Tripathi: 2022 Pivotal for Digital Health Transformation, Health IT

2022 is a pivotal year in the digital health transformation, according to Micky Tripathi, national coordinator for health IT.

At the virtual ONC annual meeting on April 13, Tripathi noted that over the last decade, the agency has established an electronic overlay of the healthcare system to move away from the constraints of paper, brick, and mortar.

"Now, the exciting part is that we get to think about how we want to redesign our healthcare system without the constraints of paper, brick, and mortar," Tripathi explained. "Our work in health IT is ultimately to create open architectures, both from a policy and a technical perspective, that allow for that reconceptualization of our healthcare system to happen."

Tripathi said that an open architecture perspective leverages open industry standards and policies built with the expectation of interoperability to break down silos between different parts of the healthcare industry.

"This isn't going to happen overnight," he noted. "It happens with discreet steps that keep pushing us in the right direction."

Information Blocking

One of these steps includes the ONC information blocking provisions. Tripathi said that ONC has continued to hear positive feedback from clinicians and their patients who are benefiting from improved access to electronic health information.

He pointed out that the agency has also received negative feedback. However, none of the feedback has been about the foundational policy direction.

"I'm pleased that the concerns that we've gotten are about wanting clarity about implementation details," Tripathi said.

"The changes engendered by the Cures Act are paradigm-shifting," he said. "They're not small tweaks, so we know it's not going to happen with the wave of a magic wand."

However, Tripathi said that the level of engagement ONC has seen from healthcare providers, technology developers, and health information networks has been heartening.

"I am encouraged by the organizations I've spoken with who are not thinking about compliance; they're thinking about opportunity," he said.

Tripathi explained that one of the scourges of the healthcare industry is minimum viable compliance, which is when organizations do just enough to meet the requirements of a regulation instead of "embracing the spirit and the opportunity of what we can do together."

He said this creates a vicious cycle of regulation followed by more detailed law. However, Tripathi noted that he has a lot of hope that the industry has turned the corner on minimum viable compliance based on what the agency is seeing.

"We encourage everyone to make compliance the floor of what you do and not the ceiling of what you do," Tripathi said.

Starting on October 6th, electronic health information (EHI) will no longer be limited to the data elements represented in the USCDI under the information blocking regulations. This means that all EHI must be accessible to providers and patients.

Additionally, certified health IT developers must make FHIR APIs available to their customers by the end of 2022.

"If you're a provider, I certainly encourage you to ask your vendor what their plans are for making that available to you so that you can start on the next chapter of the journey of making information available and for you to be able to use those FHIR APIs in whatever way you see fit," Tripathi said.

TEFCA

Tripathi noted that ONC put a critical part of the Cures Act in place on January 18th by opening the Trusted Exchange Framework and the Common Agreement (TEFCA) for network participation.

"Right now, we're working hard on operationalizing TEFCA," Tripathi said. "The Sequoia Project, our partner, is working very hard on finalizing the details of standard operating procedures. What we released on January 18th is the common agreement, which is the agreement that qualifying networks would sign with the recognized coordinating entity (RCE), The Sequoia Project."

"That also includes the technical requirements to be implemented that form the pillars of interoperability exchange between the qualified health information networks," he explained.

Tripathi said ONC's goal is to have the first QHINs exchanging health information by the end of 2022.  

Certified Health IT

The industry has taken also taken a step toward digital health transformation by way of submitting real-world testing plans for certified health IT, Tripathi said.

All certified health IT developers submitted real-world testing plans by December 15th, 2021, which was the deadline per the Cures Act.

"That's a really important step forward as we think about certification and ensuring that the requirements that are embedded in the certification are actually being met in the real world," Tripathi pointed out.

"We do testing in a laboratory environment, but the real-world testing requirements require that we get information from the field of how are the systems doing when they're in front of a clinician," he said.

Tripathi explained that the real-world testing requirements come in response to stakeholder feedback that while health IT may pass the ONC certification, those tools may not always be operational in the clinical setting.

He noted that ONC will publish the real-world testing results that certified health IT developers report by March 15, 2023.