Breast Radiology FHIR IG Proposal

Breast Radiology Logical Models and FHIR® Profiles:

Owning work group name: Clinical Interoperability Council

Contributing or Reviewing Work Groups:

   HL7 Clinical Interoperability Council (CIC)
   HL7 Clinical Information Modeling Initiative (CIMI)
   HL7 Imaging Integration / DICOM 

FHIR Development Project Insight ID: 1363

Scope of coverage:

The breast radiology implementation guide intends to formalize the radiology-specific data-elements sufficient to support breast cancer diagnosis, treatment and research, focusing on the key data necessary to facilitate clinical decision-making for medical and surgical oncologists, pathologists and the referring physician community of general practices Obstetrics and gynecology (OB/GYN) clinicians who order the vast majority of screening mammography procedures.

The implementation guide is expected to incrementally cover a wide variety breast radiology use cases, while supporting secondary data use in for clinical research, cancer registry reporting.

IG Purpose:

The purpose of this implementation guide is to provide detailed CIMI clinical models, and FHIR Profiles required to facilitate reliable and consistent capture and exchange of interoperable medical records in the breast radiology domain. Applications such as clinical decision support, clinical quality measures, evidence-based and precision medicine all require a standardized specification for computable data elements (aka clinical models). This implementation guide will provide FHIR-based representations of standardized breast radiology data to support these applications.

Content location

We already have content into the HL7 GitHub repository: https://github.com/HL7/fhir-breast-radiology-ig

Proposed IG realm and code: us/breast-radiology

Maintenance and Development Plan:

The CIC WG is aware and willing to maintain the content in the future. Among participants, at least MITRE, MRS and PenRad are committed to the maintenance of the content.

This IG comprises CIMI logical models and FHIR Profiles for breast radiology core data elements long established to be critical for breast cancer diagnosis and staging within the scope of radiology.

In the first 'For Comment' cycle the terminology bindings are preliminary, and in some cases, defined in terms of local codes only.

Our team is collaborating with the VA SOLOR groups, RSNA RadLex and Regenstrief (LOINC) to organize and fund the required unique concept authoring efforts that will be necessary to sufficiently define the data-elements and value-sets represented in the 'For Comment' and 'Informative' breast-radiology draft ballot cycles.

Short Description: Breast Radiology CIMI Logical Models and FHIR Profiles.

Long Description:

The first iteration of the CIMI logical models and FHIR Profiles for breast radiology reporting will be focused on the core modeling structures, patterns and informational relationships between these architectural elements. Our group has works extensively with the HL7 Orders and Observations workgroup to investigate the numerous 'cross cutting' concerns that

This IG defines logical models and FHIR profiles for data elements that are either directly or indirectly used in the reporting of breast radiology.

Involved parties:

The breast-radiology IG is being authored through a formal collaboration under the HL7-CIC workgroup with a wide range of organizations and individual contributors that informally refer the themselves as the 'Cancer Interoperability' Group, which includes representatives from the FDA, NIH, CCO, SBI, HSPC, CiiC, ACS, various health IT vendors and interested solution vendors.

The American College of Radiology (ACR) has will established and long standing guidelines that have been in common and broad use for almost two decades. The Radiological Society of North America (RSNA) and the Society of Breast Imaging (SBI) which the breast focused arm of the ACR are all represented on the subject matter expert team that is reviewing all content and will be used as the definitive source of truth for all our near-term deliverables.

Committed implementors include the MITRE Corporation, PenRad Inc, MRS Inc. and Intermountain Healthcare.

Expected implementations:

MITRE's Standard Health Record Collaborative, PenRad and Mammography Reporting System, inc (MRS). PenRad and MRS represent well over fifty percent of the almost forty million screening mammography studies performed each year. PenRad and MRS are also committed to participating in FHIR Connectathons to proof the draft profiles.

Specifications consulted for the development of this IG include:

   American College of Radiology Breast Reporting Guidelines 
   College of American Pathology (CAP) Breast Reporting SDC Forms
   Society of Breast Imaging Reporting Guidelines
   In addition to sources specifically providing clinical content related to cancer and breast cancer, from a modeling perspective, CIMI models were also used as a source.

Example Scenarios:

   Capture and delivery of breast radiology reports to EHR systems
   Reporting to cancer registries
   Reporting for clinical trials
   IG Relationships:  
   The breast-radiology project is intended to target compliance with  US Core v4.

Timelines:

   For Comment September 2019 Ballot
   Informative Jan 2020 Ballot
   STU May 2020 Ballot