LEAPHealthIT (002).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

Application Due Date: [08/17/2018]

Anticipated Award Date: [09/19/2018]

Table of Contents

Executive Summary

A. Funding Opportunity Description

Background Purpose Project Approach Project Activities

Performance Goals and 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

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 inhibiting the development, use, and/or advancement of well-designed, interoperable health IT, which is scalable across the health care industry. Solutions are expected to further a new generation of health IT research and inform the development, implementation, and refinement of standards, methods, and techniques for overcoming major barriers and challenges in an innovative fashion as they are identified.

It is critical that the field of health care innovate and leverage the latest technological advancements and breakthroughs far quicker than it currently does to optimize real-time solutions, especially in areas which are ripe for acceleration.

This funding opportunity is specifically interested in innovative solutions and breakthrough advances in the following areas of interest:

• Expanding the scope, scale, and utility of population-level data-focused application programming interfaces (APIs); and

• Advancing clinical knowledge at the point of care.

ONC anticipates issuing one award per area of interest (for a total of 2 recipients), up to $1 Million per recipient (for a total of up to $2 Million in funding in fiscal year 2018). These awards will have a 2-year project and budget period at initial award. However, applicants are encouraged to submit their responses based on a 5-year project and budget period. Additional funding for out years 3-5 may be provided; contingent on availability of funds and meaningful progress.

This funding opportunity will have a 3-year open application period. ONC may issue future awards under this NOFO to other eligible applicants for future priority areas of interest. This is contingent on the availability of funds and ONC priorities.

A. Funding Opportunity Description

1. Background

The Office of the National Coordinator for Health Information Technology (ONC) is the principal federal entity charged with coordination of nationwide efforts to implement and use the most advanced health IT and the electronic exchange of health information. Created in 2004 through Executive Order 133351 and statutorily authorized by the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, ONC is at the forefront of the federal government’s health IT efforts and is a resource to the entire health system to support the adoption of health IT and the promotion of nationwide health information exchange to improve health care.

In 2010, through the HITECH Act, ONC created the Strategic Health Information Technology Advanced Research Projects (SHARP) cooperative agreement program2 to close the gap between the promise of health IT and its realized benefits. Specifically, SHARP funded projects to create a more robust research infrastructure, achieve breakthrough advances needed to address well-documented problems that have impeded the adoption of health IT, and accelerate progress towards achieving nationwide use of health IT in support of a high-performing health care system.

Since then, the health care ecosystem and technology supporting it have rapidly evolved. More providers than ever have implemented electronic health record (EHR) systems3 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 7 International (HL7®)’s Fast Healthcare Interoperability Resources (FHIR®)4 and APIs are making it easier for consumers to seamlessly access and share their health data with providers and for 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 of using EHRs.

While working to implement Cures Act provisions, ONC has identified gaps with respect to leveraging EHR data to support population-level analyses and services as well as integrating clinical knowledge into routine clinical practice.6 The reasons for these gaps range from data standards and interoperability, and digitization, integration, and presentation of new evidence into clinical workflows in safe, useful, and useable ways. These challenges could compound as we move into the era of precision medicine -defined by an ever-growing corpus of data and findings.

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 health care delivery system by:

• Exploring and defining fundamental research questions within an identified set of high-priority

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 Stat. 130 (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 areas; answers to these research questions will address barriers to the nationwide electronic exchange and use of health information in a secure, private, and accurate manner;

• Providing opportunities for relevant academic and industrial researchers, health IT developers and implementers, health care providers and delivery system researchers, and other stakeholders to cooperate for the purpose of stimulating innovation and incorporating the results of research into health IT products;

• Creating breakthrough approaches, prototype(s), and/or enhancements, which may be applied in health IT in the near- and long-term, and which address identified challenges and opportunities relevant to the use of health IT;

• Identifying a range of approaches that serve as motivating and unifying forces to drive fundamental research in health IT; and

• Encouraging effective use of health IT through rapid dissemination of findings on innovations to developers and purchasers of health IT.

Taken together, these activities will significantly enhance the performance of health IT solutions to support care and research.

2. Purpose

Through the proliferation of new methods and advanced solution that are scalable across the health care industry, this funding opportunity will address well-documented and fast emerging challenges which inhibit the development, use, and/or advancement of well-designed, interoperable health IT.

New approaches are expected to further a new generation of health IT development and inform the implementation and refinement of standards, methods, and techniques for overcoming major barriers and challenges in an innovative fashion as they are identified. It is critical that the field of health care innovate and leverage the latest technological advancements and breakthroughs far quicker than it currently does to optimize real-time solutions, especially in areas which are ripe for acceleration.

This funding opportunity is specifically interested in innovative solutions and breakthrough advances in the following areas of interest:

• Expanding the scope, scale, and utility of population-level data-focused APIs; and

• Advancing clinical knowledge at the point of care.

ONC anticipates issuing one award per area of interest (for a total of 2 recipients), up to $1Million per recipient (for a total of up to $2Million in funding in fiscal year 2018). These awards will have a 2-year project and budget period at initial award. However, applicants are encouraged to submit their responses based on a 5-year project and budget period. Additional funding for out years 3-5 may be provided; contingent on availability of funds and meaningful progress.

This funding opportunity will have a 3-year open application period. ONC may issue future awards under this NOFO to other eligible applicants for future priority areas of interest. This will be contingent on the availability of funds and ONC priorities.

3. Approach

ONC expects to award two cooperative agreements to support establishment of LEAP in Health IT, each for a project period of 2 years. Each recipient will 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. Each recipient will implement a cooperative, inter-disciplinary research project addressing one of the specific areas of interest listed below.

Areas of Interest

The two areas of interest identified below will be addressed by this NOFO. The areas 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 were identified as critical areas of investigation, presenting both short-term and long-term opportunities for study and innovation.

Area 1. Expanding the scope, scale, and utility of population-level data-focused APIs

The rapid adoption of EHRs over the past several years has resulted in an ever-expanding amount of digitally available data on patients. Yet at the same time, the ease of getting data out of EHRs to inform population-level analyses (such as quality measurement by providers for their own use and assessments by payors and registries) has proven difficult. As such, there is a growing interest in the health IT community to use standardized, FHIR-based APIs to support the availability of and access to defined groups of patient data.7

More specifically, the goal of this area of interest is for the recipient to discover and document the limitations of existing FHIR, data format, and associated security specifications designed to support population-level services; propose enhancements to such specifications in consultation with relevant standards development organizations; and test the feasibility of such enhancements by developing of one or more working prototypes. After receiving ONC’s approval, these prototypes will be made publically accessible by the recipient upon completion at no cost to the general public. Further, the recipient will also need to assess the expected legal and policy landscapes in which these population services would be deployed and determine whether any such legal and policy limits would need be factored into the technology capabilities to make it easier for future users to configure/tailor their technology to applicable compliance requirements. In so doing, the recipient is expected to focus on specific objectives:

1. Reducing provider burdens associated with reporting through this technology;

2. Investigating and assessing trade-offs associated with various big data formats; and

3. Technical and legal/policy challenges to the scope and scale of FHIR-based APIs for these purposes.

Objective One envisions a future where health care providers can simply use their health IT for clinical care without the need to proactively “report” to any organization or program. Instead, via population-level API services, health care providers would be empowered to enable entities to connect their health IT to query the applicable data that would have otherwise been reported. Thus, the recipient will focus on how to fundamentally transform the current “provider reports to…” paradigm. The recipient will demonstrate through one or more working prototypes that this could be accomplished and how the applicable scope(s) of data for different requestors can be limited/compartmentalized. Ultimately, this kind of “reporting” could prove to be a valuable option in the future to help providers avoid having to invest resources to specially develop reports for the myriad of external entities to whom they must report. Examples of such reporting include, but are not limited to, federal government programs, state programs, health insurers, and accreditors.

7 https://www.healthit.gov/topic/interoperability/population-level-data-export-meeting-report https://www.healthit.gov/topic/interoperability/population-level-data-export-meeting-report

For Objectives Two and Three, the recipient will need to research and evaluate what an ideal state and functionality set would entail in the health care setting. The current state of population health APIs (as described in more detail below) has evolved in conjunction with the development of APIs that apply to single patients. However, an entirely new approach untethered from the needs of single-patient data has been identified only to a limited extent, and would provide a new, more appropriate target state. Further, the scope, scale, speed, and practical and engineering limits of FHIR-based APIs handling massive data sets has not yet been fully explored. Thus, the recipient will investigate various approaches to the population-level services FHIR APIs that explores how current and future FHIR-based APIs could lead to the ideal state identified in objective one as well as the legal/policy paradigms that could impact the scope of data that is accessible.

Before tackling the stated three primary objectives, the recipient will familiarize itself with the current state of the larger landscape of population health APIs. However, considering the resources cited within this NOFO, a full environmental scan is unnecessary. Instead, the recipient will assess the current limitations of existing technology and the pros and cons of the current alternatives.

Population health API – current state While FHIR-based APIs allow access to data from multiple patients at a time, most of the implementations are constrained to single-patient access and typically require human-mediated login.

Providers and organizations accountable for managing the health of large numbers of patients often need to efficiently access large amounts of information on a group of patients in order to calculate, for example, quality measures for reporting to payer organizations. This is often done as a custom software solution for each type of data access need, which perpetuates inefficiencies for health IT developers and yields substantial costs to health care providers and inefficiencies.

The health IT stakeholder community recognized the need to provide a more efficient population-level API service based on the FHIR standard and has developed a draft specification, the FHIR Bulk Data Export API Proposal,8 to support access and transfer of large amounts of data on groups of individuals in a scalable and secure manner. The draft specification is currently being piloted in environments using test data.

The draft specification currently supports asynchronous generation of data files for all patients or groups of patients contained in the FHIR server. The specification also contains APIs for only accessing data updated after a certain period and limiting the types of data that are primarily designed to make the APIs run efficiently and reduce infrastructure load. However, there have not been large scale efforts carried out to test that the APIs would work as designed in a production setting.

The use of the ndjson9 data format, which separates data into multiple files based on FHIR resources, is also an area for potential enhancement. While these changes were geared towards use of modern computational techniques such as parallel computing and the MapReduce10 programming model, more analysis is needed to ensure that the data formats and file structures would indeed provide sufficient efficiencies for big data analytics.

8 https://github.com/smart-on-fhir/fhir-bulk-data-docs 9 http://ndjson.org/ 10 https://en.wikipedia.org/wiki/MapReduce https://github.com/smart-on-fhir/fhir-bulk-data-docs http://ndjson.org/ https://en.wikipedia.org/wiki/MapReduce

Finally, the security model that has been developed for the use of the population-level API is based on a profile of OAuth2, called “SMART Backend Services: Authorization Guide”.11 It uses public key infrastructure (PKI) and JSON Web Tokens (JWT)12 as a means of providing access to the API. While the underlying security model is based on a robust industry standards, the security technologies have not undergone sufficient testing to support large scale adoption.

Area 2. Advancing clinical knowledge at the point of care

The volume and rate at which new clinical evidence is produced is difficult for clinicians to stay abreast of and implement into clinical practice to deliver effective care.13 The expectation that this will increase in size and complexity with the advent of precision medicine only intensifies the need for new, innovative health IT solutions and appropaches for integrating evidence in an easy to use and useful way to deliver clinical knowledge at the point of care. The goal of this area of interest is to advance clinical knowledge into the health care setting via innovative health IT tools and approaches. More specifically:

• Researching and identifying new methods to create resources or tools that will, through their incorporation into deployed technology(ies), enhance delivery of new evidence into practice, while understanding: end-user needs, workflows, data integration, and data-visualization and cognitive support. In doing so, the recipient under this area of interest will, in critical areas, close the gap between the promise of data-driven infrastructure supporting clinical knowledge precision medicine, and health IT, and its realized benefits.

• Supporting a data-driven infrastructure for improving optimal patient-specific models for improving diagnoses, interventions and outcomes that are accurate, objective, and reliable.

• Implementing new techniques and methods to incorporate and synthesize disparate but relevant data streams and evidence to advance clinical knowledge at the point of care that are accurate, objective, and reliable.

This area of interest has the following four objectives:

1. Emerging Innovations in Clinical Medicine

Investigate new and emerging methods to create data-driven resources or tools necessary to advance evidence delivery to inform clinical knowledge at the point of care. Explore the gaps and barriers inhibiting innovative approaches from advancing evidence via data-driven resources and tools to support clinical knowledge at the point of care.

Investigate clinicians from diverse care settings and backgrounds to learn what would legitimately improve their point of care decision-making using data driven tools and approaches, while considering workflows and end-user design.

2. Data-driven Medicine Infrastructure

Investigate approaches to create high quality training data sets that enable advanced analytics—clinical data combined with other data types, which are contextually relevant

11 https://github.com/smart-on-fhir/fhir-bulk-data-docs/blob/master/authorization.md 12 https://tools.ietf.org/html/rfc7523 13 Bastian H, Glasziou P, Chalmers I. Seventy-five trials and eleven systematic reviews a day: how will we ever keep up?

PLoS Med2010;7:e1000326 https://github.com/smart-on-fhir/fhir-bulk-data-docs/blob/master/authorization.md https://tools.ietf.org/html/rfc7523 and are accurate, objective, and reliable.

Investigate testing and validation approaches for advanced data science algorithms to evaluate performance of the algorithms under conditions that differ from the training set.

Consider approaches to ensure privacy and transparency of data use.

Support research to characterize the tradeoffs between data quality, information content (complexity and diversity) and sample size, with the goal of enabling quantitative prediction of the quantity and quality of data needed to support a given application.

Investigate and develop data infrastructures and standards necessary to extrapolate clinical and/or contextually relevant data to be leveraged by health IT tools and capabilities:

Clinically relevant data can include but are not limited to:

Electronic health record data Laboratory results Genomic information Medical images Prescription information Claims data

Contextual relevant data derived from the patient can include but are not limited to:

Data from wearables, medical devices, smart devices, or sensors Patient reported outcomes

Investigate protocols and IT capabilities to collect and integrate diverse data sets.

Investigate, develop, adopt, and demonstrate transparent processes and policies to ensure reproducibility for large-scale computational models.

Investigate and develop data infrastructures to capture and integrate data generated from smart devices, such as wearables and support advanced data science applications.

3. Integrating Knowledge at Point of Care

Utilize innovative tools and methods to rapidly synthesize disparate but relevant data and evidence into the point of care that is innovative and usable, while taking into account the needs of end-users, workflows, cognitive support, data-integration barriers, and enhanced data visualization requirements;

Clinically relevant data can include but are not limited to:

Electronic health record data Laboratory results Genomic information Medical images Prescription information

Claims data

Contextual relevant data derived from the patient can include but are not limited to:

Data from wearables, medical devices, smart devices, or sensors Patient reported outcomes

4. Legal and Policy Implications for Innovative Approaches

Assess the expected legal and policy landscapes in which these approaches would be deployed and determine whether any such legal and policy limits would need to be factored into the technology capabilities.

4. Project Activities

Within each area of interest, each project will carry out at least the following set of activities:

• Initially define and subsequently update or redefine on a yearly basis, the key issues and challenges within their respective area of interest. The issues and challenges identified will be those that significantly address barriers and solutions to the use of health IT. Projects to address the identified issues and challenges will be mapped via their project plan to either a short-term (2 year) and/or long-term (3-5 year) timeframe if out years are proposed. Because this is a cooperative agreement, recipients will plan and allow for collaboration with ONC and other federal staff with relevant expertise – as identified or approved by ONC – in establishing and updating the definition of key issues and challenges in the project’s area of interest;

• Conduct ambitious research addressing these key issues and challenges. This work will draw on the scientific methods and expertise of researchers and practitioners in diverse fields;

• Collect specific, uniform data about the project activities and track progress toward milestones;

• Facilitate practical and efficient processes that enable translation of project outputs into health care, facilitating the transition of multidisciplinary research outcomes into new health care products and services both the short- and long-term;

• Publish and otherwise disseminate these project findings to maximize the accessibility of this knowledge to the entire health IT community; and

• Select desired, measurable outcomes specific to the chosen research issues and challenges for attaining results.

In addition, applicants will provide a draft project plan, as an appendix to the application, with corresponding table of key dates and milestones to ensure objectives are met within the self-contained 2-year period. Recipients will also conduct virtual mid-point demonstrations/update of any proposed approaches, prototype(s), and/or enhancements to illustrate their progress on the selected area of interest.

Deliverable Table For each area of interest, applicants will provide a table that consists of expected deliverables which will be produced in support of execution of the cooperative agreement and the due date by which they s will be delivered to ONC.

No. Deliverable Due Date 1 Draft Project Plan and Timeline

The recipient will submit a detailed draft project plan, that should include (but is not limited to), key milestones, identified risks and risk mitigation strategies, stakeholder

NLT 1 month after award date

No. Deliverable Due Date cont.

coordination (as applicable), and timeline. n/a

2 Mid-point demonstration/update of proposed approach, prototype(s), and/or enhancements The recipient will provide ONC with a live, virtual demonstration of their project progress to-date

NLT 13 months after award date

3 Mid-point specification revisions revised project plan and timeline (as applicable) Based on milestone and project progress up to the mid-point, in addition to feedback from ONC from the mid-point demonstration, the recipient will submit a revised project plan and timeline and initiate any specification revisions as applicable.

NLT 1 month after completion of deliverable

4 Draft legal and policy landscape assessment The recipient will submit a draft assessment that addresses the impact of legal and policy factors on project goals

NLT 20 months after award date

5 Final legal and policy landscape assessment The recipient will submit a final assessment that addresses impact of legal and policy factors on project goals

NLT 22 months after award date

6 Submission of final approach and if applicable, prototype(s) (i.e., computer software, including all associated code and tools), and/or enhancements, as well as making prototypes publically accessible for approval by ONC.

NLT 23 months after award date

5. Performance Goals and Milestones

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

ONC’s evaluations will assess project performance and progress towards the key milestones specified below.

Potential questions for each area of interest might include, but will not be limited to, the following:

• To what extent do the project issues being pursued relate to challenges along pathway towards innovative use?

• How effective are the methods used to accelerate translation of research into health care?

• To what extent has the project identified the salient, potentially breakthrough challenges?

• What problems have been encountered in implementing all of the required features of the project?

• What relationships, as appropriate, has the project established with industry to facilitate the translation of the research?

The key project milestones include:

• Developing an initial 2-year project plan, delineating components that will complete in 2 years, as well as longer term components if proposed;

• Establishing a technical expert panel to review research methods, results, and provide guidance;

• Implementing the plan to translate project outcomes into broader uptake;

• Scheduling and conducting (as appropriate) and participating in expert panel meetings, team meetings and stakeholder meetings;

• Conducting and managing project to conclusion in 2 years;

• Conducting and managing the long-term projects to significant, demonstrable progress in out years, if awarded; and

• Communicating findings through appropriate mechanisms and making available as they are generated.

Area 1: Expanding the scope, scale, and utility of population-level data-focused APIs

ONC is seeking innovative solutions and enhancements to the currently specified population-level FHIR API approach. Such solutions will need to address ways to reduce provider reporting burden and the use of population-level FHIR-based API services at scale. Recipient’s demonstrated and communicated progress through detailed quarterly reports and monthly check-ins will determine fund drawdowns.

Recipients will work towards all three objectives identified above for this area.

Area 2: Advancing Clinical Knowledge at the Point of Care

ONC is seeking innovative health IT approaches to advance clinical knowledge into the health care setting. Recipient’s demonstrated and communicated progress through detailed quarterly reports and monthly check-ins will determine fund drawdowns. Recipients will work towards all four objectives identified above for this area.

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 - A cooperative agreement is a support mechanism used when there will be substantial Federal Involvement.

Application Type: New

Funding Opportunity Number: NAP-AX-18-003

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, 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 health care 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 must 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, 2018, Pub. L. 115-141, Division H, Title II

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

Anticipated Number of Awards: Two (one per area of interest)

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

Project Period: 09/19/2018 to 09/18/2023

Budget Period(s): 09/19/2018 to 09/18/2020

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 3-year open application period, where 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 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.

Cost-Sharing Requirements: There are no cost sharing requirements associated with this award.

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 costs to determine the net allowable costs on which the Federal share of costs is based; 2) add it to funds otherwise available for the project, generally resulting in an increase to the total approved budget; 3) use it to meet a matching or cost sharing requirement; or 4) a combination of these alternatives. If program income is generated, ONC recipients must us the additive method.

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

Intergovernmental Review: This project is excluded from Executive Order 12372

Key Dates

Milestone Date NOFO Released

06/29/2018

Informational Session

07/12/2018

Letter of Intent Due

07/19/2018

Applications Due

08/17/2018

Anticipated Award Date

09/19/2018

Anticipated Project Start Date

09/19/2018

Roles and Responsibilities Under a Cooperative Agreement The funding instrument used for this funding opportunity 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 work cooperatively with each recipient; 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 tasks and activities may be shared between the recipient and ONC include, but not limited to:

♦participating in the selection of key personnel

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

♦agency review and approval of substantive provisions of proposed subawards or contracts

♦reviewing deliverables or other grant products

♦selecting technical expert panel members

♦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

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

• 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://www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-leap-notice-funding-opportunity

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 no later than 3 days prior to the call.

Letter of Intent Although not required, applicants are strongly encouraged to submit a non-binding e-mail notice of intent to apply for this funding opportunity. This letter of intent will assist ONC in planning for the application review process. When submitting your letter of intent, please identify which area of interest your organization plans to apply for.

The letter of Intent is requested by 11:59 P.M. Eastern Standard Time on July 17, 2018, and should be sent to ONC-LEAP@hhs.gov . The letter 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://www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-leap-notice-funding-opportunity https://www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-leap-notice-funding-opportunity https://www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-leap-notice-funding-opportunity mailto:onc-leap@hhs.gov

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)

• 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 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 Funding Opportunity Description section of this NOFO. The project narrative should also align with the Performance Goals and Milestones, and Merit Review Evaluation criteria presented in this NOFO.

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 35-pages. A Project Narrative that exceeds the 35-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 35-page limit. Pages must be numbered.

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

1. Area of Interest, Vision Statement, and Key Challenges (2-3 pages)

2. Proposed Approach (10-14 pages)

3. Project Team (2-3 pages, exclusive of biosketches)

4. Plan for Disseminating and Transitioning Appropriate Research Results into Practice (2-3 pages)

5. Stakeholder Coordination (2-3 pages)

6. Project Management (3-5 pages, exclusive of project timeline and organizational chart)

7. Organizational Capability (2-4pages)

1. Area of Interest, Vision Statement, and Key Challenges. This section should offer the applicant’s conceptualization of the selected area of interest. This should also 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 self-contained project period (2 years) and challenges requiring longer (3-5 years). Applicants must clearly state which area of interest of interest the proposed project will address. (2-3 pages).

2. Proposed Approach. 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 in the area of interest and how to advance the field via proposed activities to meet the objectives of the of that specific area of interest. This section should be organized so that the relationship of each element of the plan to each of the areas objectives and associated activities are completely clear. The development or employing of novel concepts, approaches, methodologies, tools, or technologies; or combination of common research elements in an innovative fashion should be described and how it will generate much-needed insight to 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 objective being addressed should be described as a discrete activity, and each activity should have a separately itemized budget as described below. Each activity must be clearly identified as having a self-contained aim (2 year) and as appropriate long-term (3-5 year) aims delineated for each objective. While the applicant institution and sub-recipients may undertake activities that exclusively involve personnel at their own institutions, the integration and cohesiveness of the project will be enhanced by activities on which personnel from multiple projects directly collaborate.

The approach should include as much detail as possible given the page limitation. Notwithstanding, the plan for each activity, at a minimum, must 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 area of interest being addressed; 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” section described below.

Applications should justify their arguments through reliance on relevant scholarly articles and other literature. Up to 100 citations may be included. Citations will be judged by quality, not quantity.

Applicants should avoid multiple, partially-redundant citations. Where an assertion in the narrative is supported by a large number of citations, the narrative might state the number of citations that support the assertion and then include in the citation list only the most important exemplars.

All key personnel mentioned in this section must have biosketches (https://grants.nih.gov/grants/forms/biosketch-blankformat.docx) provided in a separate section of the application. (10-14 pages)

3. Project Team

• Project Director/Principal Investigator (PD/PI):

o Only one PD/PI may be designated on the application.

o An eligible PD/PI may come from a variety of areas including, but not limited to: nurses, pharmacists, medical doctors, health service researchers, economists, health system administrators, health IT experts, industrial and systems engineers, computer and cognitive scientist, human factors professionals, and health informatics. Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support.

o The PD/PI is expected to contribute a minimum of 20% effort annually throughout the course of the grant. If less time is allocated, an explicit justification of the lower level of effort must be included.

• At least one person on the proposed research team must possess health IT expertise.

• For Area of Interest 1: Expanding the scope, scale, and utility of population-level data- focused

APIs.

o Does the proposed research team have expertise in the following areas:

Data standards development and balloting expertise API development and EHR integration expertise

• For Area of Interest 2: Advancing clinical knowledge at the point of care o Does the proposed research team have expertise in the following areas:

User-Centered Design Data Visualization Cognitive Support

• Multidisciplinary research teams are strongly encouraged, as appropriate, to conduct the project and associated activities.

• The application should include a biosketch, utilizing the template found here:

https://grants.nih.gov/grants/forms/biosketch-blankformat.docx for key project personnel, including all key personnel who will participate in the project’s work.

o Project team members must describe their proposed role and why their experience and qualifications make them well-suited for this role in the “Personal Statement” section of their biographical sketch. Include only relevant or similar past and current projects as it relates to the area of interest.

https://grants.nih.gov/grants/forms/biosketch-blankformat.docx https://grants.nih.gov/grants/forms/biosketch-blankformat.docx o Biosketch for each should not exceed 5 pages in length. These will not count towards the page limit.

• For proposed research team members for whom biosketches are not required, NOFO applications must describe their proposed role and why their experience and qualifications make them well-suited for this role in the in the Budget Justification. (2-3 pages)

4. Plan for Disseminating and Transitioning Appropriate Research Results into Practice. This section should describe a plan for engaging health IT stakeholders and interested groups in promoting the dissemination and transition of appropriate research activities and results into data standards, data infrastructures, health IT products, tools, and best practices. The plan should be specific in proposing activities that will disseminate and transition the results of the proposed self-contained (2 year) projects in products and best practices. Collaborative arrangements with industry and other groups outside the applicant institution should be accompanied by appropriate letters of support. (2-3 pages)

In the event an applicant’s solution include the development of a prototype, the applicant should also submit a plan for approval by ONC, illustrating how the prototype will be made and maintained in a publically available and acceptable domain at no cost to the general public.

5. Stakeholder Coordination. This section should describe plans to establish and operate a technical expert panel of relevant and appropriate stakeholders, including names of members who have committed to join or proposed to join to help inform the work to be conducted on the relevant area of interest. (2-3 pages)

6. Project Management. This section should include a clear delineation of the roles and responsibilities of the principal investigator, participating researchers, project staff, consultants and collaborating organizations, and how they will contribute to achieving the research objectives and outcomes. If the application includes sub-recipients with contractual relationships, plans for coordinating research activities across multiple organizations should be described. This section should specify who would have day-to-day responsibility for key tasks such as: leadership of project;

monitoring the project’s on-going progress, preparation of reports; communications with other collaborating organizations, and ONC. Recipients will be required to maintain information relevant to achieving proposed milestones and performance-based outcomes. The application should describe the approach that will be used to assess project performance and monitor and track progress toward meeting key milestones.