Articles tagged with “hl7”

E2B(R3) ICSRs: A Guide to Pharmacovigilance Reporting

An in-depth guide to the ICH E2B(R3) standard for pharmacovigilance. Explore the data structure of ICSRs, electronic reporting rules, and key global systems. Updated April 2026.

35 min read

1/9/2026

e2b(r3)icsr pharmacovigilance ich e2b(r3)electronic reporting drug safety hl7 eudravigilance data harmonization

Structured Product Labeling (SPL): A Guide to Data Integrity

Updated 2026 guide to Structured Product Labeling (SPL) and data integrity. Covers FDA mandates, EMA ePI roadmap, Health Canada XML-PM, FHIR standards, and ALCOA+ compliance for pharmaceutical labeling.

35 min read

11/23/2025

structured product labeling spl data integrity pharmaceutical labeling regulatory affairs fda regulations hl7 alcoa+

SMART on FHIR: Guide to CDS Hooks & Coverage Resource

Learn about SMART on FHIR for EHR interoperability. This guide covers the FHIR Coverage resource, CDS Hooks, TEFCA, Da Vinci IGs, and the latest 2025-2026 regulatory updates for building modern healthcare applications.

60 min read

11/8/2025

smart on fhir fhir cds hooks health interoperability hl7 ehr integration clinical decision support fhir coverage resource

An Introduction to FHIR for Healthcare Interoperability

Learn about FHIR (Fast Healthcare Interoperability Resources), the modern HL7 standard for exchanging health data using web APIs and self-contained resources. Updated for 2026 with FHIR R6 ballot, TEFCA FHIR exchange, CMS-0057-F, and EU EHDS developments.

50 min read

8/26/2025

fhir healthcare interoperability hl7 health data standard api rest health informatics