FAQ Topics: LEAP in Health IT, 2020
2020 LEAP in Health IT Questions
Questions for 06-05-2020
- Q: We have gone through the process of filing for a SAM account, and a grants.gov account– yet I have heard from SAM help desk that our account will NOT be approved for 7-10 business days which will negatively impact us as it relates to filing for this application electronically on Monday June 8 through grants.gov (as grants.gov has told us we must have a SAM account).Can you tell us if there is a path to submit this manually/non-grants.gov or some escalation you can help us with to get a SAM account finalized? Our group has worked hard on developing an innovative approach to enabling a FHIR based CRN. It would be unfortunate if we could not submit our application.
A: All applications must be submitted via grants.gov. Unfortunately, any applications that are not submitted via grants.gov will not be considered for award.
- Q: Can you tell me where the attachments go into Cayuse? What is the order of attachments? Do Biosketches go under Attachment 1?
A: All applications must be submitted via grants.gov. Please refer to slide 29 of the SEN PPT or page 25 of the NOFO for application submission instructions.
- Q: I am gathering data to support a healthcare platform we are working on to improve patient treatment plans and outcomes. Does the ONC have available data about Healthcare IT spending that I may access for the providers and payers?
A: Unfortunately ONC does not have any readily available data specific to health IT spending for providers and payors.
- Q: Are these registries required to be FHIR compatible already to be eligible for the grant? Or is it okay that they are not yet FHIR compatible and that the grant is designed to help and catalyze their registries (and other registries) nationwide to *become* FHIR compatible?
A: As stated on page 5 of the SEN, “Applicants must also be utilizing a FHIR-enabled product. If an applicant is not currently FHIR-enabled, they will be required to become upgrade their software to become FHIR-enabled within six (6) months of the project award date.” - Q: I am pleased to submit my forthcoming application for the Leading-Edge Acceleration (LEAP) in Health Information Technology funding opportunity…[redacted]… I appreciate your consideration very much.
A: We are unable to accept applications at the ONC-LEAP@hhs.gov email address. All applications must be submitted following the applications instructions as outlined in the NOFO via grants.gov. Applications that are submitted using any other vehicle other than grants.gov will not be considered. - Q: Our organization is in the process of negotiating a federally-negotiated indirect cost rate, but it will likely not come through in time for the June 8 deadline. We do anticipate having a federally-negotiated indirect cost rate before project start. Is there any potential for an organization to retroactively apply an indirect rate if awarded?
A: ONC cannot retroactively apply an indirect cost rate to an award. The rate can be applied utilizing the start date of the agreement. The applicant can include the indirect cost as part of their budget to be submitted with their application, however the indirect cost rate agreement would need to be submitted to the ONC grants office prior to any budget approvals. - Q: For the FAQ: There is a 20% minimum level of effort requirement for the PI/PD. Can a portion or all of this be provided as an in-kind contribution, or must the full 20% be direct charged in the budget? For example PI LOE is 20%. Expense to ONC is 10%, expense to prime applicant is 10%.
A: We have no preference on how the 20% is budgeted as long as the PI meets the 20% minimum LOE.
- Q: Can you please provide additional information about eligibility for grant opportunity NAP-AX-18-003 (Leading Edge Acceleration Projects in Health Information Technology)? Specifically, is CDC considered an “eligible agency of the federal government”?
A: There are some federal agencies that are eligible to apply for other federal grants and cooperative agreements. If you are a federal agency and are not sure if you are eligible, please check with your budget office or general counsel. - Q: Enclosed is a project plan & timeline for your perusal. Does this document answer any potential concerns about the project’s eligibility for your program? We would hire a US business partner for the development of the application.
A: This is a competitive award and we are only able to answer general questions. ONC is unable to answer direct questions specific to an individual organization’s proposal or “pre-approve” whether a potential applicants proposal is appropriate or eligible. Please refer back to the notice of funding opportunity and special emphasis notice for applicant eligibility. - Q: I can only find the attached RFP on your site: Is this the current one we should use for our application for the June 8, 2020 deadline? If not, can you please send me the current RFP?
A: Please refer back to the notice of funding opportunity and special emphasis notice for the current announcement and application requirements. - Q:
- As it relates to the project objectives #1 under Area one, Identify the clinical registry(ies) that will be used by the project. Do the clinical registry(ies) have to be active at the time of application submission?
- Can our research under the LEAP Grant involve real patients and their associated data using a clinical research guidelines?
A:
- Yes, it is the expectation that applicants will partner with an active clinical registry. If the applicant intends to partner with a clinical registry that is not current active, the applicant must include the timeline of when the clinical registry is expected to become active.
- Yes, research conducted under this cooperative agreement may involve real patients and associated data, provided that their consent is obtained and included before any information is publicly released.
- Q: Would it be possible to extend the deadline for our responses to the ONC LEAP SEN until later in June 2020? Many of our team members are currently busy supporting COVID-19 initiatives and research for the state of [redacted]. We would like to have some additional time to allow us to prepare a thoughtful and thorough response to your RFP.
A: At this time ONC is not entertaining the possibility of a deadline extension. - Q: For Area 3, our team’s attempts to engage partners to help demonstrate and pilot “real-world implementations” of a solution have been consistently and adversely impacted by COVID-19. Unfortunately, the same people in who are instrumental to demonstrating the ability to work with both health and human service data are very busy focusing on the pandemic. Would ONC consider moving this LEAP SEN, particularly Area 3, out to a different period?
A: Due to regulations and requirements around the use of federal funds within appropriate fiscal years and federal awards under the way this NOFO is drafted, we are unable to move the period of this SEN to a different period.
- Q: We’re interested in applying for the above grant however we missed the letter of intent grace period since one of our contacts just forwarded this opportunity. I was wondering is it ok to submit the grant application?Secondly, we are using latest technologies like AI and Blockchain to facilitate instant patient data security and interoperability which can also integrate with existing FHIR technologies. Does that fall under the scope of the grant?
A: As noted in the special emphasis notice (SEN) (please refer to page 10), and stated during the informational sessions (please refer to slide 28), “Applicants are strongly encouraged but not required, to submit a nonbinding email Letter of Intent (LOI) to apply.”As a matter of fairness, ONC does not provide potential applicants on guidance or confirmation as to whether or not their proposal is applicable. We strongly encourage potential applicants to carefully review the SEN to determine whether their project idea fits within the scope of any of the 3 areas of interest. - Q: The 2018 NOFO instructions require the Proposed Approach to be linked to “Objectives”: “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” (p. 19 of 53). Yet the 2020 Special Emphasis Notice does not have the same delineation of Objectives as did earlier notices. Is it safe to assume that “Goals” are to be interpreted as “Objectives” for the purpose of developing a Proposed Approach, e.g. there should be activities for each of the five goals listed in Area 3 (p. 8 of 10)? If not, would you clarify the Objectives to be referenced in the Proposed Approach?
A: Please refer to slides 11, 14, and 17 from the Informational Session slide deck for the Associated Objectives for each area of interests’ Goals. You may also refer to the following pages in the special emphasis notice:- Area of Interest 1: Pages 4-5
- Area of Interest 2: Page 6
- Area of Interest 3: Pages 8-9
- Q: Do we need to budget for any travel expenses required as part of the grant?
A: Yes. All anticipated travel under this cooperative agreement, must be included in your budget proposal. - Q: Hello – is it still possible to submit questions about LEAP? In particular – we wanted to know if the total funding ($500K) be available if we had a shorter time frame e.g. 1 year versus 2 years? Is there any prohibition to completing the work earlier?
A: All awards made under this SEN are for a 2-year period of performance. Recipients will have two years to execute and complete their project in alignment with their project plan and associated budget.
- Q: I am working on a LEAP grant application and wondering if there is an updated full Notice of Funding Opportunity for 2020? The link that is listed on the Health IT.gov appears to describe the 2018 grant opportunity.
A: The Notice of Funding Opportunity (NOFO) on the LEAP in Health IT website is the current NOFO. The “updated” funding opportunity announcement for 2020 is the Special Emphasis Notice (SEN), which identifies the three (3) areas of interest that applicants may apply for this year. Outside of the specifics relating to the areas of interest, all other requirements, such as application instructions and evaluation criteria, as detailed in the original NOFO apply. - Q: I posed a question to the ONC LEAP as to whether a “special District government” was eligible to apply for funding through this program. Your response was that you were not familiar with this designation and needed more information in order to make a determination on eligibility.Per the U.S. Census Bureau (2002). 2002 Census of Governments, Vol 1, Number 1, Government Organization, GC02(1)-1 (PDF). Washington, DC: U.S. Government Printing Office. pp. vii–viii. “Special districts (also known as special service districts, special district governments, limited purpose entities, or special-purpose districts[failed verification] in the United States) are independent, special-purpose governmental units that exist separately from local governments such as county, municipal, and township governments, with substantial administrative and fiscal independence. They are formed to perform a single function or a set of related functions.”My organization, [redacted], is the only public teaching hospital in [redacted]. Our purpose is to provide health care to the public while we serve as a teaching hospital.
A: Provided that your entity is not a for-profit, based on the information provided, your organization would fall under the category of eligible applicants. - Q: I have a question regarding eligibility for the ONC LEAP program, as identified in the subject line. Are “special district government” organizations eligible to apply? I have reviewed the eligibility requirements available but special district governments are not specifically identified as eligible.
A: We are not familiar with “Special District Governments” and require more information as to what a “Special District Government” is, where this designation came from, etc. in order to provide an answer. Please contact us with ONC-LEAP@hhs.gov with more details regarding “Special District Governments” in order for us to be able to provide you with the appropriate guidance you are seeking. - Q: I tried to access the meeting on the 15th at 2pm with the link below but it didn’t let me in the zoom call. I was thinking the recording would be made available similarly to what happened for 2018 and 2019. I’m reaching out to confirm if this will be the case as the deadline for the letter of intent is only in 3 business days.
A:The slides and recording from the Informational Session are available on the LEAP in Health IT webpage. We apologize for the delay in posting as we encountered technical difficulties in uploading the recording. - Q: I’m checking to see where/when I can find responses to the questions raised during the LEAP presentation. I haven’t been able to locate them on the ONC site.
A: The FAQs are now posted. We apologize for the one day delay. - Q: Per the April 15 ONC LEAP SEN 2020 information session, ONC informed the audience questions would be posted to the FAQ site weekly, on Monday. I only see a May 2019 update as the last posting, are there questions that we can anticipate on the site? In addition the registration process failed us last week and our consortia was not able to view the slides, can those be posted?
A: The FAQs are now posted. We apologize for the one day delay. - Q: How might one be on the selection review or committee?
A: If you, or your organization does not intend to apply for a LEAP award, and are interested in serving as a Merit Reviewer, please email ONC-LEAP@hhs.gov. Note that all potential Merit Reviewers are required to complete a Conflict of Interest form. - Q: The LEAP 8/17/18 NOFO which is the application format, has a number of project activities that would be a challenge to fulfill with the limited funding available for Area 3: Integrating Health Care and Human Services. Since this is a Cooperative Agreement, what sort of resources can an applicant expect from CMS and ONC in support of this work? It is difficult to create a realistic budget proposal without information about what resources may be available from CMS/ONC.Much of the work envisioned under Area 3 complements and extends on-going work funded through Advanced Planning Documents. Can resources funded through the HITECH, MMIS or other APDs be used to supplement the work funded through the LEAP Cooperative Agreement?
A: This is a cooperative agreement award that is issued through ONC. CMS has provided input, but is not directly involved in the LEAP program otherwise. As a cooperative agreement, the award recipient will work collaboratively with their assigned ONC project officer to ensure the timely objectives, milestones, and deliverables under this award are met. The ONC project officer may also request CMS input as deemed appropriate. However, in terms of financial resources, it is limited to no more than $500,000 for area of interest 3; no additional financial resources will be made available to the recipient from ONC or CMS. Resources, such as outputs or deliverables that resulted from HITECH, MMIS, or other APDs may be used, provided that it is not financial. Federal funds from other projects are not allowed to supplement other federally funded awards.
- Q: I attended the virtual webinar regarding the grants in LEAP Health IT, which was wonderful and I greatly appreciated the information. I was actually looking for more information on the Community Health Peer Learning Program grant that I saw on the HealthIT.gov website under funding opportunities.I know the webinar did not cover this specific grant and the literature on the website cites an application due date in April of 2015, so I was wondering if you all had any insight as to if this grant is open again or if we are able to apply currently?
A: The funding opportunity you are inquiring about is listed under Previous Funding Announcements and is no longer an active funding opportunity. - Q: What is, or proposed to be, the most accurate and updated source of APIs available for post- market surveillance notices such as product advisories and recalls?
A: Health Level 7 International (HL7®) is the owner and steward of the HL7 fast healthcare interoperability resources (FHIR®) standard; you can find the most current and accurate FHIR-based application programming interface (API) on their website. In regards to post-market surveillance notices such as product advisories and recalls, we refer you to the Food and Drug Administration (FDA), as the regulators of post-market products. Their Global Unique Device Identification Database (GUDID) page can be found here. We also suggest checking the FDA’s Sentinel Initiative page here. - Q: I have a few questions I’d like to submit:
- Will the NIH Salary cap be used?
- Is F&A negotiable or is the institution’s negotiated rate used?
- Last year’s opportunity lists 33% of the budget for consultants, and 20% minimum commitment for PI’s. Is that true for this opportunity?
A:
- ONC does not follow NIH guidelines for maximum salary cap, however all salary costs associated with projects must be comparable for that specific position and geographical location.
- The institutions approved, negotiated rate is used. In the event an organization is applying F&A to an award, their current approved agreement must accompany the application.
- Yes. As noted in the presentation and SEN, other than the identified areas of interest and associated objectives and required expertise, all other requirements, evaluation criteria, and terms and conditions of the original NOFO apply.
- Q: My organization is exploring applying for the LEAP Health Information Technology grant and I have a couple of questions:
- My organization is classified as a Special District Government. According to eligibility requirements in the guidance, units of local and state government are eligible to apply. However, I don’t see that this eligiibliyt [sic] includes special district governments. Can you please confirm our eligibility?
- It appears that this opportunity has been available since 2018. Are funds still available for grant purposes?
A:
- We are not familiar with “Special District Governments” and will need more information regarding this matter in order to provide an answer. Please contact us with ONC-LEAP@hhs.gov with more details.
- The LEAP in Health IT notice of funding opportunity (NOFO) is open for 3-years, with funding available each fiscal year under a special emphasis notice (SEN). The full amount of allocated funds for each fiscal year has been awarded in FY 2018 (under the initial NOFO) and FY 2019 (under the 2019 SEN). New funds for FY 2020 are now being made via this year’s SEN. Only applications for the Areas of Interest as identified in this year’s SEN will be considered.
- Q: “…Easily, I can complete your application however, I wish to request ‘special handling.’ The Federal Government has spent billions of dollars on interoperability. For a tiny fraction of this expenditure, we could connect the Healthcare Community… Because of the need and yes, the savings / cost containment, I / we want to begin immediately. …”
A: Unfortunately this is a competitive award and in the interest of fairness, ONC is unable to entertain “special handling” requests that bypass the competitive award process. Anyone interested in receiving an award under this special emphasis notice (SEN) must apply using the process and required elements as outlined in the notice of funding opportunity (NOFO) and SEN, and is subjective to an objective review evaluation and selection of award recipients will be made based on evaluation scores, with programmatic concurrence. - Q: “…I have an interest in EHR improvement, including a project I’m trying to test the waters of viability about. Don’t want to take much of your time, but could you tell me if this is a project you’d be interested in? (Promise I’m not trying to bypass the normal application process, just an outsider to ONC and this venue for research funding, so thought the least time-wasting approach would be to inquire informally first!)…”
A: Unfortunately this is a competitive award and in the interest of fairness, ONC is not able to pre-vet or advise potential applicants on whether or not a proposal is appropriate or whether or not a potential applicant should submit or not submit an application.
GENERAL QUESTIONS
- Q: Are there handouts for this meeting?Can we get a copy of this webinar recording?
A: The PPT slide deck, along with the recording of the Informational Session, are available at the LEAP in Health IT webpage. - Q: Is the $1m funding level for Areas 1 and 2 equal to $500,000 per year for 2 years for each?
A: Areas of Interest 1 and 2 recipients will receive a total of no more than $1M for the full 2-year period of performance each. The Area of Interest 3 recipient receive a total of no more than $500,000 for the full 2-year period of performance. The recipients have the full 2-year period of performance to complete their proposed projects and expend their total awarded funds. - Q: What are eligible federal agencies?
A: There are some federal agencies that are eligible to apply for other federal grants and cooperative agreements. If you are a federal agency and are not sure if you are eligible, we recommend you check with your budget office or general counsel. - Q: Please explain further how a for-profit organization may participate.
A: A for-profit organization may participate if they partner with an eligible applicant (i.e., non-profit organization, university, etc.) as a sub-recipient. The applicant must be eligible, but may list project partners who are for-profit organizations as their sub-recipient(s). The applicant is responsible for managing all deliverables, performance, and expenditures of their partners, should their project be selected. If the applicants intends to partner with a for-profit organization, they must include these expenses in their budget proposal. - Q: Is an organization designated as a “special district government” eligible to apply?
A: We are not familiar with “Special District Governments” and will need more information regarding this matter in order to provide an answer. Please contact us with ONC-LEAP@hhs.gov with more details. - Q: Can “sub-recipient” be defined please? Under eligibility.
A: A sub-recipient is someone that the recipient partners with in order to complete the project. Each application may only have one applicant (prime), but a prime may work with other interested parties or partners, known as sub-recipients. - Q: Will the recipient of the award own their IP from this project?
A: Per 45 CFR 75.322 (b) The non-Federal entity may copyright any work that is subject to copyright and was developed, or for which ownership was acquired, under a Federal award. The HHS awarding agency reserves a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work for Federal purposes, and to authorize others to do so. - Q: How might one be on the selection review or committee?
A: If you, or your organization does not intend to apply for a LEAP award, and are interested in serving as a Merit Reviewer, please email ONC-LEAP@hhs.gov. Note that all potential Merit Reviewers are required to complete a Conflict of Interest form. - Q: Can there be multiple PIs in this proposal?
A: No, each project must have one Principal Investigator (PI) who serves as the sole point of authority and accountability for the project. - Q: Does the LOI need to be a PDF on letterhead, or is email format sufficient?
A: There is no preference on how an organizations submits a LOI beyond that it be sent to ONC-LEAP@hhs.gov by April 27th and includes the following information:- Name of applicant organization
- Organization type
- City and State
- NOFO No. NAP-AX-18-003
- Title: LEAP Special Emphasis Notice (Applications to Address the Development and Testing for Data Sharing Functionalities to Support Clinical Care, Research, and Improved Health Care Outcomes)
- Area of Interest
LOIs are strongly encouraged, but not required and are non-binding.
- Q: Are these 3 opportunities for non-profits only?
A: Please refer to Slide 22 of the Informational Session Webinar PPT or Section B (Page 13) of the NOFO for the full list of eligible applicants. - Q: Is the funding amount an annual amount or total over the two years? (e.g., for area 1 is it $1M total, or $1M per year?)For emphasis areas 1 and 2, is the $1 million amount for each year, or does the $1 million need to cover two years of activity?
A:The funding amount (up to $1M for Areas of Interest 1 and 2 and $500K for Area of Interest 3) is the total award amount for the entire 2-year period of performance. - Q: If we would like to submit multiple applications under multiple areas of interest, should we also email multiple LOIs, or can we indicate this all in one email?
A: You may indicate it all in one email. - Q: Will ONC facilitate collaboration between applicants who may have complementary proposals?
A: No. ONC does not facilitate collaboration between applicants who have complementary proposals. - Q: What requirements flow down to sub-contractors?
A: Please see 45 CFR 75.101 for sub-contractor flow down requirements. Please note that a sub-contractor is not the same as a sub recipient. In the event an applicant intends to have sub-recipients, all award requirements would flow down. - Q: If we are a private business (startup) how can we tell if we are eligible?
A :Please refer to Slide 22 of the Informational Session Webinar PPT or Section B (Page 13) of the NOFO for the full list of eligible applicants. - Q: Are applications limited to US applicants solely, or can they applicants be a consortium of US and Canadian entities (Organizations)?
A: Please refer to Slide 22 of the Informational Session Webinar PPT or Section B (Page 13) of the NOFO for the full list of eligible applicants. - Q: Can multiple organizations that bring complementary capabilities partner on one application?
A: Yes. Multiple organizations may partner together to apply for an award. However, there must be a single applicant (prime) and single Principal Investigator (PI) and Project Director (PD) identified that will serve as the overall project lead. - Q: If we submit an LOI will we receive a response confirming or denying our eligibility?
A: We do not confirm or deny a potential applicant’s eligibility based on a LOI. - Q: Are there specific Intellectual Property considerations? Albeit Open Source, who will hold IP rights?
A: The recipient may own IP from the project however, under 45 CFR 75.322 (b) The non-Federal entity may copyright any work that is subject to copyright and was developed, or for which ownership was acquired, under a Federal award. The HHS awarding agency reserves a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work for Federal purposes, and to authorize others to do so. - Q: Much of the guidance is focused on the first two ‘research’ projects – but don’t seem fully applicable to #3. Is there different guidance for #3?
A: It is unclear as to how the guidance is not applicable to area of interest 3. Please clarify or provide more information so that we may better address your question. - Q: The scoring also seems focused on the first two projects but appears less relevant to #3. Do you have any supplemental guidance about criteria that will be used for #3?
A: It is unclear as to how the evaluation criteria is not applicable to area of interest 3. Please clarify or provide more information so that we may better address your question. - Q: Slide 38 – Dissemination Plan did not mention open-source software. Is the open source component of the Dissemination Plan mandatory, highly desired, nice to have, or not needed?
A: The intention of these projects is to address well-documented and fast emerging challenges that inhibit the development, use, and/or advancement of well-designed, interoperable health IT. It is expected to further a new generation of health IT development and inform the innovative implementation and refinement of standards, methods, and techniques for overcoming major barriers and challenges as they are identified. Scalability is an important part of furthering a new generation of health IT development and interoperability, with open source software such as FHIR-based APIs is a big part of. If an applicant does not intent to build off of an open source platform, they must explain how they intend to make their end products widely available to the public. - Q: Does ONC follow NIH guidelines for maximum salary support of the PI and other investigators?
A: ONC does not follow NIH guidelines for maximum salary cap, however all salary costs associated with projects must be comparable for that specific position and geographical location. - Q: For project that extend beyond the first two years, must the funding allocated cover all (up to 5) years?
A: Awards made under this SEN are for a 2-year period of performance. While applications may propose additional 3 years (up to 5 years total), they are not guaranteed to the additional 3 years as supplemental awards under this SEN is subject to availability of funds and meaningful progress of the recipient. - Q: Many RFAs have extended application submission dates due to COVID. Do you anticipate such an extension?
A:Not at this time. - Q: How are institutional indirects handled?
A: Indirect costs that are to be applied to an award must be based on an approved Indirect Cost Rate Agreement. In the event that an organization does not have one, they are able to apply a 10% de minimus rate per 45 CFR 75.414. - Q: Is there a requirement that the third project duration is two full years? Can we recommend a shorter time period e.g. 1 year?
A: All awards made under this SEN are for a 2-year period of performance. - Q: Can an application focus on a specific disease area or does it have to be generalized to all health care areas?
A: We do not require that an application focus solely on a specific disease area or generalized to all health care areas. It is open to the applicant to propose. - Q: Are past LEAP in Health IT awardees eligible to submit for this funding opportunity or are they part of a separate review process and funding stream?
A: Anyone who meets the eligibility requirements as indicated on Slide 22 of the Informational Session Webinar PPT or Section B (Page 13) of the NOFO for the full list of eligible applicants. - Q: If we perceive a need for infrastructure that is not covered under the topics listed, can we submit that?
A: No. Only applications that address the objectives as described in the Areas of Interest in the SEN will be considered for funding. - Q: Will the LOIs (or a list of entities that submitted LOIs) be made public prior to the application deadline?
A:No. ONC does not release the names of people who submit LOIs or applications. - Q: Will this project be in support of VHA?
A:We are unclear as to what this question is asking for. This SEN is posted by ONC, in support of our mission and objectives. While findings and outcomes of these projects may benefit the VHA, as a provider and payor of health care services, it is not specific for any one particular VHA initiative or service. Please provide additional clarification or information in order for us to address this question. - Q: Is there a possibility to combine this funding with other funding for COVID-19 initiatives?
A: Not at this time. - Q: Are applicants from private sector encouraged, or is it better to have a university research organization to work with?
A: Anyone meeting the eligibility requirements are encouraged to apply. - Q: Is there a limit to number of partnerships allowed to form for the application of any areas of interest?
A: There is no limit on the number of partnerships allowed to form for the application in any of the areas of interest. - Q: How many applicants were there in 2018 and 2019?
A: ONC is unable to disclose that information. - Q: If there is only one award per section, is there a means to coordinate with those submitting larger projects?
A: No.
QUESTIONS SPECIFIC TO AREA OF INTEREST 1
- Q: In the slides re Goals, did you mean “increase normalization and standardization” as opposed to “reduce.” Aren’t we always promoting data exchange using shared standards?
A: The Goal is to reduce “effort” related to “data normalization and standardization” by using well-established standards for data exchange. - Q: Assuming that the correct IG is the Women’s Health Technology Coordinated Registry Network FHIR IG (v0.2.0: STU 1 Ballot 2) based on FHIR R4. However, the Implementation Guidance specifies use of FHIR versions either STU3 or DSTU2. Does the IG fully support FHIR R4?
A: The WHT CRN IG was developed based on the R4 and is currently being updated to support FHIR R4 after comments on Structured Data Capture (SDC) were received to address changes that were identified. - Q: For the Registry emphasis area, does the registry need to be multicenter?
A: While most disease registries are multi-center, we do not specify that they must be in order to propose them under this project. We leave the choice of registry (single center or multicenter) up to the applicant to propose. - Q: For the registry emphasis area, does the registry need to be an existing registry or can the work be accomplished within one or… more centers getting ready for a new registry in the planning stages, i.e., a federal NOT has been issued for a registry and centers are getting ready?
A:The selected registry(ies) must be functioning and collecting data when the response is received on this cooperative agreement.
QUESTIONS SPECIFIC TO AREA OF INTEREST 2
- Q: Can an application for No 2 utilize a software platform that is currently available on a commercial basis outside of the US to support clinical, biopharma, and research goals leveraging clinical and genomic data across institutions?
A: One of the goals of LEAP is to create scalable solutions to advance or improve the use of health IT. Applicants are encouraged to focus on utilizing platforms that integrate and leverage open standards and can be made widely accessible / scalable.
QUESTIONS SPECIFIC TO AREA OF INTEREST 3
- Q: For Area 3, is incorporating patient consent mandatory, highly desired, or nice to have?
A: Applicants must comply with applicable existing laws regarding data sharing. The intent of Area 3 is not to develop a technical consent solution. Please see page 8 of the LEAP SEN to review goals for Area 3. - Q: Per Area 3, can the project be proposed around a specific disease such as mental health?
A: The project proposal can focus on a specific population or health condition. - Q: In Area 3, are Social Determinants of Health encapsulated within your reference to Social Services? If so, would Gravity instead of FHIR qualify for Area 1 or Area 2?
A: Social determinants of health are one component of information gathered that can be counted as social services and vice versa. We are unclear as to how Gravity instead of FHIR would qualify for Area 1 or 2 since Gravity is a project within HL7, whereas FHIR a standard. Please provide clarification or more information so that we may better address your question.