This FHIR R4 implementation guide (IG) for the US Realm will be based on Clinical Quality Framework and US Core profiles where possible. This FHIR implementation guide will use the US Core profiles. If this FHIR implementation guide is unable to use a US Core profile, we will follow the Cross Group Projects WG's variance request process, and provide the US Realm Steering Committee an approved rationale for deviation in the implementation guide where applicable.

The scope of this IG will include key data elements in a longitudinal record of a mother and child for two initial research use cases:

• Pregnancy and subsequent death within a specific time frame: This use case is focused on women who died within a year (365 days) of a pregnancy regardless of cause of death or pregnancy outcome.
• Hypertensive Disorders of Pregnancy: This use case focuses on women with a diagnosis of pregnancy-induced hypertension.

During requirements gathering, we will be reviewing relevant implementation guides for existing standards:

• US Core
• Vital Records Common Profiles Library
• Vital Records Birth and Fetal Death Reporting
• Vital Records Mortality and Morbidity Reporting
• Electronic Initial Case Report (eICR) within Electronic Case Reporting (eCR)
• Supplemental Pregnancy templates for C-CDA
• Birth Defects CDA/Draft FHIR CI
• Birth Reporting DAM (extension of VR DAM).
• IHE BFDR profiles (https://www.ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_BFDR-E.pdf)
• NCHS Utah and Michigan SMART on FHIR app

The project team will review existing standards such as the Situation Awareness for Novel Epidemic Response (SANER) FHIR IG and will align and re-use profiles where applicable recognizing there are differences such as:

1) The cohort is focused on pregnant mothers

2) The time frame is a longitudinal record view, rather than a situational awareness

3) The data source is not limited to an inpatient facility but includes data from diverse EHR systems during the longitudinal care of the mother and child.

The IG will focus on longitudinal maternal care, which includes antepartum (including pre-pregnancy), intrapartum, and postpartum care of a pregnant woman. This IG will define how, from which sources (e.g., electronic health records, research protocols), and when researchers access data and will specify how to capture and link the maternal longitudinal record with the child record(s). This IG will also investigate appropriate value sets for concepts and values such as pregnancy induced hypertension, pre-term birth, and pregnancy-related death.

As the intended use of this data is for clinical research, the project will consider the appropriate de-identification of data and will review existing HL7 projects related to patient identity management such as Improving identity assurance and patient match quality through Interoperable Digital Identity and Patient Matching Capabilities.

This IG will consider the MedMorph IG and broader public health research use cases which may have a need for appropriate re-identification.

This project plans to develop a pilot project in parallel to the development of this IG. This project will also develop an interaction diagram of actors in support of this IG and the pilot.

Key Project Milestones:

Oct 22, 2021: 2022 May WG approved PSS to PMO Deadline

Nov 9, 2021: Jan 2022 Connectathon Proposals Due

Dec 19, 2021: 2022 MAY TSC-approved PSS Deadline

Jan 10, 2022: Jan FHIR Connectathon attendance

Jan 15, 2022: Create NIB, seek approval

Feb 20, 2022: May 2022 NIB submission deadline

Feb 20, 2022: May 2022 FHIR IG Proposal Approval (by FMG) due

Mar 4, 2022: FHIR Ballot Core Substantive Freeze

Mar 15, 2022: FHIR Ballot Content Freeze

Mar 15 - 24, 2022: WG approved FHIR IG for May ballot (content freeze on 3/22)

Mar 24, 2022: Submitted FHIR Ballot Readiness Checklist

Mar 25 - 27, 2022: FHIR Ballot Content QA Change

Apr 1 - May 1, 2022: Ballot open for voting

May 9 - 13, 2022 WGM: Ballot reconciliation starts

Fall 2022: Complete ballot reconciliation, Begin publication request

March 2023: Publish IG