Why FHIR is No Longer Optional in 2024, and What This Means for Your EHR Integrations

Konstantin Kalinin

Head of Content

August 20, 2024

It’s a familiar story: nurses, physicians, and medical staff buried in endless paperwork, grappling with fragmented patient information, and facing delays in critical decisions due to outdated systems. But this isn’t just their challenge; it’s a universal hurdle in healthcare. Now, imagine a world where every healthcare provider—from nurses to physicians—had real-time access to a patient’s complete medical history, administrative burdens were lifted, and patient outcomes improved dramatically through seamless data sharing. This isn’t some far-off dream—it’s becoming reality, thanks to the Fast Healthcare Interoperability Resources (FHIR) standard.

In 2024, FHIR is no longer just a buzzword but an indispensable requirement for healthcare organizations. Driven by significant regulatory mandates and an urgent need for efficient, secure data exchange, FHIR is changing the game.

Whether you’re a clinical IT leader, a health startup founder, or a practicing physician, understanding FHIR’s impact is crucial. Why? Because navigating the evolving healthcare landscape and harnessing FHIR’s full potential could be your key to staying ahead. So, let’s explore why FHIR is no longer optional and what it means for your organization—right now.

Top Takeaways:

• Mandatory Compliance: FHIR is now a regulatory requirement, driven by mandates like the CMS Prior Authorization Rule and the CURES Act, making its adoption non-negotiable for healthcare providers, payers, and EHR vendors.
• Enhanced Efficiency: Integrating using FHIR enables real-time data exchange and automation that scales readily across EHRs and connections. 
• Catalyst for Innovation: Accelerator programs like HL7 Da Vinci and FAST are paving the way for new capabilities using FHIR. Staying aligned with the latest standards helps software developers discover new niches to innovate within, driving forward the next wave of healthcare technology.

Table of Contents:

1. Why FHIR Matters for Clinical IT Leaders and Health Startup Founders
2. The Rise of Mandates: FHIR as a Requirement
3. Beyond the Mandates: The Benefits of FHIR Integration
4. Addressing the Challenges: FHIR’s Limitations and Workarounds
5. Opportunities for Innovation
6. Preparing for the Future: FHIR Implementation Strategies
7. Partnering for Success in FHIR Integration

Why FHIR Matters for Clinical IT Leaders and Health Startup Founders

The standard has matured and gained widespread acceptance, largely due to its flexibility, scalability, and the comprehensive nature of its data models.

FHIR’s prominence is underscored by significant regulatory and industry shifts:

• Interoperability and Compliance: Regulatory bodies, such as the Centers for Medicare & Medicaid Services (CMS), have championed FHIR as a cornerstone of interoperability. New rules and requirements mandate its use, making it a must-have element of any healthcare IT strategy.
• Operational Efficiency: The newest FHIR standards seek to automate old problems such as Prior Authorization and Patient Immunization Records.
• Innovation and Scalability: FHIR’s modular design allows for incremental implementation, which is essential for scalable healthcare applications. This modularity supports innovation, enabling organizations and startups to develop new products, features, and integrations without overhauling their existing systems.

In essence, FHIR is no longer a luxury but a necessity. The use of FHIR today makes integrations faster and more repeatable than ever before.

The Rise of Mandates: FHIR as a Requirement

The transition towards mandatory FHIR adoption is reshaping the healthcare landscape. Various regulations and frameworks underline the necessity of integrating FHIR into EHR systems.

The CMS Prior Authorization Rule and FHIR Adoption

The CMS Prior Authorization Rule mandates that payers must support prior authorization via FHIR, aiming to reduce administrative overhead and improve data exchange efficiency. For healthcare app developers and clinical IT leaders, this means supporting the FHIR data exchange standard and and the Da Vinci Burden Reduction standards that rely on it, is essential to comply with new regulations and streamline the authorization process.

The rule focuses on streamlining the prior authorization process for healthcare providers and aims to improve access to necessary care for patients. Some key points include:

• Faster Decisions: Insurers will need to provide decisions on prior authorization requests within specific timeframes. Standard requests will need a decision in 7 days, while urgent requests will have a 72-hour turnaround
• Clear Denial Reasons: When denying a request, insurers must give a clear explanation. This will help providers address any issues and potentially resubmit the request.
• Improved Technology: The rule requires insurers to implement technology to allow for electronic submission of requests and receiving decisions.

Historically, prior authorization involved web portals or 3rd party services and lengthy wait times. The Da Vinci Burden Reduction standards use FHIR to automate real-time communication between providers and payers, leading to faster approvals and enhanced patient care.

The CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) published in January 2024 by the Centers for Medicare & Medicaid Services outlines several key compliance dates that impact EHR integrations:

• January 1, 2026: Impacted payers must implement certain operational provisions, including:
  • Sending prior authorization decisions within 72 hours for expedited requests and seven calendar days for standard requests.
  • Providing specific reasons for denied prior authorization decisions.
  • Publicly reporting certain prior authorization metrics annually.

• January 1, 2027: Impacted payers must meet the application programming interface (API) development and enhancement requirements. This includes implementing APIs that use FHIR such as the Prior Authorization API, Patient Access API, Provider Access API, and Payer-to-Payer API.

These dates reflect CMS’s phased approach to improving interoperability and streamlining prior authorization processes to reduce administrative burdens and improve patient care. This regulation affects any payer who provides Medicare Part B, Medicare Advantage, Medicaid, and CHIP managed care plans.

California Data Exchange Framework: A FHIR-based Solution

The California Data Exchange Framework (DxF) mandates significant changes in data exchange processes for payers and providers in California, particularly for Medicaid patients. This FHIR-based solution aims to streamline prior authorization processes, reduce administrative burdens, and ensure timely access to critical information.

Key Implications for Payers and Providers with Medicaid Patients:

• Changes in Prior Authorization Processes: DxF requires all prior authorization requests and responses to use FHIR, promoting standardized and efficient workflows.
• Data Exchange Requirements: New data exchange requirements ensure that patient information is readily available and accessible through FHIR interfaces.
• Potential Administrative Burden Reduction: Automation of manual processes reduces administrative tasks, allowing healthcare professionals to focus more on patient care.

Benefits for Payers and Providers

The DxF framework offers numerous benefits for both payers and providers:

• Improved Efficiency: FHIR-based systems enable quicker approvals and reduce the back-and-forth typical in prior authorizations.
• Enhanced Data Accuracy: Standardized data formats lead to faster data retrieval processes with less back-and-forth communication.
• Cost Savings: Reduced administrative overhead translates to significant cost savings for both payers and providers.

Other Regulations Propelling the Use of FHIR

Beyond CMS and California DxF mandates, other regulations are also accelerating the adoption of FHIR:

• The CURES Act: Effective April 5, 2021, this revolutionary US law mandates that patients have access to all their health data. Built on FHIR, this ensures patients can view, share, and control their personal health records.
• The Trusted Exchange Framework and Common Agreement (TEFCA) includes a FHIR Roadmap designed to support the nationwide scalability of FHIR-based capabilities. As of April 2024, health information exchange networks participating in the TEFCA are required to support FHIR standards, facilitating secure and efficient data exchange.
• NHS and CDC Initiatives: The UK’s National Health Service (NHS) extensively uses FHIR, while US federal agencies like the Centers for Disease Control and Prevention (CDC) and the Office of the National Coordinator for Health IT (ONC) support initiatives such as the Helios effort and the 21st Century Cures Act.

These initiatives aim to streamline data sharing across all levels of public health using the FHIR standard. These regulations highlight the growing consensus around FHIR as the future of healthcare data exchange. They underscore the urgent need for healthcare organizations to adopt FHIR to stay compliant and leverage the benefits of improved interoperability.

Beyond the Mandates: The Benefits of FHIR Integration

The mandates around FHIR adoption are just the beginning. The real value lies in leveraging FHIR to create more efficient and effective healthcare workflows. In this section, we’ll explore how FHIR can streamline your operations and improve both patient and provider experiences.

Current State of FHIR Adoption in the Industry

FHIR adoption has made significant strides across the healthcare landscape, particularly in the United States. Let’s take a closer look at the statistics that highlight this progress:

• Hospitals and Clinicians: As of 2019, a remarkable 84% of hospitals and 61% of clinicians had adopted and implemented 2015 Edition certified API technology enabled with FHIR. This widespread adoption underscores the healthcare industry’s commitment to interoperability and seamless data exchange.
• Healthcare Companies: By April 2021, 24% of healthcare companies were utilizing at-scale FHIR APIs. This number was projected to rise significantly, with 67% of providers and 61% of payers anticipating the use of at-scale FHIR APIs by 2023. This growth reflects the increasing reliance on FHIR for efficient and effective data management.
• Certified Health IT Developers: As of August 2022, approximately 5% of certified health IT developers had updated their technology to comply with the Cures Update Standardized API criteria for patient and population services. While this percentage might seem modest, these developers supported a substantial portion of in-patient and ambulatory users nationwide, accounting for roughly 66% and 77%, respectively.

These statistics illustrate not only the current state of FHIR adoption but also the growing momentum towards widespread implementation. The ONC Cures Act Final Rule has further accelerated this trend, requiring certified health IT developers to support FHIR APIs by the end of 2022. This regulatory push ensures that more healthcare organizations will integrate FHIR into their systems, paving the way for enhanced interoperability and better patient outcomes.

Main Advantages of FHIR

As we’ve already established, FHIR offers several key features and benefits that make it an indispensable tool for healthcare integration: interoperability, scalability, and flexibility. But is there anything beyond that?

Supporting a Wide Range of Data Types

FHIR is designed to be extensible to  various types of healthcare data, from clinical records to administrative processes. This versatility means that you can use FHIR to integrate virtually any kind of health-related information, facilitating a holistic view of patient care, and there’s probably an accelerator group that’s working to standardize how FHIR should be used for this process.

The Advantages of FHIR Pub/Sub Capabilities

One of FHIR’s newest standout features is its publish-subscribe (Pub/Sub) capability, which facilitates real-time data exchange and automation. Here’s how it adds value:

• Real-Time Data Exchange: One of FHIR’s current challenges is that it operates on a Pull-based model. The consumer needs to know there’s new data waiting for them to retrieve it. With Pub/Sub, updates in one system can be “pushed” to  another, ensuring that all stakeholders have access to the most current information.
• Automation: Pub/Sub capabilities enable more automated workflows, reducing manual interventions and minimizing errors. For example, a change in a patient’s medication can trigger an automatic update to all relevant systems, ensuring coordinated care.

Addressing the Challenges: FHIR’s Limitations and Workarounds

While FHIR offers numerous benefits, adopting it is not without its challenges. Understanding these limitations and knowing how to address them is crucial for successful implementation.

Data Write-Back Capabilities

One significant challenge with FHIR is the adoption of “write” capabilities within EHRs. Most EHRs today offer very limited support for FHIR writes, primarily because they are not ready to enable the creation of new data points in their software via outside sources. Here’s how to navigate this:

• • HL7 V2 as a Complementary Solution: To address write-back limitations, organizations can use HL7 V2 in conjunction with FHIR. HL7 V2 is well-established for data write-backs and can effectively complement FHIR’s strengths, ensuring comprehensive data management.

• Use of Proprietary APIs: While FHIR write-back remains limited, most EHRs have enabled proprietary methods to write back many different data types. Many EHRs offer paid access to these features via their vendor marketplaces.

Knowledge and Expertise

Another major barrier to FHIR adoption is the lack of knowledge and expertise among healthcare providers and IT professionals. Integrating FHIR with existing systems and workflows can be complex and requires specialized skills.

• Training and Education: Investing in training programs and resources can equip your team with the necessary skills to implement FHIR effectively. This includes understanding FHIR standards, integration techniques, and best practices for ensuring smooth transitions.

Technical and Financial Barriers

High investment costs and the need for significant technical infrastructure pose additional challenges to FHIR adoption. These barriers can be daunting, especially for smaller healthcare organizations.

• Strategic Planning and Incremental Implementation: Developing a strategic plan that includes phased implementation can help mitigate high upfront costs. By gradually implementing FHIR integrations, organizations can spread out expenses and manage the transition more effectively.
• Leveraging Government and Industry Support: Tapping into resources from regulatory bodies and industry groups can provide financial assistance, clarify regulations, and offer technical support. For instance, the NIH’s grant program supports health IT projects that include FHIR integration. Additionally, CMS is exploring a potential transition to FHIR-based quality measurement within its eCQM (Electronic Clinical Quality Improvement) initiative.

Data Security and Privacy Concerns

Concerns about data security and privacy are significant hurdles to broader FHIR adoption. Ensuring compliant and secure data exchange is paramount in healthcare.

• Robust Security Measures: Implementing robust security protocols, such as encryption, access controls, and regular audits, can help safeguard sensitive health information. Adhering to industry standards like HIPAA ensures compliance and builds trust among stakeholders.

Lack of Comprehensive Clinical Datasets

The absence of comprehensive clinical datasets can hinder effective FHIR implementation. Accurate and complete data is essential for meaningful interoperability and improved patient outcomes.

• Data Standardization and Integration: Working towards data standardization and integrating diverse datasets can enhance the quality and completeness of clinical data. Collaboration with other healthcare entities and data-sharing initiatives can also contribute to building comprehensive datasets.

By acknowledging and addressing these challenges, healthcare organizations can successfully implement FHIR and capitalize on its benefits. Topflight’s expertise in EHR integration ensures that we can guide you through these complexities, providing strategic solutions that align with your unique needs.

Opportunities for Innovation

The mandates for FHIR adoption don’t just represent regulatory hurdles—they also pave the way for innovative solutions that can transform healthcare delivery. Let’s explore how government mandates create opportunities for startups, identify areas ripe for technological advancement, and underscore the importance of building compliant tools.

How Government Mandates Create Opportunities for Startups

Government mandates for FHIR integration are driving a wave of innovation across the healthcare industry. For startups, this represents a golden opportunity to develop new solutions that meet compliance standards while addressing critical needs in healthcare.

• Interoperability Solutions: Startups can focus on creating robust interoperability solutions that facilitate seamless data exchange between disparate systems. By leveraging FHIR, they can ensure their products are compatible with existing healthcare infrastructure, making them more attractive to potential clients.
• Efficiency Improvements: There’s a significant demand for tools that streamline administrative processes like prior authorizations and patient data sharing. Startups that develop efficient, user-friendly applications stand to gain a competitive edge.
• Patient-Centered Applications: With mandates like the CURES Act emphasizing patient access to health data, there’s a growing market for apps that empower patients to manage their health records. Startups can innovate in this space by offering secure, intuitive platforms for patients.

Areas Ripe for Technological Advancement

Several key areas within healthcare IT are primed for technological advancement, thanks to the push for FHIR compliance:

• Real-Time Data Analytics: The ability to process and analyze health data in real-time can dramatically improve patient care. Innovations in real-time analytics can help providers make faster, more informed decisions, ultimately leading to better outcomes.
• AI and Machine Learning: Integrating AI and machine learning with FHIR can revolutionize predictive analytics, personalized medicine, and automated administrative tasks. These technologies can enhance the efficiency and accuracy of healthcare delivery.
• Blockchain for Enhanced Security: Blockchain technology can provide an immutable and secure way to manage health data, ensuring patient privacy and data integrity. FHIR-based blockchain solutions can address critical security concerns and enhance trust in digital health systems.
• Telehealth and Remote Monitoring: The COVID-19 pandemic has accelerated the adoption of telehealth and remote monitoring solutions. FHIR can support these technologies by ensuring the secure and efficient exchange of patient data across platforms.

Importance of Building Compliant Tools

Compliance with health data standards and regulations is crucial for success in the healthcare industry. Building tools that adhere to these standards not only ensures regulatory compliance but also enhances the credibility and trustworthiness of your solutions.

• Regulatory Compliance: Tools that comply with FHIR and other health data standards meet federal and state regulations, reducing the risk of legal issues and fines. Compliance ensures that your solutions can be widely adopted across the healthcare sector.
• Trust and Credibility: Healthcare providers and patients need to trust that their data is secure and handled responsibly. Compliant tools demonstrate a commitment to best practices in data security and privacy, building trust among users.
• Future-Proofing: As the healthcare landscape continues to evolve, staying ahead of regulatory changes is essential. Building compliant tools positions your organization to adapt quickly to new mandates and industry shifts, ensuring long-term success.

By capitalizing on these opportunities for innovation, startups and healthcare organizations can not only meet regulatory requirements but also drive meaningful improvements in patient care and operational efficiency. Whether you’re a startup looking to break into the healthcare market or an established provider aiming to enhance your IT infrastructure, our team is here to support your journey.

Preparing for the Future: FHIR Implementation Strategies

As the healthcare landscape continues to evolve, preparing for FHIR integration is essential for maintaining compliance and enhancing operational efficiency. This section outlines practical strategies for implementing FHIR, ensuring your organization is well-equipped for the future.

Assessing Your Current EHR Integration Capabilities

Before embarking on a FHIR implementation journey, it’s crucial to evaluate your existing EHR integration capabilities. This assessment will help you identify gaps and determine the necessary steps to achieve seamless FHIR integration.

• Current Infrastructure: Review your current EHR systems and their compatibility with FHIR standards. Identify any legacy systems that may require upgrades or replacements.
• Integration Readiness: Evaluate your organization’s readiness for FHIR integration. This includes assessing your IT staff’s expertise, existing workflows, and data exchange processes.
• Stakeholder Involvement: Engage key stakeholders, including clinical staff, IT professionals, and administrative personnel, to gather insights and ensure alignment with organizational goals.

Identifying FHIR Compliance Requirements for Your Organization

Understanding the specific FHIR compliance requirements relevant to your organization is critical for successful implementation. These requirements may vary based on your role in the healthcare ecosystem, whether you’re a provider, payer, or health IT vendor.

• Regulatory Mandates: Familiarize yourself with federal and state regulations regarding FHIR adoption. Key mandates include the CMS Interoperability and Patient Access Final Rule and the ONC Cures Act Final Rule.
• Industry Standards: Stay updated on FHIR implementation guides and best practices published by organizations like HL7 and the Da Vinci Project. These resources offer valuable insights into compliant data exchange protocols.
• Organizational Policies: Align FHIR integration efforts with your organization’s policies on data security, privacy, and interoperability. Ensuring compliance with internal standards is as important as meeting external regulations.

Exploring FHIR Integration Tools and Solutions

Leveraging the right tools and solutions can streamline your FHIR integration process, making it more efficient and effective. Here are some options to consider:

• FHIR Servers and APIs: Implement FHIR servers and APIs to facilitate seamless data exchange between EHR systems and other healthcare applications. Popular options include HAPI FHIR, Microsoft Azure API for FHIR, and Google Cloud Healthcare API.
• Interoperability Platforms: Utilize interoperability platforms that support FHIR integration, such as  Mirth Connect. These platforms can simplify the process of connecting disparate systems and standardizing data formats.
• Third-Party Vendors: Partner with experienced third-party vendors specializing in FHIR integration. Topflight, for instance, offers tailored solutions and expert guidance to ensure successful FHIR adoption.

Building a Long-Term FHIR Adoption Plan

A comprehensive, long-term plan is essential for sustainable FHIR adoption. This plan should outline your integration strategy, timelines, resource allocation, and ongoing evaluation metrics.

• Phased Implementation: Break down the FHIR integration process into manageable phases. Start with high-priority areas, such as patient access APIs, and gradually expand to encompass other functionalities.
• Resource Management: Allocate appropriate resources, including budget, personnel, and technology, to support each phase of the integration. Ensure continuous training and development for your IT team to maintain expertise in FHIR standards.
• Continuous Evaluation: Establish metrics to evaluate the effectiveness of your FHIR integration efforts. Regularly review these metrics to identify areas for improvement and ensure alignment with organizational goals.

Da Vinci Implementation Guides: Streamlining Prior Authorization

The Da Vinci Project, an industry-led initiative, has developed implementation guides to streamline prior authorization using FHIR standards. These guides provide detailed workflows and best practices, ensuring organizations can adopt FHIR efficiently and effectively.

The Da Vinci Prior Authorization Guide provides more structure and guidance around the process of implementing prior authorization via FHIR by specifying how to discover Coverage Requirements, Documentation Templates and Rules, and perform Prior Auth Submission. This framework is designed to generate significant adoption and ease the administrative burden by offering specific workflows and best practices that speed up processes and improve transparency.

Topflight is already piloting several projects adhering to these latest guidelines, pushing healthcare organizations further on their interoperability journey. We’re leveraging our deep expertise in EHR integration to ensure that our clients not only comply with these mandates but also reap the benefits of streamlined operations and improved patient care. Our approach is data-driven and focused on tangible results—helping you increase efficiency, reduce costs, and enhance overall service delivery.

By following these strategies and best practices, your organization can navigate the complexities of FHIR integration and unlock its full potential. Topflight’s commitment to excellence and innovation ensures that you receive the support and solutions needed to thrive in this evolving landscape.

Partnering for Success in FHIR Integration

The future of healthcare data exchange hinges on effective FHIR integration: it’s imperative to stay ahead of the curve and ensure your organization is fully prepared for this shift.

If you need assistance with catching up to FHIR in your EHR integration initiatives, reach out to Topflight. Our expertise in EHR integration positions us as the ideal partner to guide you through these complexities, ensuring that your organization not only meets compliance requirements but also thrives in this evolving landscape.

Let us help you harness the power of FHIR for a more connected and efficient healthcare system.