Key Dates

Related Announcements

None

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

This Request for Information seeks input on how to best acquire and integrate Electronic Health Record data from Health Information Networks and Health Information Exchanges into the All of Us Research Program dataset.

The All of Us Research Program

The All of Us Research Program seeks to accelerate health research and medical breakthroughs to enable individualized prevention, treatment, and care for all of us. To do this, the program will partner with one million or more participants nationwide and build one of the most diverse biomedical data resources of its kind. Researchers may leverage the All of Us platform for studies on a wide range of health conditions.

Diversity is one of the core values of the All of Us Research Program. The program aims to reflect the diversity of the United States and has a special focus on engaging communities that have been underrepresented in health research in the past. Participants are from different races, ethnicities, and age groups. They are diverse in gender identity, sexual orientation, socioeconomic status, educational attainment, and health and disability status. Moreover, participants live in all parts of the United States (see map).

All of Us Research Program Data

When responding to this Request for Information, please review and consider the data that are currently available on the data platform, the All of Us Researcher Workbench. Data are available to researchers in several access tiers. You can refer to the data dictionary for details and use the All of Us Data Browser to explore publicly available, aggregate data and view outcomes of interest. Within the secured, cloud-based Researcher Workbench, researchers are able to make associations through the integrated dataset by cross-referencing data from these different data types:

• Participant Surveys. All of Us survey modules can be viewed here. Survey data are currently available for 372,000+ participants.

• Genomic Data. Whole genome sequencing data are currently available for over 98,000 participants and genotyping arrays for over 165,000.

• Electronic Health Record (EHR) Data. EHR data are currently available from 258,000+ participants, including a wide range of visit types, disease conditions, drug exposures, procedures, labs, and measurements.

• Physical Measurements. Physical measurement data are available for 306,000+ participants including height, weight, mean waist circumference, mean hip circumference, mean heart rate, mean blood pressure, wheelchair use, and pregnancy status at the time of the physical exam.

• Wearables. Fitbit data are available for 12,800+ participants including heart rate and physical activity.

All of Us Research Program Data Access, Privacy, and Security

You are encouraged to review publicly available All of Us Research Program policies and principles in preparing a response to this RFI. These can be found at the following webpages:

• Core Values
• Operational Protocol
• Privacy Safeguards
• Data Security Policy Principles and Framework
• Precision Medicine Initiative Privacy and Trust Principles
• Data Access and Use Policies

Importance of Electronic Health Record Data for All of Us

The precision medicine approach considers an individual’s biology, lifestyle, and environment to make more individualized preventive and medical care decisions. Data captured from participant EHR provides an important resource to enable precision medicine research and understand health. EHR data are in part a life course record of care, enabling research and advancing discovery.

Currently, most All of Us Research Program participants enroll through a network of Healthcare Provider Organizations (HPO). These participants are considered “HPO-affiliated participants.” The Program’s HPO network includes over 50 organizations supporting hundreds of enrollment locations associated with:

• Academic and Regional Medical Centers;
• Federally Qualified Health Centers (FQHC); or
• Veterans Health Administration

Concomitantly, some participants enroll directly in All of Us who are “unaffiliated” with any program HPO partner. These participants generally have little or no EHR data shared with the program.

HPO-affiliated participants may authorize sharing of their EHR data with All of Us. Participant health data are generally transferred to All of Us after curation and transformation to the Observational Medical Outcomes Partnership (OMOP) data model by an HPO. This is the primary source of All of Us EHR data.

Due to participants moving over the course of their life, obtaining specialist care or different levels of care outside their enrollment HPO, or seeking care in different ways, All of Us participants may receive care at locations that are not All of Us partner organizations. In addition, lack of interoperability, and evolving data standards contribute to gaps in the collected EHR data. Consequently, All of Us may not be receiving EHR data from these other care locations despite having participant authorization to do so.

Alternative Approaches to Collecting Electronic Health Record Data for All of Us

All of Us has explored different approaches to overcome this gap. One approach being utilized is through participant-mediated mechanisms. In this mode, participants provide All of Us with access to their EHR data through patient portals and Fast Healthcare Interoperability Resources (FHIR) based connections. Currently, this approach is available to a subset of participants. Of these participants about 8,000 (75%) contribute EHR data from one healthcare provider, while another 1,400 contribute EHR data from two providers.

An emerging area of focus for sharing EHR data is through Health Information Networks (HIN) and Health Information Exchanges (HIE). These organizations support sharing EHR data for purposes such as patient care, public health surveillance, emergency services, and patient requests. They also support sharing for additional purposes reliant upon authorizations to disclose protected health information (HIPAA authorization). All of Us obtains a HIPAA authorization from participants who agree to share their EHR data. Consequently, there is no additional participant burden to seek EHR data through an HIN or HIE. Adding EHR data for All of Us participants from HINs and HIEs would partially fill data gaps, improving the completeness of EHR data available to researchers. Therefore, we are seeking information on using HINs and HIEs as another source of EHR data.

Information Requested

We are seeking information about innovative ways to fill in the data gaps in our EHR data through utilization of HINs and/or HIEs. Respondents may address one or more of the following topics of interest. You may voluntarily include your organization name, a contact person and contact information for a person at your organization, and your organization type. All responses will be considered whether or not organization and contact information is provided.

1. Your Organization

• Organizational name
• Your name and contact information
• Organizational type (e.g., academic, consultant, contract research organization, government, HIN, HIE, hospital, service provider, software developer, systems integrator)

2. Electronic Health Record Acquisition

• HIN and HIE Population Characteristics: Describe the general population coverage for HINs and HIEs by demographic groupings. If available, please provide basic descriptive statistics showing population counts for specific HINs and HIEs by groupings such as age, county of residence, disability, education, gender identity, income, race and ethnicity, sex at birth, sexual orientation, urban/rural, and state of residence.
• Match Rate: Which data elements (e.g., first name, last name, SSN) are required to increase the sensitivity and specificity of making a match between an individual and their EHR through an HIN or HIE?
• Mobility Considerations: Individuals may move several times over the course of their life and receive care in different locations. What is the most efficient manner to query an HIN or HIE for EHR data based on individual mobility?
• Data Quality: What are the primary data quality issues using an HIN or HIE for EHR data collection? What are the known data gaps or biases with HINs or HIEs? How can these issues be mitigated?
• Platforms: Describe platforms and tools for acquiring EHR data through HINs and HIEs. What are the pros and cons of these platforms?
• Cost: What is the estimated cost to query for and acquire EHR data through HINs or HIEs for 500,000 and 1,000,000 individuals twice per year?
• Trusted Exchange Framework and Common Agreement (TEFCA) Implications: What are the short- and intermediate-term implications of TEFCA on HINs or HIEs to facilitate the needs of the All of Us Research Program?

3. Data Elements

• Describe how data are likely to be sent to All of Us from HINs or HIEs. For example, will it be a Clinical Document Architecture (CDA) document, FHIR Bundle, OMOP compatible file, or something else?
• Below is a list of data classes that are part of the United States Core Data for Interoperability (USCDI). There are three variations of USCDI, namely, version 1, version 2 and draft version 3. USCDI is a standardized set of health data classes and related data elements for nationwide, interoperable exchange of health data. If the All of Us Research Program successfully queried and matched a study participant in an HIN or HIE, which USCDI data items would currently be returned:
  • Allergies and intolerances
  • Assessment and plan of treatment
  • Clinical notes such as consultation notes, discharge summary notes, history and physical, procedure notes, progress notes
  • Clinical tests and results
  • Diagnostic imaging tests and reports
  • Encounter information, such as date and time of encounter, diagnosis, disposition, location, and type
  • Health insurance information
  • Health status, such as concerns, functional status, disability status, mental function, pregnancy status, and smoking status
  • Immunizations
  • Laboratory tests, values, specimen type, and results
  • Medications
  • Patient demographics, such as name, address, date of birth, race and/or ethnicity, education, sex (assigned at birth), sexual orientation, gender identity, and others
  • Patient implantable devices
  • Problems
  • Procedures
  • Provenance of the data
  • Vital signs such as blood pressure, height, weight, respiratory rate, body temperature, and pulse oximetry
  • Social determinants of health data elements included in USCDI
  • Other - other data that is not currently USCDI data classes and elements. Examples of areas of interest to the All of Us include claims, dental, genetic, microbiology testing, mortality, pathology, patient reported outcomes, and registry data.
• Which of these items do you anticipate could be returned by December 31, 2024?

4. Policy and Security

• All of Us obtains a HIPAA authorization from participants who agree to share their electronic health record (see the program’s initial HIPAA authorization and new version). Are these sufficient to qualify requests we would make to HINs and/or HIEs?
  • If not, what additional authorizations, measures, or language would you suggest?
• Is identity verification required for participants who agree to share their electronic health record? If so, by whom and to what standards?
• What restrictions do HINs or HIEs place on the use of these data that might restrict All of Us from making the sourced data available on the All of Us Researcher Workbench

5. Other Considerations

• What other considerations beyond those covered in the previous questions should All of Us be aware of when considering HINs and HIEs?

How to Submit a Response

Responses to the RFI questions will be accepted through August 31, 2022. All RFI responses must be submitted electronically through the Web Portal at: https://rfi.grants.nih.gov/?s=62cd7e699a2a000079006a12 . Electronic submissions through the portal received after the deadline may or may not be taken into consideration. There will be no extensions beyond the due date.

Responders are free to address any or all the questions listed above. All submitted information will be reviewed by NIH staff and contractor support personnel. Responses to this RFI are voluntary and may be submitted anonymously. You may voluntarily include your name and contact information with your response. If you choose to provide NIH with this information, NIH will not share your name and contact information outside of NIH unless required by law.

No business proprietary information, copyrighted information, classified, or personally identifiable information (aside from that requested above) should be submitted in response to this RFI. Responses to this notice are not offers, and cannot be accepted by the Federal Government to form a binding contract. Additionally, those submitting responses are solely responsible for all expenses associated with response preparation.

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 use of that information.

Questions: Interested individuals and organizations who have questions about the RFI should submit these questions electronically to [email protected]. Please include “RFI Question: HIN and HIE for the All of Us Research Program” in the subject line of the email.

Inquiries

Please direct all inquiries to:

[email protected]