Staying One Step Ahead of Interoperability Regulations: What Providers and Developers Need to Know

Over the past decade, our healthcare system has made great strides in achieving interoperability, creating new opportunities and challenges for many players across the industry. Healthcare providers can now access comprehensive health information for their patients from outside the four walls of their clinic. Product developers can leverage new standards to design technology that allows providers and patients to exchange data securely. As a result of critical regulatory proposals, we’re seeing momentum accelerate on both sides to enable transparency and efficiency in the care journey.

Regulatory compliance has emerged as a top priority for our customers in the US and abroad. Whether it includes existing legislation or draft proposals, there are several ways in which new rules affect our customer’s priorities, from technology stack to business strategy. In this post, I wanted to provide our perspective on key regulations and best practices that are advancing our customer’s interoperability initiatives in the US.

In 2016, Congress passed the 21st Century Cures Act to accelerate progress towards nationwide interoperability, and earlier this year, concrete steps were proposed to prohibit information blocking. Leveraging APIs, providers are expected to share health information with patients and their caregivers. Hospitals will need to send ADT alerts to other providers in the patient’s care circle. At the same time, the ONC’s focus has been on reducing the administrative and reporting burden on providers to ease the transition to more transparency and public quality reporting. Once these proposals become law, most healthcare organizations will have to comply to participate in Medicare.

From the rollout of 21st Century Cures, the ONC also committed to advancing a Trusted Exchange Framework and Common Agreement (TEFCA) to improve data sharing across disparate health information networks, serving as a “network of networks.” TEFCA is designed to scale health information exchange nationwide and ensures that health information networks, providers, health plans, patients, and other stakeholders have secure access to their electronic health information when and where it is needed. In 2018, the ONC released the first draft of TEFCA, and a second draft was released several months ago. We believe TEFCA is a critical next step in the evolution of interoperability, as providers and developers both scale their efforts to support the entire continuum of care. It creates “rules of the road” for all to follow and provides efficient access to different networks across the country.

To further develop and operationalize TEFCA, we support the Sequoia Project’s application for the Recognized Coordinating Entity (RCE). The RCE would serve as a governance body to qualify and elect QHINs based on requirements of the Common Agreement. Sequoia Project and Carequality have worked collaboratively with many stakeholders, including Health Gorilla, to enable large-scale, nationwide interoperability. We believe they are best positioned to take TEFCA forward.

Just earlier this week, AHA requested ONC to mandate Qualified Health Information networks (QHINs) to support FHIR, previously excluded in the second draft of TEFCA. I strongly recommend the utilization of FHIR to standardize data exchange methods across the industry. We believe patients and providers will benefit by decreasing the variation in technical and legal policies across provider organizations and vendors.

At Health Gorilla, we have been working intimately with health systems and developers to ensure they are successful once these proposals become law. We are working with diagnostics vendors, including LabCorp and Quest, several health systems, and over a dozen health tech vendors. Among our suite of interoperability products, we offer health systems a data platform that enriches third-party data before it reaches the provider’s medical record. Making third party data meaningful and actionable for providers and developers will be a focus of ours in the coming months.

We’re encouraged by the efforts of ONC and HHS to push us even further and faster towards a system that would be in complete alignment with achieving higher patient outcomes. Progressive legislation helps us better serve our customers with true national connectivity. As the regulatory landscape evolves, our team at Health Gorilla looks forward to a productive dialogue with policy leaders on behalf of our provider and developer customers. We’re proud to work with many organizations in Puerto Rico and the US who use our platform, services, and network to achieve their interoperability goals.

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