Longitudinal Maternal & Infant Health Information for Research - FHIR R4 Implementation Guide (Jira PSS-1832)

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-related and pregnancy associated deaths: 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.

- Pregnancy-induced hypertension (PIH): This use case focuses on women with a diagnosis of pregnancy-induced hypertension.

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.