C-CDAandFHIR_FOA073117.pdf

U.S. Department of Health and Human Services

Office of the National Coordinator for Health Information Technology

Funding Opportunity Announcement

Closing the Gap between Standards Development and Implementation-Maturing the Consolidated Clinical

Document Architecture (C-CDA) and Fast Healthcare Interoperability Resources (FHIR)

Standard

Application Due Date: August 31, 2017

Anticipated Award Date: September 11, 2017

Table of Contents

Executive Summary

A. Program Description/Purpose Structure and Approach

B. Funding Opportunity Award Information Key Award Parameters Key Dates Roles and Responsibilities Under a Cooperative Agreement

C. Eligibility Information

D. Application and Submission Information Application Package Application Submission Instructions Restrictions on Oral Conversations

E. Application Review Information Screening Review Merit Review Pre-Award Risk Assessment

F. Federal Award Administration Information Award Decisions Notice of Grant Award Terms and Conditions

G. Points of Contact

Appendix A – Tips for Writing a Strong Application Appendix B – Instructions – SF-424 Application for Federal Assistance Appendix C - Instructions – SF-424A, Budget Information for Non-Construction Programs Appendix D – Budget Narrative/Justification Template Appendix E – Letter of Commitment Template

Executive Summary

The Office of the National Coordinator for Health Information Technology (ONC) intends to award a sole source cooperative agreement to Health Level Seven International (HL7) to close any gaps between development and implementation of standards; develop broad and more comprehensive testing infrastructures; and disseminate additional guidance back to the health information technology (health IT) developers and health care providers. This award will consist of a five year period of performance, totaling $750,000.

The consistent implementation of standards within health IT systems is necessary to achieve interoperability among health care providers and across many different use cases. Standardized ways to format and structure data as well as represent its meaning in an unambiguous and computable way is critical to enable health care providers to send, receive, find, and use patient data when and where it is needed. Founded in 1987, Health Level Seven International (HL7), an American National Standards Institute (ANSI) accredited standards development organization (SDO) has developed and maintained a standards and implementation guidance for the exchange, integration, sharing, and retrieval of electronic health information in support of clinical practice.

HL7 and the health IT industry have worked diligently to update the Consolidated Clinical Document Architecture (C-CDA) Standard to Release 2.1 and Fast Healthcare Interoperability Resources (FHIR) standard Version 3. The FHIR standard’s data-focused approach is increasingly being leveraged by industry to support the Application Programming Interface (API) requirements in ONC’s 2015 Edition certification criteria1. The C-CDA has been included in the ONC health IT certification regulations since 2012 and is also referenced in ONC’s recently published 2017 Interoperability Standards Advisory Reference Edition. Moreover, the 21st Century Cures Act2 (the Cures Act) was signed into law and expanded the scope and conditions on which certifications to health IT must be granted, including specific conditions of certification around information blocking, application programming interfaces, and “real world” testing.

The following goals are important to continue to mature these standards:

• Improve consistency of C-CDA Implementations across Health IT developers

• Improve the use and consistency of semantic information in C-CDA

• Additional Support for developers implementing the C-CDA specification

• Publish the latest release of FHIR standard

• Comprehensive planning to ensure support for adoption of FHIR standard

• Add new capabilities to the latest version of the FHIR standard to support API based access and push of data for large number of patients in support of provider-focused exchanges and other value-added services

• Develop or upgrade existing FHIR reference server implementation with the new capabilities developed for “Bulk Access and Push”

1 See Sections (g)(7)-(g)(9) of the 45 CFR Part 170 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications; Final Rule https://www.gpo.gov/fdsys/pkg/FR-2015-10-16/pdf/2015-25597.pdf 2 See Section 4002(a) of the 21st Century Cures Act, P. L. 114-255, (Dec. 13, 2016), which amends Section 3001(c)(5) of the Public Health Service Act.

http://www.hl7.org/implement/standards/product_brief.cfm?product_id=379 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=379 http://www.fhir.org/guides/registry http://www.fhir.org/guides/registry https://www.healthit.gov/isa/ https://www.healthit.gov/isa/ https://www.gpo.gov/fdsys/pkg/FR-2015-10-16/pdf/2015-25597.pdf

A. Program Description/Purpose

Background Information

When a computer system receives electronic health information from another system, it needs to be able to process the information without time-consuming human intervention. This can only occur if the sending system has used a consistent data format that is known to – and expected by – the receiving system. Given the vast number of systems that exchange electronic health information expecting each to negotiate agreed-upon exchange formats with all other systems with which it interacts is impractical. To address this issue, stakeholders in the health IT ecosystem have organized themselves under the auspices of SDOs to develop standardized data formats pertaining to specific purposes. SDOs are primarily responsible for developing and maintaining the technical standards and any accompanying implementation specifications/profiles that provide additional implementation instructions to developers based on the particular purpose for which the standard is intended to be used. These organizations include, but are not limited to: HL7, the National Council for Prescription Drug Plans (NCPDP) and Integrating the Healthcare Enterprise (IHE). HL7 is the only SDO responsible for developing and maintaining many technical standards of significance to the C-CDA and FHIR specifications and their accompanying implementation guides. Additionally, HL7 members include organizations that are actively engaged in implementing the standards used within health IT systems.

HHS has adopted many such standards in regulation and required their implementation for the purposes of certification under the 2014 and 2015 Editions of certification criteria that are apart of the ONC Health IT Certification Program. Specifically, the 2015 Edition includes application programming interface certification criteria that require the use of C-CDA and permit the use of FHIR. Moreover, the 21st Century Cures Act3 (the Cures Act) was signed into law and expanded the scope and conditions on which certifications to health IT must be granted, including specific conditions of certification around information blocking, application programming interfaces, and “real world” testing.

This cooperative agreement reflects ONC’s intention to work directly with HL7 in order to advance greater standardization and interoperability in areas of nationwide interest and to specifically ensure that the C-CDA and the FHIR standard can be implemented consistently by the health IT community, with associated comprehensive testing resources, and gain broad industry adoption.

Consolidated Clinical Document Architecture (C-CDA)

The Consolidated Clinical Document Architecture (C-CDA) is a specification that was created in 2012 to help simplify implementations and contains commonly used HL7’s Clinical Document Architecture (CDA) templates. CDA is the base standard which provides a common architecture for the creation of electronic clinical document. Though much of the industry has implemented C-CDA there remains significant variability in its implementation. This variability impacts interoperability overall and limits a receiving system’s ability to fully process the information and properly integrate the information into a patient record. At the same time, health care providers have adopted, implemented, and are using health IT systems to send summary of care records formatted according to the C-CDA at a steadily increasing rate. Implementation experience and feedback from the field indicates that more guidance on how to

3 See Section 4002(a) of the 21st Century Cures Act, P. L. 114-255, (Dec. 13, 2016), which amends Section 3001(c)(5) of the Public Health Service Act.

https://www.healthit.gov/policy-researchers-implementers/standards-and-certification-regulations https://www.healthit.gov/policy-researchers-implementers/standards-and-certification-regulations http://www.hl7.org/implement/standards/product_brief.cfm?product_id=7 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=7 consistently implement the C-CDA specification is needed in order to support interoperability among health IT systems.

Fast Healthcare Interoperability Resources (FHIR)

HL7’s FHIR standard is maturing rapidly as the industry preferred standard for patient and provider-focused exchanges via application programming interfaces (APIs). In fact, most health IT developers are supporting FHIR Standard Version 2 based Implementation Guide, Argonaut Data Query Implementation Guide version 1.0.04 to provide data-centric access to patient-focused applications.

Additionally, a majority of health IT developers have used the FHIR standard to meet the API certification criteria that are part of ONC’s 2015 Edition certification criteria.5

Since FHIR’s initial publication in 2012, the FHIR standard has undergone rapid revisions culminating in the release of the version 3 of the FHIR standard in March 2017. In each of the prior releases, the FHIR standard has not only matured in content, but has also undergone substantial improvements in infrastructure capabilities, such as workflow, search and transport capabilities, to make it robust and ready for use by industry to perform different health information exchange scenarios.

There are several activities currently underway in HL7 to add new support to the FHIR standard in time for the next ballot cycle, which is scheduled for early 2018. The activities include updating the FHIR standard to support new use cases especially targeted to support provider-to-provider health information exchange, the exchange of large amounts of information, development of implementation guidance documents and reference implementations to support health IT developers implement the standard consistently and test tools to perform conformance testing of FHIR based health IT systems.

Additionally, the next version of the FHIR standard is expected to provide “normative” guidance on the matured resources within the FHIR standard, that will make them backward compatible with future versions of the standard. The “normative” standard is targeted primarily towards promoting the large scale adoption by the healthcare industry and rapidly transitioning the health IT systems from using older standards to the new standards that meet modern interoperability needs.

Purpose

To support advancements in the technical standards necessary to achieve interoperability among health IT systems and to reach the milestones identified in the Nationwide Interoperability Roadmap6 and 21st Century Cures Act. Specifically, this cooperative agreement will advance the implementation consistency and readiness of the current and new versions of the C-CDA and FHIR technical standard for adoption by the healthcare industry by achieving the following goals:

• Improve consistency of C-CDA Implementations across health IT developers

• Improve the use and consistency of semantic information in C-CDA

• Additional support for developers implementing the C-CDA specification

4 http://www.fhir.org/guides/argonaut/r2/ 5 https://chpl.healthit.gov/#/collections/apiDocumentation

6 From the Interoperability Vision for the Future section of “Connecting Health & Care for the Nation: A Shared Nationwide Roadmap”http://www.healthit.gov/sites/default/files/nationwide-interoperability-roadmap-draft-version-1.0.pdf http://hl7.org/fhir/STU3/ http://www.fhir.org/guides/argonaut/r2/ https://chpl.healthit.gov/#/collections/apiDocumentation http://www.healthit.gov/sites/default/files/nationwide-interoperability-roadmap-draft-version-1.0.pdf

• Publish the latest release of FHIR standard

• Comprehensive planning to ensure support for adoption of FHIR standard

• Add new capabilities to the latest version of the FHIR standard to support API based access and push of data for large number of patients in support of provider-focused exchanges and other value-added services

• Develop or upgrade existing FHIR reference server implementation with the new capabilities developed for “Bulk Access and Push”

Structure and Approach

Key Goals, Tasks, Deliverables, and Timeline

The goals and tasks listed below are explicitly for C-CDA and FHIR. It should also be noted these goals are based on the recipient working closely with the support offices in this effort and additional tasks may be required to achieve the outlined goals.

Year 1

Goal 1: Implementation Plan Provide a detailed implementation plan of how it intends to accomplish each of the tasks for each of the goals stated below. The final plan should incorporate the feedback provided by ONC on the recipient’s initial plan submitted with their application.

Goal 2: Publish the latest release of FHIR Standard 9

Under this cooperative agreement HL7 will publish and release the latest FHIR Draft Standard for Trial Use (DSTU).

• Task 1: HL7 monitors the ballot reconciliation activities and provides additional technical support as needed to the working groups, to complete the standard development process in timely manner.

• Task 2: HL7 provides administrative support for the publication of the balloted FHIR STU standard

Goal 3: Comprehensive planning to ensure support for adoption of FHIR Standard

HL7 is expected to begin thoughtful planning and infrastructure development for sustained adoption of FHIR standard.

• Task 1: HL7 develops governance and infrastructure to support development and maintenance of FHIR Profiles.

• Task 2: HL7 develops testing platform to support development of FHIR compliant systems.

Goal 4: Add new capabilities to the latest version of the FHIR standard to support API based access and push of data for large number of patients in support of provider-focused exchanges and other value-added services

Current FHIR API specifications have focused on patient-focused use cases that involve accessing resources for a single patient. While these APIs have defined common interactions (create, read, search, etc.) for either single resources or related resources via Compartments7, they may not be useable for accessing data across large number of patients (called “Bulk Access and Push’) required for provider-focused exchanges, population-level services and other value-added services being envisioned to be supported by the Cures Act.

In addition to being able to access data for large number of patients, provider-focused exchanges also have additional requirement of needing to make sure that the user has the appropriate authorization to be able to invoke the API and that the data is being accessed for appropriate purposes only, such as for treatment, payment, etc.

HL7 should enhance the FHIR infrastructure resources8 to define new APIs and services to support the “Bulk Access and Push” use case.

• Task 1: HL7 adds new capabilities in the standard, including but not limited to: APIs for “Bulk Access and Push”; new APIs around passing the purpose of data query; and automated data access over time that are necessary for effectively using the FHIR standard for provider-focused exchanges and other value-based services.

• Task 2: HL7 updates the latest version of the FHIR standard, existing implementation guides or develops new implementation guide to enable implementation of the capabilities into existing health IT products.

Goal 5: Develop or upgrade existing FHIR reference server implementation with the new capabilities developed for “Bulk Access and Push”

HL7 should demonstrate the use of APIs developed for “Bulk Access and Push” by updating existing open source, publicly available FHIR server.

• Task 1: HL7 supports the upgrade of existing open source and publicly accessible FHIR server (based on version 2.0 or later) that has implemented the capability of “Bulk Access and Push” in the context of service oriented architecture.

• Task 2: HL7 provides how-to guides, software snippets and other development support for health IT developers to upgrade their servers with the capability.

Goal 6: Improve the use and consistency of C-CDA Implementations across Health IT Developers

It is anticipated that an outcome of this cooperative agreement is that health IT systems will implement the C-CDA specification in a single and consistent manner to exchange, at a minimum, a common set

7 FHIR Compartments: http://hl7.org/fhir/compartmentdefinition.html 8 FHIR Infrastructure resources: http://hl7.org/fhir/services.html http://hl7.org/fhir/compartmentdefinition.html http://hl7.org/fhir/services.html of clinical data elements, such as those specified by ONC in its regulations. Another anticipated outcome of this cooperative agreement is to have health IT systems implement C-CDA with consistent semantic information and with greater semantic accuracy9. Additionally, HL7 must respond accurately and promptly to developer questions on implementing C-CDA specifications, and provide additional support for developers implementing the C-CDA Specification, as needed.

• Task 1: CDA Examples Task Force10 developed artifacts are used by HL7 to develop additional implementation guidance for single and consistent implementation of C-CDA.

• Task 2: HL7 organizes Implementation-a-thons to identify real-world implementation inconsistencies. And, based on the results, develops detailed guidance for developers and implementers on any identified barriers to interoperability.

• Task 3: HL7 will implement improvements to the current C-CDA ERRATA process.

• Task 4: HL7 provides guidance for use of terminology and vocabulary standards for specific sections and entries in C-CDA from large coding systems used in C-CDA, including but not limited to: Systemized Nomenclature of Medicine-Clinical Terms (SNOMED-CT); RxNorm;

and Logical Observation Identifiers Names and Codes (LOINC).

• Task 5: Provide regular updates to best practices and quantitative scoring criteria for the ONC C- CDA Scorecard

• Task 6: It is anticipated that HL7 will develop requirements for development of a new C-CDA publication approach to allow for C-CDA templates to progress at a rate similar to FHIR maturity model

• Task 7: HL7 provides administrative support for the publication of a balloted C-CDA Standard for Trial Use standard

• Task 8: Develop any necessary additional guidance to improve implementation of C-CDA 1.1,

2.1 or newer versions (e.g. Companion Guide).

Years Two (2) through Five (5)

The continuation of this cooperative agreement in Years 2 through 5 is subject to the availability of funds. Moreover, the goal/task structure provided in Years 2 through 5 may be modified based on new regulations and legislation impacting the awarding agency. However, the overarching purpose, scope, and intent of the cooperative agreement will remain intact.

9 “Are Meaningful Use Stage 2 certified EHRs ready for interoperability? Findings from the SMART C-CDA Collaborative” by John D. D’Amore et.al., http://jamia.oxfordjournals.org/content/21/6/1060 10 http://wiki.hl7.org/index.php?title=CDA_Example_Task_Force http://www.hl7.org/implement/standards/product_brief.cfm?product_id=447 http://jamia.oxfordjournals.org/content/21/6/1060 http://wiki.hl7.org/index.php?title=CDA_Example_Task_Force

Year 2

Goal 1: Updated Implementation Plan HL7 must provide a detailed implementation plan of how it intends to accomplish each of the tasks for each of the goals stated below. The updated plan should incorporate the feedback provided by ONC on the recipient’s prior year plan.

Goal 2: Publish the latest release of FHIR Standard 9

Under this cooperative agreement HL7 will publish and release the latest FHIR Draft Standard for Trial Use (DSTU).

• Task 1: Continue to monitors the ballot reconciliation activities and provides additional technical support as needed to the working groups, to complete the standard development process in timely manner.

• Task 2: HL7 provides administrative support for the publication of the balloted FHIR STU standard

Goal 3: Comprehensive planning to ensure support for adoption of FHIR Standard

HL7 is expected to begin thoughtful planning and infrastructure development for sustained adoption of FHIR standard.

• Task 1: HL7 refine governance and infrastructure to support development and maintenance of FHIR profiles.

• Task 2: HL7 refine testing platform to support development of FHIR compliant systems.

Goal 4: Improve the use and consistency of C-CDA Implementations across Health IT Developers

• Task 1: CDA Examples Task Force11 developed artifacts are used by HL7 to develop additional implementation guidance for single and consistent implementation of C-CDA.

• Task 2: HL7 continue organizing Implementation-a-thons to identify real-world implementation inconsistencies. And, based on the results, develops detailed guidance for developers and implementers on any identified barriers to interoperability.

• Task 3: Provide regular updates to best practices and quantitative scoring criteria for the ONC C- CDA Scorecard

• Task 4: Continue to iterate on requirements for development of a new C-CDA publication approach to allow for C-CDA templates to progress at a rate similar to FHIR maturity model

• Task 5: HL7 provides administrative support for the publication of a balloted C-CDA Standard for Trial Use

11 http://wiki.hl7.org/index.php?title=CDA_Example_Task_Force

• Task 6: Develop any necessary additional guidance to improve implementation of C-CDA 1.1,

2.1 or newer versions (e.g. Companion Guide).

Year 3

Goal 1: Updated Implementation Plan HL7 must provide a detailed implementation plan of how it intends to accomplish each of the tasks for each of the goals stated below. The updated plan should incorporate the feedback provided by ONC on the recipient’s prior year plan.

Goal 2: Publish the latest release of FHIR Standard 9

Under this cooperative agreement HL7 will publish and release the latest FHIR Draft Standard for Trial Use (DSTU).

• Task 1: Continue to monitors the ballot reconciliation activities and provides additional technical support as needed to the working groups, to complete the standard development process in timely manner.

• Task 2: HL7 provides administrative support for the publication of the balloted FHIR STU standard

Goal 3: Comprehensive planning to ensure support for adoption of FHIR Standard

HL7 is expected to begin thoughtful planning and infrastructure development for sustained adoption of FHIR standard.

• Task 1: HL7 refine governance and infrastructure to support development and maintenance of FHIR profiles.

• Task 2: HL7 refine testing platform to support development of FHIR compliant systems.

Goal 4: Improve the use and consistency of C-CDA Implementations across Health IT Developers

• Task 1: CDA Examples Task Force12 developed artifacts are used by HL7 to develop additional implementation guidance for single and consistent implementation of C-CDA.

• Task 2: HL7 organizes Implementation-a-thons to identify real-world implementation inconsistencies. And, based on the results, develops detailed guidance for developers and implementers on any identified barriers to interoperability.

• Task 3: Provide regular updates to best practices and quantitative scoring criteria for the ONC C- CDA Scorecard

12 http://wiki.hl7.org/index.php?title=CDA_Example_Task_Force http://www.hl7.org/implement/standards/product_brief.cfm?product_id=447

• Task 4: Continue to iterate on requirements for development of a new C-CDA publication approach to allow for C-CDA templates to progress at a rate similar to FHIR maturity model

• Task 5: HL7 provides administrative support for the publication of a balloted C-CDA Standard for Trial Use

• Task 6: Develop any necessary additional guidance to improve implementation of C-CDA 1.1,

2.1 or newer versions (e.g. Companion Guide).

Year 4

Goal 1: Updated Implementation Plan HL7 must provide a detailed implementation plan of how it intends to accomplish each of the tasks for each of the goals stated below. The updated plan should incorporate the feedback provided by ONC on the recipient’s prior year plan.

Goal 2: Publish the latest release of FHIR Standard 9

Under this cooperative agreement HL7 will publish and release the latest FHIR Draft Standard for Trial Use (DSTU).

• Task 1: Continue to monitors the ballot reconciliation activities and provides additional technical support as needed to the working groups, to complete the standard development process in timely manner.

• Task 2: HL7 provides administrative support for the publication of the balloted FHIR STU standard

Goal 3: Comprehensive planning to ensure support for adoption of FHIR Standard

HL7 is expected to begin thoughtful planning and infrastructure development for sustained adoption of FHIR standard.

• Task 1: HL7 refine governance and infrastructure to support development and maintenance of FHIR profiles.

• Task 2: HL7 refine testing platform to support development of FHIR compliant systems.

Goal 4: Improve the use and consistency of C-CDA Implementations across Health IT Developers

• Task 1: HL7 refine governance and infrastructure to support development and maintenance of FHIR profiles.

• Task 2: HL7 refine testing platform to support development of FHIR compliant systems.

• Task 3: CDA Examples Task Force13 developed artifacts are used by HL7 to develop additional implementation guidance for single and consistent implementation of C-CDA.

• Task 4: HL7 organizes Implementation-a-thons to identify real-world implementation inconsistencies. And, based on the results, develops detailed guidance for developers and implementers on any identified barriers to interoperability.

• Task 5 Provide regular updates to best practices and quantitative scoring criteria for the ONC C- CDA Scorecard

• Task 6: Continue to iterate on requirements for development of a new C-CDA publication approach to allow for C-CDA templates to progress at a rate similar to FHIR maturity model

• Task 7: HL7 provides administrative support for the publication of a balloted C-CDA Standard for Trial Use

• Task 8: Develop any necessary additional guidance to improve implementation of C-CDA 1.1,

2.1 or newer versions (e.g. Companion Guide).

Year 5

Goal 1: Updated Implementation Plan HL7 must provide a detailed implementation plan of how it intends to accomplish each of the tasks for each of the goals stated below. The updated plan should incorporate the feedback provided by ONC on the recipient’s prior year plan.

Goal 2: Publish the latest release of FHIR Standard9

Under this cooperative agreement HL7 will publish and release the latest FHIR Draft Standard for Trial Use (DSTU).

• Task 1: Continue to monitors the ballot reconciliation activities and provides additional technical support as needed to the working groups, to complete the standard development process in timely manner.

• Task 2: HL7 provides administrative support for the publication of the balloted FHIR STU standard

Goal 3: Comprehensive planning to ensure support for adoption of FHIR Standard

HL7 is expected to begin thoughtful planning and infrastructure development for sustained adoption of FHIR standard.

13 http://wiki.hl7.org/index.php?title=CDA_Example_Task_Force

• Task 1: HL7 refine governance and infrastructure to support development and maintenance of FHIR profiles.

• Task 2: HL7 refine testing platform to support development of FHIR compliant systems.

Goal 4: Improve the use and consistency of C-CDA Implementations across Health IT Developers

• Task 1: HL7 refine governance and infrastructure to support development and maintenance of FHIR profiles.

• Task 2: HL7 refine testing platform to support development of FHIR compliant systems.

• Task 3: CDA Examples Task Force14 developed artifacts are used by HL7 to develop additional implementation guidance for single and consistent implementation of C-CDA.

• Task 4: HL7 organizes Implementation-a-thons to identify real-world implementation inconsistencies. And, based on the results, develops detailed guidance for developers and implementers on any identified barriers to interoperability.

• Task 5: Provide regular updates to best practices and quantitative scoring criteria for the ONC C- CDA Scorecard

• Task 6: Continue to iterate on requirements for development of a new C-CDA publication approach to allow for C-CDA templates to progress at a rate similar to FHIR maturity model

• Task 7: HL7 provides administrative support for the publication of a balloted C-CDA Standard for Trial Use

• Task 8: Develop any necessary additional guidance to improve implementation of C-CDA 1.1,

2.1 or newer versions (e.g. Companion Guide).

Structure and Approach Year and Goal Number

Goal Description Deliverable Due Date

Year 1:

Goal 1

Provide a detailed final implementation plan

Detailed Implementation Plan from HL7 (includes specific list of goals, tasks, and deliverables approved by ONC)

2 weeks after award date and monthly updates thereafter

14 http://wiki.hl7.org/index.php?title=CDA_Example_Task_Force

Year and Goal Number

Goal Description Deliverable Due Date

Year 1:

Goal 2

Publish the latest release of the FHIR standard

Monitors the ballot reconciliation activities and provides additional technical support as needed to the working groups, to complete the standard development process in timely manner.

Provides administrative support for the publication of the balloted FHIR STU standard as soon as possible.

Publish the latest FHIR standard September 2018 or a mutually agreed upon date

Year 1:

Goal 3

Comprehensive planning to ensure support for adoption of FHIR standard

HL7 develops governance documents and infrastructure to support creation and maintenance of FHIR profiles.

HL7 develops testing platform to support development of FHIR compliant systems.

January 30th, Year 1:

Goal 4

Add new capabilities to the latest version of the FHIR standard to support API based access and push of data for large number of patients in support of provider-focused exchanges and other value-added services

HL7 adds new capabilities in the standard, including (but not limited

to) APIs for “Bulk Access and Push”, new APIs around passing the purpose of data query, and automated data access over time that are necessary for effectively using FHIR standard for provider-focused exchanges and other value-based services.

HL7 updates the latest version of the FHIR standard, existing implementation guides or develops new implementation guide to enable implementation of the capabilities into existing.

May 30th, 2018

Goal Number

Goal Description Deliverable Due Date

Year 1:

Goal 5

Develop or upgrade existing FHIR reference server implementation with the new capabilities developed for “Bulk Access and Push” capability.

HL7 supports the upgrade of existing open source and publicly accessible FHIR server (based on version 2.0 or later) that has implemented the capability of “Bulk Access and Push” in the context of service oriented architecture.

HL7 provides how-to guides, software snippets and other development support for health IT developers to upgrade their servers with the capability.

May 30th, 2017

Year 1:

Goal 6

Improve consistency of C- CDA Implementations across Health IT Developers implementers on any identified barriers to interoperability.

HL7 to use CDA Examples Task Force developed artifacts to develop additional implementation guidance for single and consistent implementation of C-CDA.

HL7 to organize implementation workshops to identify real-world implementation inconsistencies.

And, based on the results, develops detailed guidance for developers and 1.

Implement improvements to the current C-CDA ERRATA process.

HL7 develops additional guidance for use of terminology and vocabulary standards for specific sections and entries in C-CDA from large coding systems used in C- CDA, including but not limited to Systemized Nomenclature of Medicine-Clinical Terms (SNOMED-CT), RxNorm and Logical Observation Identifiers Names and Codes (LOINC).

All projects completed by September 2018 or an earlier date agreed upon by ONC and HL7

Goal Number

Goal Description Deliverable Due Date

Year 1:

Goal 6, continued

Improve consistency of C- CDA Implementations across Health IT Developers implementers on any identified barriers to interoperability.

Provide regular updates to best practices and quantitative scoring criteria for the ONC C-CDA Scorecard

Develop requirements for development of a new C-CDA publication approach to allow for C-CDA templates to progress at a rate similar to FHIR maturity model

HL7 provides administrative support for the publication of a balloted C-CDA STU standard

Develop any necessary additional guidance to improve implementation of C-CDA 2.1 or newer

All projects completed by September 2018 or an earlier date agreed upon by ONC and HL7

Years 2-5 Updated Implementation Plan Detailed Implementation Plan from HL7 (includes specific list of goals, tasks, and deliverables approved by ONC)

2 weeks after award date and monthly updates thereafter

Years 2-5:

Goal 2

Publish the latest release of theFHIR standard

Publish the latest FHIR standard. Date to be determined after coordination between project officer and recipient

Years 2-5:

Goal 3

Comprehensive planning to ensure support for adoption of FHIR standard

HL7 refine governance and infrastructure to support development and maintenance of FHIR profiles.

HL7 refine testing platform to support development of FHIR compliant systems.

Date to be determined after coordination between project officer and recipient

Goal Number

Goal Description Deliverable Due Date

Years 2-5:

Goal 4

Improve the use and consistency of C-CDA Implementations across Health IT Developers

CDA Examples Task Force developed artifacts are used by HL7 to develop additional implementation guidance for single and consistent implementation of

C-CDA.

HL7 continue organizing Implementation-a-thons to identify real-world implementation inconsistencies. And, based on the results, develops detailed guidance for developers and implementers on any identified barriers to interoperability.

Provide regular updates to best practices and quantitative scoring criteria for the ONC C-CDA Scorecard

Continue to iterate on requirements for development of a new C-CDA publication approach to allow for C-CDA templates to progress at a rate similar to FHIR maturity model

HL7 provides administrative support for the publication of a balloted C-CDA Standard for Trial Use

Develop any necessary additional guidance to improve implementation of C-CDA 1.1, 2.1 or newer versions (e.g. Companion Guide).

Date to be determined after coordination between project officer and recipient

B. Funding Opportunity Award Information

Key Award Parameters

Title:

Closing the Gap between Standards Development and Implementation - Maturing the Consolidated Clinical Document Architecture (C-CDA) and Fast Healthcare Interoperability Resources (FHIR)

Federal Funding Agency: Department of Health and Human Services

Office of the National Coordinator for Health Information Technology

Announcement Type: Cooperative Agreement.

Application Type: New

Funding Opportunity Announcement Number: NAP-AX-17-004

Catalog of Federal Domestic Assistance (CFDA) Number: 93.826

Legislative Authority: Consolidated Appropriations Act, 2017, Pub. L. No. 115-31, Division H, Title II

This is a non-competitive funding opportunity and is restricted to the HL7 organization as designated in Section C. Organizations not designated as such are not eligible to apply for this opportunity, and therefore should not submit an application. Applications submitted by organizations not designated below will not be considered.

Approximate Amount of Available Funding (inclusive of direct and indirect costs) :

Anticipated Number of Awards: 1

Approximately Amount of Each Award: $750,000

Project Period: 9/11/2017 to 9/10/2022

Budget Period(s): 9/11/2017 to 9/10/2018

Funding of future non-competing continuation awards is conditioned on the availability of funds, satisfactory progress by the recipient, and an awarding office determination that continued funding of the award is in the best interests of the Government.

The recipient may anticipate a total budget of $750,000 from ONC for the first year. Continued funding will be contingent on the recipient continuing to meet all the milestones and the availability of funds.

In accepting an ONC award, the recipient assumes legal, financial, administrative, and programmatic responsibility for administering the award in accordance with the terms and conditions of the award, as well as applicable laws, rules, regulations, and Executive Orders governing HHS assistance awards, all of which are incorporated into this award by reference. Failing to comply with these requirements may result in suspension or termination of the award and/or ONC's recovery of award funds.

Cost-Sharing Requirements: There are no matching or cost share requirements for this program.

Program Income:

There are four potential ways in which ONC may require that a recipient apply program income as specified in the Notice of Grant Award (NGA): 1) deduct it from total allowable project/program costs to determine the net allowable costs on which the Federal share of costs is based; 2) add it to funds otherwise available for the project, generally resulting in an increase to the total approved budget; 3) use it to meet a matching or cost sharing requirement; or 4) a combination of these alternatives.

Costs paid by program income generally are subject to the applicable cost principles and other Federal requirements and must be disbursed for project purposes before requesting additional payments of Federal funds. In the event program income remains at the end of the award, the additional income is considered part of the award funding and must be returned to ONC.

Intergovernmental Review: This program is excluded from Executive Order 12372

Key Dates

Milestone Date FOA Released

August 1, 2017

Applications Due

August 31, 2017

Anticipated Award Date

September 11, 2017

Anticipated Project Start Date

September 11, 2017

Roles and Responsibilities Under a Cooperative Agreement The funding instrument used for this project will be the cooperative agreement, an assistance mechanism, in which substantial ONC programmatic involvement is anticipated during the project period. Under the cooperative agreement, the ONC purpose is to support and stimulate the recipient’s activities by involvement in, and otherwise working jointly with, each recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this premise, the dominant role and prime responsibility resides with the recipient for the project as a whole.

To facilitate appropriate involvement, during the period of this cooperative agreement, ONC and the recipient will be in contact monthly and more frequently when appropriate.

Specific activities in which ONC may assume substantial involvement include, but are not limited to:

♦Releasing funds based on achievement of performance goals/project milestones

♦Reviewing and approving substantive provisions of proposed subawards or subcontracts

♦Reviewing and accepting deliverables

♦Providing tactical guidance and feedback during project execution

♦Ending an activity if performance goals/project milestones are not met

♦Meeting with recipient(s) monthly at a minimum, and more frequently as requested by the recipient(s) or ONC

C. Eligibility Information

Eligible Applicants: Eligible applicants must have the following experience:

• Must have the appropriate rights and tools to be the American National Standards Institute (ANSI) accredited standards developing organization responsible for developing and maintaining many technical standards of significance to the C-CDA and FHIR specifications and their accompanying implementation guides

• Must have a relationship with organizations that are actively engaged in implementing the standards used within health IT systems.

Sole Source Justification

The primary responsibility of SDOs are the development and maintenance of health IT technical standards, as well as any accompanying implementation specifications that provide additional implementation instructions for developers. Health Level 7 International is the exclusive standards development organization with the ability, authority, and intellectual property rights to develop and maintain the C-CDA specification and FHIR standard. HL7 is the single organization responsible for the development and maintenance of the C-CDA and the FHIR standard and solely governs the processes by which these standards and accompanying implementation guidance are issued and updated.

Attempting to complete these or any future tasks specific to HL7 standards with another SDO or organization would require HL7 engagement to ballot and publish a final product. Thus, HL7’s involvement is both fundamental and necessary to publish an HL7 standard or implementation guide

Additionally, HL7 members include organizations that are actively engaged in implementing the C- CDA and FHIR standard in health IT systems, and hence can provide necessary feedback in timely manner through a well-established and ANSI-accredited process for consensus standards development.

The goals and expected outcomes of this cooperative agreement can only be achieved accurately and in a timely manner by HL7.

Furthermore, it is ONC’s intent to broadly coordinate with health IT industry stakeholders to improve and advance the technical standards and specifications required for interoperability. Working directly with HL7 will enable this coordination to be more effective and efficient and will enable broad industry consensus to be more rapidly achieved when done through HL7’s processes. As a result, it is ONCs assertion that HL7 is the only organization that can successfully deliver the goals articulated in this cooperative agreement.

D. Application and Submission Information

Application Package

The following documents comprise, as applicable, the application package. Additional information regarding each of these documents is further provided.

• Project Abstract

• Project Narrative

• Form SF-424, Application for Federal Assistance

• Form SF-424A, Budget Information for Non-Construction Programs

• Form SF-424B, Assurances for Non-Construction Programs

• Form SF-LLL, Disclosure of Lobbying Activities

• Budget Narrative

• Letters of Commitment

• Proof of Non-Profit Status (if, applicable)

Appendix A, Tips for Writing a Strong Application, can be used as a resource.

The Project Narrative and Budget Narrative sections of the application must be double-spaced, on 8-1/2” X 11” plain white paper with 1” margins on all sides, and use either Cambria or Times New Roman font size of not less than 11 point. Smaller font sizes may be used to fill in the Standard Forms, exhibits, and figures, though all text in forms, exhibits, and figures must not be smaller than 8 point font.

Project Abstract Applicants shall include a one-page abstract that is no more than 500 words. This abstract is often distributed to the public and Congress and represents a high-level summary of the project. As a result, applicant should prepare a clear, accurate, concise abstract that can be understood without reference to other parts of the application and that provides a description of the proposed project, including: the project’s goal(s), objectives, overall approach, anticipated outcomes, products, and duration.

The applicant shall place the following information at the top of the Project Abstract (this information is not included in the 500 word maximum):

• Project Title

• Applicant Name

• Physical Address

• Contact Name

• Contact Phone Numbers (Voice, Fax)

• E-Mail Address

• Web Site Address, if applicable

Project Narrative The project narrative provides the most substantive information regarding the proposed project in a clear and concise manner. To that end, the project narrative should address the elements articulated in the Program Description/Purpose and Structure and Approach sections of this FOA. The project narrative should also align with the Performance Goals/Program Milestones and Merit Review Evaluation criteria presented in this FOA (e.g., organizational experience, past performance).

The Project Narrative must be double-spaced, formatted to 8 ½” x 11” (letter-size) pages, 1” or larger margins on all sides, and a font size of not less than 11 point. The maximum length allowed for the Project Narrative is 20 pages. A Project Narrative that exceeds the 20-page limit will not be accepted.

Resumes of Key Personnel, if requested, are not counted as part of the Project Narrative and are not included in the 10-page limit. The specific sections that must be included in the Project Narrative are detailed below.

Form SF-424, Application for Federal Assistance Appendix B provides line-by-line instructions to complete the form. Please note that the SF-424 is used for a wide variety of Federal grant programs, and Federal agencies have the discretion to require some or all of the information on these forms. Accordingly, when completing the form, please use the instructions in Appendix B in lieu of the standard instructions attached to SF-424.

Form SF-424A, Budget Information for Non-Construction Programs Appendix C provides line-by-line instructions to complete the form. Please note that the SF-424A is used for a wide variety of Federal grant programs, and Federal agencies have the discretion to require some or all of the information on these forms. Accordingly, when completing the form, please use the instructions in Appendix C in lieu of the standard instructions attached to SF-424A. All direct and indirect costs must be allowable, allocable, reasonable and necessary.

Form SF-424B, Assurances for Non-Construction Programs This form contains laws and other assurances applicants must comply with under the discretionary funds programs administered by the Office of the National Coordinator for Health Information Technology.

Please note that a duly authorized representative of the applicant organization must certify that the organization is in compliance with these assurances.

Form SF-LLL, Disclosure of Lobbying Activities This form contains the name and address of lobbying registrants. Please note that a duly authorized representative of the applicant organization must sign the disclosure form. Failure to complete and sign the form may result in civil penalties ranging from $10,000 to $100,000.

Budget Narrative The budget narrative describes how the proposed budget, as articulated in the SF-424A, aligns with the applicant’s project narrative. That is to ensure that costs are realistic (not artificially too low) and reasonable (not inflated) in view of programmatic requirements. Appendix D provides a template to complete the budget narrative populated with sample information.

When more than 33% of a project’s total budget falls under a contractual expense, a detailed budget narrative/justification must be provided for each sub-contractor or sub-recipient. Applicants requesting funding for multi-year grant programs are required to provide a combined multi-year budget narrative/justification, as well as a detailed budget narrative/justification for each year of potential grant funding. A separate budget narrative/justification is also required for each potential year of grant funding requested.

The full Budget Narrative/Justification should be included in the application immediately following the SF 424 forms. The Budget Narrative must be double-spaced, formatted to 8 ½” x 11” (letter-size) pages, 1” or larger margins on all sides, and a font size of not less than 11 point.

The duration of this award is for a maximum of 5 years. The budget and justification must reflect the costs for the initial 12- month budget period.

Applicants must submit a proposal which covers the full 5-year project period. Although initial funding awarded through this FOA will cover only the first 12-month budget period of the 60 month project period, applicants must still submit an estimated budget for each budget period (years 1, 2, 3, 4, and 5).

In subsequent years, recipients will be able to revise their budgets, based on actual funding available from HHS, as part of their non-competing continuation applications which will be required from all recipients prior to the end of each budget period. The budget proposal must include:

1. An explanation of how the proposed budget supports the proposed Project and is reasonable to meet the Project’s needs;

2. How proposed costs support Project activities; and

3. A description of how the proposed expenditures align with Project Plan.

Please see the Budget Detail in Appendix B for instructions for completing the SF424, and Appendices C through E for instructions for completing the SF424A, Budget Narrative, Justification, and other required forms. A non-competing continuation application is a financial assistance request (in the form of an application or performance/progress report) for a subsequent budget period within a previously approved project period for which a recipient does not have to compete with other applicants.