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The Rules of the Road Have Changed: A Leader’s Guide to Healthcare’s Data-Sharing Mandates

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The healthcare data landscape is crowded with acronyms. You have TEFCA, FHIR, the 21st Century Cures Act, HTI-1, and now, the new CMS Interoperability Framework announced by the White House. For any healthcare leader, just keeping track of the terms is a challenge, let alone understanding how they fit together and what you need to do to comply.
These frameworks represent a major shift in how the industry is expected to manage and share information. The goal is to create a system where data flows securely and seamlessly between providers, payers, and patients to lower costs, improve outcomes, and empower consumers. But as the latest CMS initiative shows, the path to achieving this goal is still being paved, leaving many organizations wondering where to even begin.
Instead of getting lost in the details of each individual mandate, it’s more effective to understand the role each one plays in the bigger picture of building a national data-sharing network.
- FHIR (Fast Healthcare Interoperability Resources): This is the common language of the network. It’s a technical standard that dictates how electronic health information should be structured so that different systems can exchange and understand it. However, as experts have noted, different organizations can implement different versions or "dialects" of FHIR, which can still create communication barriers.
- TEFCA (Trusted Exchange Framework and Common Agreement): These are the rules of the road for the network. TEFCA establishes the governance, technical requirements, and security protocols for a nationwide system of Qualified Health Information Networks (QHINs). Its primary focus has been on creating a trusted environment for providers and health organizations to share data with each other to improve care coordination.
- HTI-1 (Health Data, Technology, and Interoperability): This is about ensuring the traffic flowing on the network is fair and transparent. It’ a recent addition that builds on the foundation of the 21st Century Cures Act. The HTI-1 final rule enhances the requirements for health IT certification and pushes for greater transparency, especially around the algorithms used in clinical decision-making. It’s
- The New CMS Interoperability Framework: This is the latest effort to open a high-speed lane directly to the consumer. While it builds on the principles of FHIR and TEFCA, its defining feature is a strong emphasis on patient access. The goal is to ensure patients can easily get their clinical data, claims, and prior authorization information through applications of their choice. It raises the bar significantly, putting pressure on payers and providers to not just exchange data, but to deliver it in a consumer-friendly way.
The Real Problem Isn't the Rules, It's the Data
Complying with this web of regulations isn't just about setting up new APIs or joining a network. The biggest challenge isn't connecting the systems; it's ensuring the information flowing between them is accurate, reliable, and trustworthy.
You can build a perfect highway system, but if the cars on it are carrying the wrong cargo or breaking down mid-journey, you have chaos. The same is true for interoperability. If you send fragmented, duplicated, or inaccurate patient data through a FHIR-based API, you haven't solved the problem—you've just made bad data move faster. The new CMS framework's focus on putting data in patients' hands makes this issue even more critical. What happens when a patient sees conflicting information from their doctor and their health plan, or when a lab result appears without the context to understand it?
This is the foundational challenge that no single regulation can solve on its own. True interoperability depends on having a clean, centralized, and governed source of truth for your data before you try to share it.
A Modern Data Platform: Your Control Tower for the Interoperability Maze
Instead of chasing compliance for each new rule, a more strategic approach is to invest in a foundational health data management platform like the Gaine Health Data Management Platform (HDMP). This platform acts as your organization's air traffic control—a central hub that can ingest, understand, and manage data from any source, in any format, and prepare it to meet the demands of any regulation, today or tomorrow.
A modern health data management platform helps you navigate this complex environment in three key ways:
- It Translates and Harmonizes Your Data: A robust platform can ingest data from all your internal and external sources—your claims system, EHRs, provider directories, and third-party feeds. It cleanses, standardizes, and de-duplicates this information, creating a single, reliable source of truth for every member, provider, and clinical record. It resolves the "different dialects" of FHIR by harmonizing all data into one consistent format.
- It Provides Centralized Governance: The push for patient access brings complex challenges around consent and data privacy. Gaine HDMP provides a central place to manage these rules. You can define and enforce policies for data access and sharing, ensuring that sensitive information is only shared with the right people at the right time, regardless of the app or system being used to access it.
- It Makes You Future-Proof: The regulatory landscape will continue to evolve. Another framework or mandate is always on the horizon. With a flexible data platform, you are no longer reacting to each new rule with a costly, one-off IT project. Your data is already clean, governed, and ready. The platform provides the agility to adapt to new standards and sharing requirements, allowing you to stay compliant and focus on using your data for strategic initiatives like value-based care and AI.
The journey to interoperability is a marathon, not a sprint. By focusing on building a strong data foundation, you can move beyond simply reacting to the flurry of new regulations and begin unlocking the true value of your data to build a more connected and efficient healthcare experience for everyone.
At Gaine, we’d love to help you build a data foundation to meet the challenges of today and tomorrow. Contact us to speak to one of our data management experts about your organization’s needs.