LEAP-FY2022-NOFO-FINAL.pdf

U.S. Department of Health and Human Services

Office of the National Coordinator for Health Information

Technology

Notice of Funding Opportunity

Leading Edge Acceleration Projects (LEAP) in Health

Information Technology

Assistance Listings (CFDA) Number

93.345

Application Due Date: August 15, 2022

Anticipated Award Date: September 26, 2022

Program Contact

Wei Chang

Anastasia Perchem

Office of the National Coordinator

330 C Street SW

Washington, D.C., 20201

ONC-LEAP@hhs.gov

Grants Contact

Carmel Halloun

Office of the National Coordinator

330 C Street SW

Washington, D.C., 20201

ONCGrants@hhs.gov mailto:ONC-LEAP@hhs.gov mailto:ONCGrants@hhs.gov

Table of Contents

Executive Summary

A. Program Description/Purpose Background Description

Purpose

Structure and Approach

Areas of Interest

Project Activities

Performance Goals and Objectives

B. Funding Opportunity Award Information Key Award Parameters

Cooperative Agreement and Substantial ONC Involvement

Intergovernmental Review

Key Dates

Informational Session

Letter of Intent

C. Eligibility Information

D. Application and Submission Information Application Package

Application Submission Instructions

Restrictions on Oral Conversations

Funding Restrictions

E. Application Review Information Screening Review

Merit Review

Pre-Award Risk Assessment

Award Decisions

F. Federal Award Administration Information Federal Award Notices

Terms and Conditions

G. Appendix

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

This Notice of Funding Opportunity (NOFO) seeks Leading Edge Acceleration Projects (LEAP) in

Health Information Technology (Health IT) to address well-documented and fast emerging challenges that inhibit the development, use, and/or advancement of well-designed, interoperable health IT. Project solutions are expected to further a new generation of innovative health IT research and inform the development, implementation, and refinement of standards, methods, and techniques for overcoming major barriers in health information access, exchange, and use.

This NOFO outlines two Areas of Interest that are a priority for the Office of the National Coordinator for Health Information Technology (ONC):

• Area 1: Address health equity and social determinants of health through innovative, open-source technology tools, and electronic health records; and

• Area 2: Demonstrate the use of equity-enhancing patient-generated health data for clinical care and research.

ONC expects to issue one cooperative agreement award per area of interest (the “Area of Interest”), up to $1 million per award, totaling up to $2 million for the two awards in fiscal year 2022. These awards will have a two-year project and budget period at initial award. However, applicants are encouraged to submit their applications based on a five-year budget period. Additional funding for years three to five may be provided, contingent upon availability of funds, meaningful progress, and ONC priorities.

This funding opportunity will have a five-year open application period. ONC may issue future awards under this NOFO to other eligible applicants for future areas of interest.

A. Program Description/Purpose

Background Description

Created in 2004 through Executive Order 133351 and statutorily authorized by the Health Information

Technology for Economic and Clinical Health Act (HITECH Act) of 2009, ONC is the principal federal entity charged with coordination of nationwide efforts to implement the most advanced health IT and the electronic exchange of health information. At the forefront of the administration’s health IT efforts, ONC is a resource to the entire health system to support the adoption of health IT and the promotion of nationwide, standards-based health information exchange to improve healthcare.

In 2010, through the HITECH Act, ONC created the Strategic Health Information Technology

Advanced Research Projects (SHARP) cooperative agreement program.2 The SHARP program was created to support advanced research activities to address short- and long-term challenges to the implementation of HITECH and its programs, with a focus on solving currently known, as well as anticipated challenges to the adoption and the meaningful use of health IT.

Since the HITECH Act was enacted and the SHARP program was created, the healthcare ecosystem and the technology supporting it have rapidly evolved. Many providers have implemented electronic health record (EHR) systems,3 and sophisticated health IT tools and applications are quickly coming to market.

As the electronic exchange of health information has matured, the amount and types of health data available has expanded. Data standards such as Health Level Seven International (HL7®)’s Fast

Healthcare Interoperability Resources (FHIR®)4 and application programming interfaces (APIs) are making it easier for consumers to seamlessly access and share their health data with providers and allow health systems to integrate disparate data sources.

Passage of the 21st Century Cures Act5 (Cures Act) in 2016 strengthened ONC’s mandate to improve the interoperability of health information, facilitate information exchange, address barriers to interoperability, and reduce provider burden when using EHRs.

Purpose

While working to implement Cures Act provisions, ONC identified gaps with respect to leveraging EHR data to support population-level analyses and delivery of services, as well as integrating clinical knowledge into routine clinical practice.6 The reasons for these gaps range from a lack of data standards and interoperability to the digitization, integration, and presentation of new evidence into clinical workflows in safe, useful, and useable ways.

1 https://www.gpo.gov/fdsys/pkg/FR-2004-04-30/pdf/04-10024.pdf 2 https://www.healthit.gov/buzz-blog/sharp/health-it-challenges-and-the-future-of-healthcare/ 3 https://www.healthit.gov/sites/default/files/2016_report_to_congress_on_healthit_progress.pdf 4 http://www.hl7.org/fhir/ 5 21st Century Cures Act, Pub. L. No. 114-255, 130 Stat. 1033 (December 13, 2016).

6 https://www.healthit.gov/sites/default/files/jsr-17-task-002_aiforhealthandhealthcare12122017.pdf https://www.gpo.gov/fdsys/pkg/FR-2004-04-30/pdf/04-10024.pdf https://www.healthit.gov/buzz-blog/sharp/health-it-challenges-and-the-future-of-healthcare/ https://www.healthit.gov/sites/default/files/2016_report_to_congress_on_healthit_progress.pdf http://www.hl7.org/fhir/ https://www.healthit.gov/sites/default/files/jsr-17-task-002_aiforhealthandhealthcare12122017.pdf

Therefore, this funding opportunity will support innovative and breakthrough solutions critical to maximize the potential of health IT and achieve the goal of a transformed healthcare delivery system through various methods, such as:

• Determining the fundamental questions, the answers to which will identify barriers to nationwide interoperability and electronic exchange of health data.

• Engaging the health IT industry, along with academic researchers, to identify and develop innovative solutions that address barriers to interoperability.

• Disseminating findings from research while fostering collaboration, advancement, and implementation of solutions and lessons learned with the health IT industry.

Structure and Approach

ONC expects to award two cooperative agreements for a project period of two years for each recipient to focus on areas where breakthrough improvements are needed to address problems that have impeded the innovative use of health IT and thereby accelerate progress in the areas identified.

Areas of Interest

The two Areas of Interest identified below describe priorities ONC is interested in continuing to explore and advance. The descriptions include ways in which applicants may approach developing a project. The Areas of Interest have been assigned numbers for ease of reference, not for prioritization. While there are many challenges associated with the use of health IT, these two Areas of Interest have been identified as critical priority areas for ONC.

Area 1: Address health equity and social determinants of health through innovative, open-source technology tools, and electronic health records

Background

Social determinants of health (SDOH) refer to the conditions in which people live, learn, work, and play, and affects a wide range of health risks and outcomes while health equity is everyone attaining their full potential for health and well-being.7 An integral part of healthcare delivery involves understanding the social and environmental factors of patients’ lives outside of the healthcare system. Addressing inequities in these conditions may be supported by the collection, exchange, and use of SDOH data.8

This data can be used to identify and help eliminate health disparities by improving health outcomes at an individual and population level. Advancing the use and interoperability of SDOH data is a priority for

ONC in keeping with our mission to improve the health and well-being of individuals and communities through the use of technology and health information that is accessible when and where it matters most.

In January of 2021, the President issued an Executive Order on Advancing Racial Equity and Support for Underserved Communities to address barriers to equity via program delivery and stakeholder engagement. Taking a comprehensive approach to address barriers to health equity across the federal government as well as among private and public stakeholders will be fundamental to improving health and reducing health inequities. As part of that approach, ONC is committed to advancing the development and use of health IT, establishing expectations for standardizing and sharing data, and ensuring that these benefits are available to communities that have historically faced structural barriers

7 https://www.who.int/health-topics/health-equity#tab=tab_1 8 https://www.healthit.gov/sites/default/files/page/2020-10/Federal%20Health%20IT%20Strategic%20Plan_2020_2025.pdf https://www.healthit.gov/topic/about-onc https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/ https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/ https://www.who.int/health-topics/health-equity%23tab=tab_1 https://www.healthit.gov/sites/default/files/page/2020-10/Federal%20Health%20IT%20Strategic%20Plan_2020_2025.pdf to accessing healthcare and health IT. More specifically, ONC is focused on improving data collection through the development and adoption of standards to mitigate some of the challenges encountered in the collection and the equity-focused analysis of race, ethnicity, and SDOH data.9,10,11

Project Goals

Through this Area of Interest, ONC aims to advance the adoption and use of SDOH-related standards and data in underserved communities to address disparities, and to identify the challenges and opportunities inherent in scaling health IT solutions across communities.

In alignment with the Executive Order on Advancing Racial Equity and Support for Underserved

Communities, this Area of Interest seeks to help address barriers to health equity by implementing innovative, scalable, and easily replicable data-system based, non-proprietary health IT solutions to support SDOH data collection, exchange, and use among individuals who belong to underserved communities (including Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas;

and persons otherwise adversely affected by persistent poverty or inequality).12

Using open, non-proprietary standards, the awardee shall create and implement a comprehensive technology solution that supports 1) the collection and analysis of SDOH data in an EHR to identify population-level use cases for addressing health disparities, 2) closed loop referrals between an EHR and appropriate Community Based Organizations (CBOs) 13 supporting human and social services, and 3) patient-facing technology, such as, but not limited to web-based platforms and applications (apps) that allows patients to manage their data, provide consent for various purposes, and share sensitive information with other organizations. The comprehensive technology solution may include, without limitation, a combination of apps, web-based platforms, and directories via APIs to allow data to be shared between an EHR, a CBO, and a patient.

Key Objectives

1) Create specific use cases for the technology platform based on high-risk population factors like chronic diseases (which may include, but are not limited to, heart disease, hypertension, and cancer) and/or social risk factors (which may include, but are not limited to housing instability, food insecurity, and transportation insecurity) in underserved communities. While creating the use cases, the applicant must use standardized SDOH data collected within the EHR.

2) Create and implement non-proprietary technical solutions for referring patients to CBOs that interface seamlessly with a health system or community health center’s EHR.

9 https://www.healthit.gov/sites/default/files/page/2021-07/Standards_Bulletin_2021-3.pdf 10 https://www.healthit.gov/isa/sites/isa/files/2021-07/USCDI-Version-2-July-2021-Final.pdf 11 https://www.healthit.gov/buzz-blog/interoperability/onc-health-it-framework-for-advancing-sdoh-data-use-and-interoperability 12 https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/ 13A CBO refers to public or private not-for-profit resource hubs that provide specific services to the community or a targeted population within the community.

https://www.phe.gov/Preparedness/planning/abc/Pages/engaging-CBO.aspx https://www.healthit.gov/sites/default/files/page/2021-07/Standards_Bulletin_2021-3.pdf https://www.healthit.gov/isa/sites/isa/files/2021-07/USCDI-Version-2-July-2021-Final.pdf https://www.healthit.gov/buzz-blog/interoperability/onc-health-it-framework-for-advancing-sdoh-data-use-and-interoperability https://www.healthit.gov/buzz-blog/interoperability/onc-health-it-framework-for-advancing-sdoh-data-use-and-interoperability https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/ https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/ https://www.phe.gov/Preparedness/planning/abc/Pages/engaging-CBO.aspx

3) Create and implement technology that supports patient engagement that at minimum allows patients to manage their data by suggesting edits to their SDOH data and provide consent and authorization to use sensitive data.

4) Coordinate forums to share implementation strategies, lessons learned, and recommendations with other healthcare providers and CBOs.14 Forums may include, but are not limited to, workshops, webinars, and documents.

Applicants shall include the following activities in the project plan that they will develop15:

• Assess current SDOH data collection and use activities to ensure efforts are aligned with prior work, including, but not limited to, previous ONC LEAP projects, the Gravity Project, and 360X.

• Collect SDOH data using nationally recognized16 open standards (e.g., United States Core Data for Interoperability (USCDI), US Core Implementation Guide , 360X, and the Social

Determinants of Health Clinical Care Implementation Guide (SDOHCC IG)).

• Utilize innovative analysis techniques and real data to identify patients with negative health outcomes among underserved populations with a need for human and social services, such as, but not limited to, elderly and aging services, access to medicine, and shelter assistance.

Innovative analysis techniques could include linking different types of data, stratifying data, natural language processing.

• Use findings from the above analysis to develop at least one use case for referring patients to

CBOs using non-proprietary EHR-embedded or third party closed loop referral technology.

CBOs that are expected to use this technology shall be included in the development of the use case. This may require a CBO to understand the feasibility of developing the use case and the technology, which may require education from the project team.

• Create and implement closed loop referral technology in a real-world environment involving at least one health system or community health center, their EHR developer, and at least one

CBO.17 The awardee will be expected to provide feedback on the challenges and successes that the health system or community health center and CBO experience while using the technology in underserved communities.18

• Create and implement patient-facing technology that allows a patient to indicate changes in social risk factors and allows those changes to be incorporated into an EHR.19

• Develop, publish, and disseminate training and education tools (such as, but not limited to, white papers, blog posts, and reports) that document implementation strategies, lessons learned, and best practices for implementation. The strategies, lessons learned, and best practices should reflect input from implementers, CBO sites, developers, and health IT experts. The training tools should include guidance for using the technology solution.20

14 https://www.phe.gov/Preparedness/planning/abc/Pages/engaging-CBO.aspx 15 The Project Activities and Performance Goals and Objectives sections of this NOFO describe the project plan requirement.

16 https://www.healthit.gov/isa/ 17 https://www.ahrq.gov/chsp/chsp-reports/resources-for-understanding-health-systems/defining-health-systems.html 18 https://www.healthit.gov/topic/leading-edge-acceleration-projects-leap-health-information-technology-health-it 19 https://www.healthit.gov/topic/leading-edge-acceleration-projects-leap-health-information-technology-health-it 20 May also include an overview of SDOH data collection, use, and exchange and its impact on health equity. The awardee may work in collaboration with awardees from the Public Health Informatics & Technology (PHIT) Workforce Development

Program.

https://www.healthit.gov/topic/leading-edge-acceleration-projects-leap-health-information-technology-health-it https://www.hl7.org/gravity/ https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi https://www.hl7.org/fhir/us/core/ https://oncprojectracking.healthit.gov/wiki/display/TechLab360X/360X+Home http://hl7.org/fhir/us/sdoh-clinicalcare/2021Jan/ http://hl7.org/fhir/us/sdoh-clinicalcare/2021Jan/ https://www.phe.gov/Preparedness/planning/abc/Pages/engaging-CBO.aspx https://www.healthit.gov/isa/ https://www.healthit.gov/topic/leading-edge-acceleration-projects-leap-health-information-technology-health-it https://www.healthit.gov/topic/leading-edge-acceleration-projects-leap-health-information-technology-health-it

• Conduct forums to educate participants on implementation strategies, lessons learned, and best practices from the project to allow the work to expand across communities.

• Develop and implement evaluation tools that measure and document the outcomes of the implementation of the technology platform and the return on investment of the technology in supporting underserved communities.

An applicant’s proposal shall not rely on proprietary technology for apps or web portals. The proposed technical solution for this Area of Interest should leverage previous work funded by ONC (such as, but not limited to ONC LEAP projects, the Gravity Project, 360X) and not duplicate efforts.

Area 2: Demonstrate the use of equity-enhancing patient-generated health data for clinical care and research

Background

Patient-generated health data (PGHD) is increasingly becoming critical for both clinical care and research. PGHD are health-related data that are created, recorded, or gathered by or from patients (or family members or other caregivers) to help address a health concern.21 PGHD related technologies such as mobile phones, apps, remote monitoring devices, and wearable technology (such as, but not limited to fitness trackers, smart watches, and body-mounted sensors) are more accessible now than before and can be cost effective methods to monitor and track health outside of the clinical care setting. PGHD can also support patients’ healthcare goals by providing patients, providers, and researchers with more information about a patient’s conditions or health situation.

The 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT

Certification Program Final Rule adopted the United States Core Data for Interoperability (USCDI) version 1 as a standard.22 USCDI version 1 sets a foundation for broader sharing of electronic health information to support patient care23and USCDI version 2 reinforced the importance of incorporating

SDOH in healthcare settings. SDOH may prevent or make it difficult for some patients to appropriately follow up with providers, have their conditions monitored24, or obtain and adhere to medical care. It is also well documented that these types of factors disproportionately affect underserved communities when they try to access care and that these communities are underrepresented in research.25,26

PGHD technologies may ease some of these barriers. For example, PGHD technologies can facilitate patient engagement by providing patients the opportunity to monitor and track their condition outside of the clinical care setting via multiple avenues such as a patient portal or via a third-party app on their smartphone. Patients can also decide when and with whom to share their clinical data. Improving the interoperability of PGHD can also increase patient knowledge, access to care, and control of their conditions.27 Providers can use PGHD to monitor aspects of their patients’ healthcare from a distance and between visits. Providers can also use these data to facilitate joint decision-making, resulting in the provision of better care over time. Currently, the integration of PGHD into EHR and clinical workflows

21 https://www.healthit.gov/topic/otherhot-topics/what-are-patient-generated-health-data 22 https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification 23 https://www.healthit.gov/cures/sites/default/files/cures/2020-03/USCDI.pdf 24 https://pubmed.ncbi.nlm.nih.gov/22092449/ 25 https://muse.jhu.edu/article/430672 26 https://www.nature.com/articles/d41586-018-05049-5 27 https://www.healthit.gov/sites/default/files/onc_pghd_final_white_paper.pdf https://www.healthit.gov/topic/leading-edge-acceleration-projects-leap-health-information-technology-health-it https://www.hl7.org/gravity/ https://www.healthit.gov/topic/otherhot-topics/what-are-patient-generated-health-data https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-%20%20blocking-and-the-onc-health-it-certification https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-%20%20blocking-and-the-onc-health-it-certification https://www.healthit.gov/cures/sites/default/files/cures/2020-03/USCDI.pdf https://pubmed.ncbi.nlm.nih.gov/22092449/ https://muse.jhu.edu/article/430672 https://www.nature.com/articles/d41586-018-05049-5 https://www.healthit.gov/sites/default/files/onc_pghd_final_white_paper.pdf is not robust. Subsequently, it is often difficult for researchers to access PGHD that are connected to

EHR data they may already be requesting. Researchers will often have to set up separate systems to collect PGHD.

The ONC National Health IT Priorities for Research: A Policy and Development Agenda (the Agenda) highlighted key several of which are related to the enhancement of PGHD.28 Specifically, Priority 5 spotlights the need to integrate emerging health and health-related data sources.29 Improvements in the collection, use, and sharing of PGHD will contribute to the types of data that can be leveraged for research and the advancement of a health IT infrastructure that supports research. Not only has the usefulness of PGHD technologies been identified in literature and in practice, but ONC has also highlighted its value in previous work as well. Projects such as Advancing Standards for Precision

Medicine and the Patient-Centered Outcomes Research (PCOR) project on PGHD have examined the collection, use, and standardization of PGHD and demonstrated the opportunities that PGHD can provide.30,31 PGHD technologies offer a unique opportunity to leverage health IT to directly support the

Biden Administration’s priority of ending “disparities in healthcare access and education”, particularly by addressing barriers to health equity among underserved communities (i.e. Black, Latino, and

Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas).32

Despite the innovative possibilities that the use of PGHD brings to care and research, there are also several challenges associated with the advancement of PGHD. Difficulties experienced by patients include a lack of access to PGHD technologies, varying health and technology literacy levels, and data privacy and security concerns.33 Clinician and researcher challenges include apprehension regarding the accuracy of PGHD and specifically for providers, the impact on clinical workflow.34 In addition, the sharing of PGHD for research is still nascent. Though many wearable technology and apps use APIs, the capture, use, and sharing of PGHD are not standardized.35 For example, many PGHD related technologies have not adopted standards, such as FHIR, and the interoperability of PGHD, though emerging, is still relatively new.36 Even with the promising use of PGHD for greater health equity, there is also the concern that collection of PGHD may have unintended consequences on underserved communities, based on a potential “digital divide” resulting from the use of costly PGHD related technologies.

Project Goals

The goal of this project is to develop the infrastructure and standards-based PGHD technologies needed to demonstrate the scalable use of equity enhancing patient-generated health data for clinical care and research from the point of care to the researcher. The proposed PGHD technology solution can be comprised of apps, remote monitoring devices, or wearable technology that collect data to monitor and

28 https://www.healthit.gov/topic/scientific-initiatives/national-health-it-priorities-research-policy-and-development-agenda 29 https://www.healthit.gov/topic/scientific-initiatives/national-health-it-priorities-research-policy-and-development-agenda 30 https://www.healthit.gov/topic/advancing-standards-precision-medicine 31 https://www.healthit.gov/topic/scientific-initiatives/pcor/patient-generated-health-data-pghd 32 https://www.whitehouse.gov/priorities/ 33 https://www.healthit.gov/sites/default/files/onc_pghd_final_white_paper.pdf 34 https://www.healthit.gov/sites/default/files/onc_pghd_practical_guide.pdf 35 https://www.healthit.gov/sites/default/files/page/2021-01/Advancing-Standards-in-Precision-Medicine.pdf 36 Hussein, R., Crutzen, R., Gutenberg, J., Kulnik, S. T., Sareban, M., & Niebauer, J. (2021). Patient-Generated Health Data

(PGHD) Interoperability: An Integrative Perspective. In Public Health and Informatics (pp. 228-232). IOS Press.

https://www.healthit.gov/topic/scientific-initiatives/national-health-it-priorities-research-policy-and-development-agenda https://www.healthit.gov/topic/scientific-initiatives/national-health-it-priorities-research-policy-and-development-agenda https://www.healthit.gov/topic/advancing-standards-precision-medicine https://www.healthit.gov/topic/scientific-initiatives/pcor/patient-generated-health-data-pghd https://www.whitehouse.gov/priorities/ https://www.healthit.gov/sites/default/files/onc_pghd_final_white_paper.pdf https://www.healthit.gov/sites/default/files/onc_pghd_practical_guide.pdf https://www.healthit.gov/sites/default/files/page/2021-01/Advancing-Standards-in-Precision-Medicine.pdf track health outside of the clinical care setting. Additionally, the awardee of the project shall do the following:

• Examine the capabilities of current health IT infrastructure that is available to support PGHD technologies and identify standards-based technology that needs to be developed to effectively integrate PGHD into one or multiple EHRs and for PGHD to subsequently be used by both clinicians and researchers.

• Identify and propose a PGHD technology solution that is most useful for healthcare research with an emphasis on underserved communities and their unique needs, while considering the accuracy of the type of PGHD that is collected.

• Demonstrate the use of a PGHD solution that leverages nationally recognized open standards

(e.g. USCDI37 and the Interoperability Standards Advisory (ISA)38) and standards-based approaches or resources (e.g. FHIR “Write” APIs, HL7 FHIR, Substitutable Medical

Applications and Reusable Technologies (SMART) on FHIR, and Mobile Health

Implementation Guides) for integrating PGHD with clinical EHR data, with the appropriate privacy, security, and other data provenance considerations.

• Demonstrate a path to scalability by implementing the proposed PGHD technology solution in at least two separate healthcare locations or by demonstrating how the same proposed PGHD technology solution can be used for two different use cases.

• Capture and document lessons learned, challenges encountered, and recommendations for a blueprint that can be used by others to advance the use of PGHD for research and in clinical care.

Key Objectives

1) Perform a landscape analysis/environmental scan to understand the current standards and interoperability of PGHD technologies related to the proposed PGHD technology solution (such as across device manufacturers and different EHRs).

2) Per the above landscape analysis/environmental scan, identify at least two separate healthcare locations and at least two use cases around clinical care and research that require PGHD and incorporate the needs of underserved communities.

3) Create and develop plans for at least two demonstration projects with consideration on reuse and scalability of the proposed PGHD technology solution. To result in two demonstration projects, the proposed PGHD technology solution should be implemented at two separate healthcare locations affiliated with the awardee, and the proposed PGHD technology solution should be implemented for two different use cases (e.g. high blood pressure and respiratory diseases) that use the same underlying technology. This will show how the solution can be reused.

4) Convene a coalition of key stakeholders (e.g. clinicians, researchers, technical experts, and/or patients) that will be directly involved in the development and implementation of the demonstration projects.

5) Engage standards development organizations (SDOs) to identify opportunities and practical solutions for the advancement of standards that are necessary to capture, exchange, integrate, and use PGHD in clinical and research settings. This includes leveraging and testing existing standards for the proposed PGHD technology solution and can also include balloting and updating implementation guides with information resulting from the demonstration projects.

6) Develop the proposed PGHD technology solution (incorporating standards-based solutions) that collects and shares PGHD among patients, providers, and researchers.

37 https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi 38 https://www.healthit.gov/isa/ https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi https://www.healthit.gov/isa/

7) Prepare a final report that includes lessons learned and recommendations that provide experiential insights for others who wish to implement similar types of PGHD technology solutions at their organizations.

8) Develop at least one manuscript that details the demonstration project results and submit to appropriate journal.

Project Activities

Awardees shall carry out at a minimum, the following set of activities:

• Define a project plan that will include all key objectives o The project plan will identify key issues and potential challenges.

o The project plan will map all project activities to a two-year timeframe.

o Engage with ONC and other federal HHS partners as identified by ONC, to establish and refine key issues and potential challenges in the project’s Area of Interest.

• Document and report progress throughout the project timeframe.

• Utilize research methods to inform the demonstration projects.

• Publish (e.g., manuscript, report, blog post, and white paper) and disseminate project findings in a way that translates project outcomes into useable knowledge and insights for federal partners, health IT industry, SDOs, CBOs, developers, healthcare systems, and providers to maximize the accessibility of this knowledge to the entire health IT community.

• Select measurable outcomes that are specific to the project’s Area of Interest and key objectives.

• Conduct virtual mid-point demonstrations and provide an update regarding any proposed approaches, prototype(s), and/or revisions to the project plan to illustrate their progress on the

Area of Interest.

In addition, applicants will provide a draft project plan as an appendix to the application, with a corresponding table of key dates and objectives to demonstrate that key objectives can be met within the two-year period (see Section D, Application and Submission Information).

Performance Goals and Objectives

A performance goal is a target level of performance expressed as a tangible, measurable objective, against which actual achievement can be compared.

ONC will utilize the following objectives to assess project performance and progress:

• The quality of the two-year project plan and the description of how performance goals and objectives will be met.

• The identification and securement of subject matter experts (SMEs), as appropriate, to provide guidance and review strategies, research methods, and results.

• Scheduling, conducting, and participating in status, strategy and/or SME meetings with ONC and the coalition of key stakeholders.

• Communicating findings and providing quarterly programmatic progress reports, including a risk register to ensure timely deliverables.

B. Funding Opportunity Award Information

Key Award Parameters

Title: Leading Edge Acceleration Projects (LEAP) in Health Information Technology

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 Number: NAP-AX-22-001

Catalog of Federal Domestic Assistance (CFDA) Number: 93.345

Eligible Applicants:

This is a competitive funding opportunity open to public or non-profit private institutions, such as a university, college, or a faith-based or community-based organization; units of local or state government, eligible agencies of the federal government, Indian/Native American Tribal Governments

(federally recognized, other than federally recognized, and tribally designated organizations).

For-profit organizations may participate in projects as members of a consortia or as a sub-recipient only. Because the purpose of this NOFO is to improve healthcare in the United States, foreign institutions may participate in projects as members of a consortia or as a sub-recipient only.

Applications submitted by for-profit organizations or foreign institutions will not be reviewed.

Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying activities are not eligible.

HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant shall justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the recipient and what substantive role the applicant organization will play.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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

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

Anticipated Number of Awards: 2 (1 award per Area of Interest)

Approximately Amount of Each Award: $1,000,000

Project Period: September 26, 2022-September 25, 2027

Budget Period(s): September 26, 2022-September 25, 2024

Under this announcement, as new emerging issues and vexing problems/challenges are documented, program will call attention to these specific areas of interest for further investigation via a special emphasis notice (SEN). This funding opportunity will have a 5-year open application period. ONC may issue future awards to other eligible applicants for future priority areas of interest to address emerging challenges in the field, via SEN; again, contingent on the availability of funds and ONC priorities. Any SENs will be issued at least 60 days prior to the due date of applications.

Funding of future non-competing continuation awards will be determined by ONC and 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.

Cooperative Agreement and Substantial ONC Involvement

The funding instrument used for this program 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.

ONC involvement may include, but is not limited to:

• Participating in monthly (minimum) check-in meetings

• Ensuring compliance of timely programmatic reporting, project progress, and other terms and conditions of the award

• Review and approve quarterly programmatic progress reports on Confluence o Quarterly programmatic progress reports are due one month after each quarter

(January, April, July, and October)

• Participating in the selection of key personnel

• Releasing funds based on achievement of performance goals and objectives

• Agency review and approval of substantive provisions of proposed subawards or contracts

• Reviewing and approving deliverables

• Selecting meeting/panel members and subject matter experts

• Participating in communities of practice

• Providing tactical guidance and feedback during project execution

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

• Ending an activity if performance specifications are not met

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 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

June 14, 2022

Informational Session

June 28, 2022

Letters of Intent Due

June 30, 2022

Applications Due

August 15, 2022

Anticipated Award Date

September 26, 2022

Anticipated Project Start Date

September 26, 2022

Informational Session

ONC will conduct an informational session, via a webinar, to:

• Discuss the background, purpose, scope, terms and conditions and other provisions in the NOFO;

• Explain the eligibility and application requirements;

• Describe the application review process; and

• Provide an opportunity for interested parties to ask questions.

Further details about the informational session – including the date, time, and instructions for joining – are available at https://us06web.zoom.us/meeting/register/tZMtf-yurDgvH9wNRzED7Sm0MZR76l8vs0Nq

To ensure that ONC addresses all comments and questions regarding this announcement during the information session, please submit any comments and questions, via email, to ONC-LEAP@hhs.gov no later than three days prior to the call.

Letter of Intent

Although not required, applicants are strongly encouraged to submit a non-binding e-mail letter of intent to apply for this funding opportunity. This letter of intent will assist ONC in planning for the application review process.

The Letter of Intent is requested by 11:59 P.M. Eastern Standard Time on June 30, 2022 and should be sent to ONC-LEAP@hhs.gov. The notice should identify the name of the applicant organization, the city and state in which the applicant organization is located, and the Notice of Funding Opportunity title and number.

https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fus06web.zoom.us%2Fmeeting%2Fregister%2FtZMtf-yurDgvH9wNRzED7Sm0MZR76l8vs0Nq&data=05%7C01%7CYolonda.Thompson%40hhs.gov%7C8a809188d71e4e0cfbae08da39d04b55%7Cd58addea50534a808499ba4d944910df%7C0%7C0%7C637885864748364884%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=Dpc%2BCFt0yxoszbD8eiv%2B2lG9NxZkdiEMjCr9It2QhzM%3D&reserved=0 mailto:ONC-LEAP@hhs.gov

C. Eligibility Information

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

Priority will be given to applicants who demonstrate provision of services to primarily underserved communities (i.e. Black, Latino, and Indigenous and Native American persons, Asian Americans and

Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas) and provide evidence of this in the application.

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

• Appendices o Form SF-424, Application for Federal Assistance o Form SF-424A, Budget Information for Non-Construction Programs o Form SF-424B, Assurances for Non-Construction Programs o Form SF-LLL, Disclosure of Lobbying Activities o Budget Narrative o Letters of Commitment o Proof of Non-Profit Status (if, applicable) o Indirect Cost Agreement(s) – including recipient, sub-recipient, and contractors’ agreements (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 shall 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 shall 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 should describe the proposed project in a clear and concise manner. The project narrative should address the elements articulated in the Areas of Interest section of this NOFO. The project narrative should also align with the Performance Goals and Objectives and Merit Review criteria presented in this NOFO.

The project narrative shall be double-spaced, formatted to 8 ½” x 11” (letter-size) pages, 1” or larger margins on all sides, and using no less than 11-point font size. The maximum length allowed for the project narrative is 35 pages. A project narrative that exceeds the 35-page limit will not be accepted.

Resumes of key personnel (personnel required for the project), are not counted as part of the project narrative and are not included in the 35-page limit.

Your project narrative should include the following components. These components will be counted as part of the page limit. The suggested lengths of the components, given below, are guidelines to help applicants create a balanced document. They are not mandatory restrictions:

1. Understanding of Project Purpose (2-3 pages)

2. Proposed Approach and Activities (10-14 pages)

3. Applicant Capabilities (9-15 pages)

4. Budget Narrative (2-3 Pages)

1. Understanding of Project Purpose

This section should offer the applicant’s conceptualization of the selected Area of Interest. This should include, from the applicant’s perspective, a specific delineation of the objectives and research challenges the proposed project will address, specifically distinguishing between challenges that can be addressed in the self-contained project period (two years) and challenges requiring a longer period (three to five years). Applicants shall clearly state which Area of Interest the proposed project will address. (2-3 pages).

2. Proposed Approach and Activities

This section should provide a clear and concise description of the approach the applicant is proposing to use to conduct the research and development work, including identifying the major challenges and proposed activities used in the approach. This section should be organized so that each element of the project plan is clear and aligns to the project’s key objectives and project goals.

The applicant should include the usage of novel concepts, approaches, methodologies, tools, and/or technologies and provide insight as to how their usage will inform the field of health IT.

Additionally, the approach should include proposed strategies on how the results of the project may be disseminated and transitioned to field at large.

Each key objective being addressed should be described as a discrete activity, and each activity should have a separately itemized budget as described below. The applicant shall clearly identify each activity and denote whether it is a short-term objective (two years) or a long-term objective

(three to five years).

The approach should include as much details as possible given the page limitation. Notwithstanding, the plan for each activity, at a minimum, shall state, (a) specific aims, (b) previous work of the investigative team on which the proposed research is directly based, (c) the methods that will be applied, the anticipated outcomes of the work, and their potential significance in addressing the challenges of the selected Area of Interest, and (d) the key personnel who will be involved.

Statements of previous work should not be redundant with general statements of experience in the

“Organizational Capability Statement” section described below.

Applications should justify the project’s proposed approaches through relevant scholarly…