NOT-OD-19-127: Notice of Special Interest: Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Applications Directed at the Adoption of the Fast Healthcare Interoperability Resources (FHIR) Standard

Notice of Special Interest: Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Applications Directed at the Adoption of the Fast Healthcare Interoperability Resources (FHIR ) Standard

Notice Number: NOT-OD-19-127

Key Dates
Release Date: July 30, 2019
First Available Due Date: September 5, 2019
Expiration Date:April 7, 2020

Related Announcements

PA-19-270 PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

PA-19-271 PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

PA-19-272 PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

PA-19-273 PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

NOT-OD-19-150

Issued by

OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH (OD)

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute (NHGRI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of General Medical Sciences (NIGMS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

National Library of Medicine (NLM)

National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

Purpose

The purpose of this Notice is to inform SBIR and STTR applicants and awardees about areas of special interest related to the use of the Fast Healthcare Interoperability Resources (FHIR ) standard in the development of health information technology (health IT) products and services. Health IT can improve health care quality and outcomes by enabling health care providers to effectively share information and apply evidence to support care decisions. The NIH is seeking innovative health IT solutions, implementing the FHIR standard, to enable more effective patient-centered care coordination, population health management, and data science research support.

FHIR is a standardized way of transmitting health data from one health information system to another through an API. An API is a specified set of protocols and data standards that establish the ground rules by which one information system directly communicates with another. Software developers can seamlessly connect their program to another computer through a FHIR API to transmit electronic health data. FHIR enables the exchange of many different health data types such as clinical information, demographics, and billing and claims data. Of special relevance, a complementary specification, Substitutable Medical Applications, Reusable Technologies (SMART) on FHIR, enables third party applications (or apps) to access the data in electronic health record (EHR) systems for approved purposes, including research. FHIR also specifies many of the specific coding systems required for interoperability of health data.

Several Federal health agencies are promoting the use of FHIR in EHR systems. The 21st Century Cures Act requires that a health information technology developer or entity allow health information to be accessed, exchanged, and used without special effort through the use of application programming interfaces (APIs) including providing access to all data elements of a patient's electronic health record. ^[1] To implement this provision, the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology (ONC) has proposed a new rule to support seamless and secure access, exchange, and use of electronic health information.^[2] Specifically, the proposed rule calls on the health care industry to adopt standardized APIs by using the FHIR standard to share patient data.

The NIH is issuing this Notice to highlight interest in receiving grant and administrative supplement applications focused on implementation of the FHIR standard in health IT applications including, but not limited to, the following area(s):

Integration of patient- and population-level data from EHR systems
Access to and management of electronic health information
Development of clinical decision support systems
Exchange of EHR data and health documentation
Enhancement of privacy and security for electronic health information
Inclusion of common data elements (CDEs) and clinical terminologies to improve interoperability of EHR data for research and clinical care
Support for a common structure for sharing clinical research data
Integration of EHR and patient-originated data with clinical research data
Design and monitoring of clinical trial protocols
Enhancement of patient recruitment, enrollment, and consent in clinical trials

Application and Submission Information

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

Activity Code	FOA	First Available Due Date
R43/R44	PA-19-272: PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)	September 5, 2019
R41/R42	PA-19-270: PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)	September 5, 2019
R43/R44	PA-19-273: PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)	September 5, 2019
R41/R42	PA-19-271: PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)	September 5, 2019
R41/R42 R43/R44	PA-18-591: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)	September 5, 2019

Competing grant applications submitted in response to PA-19-270, PA-19-271, PA-19-272, or PA-19-273:

Applications may be submitted for due dates on or after September 5, 2019 and subsequent receipt dates through April 7, 2020.

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

For funding consideration, applicants must include NOT-OD-19-127 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to the terms of this notice and the FOA used for submission will be withdrawn

Non-competing administrative supplement applications submitted in response to PA-18-591:

Applications may be submitted from September 5, 2019 through the expiration date of this notice, April 7, 2020.

All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:

Applications are due by 5:00 PM local time of applicant organization.
The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
For funding consideration, applicants must include NOT-OD-19-127 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

[1] Section 4002(D)(iv) of the 21st Century Cures Act (P.L. 114 255)

[2] https://www.federalregister.gov/documents/2019/03/04/2019-02224/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification

Inquiries

Please direct all inquiries to:

Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed funding opportunity announcements.