HL7 FHIR C-CDA NOFO FINAL.pdf

U.S. Department of Health and Human Services

Office of the National Coordinator for Health Information Technology

Notice of Funding Opportunity

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

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

Assistance Listings (CFDA) Number 93.826

Application Due Date: August 11, 2022 Anticipated Award Date: September 13, 2022

Program Contact Wanda Govan-Jenkins Office of the National Coordinator 330 C Street SW Washington, D.C., 20201 ONCOTECH-Programs@hhs.gov

Grants Contact Carmel Halloun Office of the National Coordinator 330 C Street SW Washington, D.C., 20201 ONCGrants@hhs.gov mailto:ONCOTECH-Program@hhs.gov mailto:ONCGrants@hhs.gov

Table of Contents

Executive Summary

A. Program Description/Purpose Structure and Approach

Performance Goals/Program Milestones

B. Funding Opportunity Award Information Key Award Parameters Key Dates Roles and Responsibilities Under a Cooperative Agreement Informational Session Notice of Intent

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 single source cooperative agreement to Health Level Seven International (HL7®), an exclusive governing body of standards, to accelerate development of technical standards, provide necessary implementation support via implementation guides, and improve standards development infrastructure to enable health information technology (health IT) developers to implement and use standards effectively. This award will consist of a five-year period of performance. The first budget period (12 months) of the award will total $1,360,000. Future funding is subject to the availability of funds.

Enabling health care providers and patients to easily access, exchange, and use electronic health information (EHI) requires data that is structured and formatted consistently, and exchanged in a consistent and computable manner. Founded in 1987, HL7 is an American National Standards Institute (ANSI) accredited standards development organization (SDO). HL7’s portfolio of standards includes HL7 v2,1 v3,2 Consolidated Clinical Document Architecture (C-CDA),3 and Fast Healthcare Interoperability Resources (FHIR®).4 HL7 standards provide the necessary syntactic and semantic interoperability for seamless access, exchange, and use of EHI.

HL7 standards are widely used in the healthcare industry to support access, exchange, and use of EHI for a variety of use cases including patient access to their EHI, clinical decision-making for patient care, and quality and public health reporting. For example, HL7 v2 standards are commonly used for public health reporting and delivering admission, discharge, and transfer notifications to support continuity of care. Millions of C-CDA documents have been exchanged between healthcare organizations participating in national health information networks like Commonwell and eHealth Exchange. Adoption of the HL7 FHIR standard is growing rapidly as healthcare organizations implement application programming interfaces (APIs) to more efficiently enable access to EHI.

1 https://www.hl7.org/implement/standards/product_brief.cfm?product_id=185 2 https://www.hl7.org/implement/standards/product_brief.cfm?product_id=186 3 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=7 4 http://hl7.org/fhir/ https://www.hl7.org/implement/standards/product_brief.cfm?product_id=185 https://www.hl7.org/implement/standards/product_brief.cfm?product_id=186 http://hl7.org/fhir/

A. Program Description/Purpose

Background Information

When a computer system receives EHI from another system, it needs the ability 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 EHI, expecting each to negotiate and agree on exchange formats and methods 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 the HL7 standards development organization (SDO) to develop standardized data formats and exchange methods to support common use cases and business transactions. HL7 provides a collaborative environment for developing and maintaining the technical standards and accompanying implementation specifications/profiles that provide additional instructions to implementers.

HL7 possesses a unique skill-set, which includes being the exclusive SDO with the ability, authority, and intellectual property rights to develop and maintain many technical standards of significance to health information exchange and interoperability across health IT systems, such as the C-CDA and FHIR specifications and their accompanying implementation guidance. HL7 standards are developed through a public, transparent, and collaborative process and made freely available for use in the public domain.

HL7 cultivates a broad, multi-stakeholder standards development community and empowers the community to work with, improve, test, and implement HL7 standards. HL7 deploys and maintains tools that support collaboration and information sharing, infrastructure to enable the standards development community to ballot standards, and software for creating and publishing implementation guidance and managing terminologies. HL7 also supports the standards development community through educational programming, testing events and connectathons, and professional certification.

ONC is the principal federal entity charged with the coordination of nationwide efforts to implement and effectively use health IT. One of ONC’s major strategic objectives is to advance the development and use of health IT capabilities. To this end, ONC has worked closely with HL7 for many years, including by entering into a series of cooperative agreements with HL7 beginning in 2015. ONC’s support has enabled HL7 to develop many of the tools and standards development infrastructure that HL7 makes freely available to the public. ONC funding has directly contributed to the development of HL7 standards and implementation guides that are critical to the function of the US healthcare system.

Through this Notice of Funding Opportunity (NOFO), ONC will fund HL7 standards development and implementation activities under a cooperative agreement, which will enable ONC to work directly with HL7 to advance greater standardization and interoperability in areas of nationwide interest. Specifically, the cooperative agreement will improve the implementation consistency and readiness of the current and new versions of HL7 standards by achieving the following goals:

• Facilitate ongoing development and publication of HL7 standards for the benefit of the general public

• Enhance the underlying infrastructure necessary to effectively implement and use HL7 standards

• Empower the HL7 standards development community

Structure and Approach Key Goals and Timeline

The goals and tasks listed below support HL7 standards development and implementation activities. The recipient of the cooperative agreement is expected to work closely with programmatic support offices at ONC to accomplish these goals. The recipient is encouraged to make the products of all standards development and implementation activities conducted under this cooperative agreement freely and publicly available.

Goal 1: Facilitate ongoing development and publication of HL7 standards for the benefit of the general public

Recipient is expected to facilitate general standards development and implementation activities to support health IT priorities identified by HL7 stakeholders. For example, the recipient may:

• Develop profiles, templates, terminologies, implementation guidance, and other technical content specifications.

• Facilitate balloting, testing, certifying, publishing, and other activities associated with the standards development process.

• Publish new or updated content models, transport specifications, implementation guidance, profiles, and other technical documentation associated with HL7 standards.

• Provide governance for the standards development process, including but not limited to policies and procedures, technical assistance, and administrative support for working groups and the balloting process.

Recipient should work with the standards development community and ONC as applicable to identify health IT priorities for standards development and implementation activities. Health IT priorities may include but are not limited to interoperability and health information exchange for public health, research, patient-generated health data, genomics, social determinants of health, clinical decision support, and population health.

Recipient is encouraged to facilitate standards development activities to support consistency in implementation experience. For example, the recipient may:

• Provide guidance for using terminology and vocabulary standards in specific CDA templates, including but not limited to standards from: Systemized Nomenclature of Medicine-Clinical Terms (SNOMED-CT), RxNorm, and Logical Observation Identifiers Names and Codes (LOINC).

• Develop and implement improvements to the CDA standards development process, e.g., a maturity model to accelerate the development of new CDA templates.

• Advance the maturity of the FHIR standard by supporting future releases of the FHIR standard, including support for additional normative content.

Goal 2: Enhance the underlying HL7 tools and infrastructure necessary to support effective implementation and use HL7 standards

Recipient is expected to facilitate standards development and implementation activities across the HL7 community by providing tools and other underlying infrastructure. For example, the recipient may provide:

• Tools for updating, creating, and publishing profiles and implementation guidance.

• Tools for testing the conformance of implementations to HL7 standards and implementation guidance.

• Infrastructure to enable the HL7 community and working groups to collaborate.

Recipient is encouraged to support the ongoing development and maintenance of existing tools, including but not limited to:

• The FHIR Implementation Guide Publisher.

• Tools associated with the Unified Terminology Governance project.

• The FHIR Registry.

Recipient should consider developing new tools, software, or platforms, or supporting ongoing development to and maintenance of existing tools, software, or platforms that enable:

• Conformance testing, creation/hosting of reference implementations, mapping between standards, publication of technical documentation, accelerator programs, or other activities that expand the capability of the healthcare industry to develop, test, and implement HL7 standards and implementation guidance.

• Use of terminology and vocabulary systems in HL7 standards and development of new or updated code systems and value sets for use in HL7 standards.

• Collaboration among the standards development community.

• Effective balloting and ballot reconciliation, development and publication of implementation guidance, and productive working group meetings.

• Mapping or translation between different HL7 standards or versions of standards (e.g. C-CDA on FHIR

Implementation Guide)

Goal 3: Empower the HL7 standards development community

Recipient is expected to thoughtfully plan for and deploy processes, guidance, tools, and educational materials to support the sustained adoption of HL7 standards and build standards development and implementation capacity among HL7’s standards development community. For example, the recipient may provide:

• Trainings related to development, implementation, and use of HL7 standards.

• Collaborative meetings to test HL7 standards implementations.

• Educational materials to inform the public about HL7 standards and their role in the health care system.

Recipient is encouraged to:

• Organize “implementation-a-thons,” “connectathons,” “hackathons,” or other collaborative meetings for the HL7 community to test standards implementations, identify real-world implementation inconsistencies, and facilitate deployment of HL7 standards in health IT systems.

• Develop and maintain new or updated educational materials for health IT developers and implementers, including but not limited to FAQs, whitepapers, webinars, slide presentations, training programs, and toolkits.

• Develop any additional processes, guidance, tools, and infrastructure to support consistent implementation and widespread adoption of HL7 standards.

• Organize training events or materials to educate individuals about the development, implementation, and use of FHIR.

Years Two (2) through Five (5)

Continuation of this cooperative agreement is subject to 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 goals and tasks expected of the recipient in years 2 through 5 are similar to those in year 1.

However, these goals and tasks may be modified as necessary based on new legislation/regulation, agency priorities, or other events that require additional HL7 standards development and implementation activities.

Year 2

Goal 1: Facilitate ongoing development and publication of HL7 standards for the benefit of the general public

Recipient is expected to facilitate general standards development and implementation activities to support health IT priorities identified by HL7 stakeholders. For example, the recipient may:

• Develop profiles, templates, terminologies, implementation guidance, and other technical content specifications.

• Facilitate balloting, testing, certifying, publishing, and other activities associated with the standards development process.

• Publish new or updated content models, transport specifications, implementation guidance, profiles, and other technical documentation associated with HL7 standards.

• Provide governance for the standards development process, including but not limited to policies and procedures, technical assistance, and administrative support for working groups and the balloting process.

Recipient should work with the standards development community and ONC as applicable to identify health IT priorities for standards development and implementation activities. Health IT priorities may include but are not limited to interoperability and health information exchange for public health, research, patient-generated health data, genomics, social determinants of health, clinical decision support, and population health.

Recipient is encouraged to facilitate standards development activities to support consistency in implementation experience. For example, the recipient may:

• Provide guidance for using terminology and vocabulary standards in specific CDA templates, including but not limited to standards from: Systemized Nomenclature of Medicine-Clinical Terms (SNOMED-CT), RxNorm, and Logical Observation Identifiers Names and Codes (LOINC).

• Develop and implement improvements to the CDA standards development process, e.g., a maturity model to accelerate the development of new CDA templates.

• Advance the maturity of the FHIR standard by supporting future releases of the FHIR standard, including

Goal 2: Enhance the underlying HL7 tools and infrastructure necessary to support effective implementation

Recipient is expected to facilitate standards development and implementation activities across the HL7 community by providing tools and other underlying infrastructure. For example, the recipient may provide:

• Tools for updating, creating, and publishing profiles and implementation guidance.

Recipient is encouraged to support the ongoing development and maintenance of existing tools, including but not limited to:

• The FHIR Implementation Guide Publisher.

Recipient should consider developing new tools, software, or platforms, or supporting ongoing development to and maintenance of existing tools, software, or platforms that enable:

• Conformance testing, creation/hosting of reference implementations, mapping between standards, publication of technical documentation, accelerator programs, or other activities that expand the capability of the healthcare industry to develop, test, and implement HL7 standards and implementation guidance.

• Use of terminology and vocabulary systems in HL7 standards and development of new or updated code systems and value sets for use in HL7 standards.

• Collaboration among the standards development community.

• Effective balloting and ballot reconciliation, development and publication of implementation guidance, and productive working group meetings.

• Mapping or translation between different HL7 standards or versions of standards (e.g. C-CDA on FHIR

Implementation Guide)

Goal 3: Empower the HL7 standards development community

Recipient is expected to thoughtfully plan for and deploy processes, guidance, tools, and educational materials to support the sustained adoption of HL7 standards and build standards development and implementation capacity among HL7’s standards development community. For example, the recipient may provide:

• Trainings related to development, implementation, and use of HL7 standards.

• Educational materials to inform the public about HL7 standards and their role in the health care system.

• Organize “implementation-a-thons,” “connectathons,” “hackathons,” or other collaborative meetings for the HL7 community to test standards implementations, identify real-world implementation inconsistencies, and facilitate deployment of HL7 standards in health IT systems.

• Develop and maintain new or updated educational materials for health IT developers and implementers, including but not limited to FAQs, whitepapers, webinars, slide presentations, training programs, and toolkits.

• Develop any additional processes, guidance, tools, and infrastructure to support consistent implementation and widespread adoption of HL7 standards.

• Organize training events or materials to educate individuals about the development, implementation, and

Year 3

Goal 1: Facilitate ongoing development and publication of HL7 standards for the benefit of the general public

Recipient is expected to facilitate general standards development and implementation activities to support health IT priorities identified by HL7 stakeholders. For example, the recipient may:

• Develop profiles, templates, terminologies, implementation guidance, and other technical content specifications.

• Facilitate balloting, testing, certifying, publishing, and other activities associated with the standards development process.

• Publish new or updated content models, transport specifications, implementation guidance, profiles, and other technical documentation associated with HL7 standards.

• Provide governance for the standards development process, including but not limited to policies and procedures, technical assistance, and administrative support for working groups and the balloting process.

Recipient should work with the standards development community and ONC as applicable to identify health IT priorities for standards development and implementation activities. Health IT priorities may include but are not limited to interoperability and health information exchange for public health, research, patient-generated health data, genomics, social determinants of health, clinical decision support, and population health.

Recipient is encouraged to facilitate standards development activities to support consistency in implementation experience. For example, the recipient may:

• Provide guidance for using terminology and vocabulary standards in specific CDA templates, including but not limited to standards from: Systemized Nomenclature of Medicine-Clinical Terms (SNOMED-CT), RxNorm, and Logical Observation Identifiers Names and Codes (LOINC).

• Develop and implement improvements to the CDA standards development process, e.g., a maturity model to accelerate the development of new CDA templates.

• Advance the maturity of the FHIR standard by supporting future releases of the FHIR standard, including

Goal 2: Enhance the underlying HL7 tools and infrastructure necessary to support effective implementation

Recipient is expected to facilitate standards development and implementation activities across the HL7 community by providing tools and other underlying infrastructure. For example, the recipient may provide:

• Tools for updating, creating, and publishing profiles and implementation guidance.

Recipient is encouraged to support the ongoing development and maintenance of existing tools, including but not

• The FHIR Implementation Guide Publisher.

Recipient should consider developing new tools, software, or platforms, or supporting ongoing development to

• Conformance testing, creation/hosting of reference implementations, mapping between standards, publication of technical documentation, accelerator programs, or other activities that expand the capability of the healthcare industry to develop, test, and implement HL7 standards and implementation guidance.

• Use of terminology and vocabulary systems in HL7 standards and development of new or updated code systems and value sets for use in HL7 standards.

• Collaboration among the standards development community.

• Effective balloting and ballot reconciliation, development and publication of implementation guidance, and productive working group meetings.

• Mapping or translation between different HL7 standards or versions of standards (e.g. C-CDA on FHIR

Implementation Guide)

Goal 3: Empower the HL7 standards development community

Recipient is expected to thoughtfully plan for and deploy processes, guidance, tools, and educational materials to support the sustained adoption of HL7 standards and build standards development and implementation capacity among HL7’s standards development community. For example, the recipient may provide:

• Trainings related to development, implementation, and use of HL7 standards.

• Educational materials to inform the public about HL7 standards and their role in the health care system.

• Organize “implementation-a-thons,” “connectathons,” “hackathons,” or other collaborative meetings for the HL7 community to test standards implementations, identify real-world implementation inconsistencies, and facilitate deployment of HL7 standards in health IT systems.

• Develop and maintain new or updated educational materials for health IT developers and implementers, including but not limited to FAQs, whitepapers, webinars, slide presentations, training programs, and toolkits.

• Develop any additional processes, guidance, tools, and infrastructure to support consistent implementation and widespread adoption of HL7 standards.

• Organize training events or materials to educate individuals about the development, implementation, and

Year 4

Goal 1: Facilitate ongoing development and publication of HL7 standards for the benefit of the general public

Recipient is expected to facilitate general standards development and implementation activities to support health IT priorities identified by HL7 stakeholders. For example, the recipient may:

• Develop profiles, templates, terminologies, implementation guidance, and other technical content specifications.

• Facilitate balloting, testing, certifying, publishing, and other activities associated with the standards development process.

• Publish new or updated content models, transport specifications, implementation guidance, profiles, and other technical documentation associated with HL7 standards.

• Provide governance for the standards development process, including but not limited to policies and procedures, technical assistance, and administrative support for working groups and the balloting process.

Recipient should work with the standards development community and ONC as applicable to identify health IT priorities for standards development and implementation activities. Health IT priorities may include but are not limited to interoperability and health information exchange for public health, research, patient-generated health data, genomics, social determinants of health, clinical decision support, and population health.

Recipient is encouraged to facilitate standards development activities to support consistency in implementation experience. For example, the recipient may:

• Provide guidance for using terminology and vocabulary standards in specific CDA templates, including but not limited to standards from: Systemized Nomenclature of Medicine-Clinical Terms (SNOMED-CT), RxNorm, and Logical Observation Identifiers Names and Codes (LOINC).

• Develop and implement improvements to the CDA standards development process, e.g., a maturity model to accelerate the development of new CDA templates.

• Advance the maturity of the FHIR standard by supporting future releases of the FHIR standard, including

Goal 2: Enhance the underlying HL7 tools and infrastructure necessary to support effective implementation

Recipient is expected to facilitate standards development and implementation activities across the HL7 community by providing tools and other underlying infrastructure. For example, the recipient may provide:

• Tools for updating, creating, and publishing profiles and implementation guidance.

Recipient is encouraged to support the ongoing development and maintenance of existing tools, including but not

• The FHIR Implementation Guide Publisher.

Recipient should consider developing new tools, software, or platforms, or supporting ongoing development to

• Conformance testing, creation/hosting of reference implementations, mapping between standards, publication of technical documentation, accelerator programs, or other activities that expand the capability of the healthcare industry to develop, test, and implement HL7 standards and implementation guidance.

• Use of terminology and vocabulary systems in HL7 standards and development of new or updated code systems and value sets for use in HL7 standards.

• Collaboration among the standards development community.

• Effective balloting and ballot reconciliation, development and publication of implementation guidance, and productive working group meetings.

• Mapping or translation between different HL7 standards or versions of standards (e.g. C-CDA on FHIR

Implementation Guide)

Goal 3: Empower the HL7 standards development community

Recipient is expected to thoughtfully plan for and deploy processes, guidance, tools, and educational materials to support the sustained adoption of HL7 standards and build standards development and implementation capacity among HL7’s standards development community. For example, the recipient may provide:

• Trainings related to development, implementation, and use of HL7 standards.

• Educational materials to inform the public about HL7 standards and their role in the health care system.

• Organize “implementation-a-thons,” “connectathons,” “hackathons,” or other collaborative meetings for the HL7 community to test standards implementations, identify real-world implementation inconsistencies, and facilitate deployment of HL7 standards in health IT systems.

• Develop and maintain new or updated educational materials for health IT developers and implementers, including but not limited to FAQs, whitepapers, webinars, slide presentations, training programs, and toolkits.

• Develop any additional processes, guidance, tools, and infrastructure to support consistent implementation and widespread adoption of HL7 standards.

• Organize training events or materials to educate individuals about the development, implementation, and

Year 5

Goal 1: Facilitate ongoing development and publication of HL7 standards for the benefit of the general public

Recipient is expected to facilitate general standards development and implementation activities to support health IT priorities identified by HL7 stakeholders. For example, the recipient may:

• Develop profiles, templates, terminologies, implementation guidance, and other technical content specifications.

• Facilitate balloting, testing, certifying, publishing, and other activities associated with the standards development process.

• Publish new or updated content models, transport specifications, implementation guidance, profiles, and other technical documentation associated with HL7 standards.

• Provide governance for the standards development process, including but not limited to policies and procedures, technical assistance, and administrative support for working groups and the balloting process.

Recipient should work with the standards development community and ONC as applicable to identify health IT priorities for standards development and implementation activities. Health IT priorities may include but are not limited to interoperability and health information exchange for public health, research, patient-generated health data, genomics, social determinants of health, clinical decision support, and population health.

Recipient is encouraged to facilitate standards development activities to support consistency in implementation experience. For example, the recipient may:

• Provide guidance for using terminology and vocabulary standards in specific CDA templates, including but not limited to standards from: Systemized Nomenclature of Medicine-Clinical Terms (SNOMED-CT), RxNorm, and Logical Observation Identifiers Names and Codes (LOINC).

• Develop and implement improvements to the CDA standards development process, e.g., a maturity model to accelerate the development of new CDA templates.

• Advance the maturity of the FHIR standard by supporting future releases of the FHIR standard, including

Goal 2: Enhance the underlying HL7 tools and infrastructure necessary to support effective implementation

Recipient is expected to facilitate standards development and implementation activities across the HL7 community by providing tools and other underlying infrastructure. For example, the recipient may provide:

• Tools for updating, creating, and publishing profiles and implementation guidance.

Recipient is encouraged to support the ongoing development and maintenance of existing tools, including but not limited to:

• The FHIR Implementation Guide Publisher.

Recipient should consider developing new tools, software, or platforms, or supporting ongoing development to

• Conformance testing, creation/hosting of reference implementations, mapping between standards, publication of technical documentation, accelerator programs, or other activities that expand the capability of the healthcare industry to develop, test, and implement HL7 standards and implementation guidance.

• Use of terminology and vocabulary systems in HL7 standards and development of new or updated code systems and value sets for use in HL7 standards.

• Collaboration among the standards development community.

• Effective balloting and ballot reconciliation, development and publication of implementation guidance, and productive working group meetings.

• Mapping or translation between different HL7 standards or versions of standards (e.g. C-CDA on FHIR

Implementation Guide)

Goal 3: Empower the HL7 standards development community

Recipient is expected to thoughtfully plan for and deploy processes, guidance, tools, and educational materials to support the sustained adoption of HL7 standards and build standards development and implementation capacity among HL7’s standards development community. For example, the recipient may provide:

• Trainings related to development, implementation, and use of HL7 standards.

• Educational materials to inform the public about HL7 standards and their role in the health care system.

• Organize “implementation-a-thons,” “connectathons,” “hackathons,” or other collaborative meetings for the HL7 community to test standards implementations, identify real-world implementation inconsistencies, and facilitate deployment of HL7 standards in health IT systems.

• Develop and maintain new or updated educational materials for health IT developers and implementers, including but not limited to FAQs, whitepapers, webinars, slide presentations, training programs, and toolkits.

• Develop any additional processes, guidance, tools, and infrastructure to support consistent implementation and widespread adoption of HL7 standards.

• Organize training events or materials to educate individuals about the development, implementation, and

Performance Goals/Program Milestones

To ensure the success of this cooperative agreement, the applicant must propose baseline measurements or performance metrics that demonstrate the applicant’s progress toward achieving the goals outlined above. For each milestone or metric, ONC will work with the applicant to determine the appropriate targets and reporting requirements.

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) Standards

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

Notice of Funding Opportunity Number: NAP-AX-22-002

Catalog of Federal Domestic Assistance (CFDA) Number: 93.826

Legislative Authority: Consolidated Appropriations Act, 2022, Pub. L. 117-103, Division H, Title II (Mar. 15, 2022)

Eligible Applicants: This is a non-competitive funding opportunity and is restricted to the organization designated below. 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.

Designated Organization: Health Level 7 International (HL7®)

Sole Source Justification

The primary responsibility of Health Level 7 (HL7®) is the development and maintenance of health IT technical standards, as well as any accompanying implementation specifications and guidance that provide additional implementation instructions for developers.

Through ONC rulemaking, which included a transparent decision-making process with public feedback and involvement, multiple HL7 owned standards and implementation guides (e.g. C-CDA R2.1, FHIR US Core 3.1.1, etc.) are required for health IT developers to certify their products. ONC’s programmatic goals of this NOFO require the recipient to utilize the intellectual property of HL7, such as their standards and implementation guides mentioned above. HL7 is the exclusive organization with the necessary intellectual property rights to maintain and publish these standards and implementation guides. HL7 solely owns and governs the processes by which these standards and accompanying implementation guidance are issued and updated. Another entity could not develop an HL7 standard outside of HL7’s processes and publish it as an HL7 standard. This makes HL7’s involvement both fundamental and necessary to publish an HL7 standard or implementation guide.

HL7 is the only organization that can provide the infrastructure and tools that are essential to the HL7 standards development process. For example, the FHIR IG publisher compiles all of the content associated with a FHIR IG and produces the IG in a format that meets HL7 requirements for publication. After an IG is balloted, the IG publisher is used to validate the content before the IG can be published. Other tools like Confluence and Jira are necessary for HL7 standards development, beginning from a project’s inception through ballot. Additionally, HL7 must update their Terminology Server, which they own and can’t be owned by any other entity

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

Anticipated Number of Awards: 1

Approximate Amount of Award: $1,360,000

Project Period: September 13, 2022-September 12, 2026

Budget Period(s): September 13, 2022-September 12, 2023

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.

Continued funding will be contingent on the recipient continuing to address ONC’s regulatory and key goals outlined above 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.

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.

♦ Working with the recipient to set the priorities and implementation direction that will be detailed in the Implementation Plan and all other deliverables submitted to meet the goals of the project.

♦Conduct, on an annual basis, reassessments of health IT priorities and standards development activities, and in collaboration, update the Implementation Plan and any other related activities and priorities. The Implementation Plan and any other related activities and priorities may also be reassessed and adjusted at any time if deemed necessary by ONC and/or the recipient.

♦ Participating in the selection of key personnel, as deemed necessary.

♦ Agency review, assessment, and final approval of priorities and deliverables as identified by the recipient.

♦ Engaging with leadership of the recipient’s organization to ensure successful execution of the cooperative agreement.

♦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.

◆ Collaborate to identify and prioritize the types and numbers of health IT priorities and standards development activities needed, as well as timelines for these activities.

◆ Provide substantive input in the development of the Connect-a-thons and other in-person or virtual testing events.

Informational Session An Informational Session will not be conducted.

Letter of Intent A letter of intent is not required for this award.

Program Income

There are four potential ways in which ONC may require that a recipient apply program income as specified in the NGA: 1) deduct it from total allowable 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 program, 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 shall be disbursed for program 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 shall be returned to ONC. If program income is generated, the recipient shall use the additive method.

Intergovernmental Review Applications for this Cooperative Agreement are not subject to review by states under Executive Order 12372, “Intergovernmental Review of Federal Programs” (45 CFR 100). Please check box “C” on item 19 of the SF 424 (Application for Federal Assistance) as Review by State Executive Order 12372, does not apply to this Cooperative Agreement.

Key Dates

Milestone Date

NOFO Released

July 12, 2022

Applications Due

August 11, 2022

Anticipated Award Date

September 13, 2022

Anticipated Project Start Date

September 13, 2022

C. Eligibility Information

See Section B, Funding Opportunity Award Information, for eligibility, cost-sharing, and other key award information.

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 NOFO. The project narrative should also align with the Performance Goals/Program Milestones and Merit Review Evaluation criteria presented in this NOFO (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.

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. Approval of this application will allow the recipient to continue implementing their project plan and to receive its next 12-month increment of funding. Non-competing continuation applications should be submitted no later than 90 days before the end of the current budget period (i.e., if the budget period will end on August 31, submit the non-competing continuation application by May 10). Exact due dates will be laid out in the terms and conditions that accompany each recipient’s Notice of Grant Award.

Continued funding throughout the 5-year project period will be contingent on timely submission of the non-competing continuation application, strong performance during the previous budget period(s), funding availability, and the recipient’s ability to continue meeting all eligibility requirements laid out in this NOFO. Due to their non-competitive nature, continuation applications will not be reviewed or scored by an Objective Review Committee. Instead, all continuation applications will be reviewed by ONC staff.