Profiles for DAF on top of a resource or set of resources that are subject to change
Impact Description / FHIR Resources are in DSTU and are subject to changes or updates. This could create mapping discrepancies at time of implementation due to changes in source standards.
Probability: / High / Medium / Low
/ Severity: / High / Medium / Low
Mitigation Plan / For FHIR Resources, when a build process is run, a user is notified whether the design is aligned to the latest structure or not. S&I Framework will devote necessary time to incorporate changes and adapt content to FHIR Resources down the road.
Risk Description / Overlap of project with other efforts across HL7 – such as C-CDA on FHIR
Impact Description / Duplication of work effort will impact identification and adoption of one standard for DE definition
Probability: / High / Medium / Low
/ Severity: / High / Medium / Low
Mitigation Plan / The project team will consult with work groups frequently and provide opportunity for review and discussion and would like to collaborate with other projects creating profiles on the same resources as DAF.

2.g. Project Dependencies

1. FHIR’s tools and publication mechanisms
2. Collaboration with C-CDA on FHIR

2.h. Project Document Repository Location

http://wiki.siframework.org/Data+Access+Framework+Homepage
FHIR's SVN repository

2.i. Backwards Compatibility

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/ Health Level Seven®, International
2013.1 Project Scope Statement
Are the items being produced by this project backward compatible? / Yes / No / Don’t Know / N/A
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/ Health Level Seven®, International
2013.1 Project Scope Statement

3. Products

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

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/ Health Level Seven®, International
2013.1 Project Scope Statement
Non Product Project- (Educ. Marketing, Elec. Services, etc.)
/ V3 Documents – Knowledge
Arden Syntax
/ V3 Foundation – RIM
Clinical Context Object Workgroup (CCOW)
/ V3 Foundation – Vocab Domains & Value Sets
Domain Analysis Model (DAM)
/ V3 Messages - Administrative
Electronic Health Record (EHR)
/ V3 Messages – Clinical
Functional Profile
/ V3 Messages - Departmental
V2 Messages – Administrative
/ V3 Messages - Infrastructure
V2 Messages – Clinical
/ V3 Rules – GELLO
V2 Messages - Departmental
/ V3 Services – Java Services (ITS Work Group)
V2 Messages – Infrastructure
/ V3 Services – Web Services
V3 Documents – Administrative (e.g. SPL)
/ FHIR Resource
FHIR Profile Definition
V3 Documents – Clinical (e.g. CDA)
/ - New/Modified HL7 Policy/Procedure/Process -
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/ Health Level Seven®, International
2013.1 Project Scope Statement

4. Project Intent (check all that apply)

Create new standard
Revise current standard (see text box below)
Reaffirmation of a standard
New/Modified HL7 Policy/Procedure/Process
Withdraw an Informative Document
N/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 Adopted
Externally developed IG is to be Endorsed
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/ Health Level Seven®, International
2013.1 Project Scope Statement
DAF FHIR Profile PSS 2014_09_10.doc / 2013.1 Release / Page 4 of 5

/ Health Level Seven®, International
2013.1 Project Scope Statement

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

Comment Only
Informative
DSTU to Normative
/ Normative (no DSTU)
Joint Ballot (with other SDOs or HL7 Work Groups)
N/A (project won’t go through ballot)
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/ Health Level Seven®, International
2013.1 Project Scope Statement
Comment Only targeted for December HL7 ballot
DSTU targeted for March HL7 ballot

4.b. Joint Copyright

Joint Copyrighted Material will be produced

5. Project Approval Dates

Sponsoring Group Approval Date / October 10, 2014
Steering Division Approval Date
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/ Health Level Seven®, International
2013.1 Project Scope Statement
PBS Metrics and Work Group Health Reviewed? (required for SD Approval) / Yes / No
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/ Health Level Seven®, International
2013.1 Project Scope Statement
FMG Approval Date
Technical Steering Committee Approval Date / TSC Approval Date CCYY-MM-DD
Joint Copyright Letter of Agreement received? (req'd for Joint Copyrighted material) / Yes / No

6. External Project Collaboration

This project is based on community input from a group of experts and stakeholders across the public, private and academic sectors in the United States. These broad stakeholder groups confer, convene and collaborate as part of the ONC S&I Framework, while offering guidance consistent with their policymaking responsibilities.
Collaborations:
-HL7 International Affiliates
-Governments: United States
-Federal Agencies: Office of the National Coordinator for Health IT, National Institutes of Health, Agency for Healthcare Research and Quality, Food and Drug Administration, Centers for Medicare and Medicaid Services, Center for Disease Control

6.a. Stakeholders / Vendors / Providers

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/ Health Level Seven®, International
2013.1 Project Scope Statement
Stakeholders / 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/A
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