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Issued by

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Purpose

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) seeks input on the technical feasibility and practical implications of integrating at-home test results with electronic health records (EHRs).

This RFI invites comments from health information technology (IT) developers, healthcare organizations, healthcare providers, pharmacies, payors, patients, and others who have input on the topic.

Background

The COVID-19 pandemic spawned a shift in diagnostic testing away from the healthcare setting and into people’s homes. At-home tests for SARS-CoV-2, influenza, and pregnancy are already widely available, with additional types of home tests (other respiratory diseases, sexually transmitted infections, etc.) expected to reach the market in the near future.

Through its Rapid Acceleration of Diagnostics (RADx^®) Mobile At-home Reporting through Standards (MARS) program, NIBIB has developed data standards, pathways, and tools to facilitate standardized reporting of at-home test results into public health systems. Yet there remains no universal solution for streamlined reporting of at-home test results into patient EHR systems.

The goal of this RFI is to better understand 1) the technical feasibility of a universal approach to pushing at-home test results into EHRs, and 2) stakeholder viewpoints on the benefits and drawbacks of such an approach.

Information Requested

Constraints

For this RFI, at-home tests (also called self-tests) are those that are administered and interpreted at home, as opposed to being shipped away for analysis.

Responses to this RFI should be limited to EHR data integration approaches that:

• Allow the patient to specify their doctor and/or health system for reporting;
• Capture the required reporting information from the patient through a simple interface (e.g., web or mobile application);
• Ensure the patient is authorizing transfer of the reporting information into their EHR (for example, by using OAuth 2.0);
• Represent the at-home test result and related metadata as structured electronic health information (EHI) within the patient’s EHR (as opposed to, for example, sending the test result to the provider via a secure message);
• Do not require the provider to perform manual import steps (such as patient matching or placing an order for the test); and
• Are compatible out-of-the-box with most or all EHR systems that are certified by the Office of the National Coordinator for Health IT (ONC), without requiring custom EHR integrations.

Request for Comments

NIBIB invites feedback from the following stakeholders on the technical feasibility and practical implications of universal approaches for pushing at-home test results into patient EHRs. Input sought includes, but is not limited to:

Health IT developers: Is it technically feasible to develop a method for pushing at-home test results into EHRs, according to the constraints defined above? If so: How would it work? What steps would the patient need to take to report, and how could the required patient effort be minimized (e.g., what would the user interface look like for patients to specify their doctor / health system, provide the test result and related metadata, grant EHR authorization, etc.)? Where within the EHR interface would the test result EHI appear? How would the provenance be kept so that providers know the EHI came from an external system? Would there be unique challenges in distinguishing at-home tests from lab tests in the EHR, and if so, how could they be addressed? What precautions would be taken to ensure that the test result is assigned to the correct patient and to prevent bad actors from reporting fake test results for others? What would the solution cost to develop? Would there be a pay-per-use cost associated with the approach? Could the functionality be packaged into an application programming interface (API)?

Healthcare organizations, healthcare providers, pharmacies, payors: Would you welcome the ability for patients to push their home test results into their EHRs, much like how laboratory diagnostic test results are pushed into EHRs? Why or why not? What would be the benefits and drawbacks? What use cases would be most attractive (test types, diseases, etc.)? Would the submission of home tests to EHRs introduce resource challenges to your organization? How could those challenges be addressed, either through new technology or workflow modification? How important would it be to have photographic proof of the test result? To what extent are your patients already sharing their home test results with you in other ways?

Patients: Would you like the ability to easily share your at-home test results with your doctor, by filling out a form that pushes the test results into your EHR? Why or why not? Under what circumstances? Do you already share home test results with your doctors in other ways (e.g., patient portal message, phone call, mobile app, etc.)?

How to Submit a Response

All responses must be submitted via email to ehr-rfi@nih.gov.

Responses must be received by: July 26, 2024 11:59:59 PM EDT

The NIH encourages organizations (e.g., patient advocacy groups, healthcare organizations) to submit a single response reflective of the views of the organization and membership as a whole.

Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for the use of that information.

We look forward to your input and hope you will share this RFI opportunity with your colleagues.

Inquiries

Please direct all inquiries to:

Andrew Weitz, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Email: ehr-rfi@nih.gov