FHIR API navigates rules and regulation

FHIR API Mandates 2024: Navigating the Rule and Regulations

The healthcare industry is constantly evolving, with new technologies and regulations shaping the way organizations operate. One such regulation that has gained significant attention is the requirement for healthcare organizations to implement Fast Healthcare Interoperability Resources (FHIR) Application Programming Interfaces (APIs). In this article, I will demystify FHIR API mandates and provide guidance on how to navigate the rules and regulations surrounding them.

Understanding the ONC and CMS regulations

To fully comprehend the FHIR API mandates, it is essential to understand the two regulatory bodies involved: the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS). The ONC is responsible for promoting the adoption and use of health information technology, while the CMS oversees the administration of healthcare programs.

The ONC's regulations focus on the interoperability and secure exchange of health information. These regulations require healthcare organizations to implement FHIR APIs to enable the seamless sharing of patient data between different systems and providers. On the other hand, the CMS regulations require healthcare providers to make patient health information accessible via FHIR APIs, empowering patients to have greater control over their health data.

Overview of CMS Rule and FHIR API Requirements

The introduction of the CMS ePA rule addresses several challenges prevalent in the current prior authorization (PA) process within the healthcare system. Here's a breakdown of how the CMS Interoperability Rule ties into FHIR APIs:

  1. Focus of the Rule: This 2020 rule by the Centers for Medicare & Medicaid Services (CMS) aims to improve interoperability and empower patients to access their health information more easily.
  2. FHIR API Requirements: The rule mandates the use of specific FHIR APIs for health plans (Medicare Advantage, Medicaid, CHIP, QHP issuers):
  3. To ensure smooth access to claim information for both providers and patients, payer systems need to develop APIs based on HL7 FHIR standards. These APIs include:

  1. Patient Access API: Lets patients view their claims and clinical data promptly
  2. Provider Access API: Allows in-network providers quick access to claims and encounter data.
  3. Payer-to-Payer API: Facilitates data exchange between payers for better care coordination.
  4. Prior Authorization API: Streamlines the prior authorization process for providers

RELATED: CMS Electronic Prior Authorization Rule Guide

Overview of the Cures Act and its Impact on FHIR API Mandates

The 21st Century Cures Act, signed into law in 2016, has had a significant impact on FHIR API mandates. This legislation aims to accelerate medical product development and bring innovations to patients more quickly. The Cures Act specifically addresses the need for interoperability and prohibits information blocking, which impedes the sharing of health information.

Under the Cures Act, healthcare organizations are required to implement FHIR APIs to facilitate the exchange of health information. This ensures that patients can access their medical records easily and share them with other healthcare providers. The Act also imposes penalties up to $1 Million for non-compliance, further emphasizing the importance of adhering to FHIR API mandates.

RELATED: 21st Century Cures Act Updates and Penalty Deadlines 2023

Navigating the TEFCA Guidelines for FHIR API Implementation

The Trusted Exchange Framework and Common Agreement (TEFCA) provides guidelines for the implementation of FHIR APIs. TEFCA aims to establish a nationwide health information exchange framework that allows for the secure and interoperable exchange of health information across different networks

To navigate the TEFCA guidelines, healthcare organizations must first assess their current IT infrastructure and determine any gaps in interoperability. They should then develop a plan to implement FHIR APIs that aligns with TEFCA requirements. This may involve collaborating with health information networks and technology vendors to ensure seamless data exchange.

TEFCA Version 2 Update

The Office of the National Coordinator for Health IT (ONC) has released Version 2.0 of the Common Agreement defining how different health information networks and their users securely share clinical information with each other. The most significant update is that Version 2.0 requires support for FHIR application programming interface (API) exchange.

RELATED: TEFCA: How Does It Empower HIE and Streamline Interoperability?

Compliance Requirements for Healthcare Organizations

Compliance with FHIR API mandates is crucial for healthcare organizations to avoid penalties and ensure the secure exchange of health information. Organizations must adhere to the technical, operational, and privacy and security requirements outlined by the ONC and CMS.

From a technical standpoint, healthcare organizations need to implement FHIR APIs that conform to the standards set by the HL7 organization. This ensures that the APIs can effectively communicate and exchange health data with other systems. Additionally, organizations must have the necessary infrastructure and resources in place to support the implementation and ongoing maintenance of FHIR APIs

In terms of privacy and security, healthcare organizations must implement measures to protect patient data exchanged through FHIR APIs. This includes employing encryption techniques, access controls, and data breach response protocols. While there might not be explicit mandates in every jurisdiction, some regulations and initiatives encourage or require FHIR API implementation for healthcare organizations mentioned below.

  1. HIPAA (Health Insurance Portability and Accountability Act): While HIPAA doesn't specifically mandate FHIR API implementation, it emphasizes the importance of securely sharing patient information. FHIR APIs offer a standardized and secure way to exchange health data, aligning with HIPAA's goals.
  2. Promoting Interoperability (PI) Programs: Formerly known as Meaningful Use,these programs incentivize eligible healthcare providers to adopt certified EHR (Electronic Health Record) technology. Many EHR vendors are incorpora
  3. RELATED: Practical Applications of FHIR in Healthcare: Real-world Use Cases Explored

Key Considerations when Implementing FHIR API Mandates

Implementing FHIR API mandates requires careful planning and consideration. Here are some key factors to keep in mind:

  1. Assessing organizational readiness: Before embarking on FHIR API implementation, healthcare organizations should evaluate their readiness in terms of IT infrastructure, resources, and staff expertise. This assessment will help identify any gaps that need to be addressed before proceeding.
  2. Engaging stakeholders: Successful implementation of FHIR APIs requires collaboration and engagement with various stakeholders, including healthcare providers, technology vendors, and patients. Involving these stakeholders from the beginning ensures that their needs and concerns are addressed, fostering a smoother implementation process.
  3. Ensuring data quality and integrity: Healthcare organizations must ensure that the data exchanged through FHIR APIs is accurate, complete, and up-to-date. This may involve implementing data validation processes and establishing data governance policies to maintain data quality.
  4. Monitoring and evaluating performance: Continuous monitoring and evaluation of FHIR API performance is crucial to identify any issues or bottlenecks. This allows for timely resolution and optimization of the API implementation.

Tips for Successful FHIR API Adoption

Adopting FHIR APIs successfully requires careful planning and execution. Here are some tips to ensure a smooth adoption process:

  1. Engage leadership support: Obtain buy-in from senior leadership within the organization to prioritize FHIR API adoption. This support will help allocate necessary resources and overcome any potential barriers.
  2. Educate and train staff: Provide comprehensive training and education to staff members regarding the benefits and proper usage of FHIR APIs. This ensures that everyone understands their roles and responsibilities in the API adoption process
  3. Collaborate with technology vendors: Work closely with technology vendors to select the right FHIR API solutions that align with organizational requirements. Vendors can provide valuable insights and expertise to ensure successful implementation.
  4. Start small and scale: Begin with a phased approach, starting with a pilot project or a specific department before scaling up organization-wide. This allows for testing and fine-tuning of the API implementation before full deployment.

Available Resources and Tools for FHIR API Implementation

Implementing FHIR APIs can be made easier with the help of available resources and tools. Here are some that can assist healthcare organizations in their adoption journey:

  1. . HL7 FHIR specification: The HL7 organization provides detailed specifications and resources for implementing FHIR APIs. These resources include implementation guides, reference libraries, and testing tools.
  2. Health information exchange networks: Collaborating with health information exchange networks (HIE) can facilitate the implementation of FHIR APIs by providing a platform for secure data exchange and interoperability
  3. API management platforms: API management platforms offer solutions for managing and monitoring FHIR APIs. These platforms provide features such as security, analytics, and developer portal capabilities.
  4. Consulting services: Engaging FHIR consulting services specializing in healthcare IT can provide guidance and expertise in FHIR API implementation. These services can assist with strategy development, technical implementation, and compliance requirements.

RELATED: FHIR Implementation for Interoperability Success in Healthcare

The Future of FHIR API in the Healthcare Industry

FHIR API mandates are expected to shape the future of healthcare interoperability. As technology advances and more healthcare organizations adopt FHIR APIs, the seamless exchange of health information will become the norm. This will enable better care coordination, improved patient outcomes, and enhanced research opportunities. The healthcare industry will continue to see advancements in FHIR API standards and regulations to further promote interoperability and data exchange. It is crucial for healthcare organizations to stay updated with these changes and adapt their API implementation strategies accordingly.


In conclusion, navigating the rules and regulations surrounding FHIR API mandates can be a complex process for healthcare organizations. By understanding the ONC and CMS regulations, the impact of the Cures Act, and the guidelines provided by TEFCA, organizations can ensure compliance and successful implementation. Key considerations such as organizational readiness, stakeholder engagement, and data quality must be taken into account. With the right resources, tools, and tips, healthcare organizations can adopt FHIR APIs effectively and contribute to the advancement of healthcare interoperability. Embracing FHIR API mandates will pave the way for a future where seamless data exchange improves patient care and outcomes.

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