Regulatory Compliance for Healthcare Data Exchange: Addressing FHIR and Key Regulations
Regulatory Compliance - Healthcare Interoperability Solutions - CodeFhir
Summary
This article details the technical requirements necessary to enable access and exchange of electronic health information (EHI) based on multiple U.S. federal regulations, such as HIPAA and the Cures Act. It emphasizes that compliance with standards like FHIR R4 and US Core is crucial for data sharing.
Details
This document comprehensively outlines major interoperability regulations and industry standards in the U.S. healthcare sector (including HIPAA Security Rule, ONC Cures Act, CMS Interoperability Final Rule). These laws mandate specific data exchange functionalities, such as Patient Access APIs, Provider Access APIs, and Prior Authorization APIs. Technically, FHIR R4 and US Core 6.1.0 are designated as baseline standards, requiring strict adherence. Furthermore, to prevent Information Blocking, it is essential to transform data from legacy formats like HL7 v2.x or X12 into standardized FHIR. From a security perspective, multi-layered technical safeguards—including access control, encryption, and audit logging (per HIPAA)—are required. The document presents the necessity of specific APIs and data transformations for meeting these complex regulatory requirements.
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