HL7 FHIR® Implementation Guide: Cancer Pathology Data Sharing, Edition 2 - US Realm

DESCRIPTION

This project aims to leverage the FHIR standard to support the electronic exchange of cancer pathology information between hospital or facility-based Laboratory Information Systems (LIS), Electronic Health Record (EHR) systems and Cancer Registries by developing a single FHIR Implementation Guide for the US Realm, anchored in the NAACCR Standards for Cancer Registries Volume V, Laboratory Electronic Reporting Pathology Version 5.1 (Revised March 2024).

 

 

See the specification at http://hl7.org/fhir/us/cancer-reporting/STU2

ALTERNATIVE NAMES

HL7 FHIR® Implementation Guide: Cancer Pathology Data Sharing, Edition 2 - US Realm may also go by the following names or acronyms:

BENEFITS

• Enables laboratories to have one cancer pathology IG that can be used to exchange pathology data with EHRs and cancer registries
• Reduces burden of supporting multiple exchange standards to meet reporting requirements
• Supports EHRs by receiving discrete data that can be automatically consumed into the system without human intervention
• Supports central cancer registries by receiving discrete cancer pathology data that can be automatically consumed by cancer registry systems for reporting cancer surveillance data
• Supports CDS by having discrete pathology lab data available in the EHR to assist physicians with automated decision support for treatments. 

IMPLEMENTATIONS/CASE STUDIES

• mTuitive,
• CAP,
• California Cancer Registry,
• LA Cancer Registry

DEVELOPMENT BACKGROUND

This guide has been developed over a 4 year collaboration between industry stakeholders (CDC/NCPR, CAP, Lab and Healthcare vendors) through HL7 FHIR project infrastructure- Orders & Observation sponsorship, multiple Connectathons and balloting. This guide has also been developed in concert with IHE SDC on FHIR to effectively share CAP protocols via FHIR, and is based on MedMorph's Reference Architecture.

 

RELATED DOCUMENTS

HL7 FHIR® Implementation Guide: Cancer Pathology Data Sharing, Edition 2 - US Realm

(Download)

STU DOCUMENTS

	HL7 FHIR® Implementation Guide: Cancer Pathology Data Sharing, Edition 2 - US Realm See the standard at http://hl7.org/fhir/us/cancer-reporting/STU2.	(Submit Feedback on STU)
	HL7 FHIR® Implementation Guide: Cancer Pathology Data Sharing, Release 1.0.1 - US Realm See the standard at http://hl7.org/fhir/us/cancer-reporting/STU1.0.1.	Expiration May 2026

ADDITIONAL DETAILS

Implementation of this profile provides benefits to multiple stakeholders. The laboratory will benefit from having one cancer pathology IG that can be used to exchange pathology data with EHRs and cancer registries. This eliminates the burden of supporting multiple exchange standards to meet reporting requirements. The EHRs will benefit by receiving discrete data that can be automatically consumed into the system without human intervention. The results will populate into the appropriate field within the EHR, so that it is immediately available to the physician and can also be linked to additional data for other public health or research needs. The central cancer registries will benefit from receiving discrete cancer pathology data that can be automatically consumed by cancer registry systems for reporting cancer surveillance data. CDS will benefit from having discrete pathology lab data available in the EHR to assist physicians with automated decision support for treatments. The CDC will even benefit from this upstream data collection protocol since standard data collection at the source increases data quality and decreases data processing time. Technically, the cancer pathology IG aligns with MedMorph for facilitated implementation and scalability.

At present, patient and specimen data flow from the clinic and EHR to the pathology lab in a variety of formats (HL7 V2, CDA, etc.). There is a need for an electronic data exchange standard that maintains the discrete cancer data when exchanging information among pathology laboratories, hospital systems, and registries for continuity of care, cancer reporting, and research. In addition, starting in December 2022, CMS and ONC require a FHIR-based API to be in place for certified HIT vendors (see ONC’s Cure Act Final Rules). This IG seeks to address these issues with structured data collection, storage, and exchange. This cancer pathology reporting FHIR IG has been developed by Cancer ePathology Reporting Project in collaboration with the IHE SDC/eCC on FHIR Project, both under the Orders & Observations Working Group, and with other stakeholders. It provides an alternative to the HL7 Version 2.5.1 Message approach used by the NAACCR Standards for Cancer Registries Volume V for cancer pathology synoptic reports.

This IG uses the FHIR message bundle paradigm and profile data from NAACCR Volume 5, including MessageHeader, DiagnosticReports, and Specimen. It is based on US Core profiles where possible, binding to terminologies such as SNOMED CT and the North American Association of Central Cancer Registries Volume II, Data Standards & Data Dictionary. It will also include CAP eCP Protocol CKey Identifier to SNOMED translation. We have tested these implementation guides in tandem to ensure alignment, as well as implementing an app to query an EHR, compile pathology reporting data, and send it to a registry.

TOPICS

• Laboratory
• Medical Records
• Public Health

BALLOT TYPE

• STU

STATUS DATE

2025-10-03

RESPONSIBLE WORK GROUP

PRODUCT TYPE

• Implementation Guide

STAKEHOLDERS

• Clinical and Public Health Laboratories
• EHR, PHR Vendors
• Healthcare Institutions
• Lab Vendors

FAMILY

• FHIR

CURRENT STATE

• Active

REALM

• US Realm