Going beyond compliance and driving innovation with TEFCA
It’s not hard to imagine this familiar and frustrating scenario: a person travels to another state, experiences a sudden health emergency, and arrives at an emergency room where the clinicians have no existing relationship with their primary doctor. Despite it being a pre-existing condition, the care team has no access to existing medical records. The patient must repeat their medical history, undergo duplicate tests, and update the clinicians on current treatment and medication before receiving the care they urgently need.
This situation is far more common than it should be. For hospitals, gaining access to patient information requires multiple data-sharing agreements across networks and providers, an administrative burden that delays care and increases cost. Even in non-emergency settings, a primary care physician may not have seamless visibility into a patient’s wearable device data, limiting their ability to intervene early when critical changes occur.
These challenges may soon be a thing of the past with the changes in the Trusted Exchange Framework and Common Agreement (TEFCA). While fundamentally a set of guidelines meant to drive compliance and interoperability in the healthcare and MedTech landscape, TEFCA has the potential to unlock the next wave of innovation for medical device and technology firms.
TEFCA’s architecture as a “network of networks” transforms how healthcare data moves across stakeholders, making it an innovation launchpad for MedTech enterprises.
Streamlining data access
The framework formally authorizes six exchange purposes: treatment, payment, health care operations, public health, government benefits determination and individual access services. Under the treatment exchange guidelines, situations like the one described above can be prevented as the hospital can access and share health information like clinical data, lab and imaging reports across the network.
TEFCA integration also facilitates pre-authorising payments for healthcare services by streamlining eligibility checks and prior authorisation support. Giving payers access to clinical data helps with decision making on outcome-based contracts where reimbursement is linked with clinical outcomes like device performance.
The use of digital certificates and a technical trust framework simplifies direct data exchange between parties. If MedTech firms design with Fast Healthcare Interoperability Roadmap (FHIR)-first APIs then the device data can integrate directly with electronic health records, payer platforms, and patient apps without building custom interfaces for each scenario. Partnering with a technology solutions provider with healthcare expertise to develop this plug-and-play integration can significantly compress design cycles and accelerate deployment.
With standardized, secure, and scalable data-sharing mechanisms, device manufacturers can build solutions that were simply not feasible at scale in the past. As TEFCA connects users and providers to their medical records through participating Qualified Health Information Networks (QHINs), every device or platform that plugs into the system operates as a node capable of exchanging data across the nationwide ecosystem. This dramatically simplifies data accessibility in scenarios like the emergency example above.
Driving Innovation with Compliance
TEFCA is a cornerstone of compliance for healthcare and MedTech stakeholders. When viewed through the prism of product and system design, it provides tremendous potential for designing new products and clinical workflows. We feel this has strong applications in areas like data-centric diagnostics, clinical decision support and public-health integration given the scale of interconnectivity it facilitates.
This level of integration can help with a “hospitalathome” set up where a MedTech platform ships kits with Bluetooth BP cuffs, pulse oximeters, thermometers, weight scales, and a hub. The platform connects to a QHIN and normalizes all device data into FHIR. After the episode, that data is no longer trapped in the vendor’s portal: any future provider treating that patient can query TEFCA and see homemonitoring trends alongside all other recorded clinical data. This then fundamentally transforms how care is currently provided and enhances outcomes and patient experience.
Empowering Patients
Enterprises must ensure that they design devices that work seamlessly across multiple healthcare networks. Enabling features like federated identity and cross-network consent management allow for smoother data transfers. Any device that is plugged into the network operates as a node which can exchange data with other members.
This unlocks value for healthcare practitioners and patient alike. Individual Access Services (IAS) allow individuals to request their own health information and supports consumer facing tools like personal health record apps, mobile health apps, wellness apps that integrate clinical data as well as FHIR based apps. Data from glucose monitors, imaging systems, or remote cardiac monitors can flow directly into EHRs or clinician dashboards without needing custom interfaces, provided they are a part of TEFCA.
Creating simple, intuitive mechanisms for patients to grant or withdraw consent and giving them visibility into who accessed their data and why are essential to fostering trust. Embedding these capabilities as part of the design process can help turn what is a compliance requirement into a tool for accelerating adoption and strengthening customer loyalty.
Providing patients access to their own healthcare data empowers them and lets them become active participants in their own care. Given the challenges that currently exist for patients wanting to access their own health data, we believe that any MedTech firm who is an early mover in this space stands to gain a considerable competitive advantage.
Innovation-led design
The way we see it, the device itself evolves from being a single point solution to a critical component of an interoperable system. This can be the starting point for a series of innovative interventions from the design stage itself. TEFCA becomes a launchpad for a new wave of device innovation by reducing integration friction, accelerating deployment, and enabling the development of advanced applications and tools.
As TEFCA volumes grow and policies around secondary use mature, a device maker could use TEFCAsourced clinical data to maintain national outcome registries for implants or complex devices. Instead of building bilateral datause agreements with dozens of health systems, it uses a QHIN connection and standardized FHIR resources to follow device performance, complications, and reinterventions across the country, feeding into safety surveillance and nextgen product design.
That said, MedTech firms would do well to remember that the TEFCA governance framework is still maturing. Getting the requisite certifications and QHIN participation requires investments, and companies will have to work with vendors to iron out data models and business terms.
We believe that the new TEFCA guidelines represent a paradigm shift in how medical devices will impact healthcare delivery and patient management in the future. Being able to share and access patient data in a seamless, efficient manner has the potential to improve diagnostic accuracy, response times and the overall quality of care provided.
This can, over time, give MedTech firms an early mover advantage, helping them grow faster as TEFCA matures. Partnering with a technology provider who understands the complexities of the healthcare ecosystem can help companies navigate this transition effectively. Viewing TEFCA not just as a compliance checklist but as an innovation catalyst can be the key to unlocking the next generation of patient-centric products and business models.
