LEAP FY2023 Special Emphasis Notice.pdf

The Office of the National Coordinator for Health Information Technology (ONC) Announces Special Emphasis Notice (SEN) Interest in Applications to Advance Fast Healthcare Interoperability Resources (FHIR®) Capabilities and Identify Data Quality Improvements for USCDI Data Elements

Notice Number: NAP-AX-22-001

Key Dates Release Date: April 10, 2023 Expiration Date: June 12, 2023

Issued by Office of the National Coordinator for Health Information Technology (ONC)

Purpose

This notice announces ONC’s interest in funding projects under the Leading Edge Acceleration Projects (LEAP) in Health Information Technology (IT) funding opportunity (see NAP-AX-22- 001 at https://www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001) in fiscal year 2023 to advance Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) Capabilities and Identify Data Quality Improvements for USCDI Data Elements.

Areas of Interest

ONC is the principal federal entity charged with coordination of nationwide efforts to implement and use the most advanced health information technology and the electronic exchange of health information. Created in 2004 through Executive Order 133351 and legislatively authorized in the Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009,2 ONC is at the forefront of the federal government’s health IT efforts and is a resource to the entire health IT and health care community to support the adoption of health IT and the promotion of nationwide health information exchange (HIE) to improve health care.

The goal of the LEAP in Health IT funding opportunity is to address well-documented and fast emerging challenges inhibiting the development, use, or advancement of well-designed, interoperable health IT, which are 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. The descriptions provided for Area 1 and Area 2 include ways in which applicants may approach developing a project. The Areas of

1 https://www.govinfo.gov/content/pkg/WCPD-2004-05-03/pdf/WCPD-2004-05-03-Pg702.pdf 2 https://www.healthit.gov/sites/default/files/hitech_act_excerpt_from_arra_with_index.pdf https://www.healthit.gov/ https://www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001 https://www.govinfo.gov/content/pkg/WCPD-2004-05-03/pdf/WCPD-2004-05-03-Pg702.pdf https://www.healthit.gov/sites/default/files/hitech_act_excerpt_from_arra_with_index.pdf

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.

In fiscal year 2023, ONC is soliciting applications pursuant to the LEAP in Health IT funding opportunity for projects that address one of the following areas of interest:

• Area 1: Exploring the Use of Advanced Fast Healthcare Interoperability Resources (FHIR®) Capabilities

• Area 2: Identifying Data Quality Improvements for USCDI Data Elements

ONC expects to issue one cooperative agreement award per area of interest up to $1 million per award, totaling up to $2 million for the two awards in fiscal year 2023. Please note that all applicants must explicitly state the area of interest for which they are applying. Applications that do not clearly state their intended area of interest will not be considered. Eligible applicants may apply for more than one area of interest; however, a separate application is required for each area. Except for the specific areas of interest listed above and described below for fiscal year 2023, and the required expertise noted for each area of interest described below, all other requirements and evaluation criteria described in the LEAP in Health IT Notice of Funding Opportunity (NOFO) (NAP-AX-22-001 at https://www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001) shall apply.

Area 1: Exploring the Use of Advanced FHIR Capabilities

The goal of this area of interest is to accelerate the adoption readiness of existing, advanced FHIR capabilities developed by the health IT community and demonstrate the value of health IT to solving complex problems in health care. Applicants can achieve this goal by performing a rigorous technical exploration of advanced FHIR capabilities, including identifying use case(s) that will benefit from the use of the advanced feature(s), software development, implementation, testing, and piloting under real-world conditions.

During 2023, ONC anticipates the continued deployment of secure, standardized application programming interfaces (APIs).3 Due to substantial efforts made over the last decade, the FHIR standard has matured since it was first created in 20124 and is now broadly adopted by the health IT industry.5 The business and technical advances ushered in by the 21st Century Cures Act:

Interoperability, Information Blocking, and the ONC Health IT Certification Program6 (ONC Cures Act Final Rule)7 have established APIs and apps as core drivers of enhanced access, functionality, and user and patient experience in health care interoperability.

3 https://www.healthaffairs.org/do/10.1377/forefront.20220217.71427 4 http://hl7.org/fhir/directory.html 5 https://www.healthit.gov/buzz-blog/health-it/the-heat-is-on-us-caught-fhir-in-2019 6 https://www.govinfo.gov/content/pkg/FR-2020-05-01/pdf/2020-07419.pdf 7 https://www.healthit.gov/topic/oncs-cures-act-final-rule#:~:text=ONC's%20Cures%20Act%20Final%20Rule%20supports%20seamless%20and%20secure%20access,se cure%20access%20to%20health%20information.

https://www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001 https://www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001 https://www.healthaffairs.org/do/10.1377/forefront.20220217.71427 http://hl7.org/fhir/directory.html https://www.healthit.gov/buzz-blog/health-it/the-heat-is-on-us-caught-fhir-in-2019 https://www.govinfo.gov/content/pkg/FR-2020-05-01/pdf/2020-07419.pdf https://www.healthit.gov/topic/oncs-cures-act-final-rule#:%7E:text=ONC's%20Cures%20Act%20Final%20Rule%20supports%20seamless%20and%20secure%20access,secure%20access%20to%20health%20information https://www.healthit.gov/topic/oncs-cures-act-final-rule#:%7E:text=ONC's%20Cures%20Act%20Final%20Rule%20supports%20seamless%20and%20secure%20access,secure%20access%20to%20health%20information https://www.healthit.gov/topic/oncs-cures-act-final-rule#:%7E:text=ONC's%20Cures%20Act%20Final%20Rule%20supports%20seamless%20and%20secure%20access,secure%20access%20to%20health%20information

The Recognized Coordinating Entity, which administers the Common Agreement component of the Trusted Exchange Framework and Common Agreement (TEFCA)8 on behalf of ONC, has released a FHIR Roadmap9 that outlines how FHIR APIs can also become an established part of network exchange, such as through business-to-business (B2B) clinical interoperability supporting high-volume, high-reliability, high-trust exchange patterns. Adding FHIR-based exchange to network exchange creates the ability to conduct exchange at-scale.10

The health IT community has leveraged this common, industry-wide specification to innovate and extend FHIR to address more advanced use cases to meet the complex needs of health care, including performing more complex interactions with FHIR servers that go beyond the secure API-enabled “read” services for single and multiple patients established as part of the ONC Health IT Certification Program.11 These types of FHIR-based capabilities, if further proven, could improve interoperability as well as user experiences for patients and providers. The following are examples of advanced FHIR capabilities of which ONC is aware:

• FHIR Subscription12

• Clinical Decision Support (CDS) Hooks13

• FHIR Standard for Scheduling14

• SMART Health Cards15

• SMART Health Links16

• FHIR Write17

• Electronic Health Information (EHI) Export API18

• FHIRCast19

• Network-facilitated FHIR Exchange20

Each of these advanced FHIR capabilities has support across the health IT community, and some are actively being addressed by the developer community through the Argonaut Project.21 Additionally, most of these capabilities have a draft implementation specification that has gone through peer review; multiple rounds of testing, piloting, and standardization; or both, by the HL7 standards development organization.

8 https://rce.sequoiaproject.org/tefca-and-rce-resources/ 9 https://rce.sequoiaproject.org/wp-content/uploads/2022/01/FHIR-Roadmap-v1.0_updated.pdf 10 https://confluence.hl7.org/display/FAST/FHIR+at+Scale+Taskforce+%28FAST%29+Home 11 https://www.healthit.gov/test-method/standardized-api-patient-and-population-services#ccg 12 https://build.fhir.org/subscription 13 https://cds-hooks.org/specification/current 14 https://github.com/smart-on-fhir/smart-scheduling-links 15 https://smarthealth.cards/en/ 16 https://hackmd.io/kvyVFD5cQK2Bg1_vnXSh_Q 17 https://confluence.hl7.org/display/AP/Argo+Write+Homepage 18 https://confluence.hl7.org/display/AP/EHI+Export+API 19 https://fhircast.org/ 20 https://rce.sequoiaproject.org/wp-content/uploads/2022/12/TEFCA-Facilitated-FHIR-Implementation-Guide- Draft-2-Pilot-Version.pdf 21 https://confluence.hl7.org/display/AP/Argonaut+Project+Home https://rce.sequoiaproject.org/tefca-and-rce-resources/ https://rce.sequoiaproject.org/wp-content/uploads/2022/01/FHIR-Roadmap-v1.0_updated.pdf https://confluence.hl7.org/display/FAST/FHIR+at+Scale+Taskforce+%28FAST%29+Home https://www.healthit.gov/test-method/standardized-api-patient-and-population-services#ccg https://build.fhir.org/subscription https://cds-hooks.org/specification/current https://github.com/smart-on-fhir/smart-scheduling-links https://smarthealth.cards/en/ https://hackmd.io/kvyVFD5cQK2Bg1_vnXSh_Q https://confluence.hl7.org/display/AP/Argo+Write+Homepage https://confluence.hl7.org/display/AP/EHI+Export+API https://fhircast.org/ https://rce.sequoiaproject.org/wp-content/uploads/2022/12/TEFCA-Facilitated-FHIR-Implementation-Guide-Draft-2-Pilot-Version.pdf https://rce.sequoiaproject.org/wp-content/uploads/2022/12/TEFCA-Facilitated-FHIR-Implementation-Guide-Draft-2-Pilot-Version.pdf https://confluence.hl7.org/display/AP/Argonaut+Project+Home

While many of these advanced FHIR capabilities show great promise in meeting health care organizations’ technology needs, they have not yet been widely adopted by health IT developers or requested by health care organizations for these capabilities.22 Several reasons may exist for this, including a lack of sustained resources among the health IT community to fully test these capabilities in real-world settings (e.g., test and validate that these capabilities can handle the scale, response times, workflow integration, implementation, and other requirements from health IT systems running in production environment) and a lack of sustained resources to mature the specifications to provide evidence to the health IT community of their readiness for industry-wide adoption.

As an example, the HL7 SMART Application Launch Framework Implementation Guide,23 which is widely adopted by industry and the Secretary has adopted for use in certified health IT,24 was initially developed as an advanced FHIR capability by the SMART Health IT program.25 It took sustained time and resources from the standards community to mature the specification and health IT industry-led testing by the Argonaut Project,26 which eventually resulted in the publication of Version 1.0.0 in 2018 by the HL7 Standards Development Organization. The Secretary finalized the adoption of SMART Application Launch Framework Implementation Guide Version 1.0.0, at 45 C.F.R. § 170.215(a)(3), in the ONC Cures Act Final Rule (85 FR 25741).27

There are several other examples that have undergone a similar process, including the maturation and adoption of the FHIR Bulk Data Access (Flat FHIR) implementation specification.28

Applicants can seek the expertise of the health IT community and health care organizations to work together to implement and pilot advanced FHIR capabilities. Implementation pilots of the advanced FHIR capabilities can provide insights into technical limitations of the health IT infrastructure and the capability of the electronic health record (EHR) system to scale FHIR across multiple health care settings. The observations derived from these pilots help industry make necessary changes to ensure advanced FHIR capabilities are ready for industry-wide adoption. Industry-wide adoption of advanced FHIR capabilities can improve the exchange of health information, patient access to health data, and health data management.

22 https://ehrintelligence.com/news/api-adoption-slow-widespread-fhir-uptake-expected-by-2024; Maisel, N. (2022, September 16). Uptake of FHIR: Where are We Today and What are the Challenges that Lie Ahead? [PowerPoint presentation]. 2022 ONC Virtual Tech Forum, https://www.healthit.gov/news/events/2022-onc-virtual-tech-forum 23 https://www.hl7.org/fhir/smart-app-launch/ 24 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B/section-170.215 25 https://smarthealthit.org/ 26 https://confluence.hl7.org/display/AP/Implementation+Guides 27 https://www.federalregister.gov/d/2020-07419/p-1184 28 http://hl7.org/fhir/uv/bulkdata/STU1/ https://ehrintelligence.com/news/api-adoption-slow-widespread-fhir-uptake-expected-by-2024 https://www.healthit.gov/news/events/2022-onc-virtual-tech-forum https://www.hl7.org/fhir/smart-app-launch/ https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B/section-170.215 https://smarthealthit.org/ https://confluence.hl7.org/display/AP/Implementation+Guides https://www.federalregister.gov/d/2020-07419/p-1184 http://hl7.org/fhir/uv/bulkdata/STU1/

Applicants are encouraged to consider the following as activities that could achieve the overall goal of Area 1:

• Performing technical exploration, as described hereafter, of one or more existing advanced FHIR capabilities in at least two use cases.

• The technical exploration of the FHIR capability could include:

o Testing the advanced FHIR capability across multiple dimensions, such as scalability, response times, infrastructure needs, and other relevant technical functions to determine if the advanced FHIR capabilities can meet the needs of industry.

o Piloting the FHIR capability or capabilities in a setting that provides maximum insights into an organization’s ability to adopt advanced FHIR capabilities within the organization.

o Additional testing or other activities necessary for production implementation of the FHIR capability or capabilities, if planned by the applicant as part of their proposal.

o Actively participating in all relevant FHIR standards activities, including supporting the advancement of specifications within the HL7 standards development organization29 and associated FHIR Accelerator Projects,30 keeping the FHIR community aware of the findings, and implementing the solutions, for the use cases proposed, in an open-source environment that enables other developers to implement the software in their own environment.

• Documenting the software requirements and associated artifacts of the advanced FHIR capability or capabilities so that the software source code can be readily used by software developers as an open-source tool and a learning example for independently implementing software in their own development environments.

• Demonstrating the applicability of the advanced FHIR capability or capabilities to meet the goals of the use cases and enhance access, functionality, and user experience in health care interoperability.

• Developing, publishing, and disseminating a report on each advanced FHIR capability and its readiness for industry-wide adoption. This type of report would help health IT implementers to advance FHIR capabilities to improve the exchange of health information and health data management to improve patient care. For example, the report could include the following types of information:

o Standard technical security configurations and considerations with the adoption of FHIR that can be used as a secure implementation guide.

o Findings on limitations or challenges in the FHIR capability, recommendations, and next steps to mitigate these limitations and challenges.

29 https://www.hl7.org/index.cfm 30 https://confluence.hl7.org/ https://www.hl7.org/index.cfm https://confluence.hl7.org/

Applicants for an award in this area of interest are encouraged to include, as part of their applications, a coalition of key stakeholders who will be directly involved in the project, such as health IT developers, Certified Health IT vendors, health care providers, payers (i.e., Medicare, commercial healthcare insurers), public health agencies, and health information networks.

Applicants should include letters of commitment from key stakeholders.

An applicant’s proposal must not rely on proprietary technology.

Applicants for an award in this area of interest shall demonstrate expertise in the following:

• API Standards31 adopted for the ONC Health IT Certification Program.

• The advanced FHIR capability or capabilities they propose in their use cases.

Applicants for an award in this area of interest shall include the following in their application:

• Propose at least one advanced FHIR capability, including but not limited to those explicitly listed in this SEN, so long as they provide evidence that the selected advanced capability or capabilities were previously developed by the FHIR community and are openly available for implementation. This is to ensure that the applicant focuses on existing advanced FHIR capabilities in need of maturity rather than developing a brand-new capability as part of this LEAP award.

o Applicants can propose a single advanced FHIR capability to meet two separate use cases if each use case is independently tested as specified further below.

• Identify at least two use cases and provide detailed explanation on how the applicant plans to test the advanced FHIR capability or capabilities to solve the problem associated with the use case effectively, as compared to existing solutions.

• Provide a detailed project plan for meeting the goal of this area of interest, including performing technical exploration, as described in this SEN.

Area 2: Identifying Data Quality Improvements for USCDI Data Elements

The goal of this area of interest is to identify, understand, and assess the quality of USCDI data elements that are collected, exchanged, and used by various health IT systems (e.g., EHRs, health information networks, laboratory information systems, etc.) and implement non-proprietary solutions to improve data quality. Applicants can achieve this goal by performing a 360-degree evaluation, in real world clinical settings, of data quality of the selected data elements collected (e.g., identify and assess any missing), the degree of conformance to data standards (e.g., use of mature standards and vocabulary codes) and the ability (or lack thereof) to successfully match patient records, perform aggregation of the data, and compare data obtained from disparate sources.

31 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B/section-170.215 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B/section-170.215

Ready, reliable, and consistent access, exchange, and use of EHI32 can improve health care quality, safety, and patient outcomes. High quality, interoperable data will help power future generations of tools for clinical decision making, population health management, disease surveillance, and research. Data quality is defined as data that is fit for use within a specific context and is typically addressed in the following dimensions: (1) measurable components of data quality to include accuracy, completeness, concordance, consistency, currency, and redundancy, and (2) conformance to mature health IT content, terminology, and exchange standards.

For this area of interest, “data quality” focuses on when, where in workflows/practices, and how data needs to be standardized so that it can be effectively and efficiently used for, as well as beyond, the initial purpose for which it was collected or exchanged (e.g., medication reconciliation, quality measurement, health equity analyses). What makes data “high” quality to its users and recipients involves several sociotechnical factors. Such factors include the clinical and business processes motivating collection of data workflows involved in recording the data, what standards may be attributed to the data, mechanisms influencing enforcement of standards, and data comprehensiveness, completeness, and accuracy.

Data quality assessment is key for enabling appropriate use and analysis as well as understanding and quantifying research limitations.33 Assessing data quality is subjective, where the quality of the data being evaluated must be judged in relation to the activities for which they are used. In this way, data quality assessment outputs may only be comparable within a specific use case, such as immunization or laboratory reporting. Further, data quality improvement and standardization can improve patient matching, thus ensuring that patients and clinicians have better data on which to make decisions to enhance patient safety and care quality.34 Thus, data quality evaluation involves identifying root causes as to why certain use cases have “low” quality data, whether standards are available, whether such standards are used and applied consistently, and ultimately proposing solutions to make improvements.

Often, when it comes to interoperability and data quality, format (structure) and meaning (code systems and value sets) are two relevant standards facets. For instance, when coding for race, using the same code system is necessary for race data to be aggregated and consistently compared across different data sources. Race and ethnicity data in patient demographics are important to support everything from precision medicine initiatives to identifying health care disparities on a population health level. However, the quality and completeness of this

32 https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification#p-216 33 Rajan, N. S., Gouripeddi, R., Mo, P., Madsen, R. K., & Facelli, J. C. (2019). Towards a content agnostic computable knowledge repository for data quality assessment. Computer methods and programs in biomedicine, 177, 193–201. https://doi.org/10.1016/j.cmpb.2019.05.017 34 Shaun J Grannis, Huiping Xu, Joshua R Vest, Suranga Kasthurirathne, Na Bo, Ben Moscovitch, Rita Torkzadeh, Josh Rising, Evaluating the effect of data standardization and validation on patient matching accuracy, Journal of the American Medical Informatics Association, Volume 26, Issue 5, May 2019, Pages 447–456, https://doi.org/10.1093/jamia/ocy191 https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification#p-216 https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification#p-216 https://doi.org/10.1016/j.cmpb.2019.05.017 https://doi.org/10.1093/jamia/ocy191 information is a challenge,35 and this data may be collected in non-standardized ways or different stakeholders may adhere to different standards.36

Another example of the importance of data quality is understanding the uptake and use of Logical Observation Identifiers Names and Codes (LOINC) among laboratories in the United States. Gaining a better understanding of the update and use of LOINC would broaden awareness of the types of tests for which they are being used.37 Much attention has been given to lab interoperability due to the COVID-19 pandemic, thus highlighting the need to prioritize and ensure consistent and accurate intake and exchange of laboratory data. For example, the Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) collaborative, a current federal and industry initiative, aims to improve the quality of laboratory data within and between institutions.37 Based on preliminary findings from the 2022 Lab Interoperability Survey developed by SHIELD, only 1 in 5 hospital laboratories are using LOINC for issuing orders; and only 2 in 5 are using LOINC for reporting results.38 Thus a more granular and systematic approach is needed to assess not only the extent of coding, but also how the standards are being used.

While there is a need to assess and improve the quality of EHI data broadly, given the variability of EHI across health care,39 it is more practical and feasible for this LEAP award to focus on the data elements specified in United States Core Data for Interoperability versions 1 through 3 (USCDI v1 through USCDI v3).40 As part of the ONC Cures Act Final Rule,41 ONC established USCDI v1 as a standardized set of health data classes and constituent data elements that could be used for nationwide health information exchange. Such data elements include patient demographics related to race, ethnicity, and preferred language, as well as laboratory test results, medication data, and problems. USCDI v1 includes key data elements which are critical to be accessed, exchanged, and used accurately amongst all health care participants to support patients’ health care.

Applicants can seek the expertise of the health IT community and health care organizations to work together to determine patterns and root causes (where possible) of data quality issues, with an aim towards improving the interoperability (exchange) of USCDI data elements. Identifying data quality issues and creating solutions to address these issues can improve interoperability of USCDI data elements and lead to improved clinical decision making, population health management, disease surveillance, and research.

35 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6696496/ 36 Andrews, R. M. (2011). Race and Ethnicity Reporting in Statewide Hospital Data. Journal of Public Health Management and Practice, 17 (2), 167-173. doi: 10.1097/PHH.0b013e3181f5426c.

37 https://aspe.hhs.gov/shield-standardization-lab-data-enhance-patient-centered-outcomes-research-value-based-care 38 Patel, V. & Richwine, C. (2022, October 26). Lab Interoperability and Use of LOINC among U.S. Based Laboratories [PowerPoint presentation]. LOINC Annual Meeting, https://loinc.org/conference/france-2022/ 39 https://www.healthit.gov/buzz-blog/information-blocking/say-hi-to-ehi 40 https://www.healthit.gov/isa/sites/isa/files/2020-10/USCDI-Version-1-July-2020-Errata-Final_0.pdf;

https://www.healthit.gov/isa/sites/isa/files/2021-07/USCDI-Version-2-July-2021-Final.pdf;

https://www.healthit.gov/isa/sites/isa/files/2022-10/USCDI-Version-3-October-2022-Errata-Final.pdf 41 https://www.govinfo.gov/content/pkg/FR-2020-05-01/pdf/2020-07419.pdf https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6696496/ https://aspe.hhs.gov/shield-standardization-lab-data-enhance-patient-centered-outcomes-research-value-based-care https://aspe.hhs.gov/shield-standardization-lab-data-enhance-patient-centered-outcomes-research-value-based-care https://loinc.org/conference/france-2022/ https://www.healthit.gov/buzz-blog/information-blocking/say-hi-to-ehi https://www.healthit.gov/isa/sites/isa/files/2020-10/USCDI-Version-1-July-2020-Errata-Final_0.pdf https://www.healthit.gov/isa/sites/isa/files/2021-07/USCDI-Version-2-July-2021-Final.pdf https://www.healthit.gov/isa/sites/isa/files/2022-10/USCDI-Version-3-October-2022-Errata-Final.pdf https://www.govinfo.gov/content/pkg/FR-2020-05-01/pdf/2020-07419.pdf

Applicants are encouraged to consider the following activities as activities that could achieve the overall goal of Area 2:

• Identifying at least two data elements in USCDI (v1 through v3) and assess the data quality of these data elements collected in real world clinical settings. Such data elements include race, ethnicity, and preferred language,42 as well as tests, medications, and problems.43,44,45 While ONC has identified these data elements related to health equity and laboratory interoperability as being of interest to meet critical program needs, as described above, applicant could propose any data elements present in USCDI, subject to the requirement immediately below.

o Any identified data elements proposed must have applicable vocabulary standard(s) specified in USCDI as well as content exchange standard and implementation specifications as adopted in the ONC Cures Act Final Rule (85

FR 25676).

• Developing one or more measures to assess data quality of the identified data elements across selected health IT system actors or within a health care system. The assessments of data quality and detailed “root cause” analysis of data quality issues should be based on large production data sets aggregated from disparate practice settings and health IT systems to clearly surface variations that exist in real world settings.

• Based on the assessment of the current state of data quality, piloting at least one non-proprietary solution to assess and improve the quality of data that can be scaled across other health care settings and health IT systems. The solution could include a focus on policies and workflows.

• Developing and publicly sharing a comprehensive dissemination plan so that project findings may be used by other interested parties. The dissemination plan could include a plan for sharing scalable actions, strategies, and the solution piloted by the applicant, along with recommendations and lessons learned resulting from the assessment related to data quality, standards conformance, and patient matching.

• Developing, publishing, and disseminating a report on each identified data element, with information on root causes of data quality issues (where possible) and readiness for industry-wide adoption of the solution. The report could include the following: any limitations and challenges in the capability and considerations by potential adopting organization, recommendations and next steps around these limitations and challenges.

This report would help inform industry and health IT implementers by providing potential solutions to address data quality issues to improve data exchange of USCDI data elements.

Applicants for an award in this area of interest are encouraged to include a coalition of key stakeholders, who will be directly involved in the project, such as health IT developers, EHR vendors, health care providers, payers (i.e., Medicare, commercial healthcare insurers), public

42 https://www.healthit.gov/isa/uscdi-data-class/patient-demographicsinformation#uscdi-v3 43 https://www.healthit.gov/isa/uscdi-data-class/laboratory#uscdi-v3 44 https://www.healthit.gov/isa/uscdi-data-class/medications#uscdi-v3 45 https://www.healthit.gov/isa/uscdi-data-class/problems#uscdi-v3 https://www.healthit.gov/isa/uscdi-data-class/patient-demographicsinformation#uscdi-v3 https://www.healthit.gov/isa/uscdi-data-class/laboratory#uscdi-v3 https://www.healthit.gov/isa/uscdi-data-class/medications#uscdi-v3 https://www.healthit.gov/isa/uscdi-data-class/problems#uscdi-v3 health agencies, and health information networks (HINs). Applicants should include letters of commitment from key stakeholders.

An applicant’s proposal shall not rely on proprietary technology.

Applicants for an award in this area of interest shall demonstrate, in their application, familiarity with and understanding of the following:

• USCDI, applicable vocabulary standards and the appropriate content and exchange standards and implementation specifications used in the access, exchange, and use of these data elements.

• Ability to perform data quality assessment and standards conformance on real-world demographic and clinical data in real word settings (e.g., hospitals, integrated delivery networks, academic medical centers, HINs, etc.)

• Ability to develop scalable measures that can provide clear and transparent assessment of the quality of identified data elements.

Applicants for an award in this area of interest shall include the following in their application:

• Provide detailed explanation on their ability to conduct a pilot(s) of any identified solution(s).

• Provide a detailed project plan for meeting the goal of this area of interest.

Further Guidance

Unless otherwise indicated in this Notice, all requirements, instructions, and terms and conditions of the Leading Edge Acceleration Projects (LEAP) in Health Information Technology (IT) funding opportunity (NAP-AX-22-001 at https://www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001) will apply to applications submitted and awards made in response to this Notice.

Application Submission and Special Application Receipt Date. Information about the application process can be found at https://www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-leap-health-information or https://www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001.

An informational session will be held on April 25, 2023. 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-health-information.

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. 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 April 28, 2023. Interested organizations can send the letter of intent to ONC-LEAP@hhs.gov. Please identify the name of the applicant organization, the city and state in which the applicant organization is located, the intended area(s) of interest, and the Notice of Funding Opportunity title and number.

https://www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001 https://www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001 https://www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-leap-health-information https://www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-leap-health-information https://www.grants.gov/web/grants/search-grants.html?keywords=nap-ax-22-001 https://www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-leap-health-information https://www.healthit.gov/topic/onc-funding-opportunities/leading-edge-acceleration-projects-leap-health-information mailto:ONC-LEAP@hhs.gov

Submit applications focused on the areas of interest identified in this Notice by NOON Eastern Standard Time on June 12, 2023. This Notice will expire on June 12, 2023.

Inquiries

Please direct all program related inquiries to:

Lolita Kachay LEAP Program Manager Office of the National Coordinator for Health Information Technology (ONC) Email: ONC-LEAP@hhs.gov

Please direct all grant related inquiries to:

Carmel Halloun Grants Branch Chief Office of the National Coordinator for Health Information Technology (ONC) Email: oncgrants@hhs.gov mailto:ONC-LEAP@hhs.gov mailto:oncgrants@hhs.gov