ONC Leader Tripathi Offers Tips for Interoperability Rule Success

The Office of the National Coordinator for Health IT is gearing up to help organizations succeed with all phases of the interoperability rule, focused mainly on moving a range of health IT levers in unison in both the short and long term, according to the newly appointed national coordinator for health IT, Micky Tripathi, PhD, MMP.

Whether it is information blocking, patient data exchange, or interoperability, Tripathi said ONC’s goal is to “pull all of those levers so that they’re working as an orchestra” by correctly pulling them at the right time, and most importantly, in the same direction.

“There's this whole range of levers that we have,” Tripathi said in an interview. Some of them are soft, tiny levers. And some of them are really hard levers, like our regulation. One of the things we spend a fair amount of time doing is thinking, “how do we think about all of those levers and making sure that we have a set of goals?”

As of April 5, 2021, healthcare providers, certified health IT developers, and health information exchanges (HIEs) needed to abide by the information blocking regulations. Yet, Tripathi wants healthcare organizations to look at the larger picture, with several compliance dates on the horizon within the next 18 months.

“What I don't want is that those regulatory dates end up becoming the pace at which the industry progresses, because if we're going to wait 18 months for more robust FHIR-based capabilities, that's just not a good answer in a fast-moving space where you have business models and technology moving at the internet speed, as it were,” he explained.

Now that the regulations are published, Tripathi said ONC is working on getting the message out through media channels and speaking directly with healthcare stakeholders.

“Our policy team and our clinical team meet every week on a proactive basis with stakeholder groups, such as clinicians, providers, CEOs, and others to educate as much as we can, respond to questions that we get, and to take as many questions from them as we can to be able to make sure that we're being as responsible as possible for them,” he explained. “It's just a coordinated effort across with using all of the tools that we have at hand.”

Tripathi added that although April 5 provided healthcare stakeholders with the information blocking regulations, that’s currently limited to structured data under the US Core Data for Interoperability (USCDI). That’s a more limited group of patient data that healthcare organizations are beholden to make available.

In 18 months, the floodgates will open, making healthcare organizations responsible for sharing that structured data as well as some unstructured data, presenting a bigger challenge, Tripathi said.

To prepare for October 2022, Tripathi encouraged healthcare organizations to make all patient data available as if ONC did not limit the scope of data over those 18 months.

Ahead of the October 22 deadline, at which point organizations need to make all data--structured and unstructured--available, organizations need to think about inbound and outbound data.

According to Tripathi, healthcare organizations must establish what types of patient data to make available and how they are going to make those data sets available.

“There is this notion of EHI being the electronic portion of the designated record set, which is a HIPAA construct,” Tripathi explained. “But the designated record set is a little bit amorphous because every organization is, in theory, allowed to define what is the designated record set.”

“Now you have this concept of EHI, which is just drawing an electronic circle around the designated record set and saying, ‘Okay, so the electronic piece of that is now EHI, and that's what's made available,’” Tripathi continued.

However, there is no clear-cut definition that explains the elements of electronic patient data, he noted. Healthcare organization leaders will have to define patient data, then decide how that definition matches the requirement and how the data will be made available.

From an inbound perspective, healthcare leaders will also have to decide how providers will be able to get access to patient data from outside provider organizations and what they will do with it, Tripathi described. That’s a significant health information exchange question.

Furthermore, leaders will have to decide which health IT tools will be needed, which processes will be in place, and if increased unstructured data access is essential for their specific healthcare organization.

“It's not going to make sense for every provider organization,” Tripathi continued about unstructured data access. “But the organizations who it does make sense for, what are the technologies that you're going to use for that? How are you going to incorporate that? And what's the bridge between the analytics that you're going to apply to that, to the actual actions and the workflows, that at the end of the day you want to be able to enable?”

A recent ONC report said current application programming interfaces (APIs) need increased standardization and tools to expand research and data extraction use.

Specifically, ONC said there needs to be more standardization and better tools for configuring, extracting, and mapping data across separate healthcare organizations. Researchers also need to be more aware of and educated about Fast Healthcare Interoperability Resources (FHIR) and FHIR Bulk Data Access APIs to utilize full API potential.

“The 21st Century Cure is going to help this process along,” Tripathi said. “We've got a paradigm right now where analytics is focused on these structured quality measures and structured reporting based on data that has been standardized. Then it's made available in a standardized way.”

The ONC Head added the organization plans to use the next 18 months to get stakeholders accustomed to patient data exchange within structured limits defined under USCDI. Once stakeholders have a better grasp on standardized patient data definitions over the next 18 months, stakeholders can move on to unstructured data.

“Once that 18 months is over, it is everything. It's text notes, transcriptions, and other kinds of documents. The only way that we'll be able to get our arms around that is using algorithms, machine learning, and other kinds of approaches, such as natural language processing, to be able to take advantage of on behalf of the patient, on behalf of better quality, to be able to take advantage of that broader, comprehensive information that's available.”

Although 18 months might seem like a long time, it’s vital for healthcare stakeholders to begin that complicated learning process right away, Tripathi recommended.

“That's one of the key messages I like to give to providers and payers and others is, don't forget, don't take your eye off of the EHI ball, because once that information is available you're going to want to be in a position to start doing whatever you can to take advantage of that information and have it supplement what you're able to do with the structured data,” Tripathi concluded.