Several overlapping federal requirements – including the need for annual projects to maintain information blocking compliance and an aggressive time frame for decision support certification – represent big challenges for health IT developers, say leaders from the HIMSS Electronic Health Record Association. 

WHY IT MATTERS

With a spate of regulations driving health IT product development, complying with regs that don't always work well with each other is a big ask, according to Leigh Burchell with Altera Digital Health, vice chair of the EHRA's information blocking compliance task force and member of the organization's executive committee. 

"It's very challenging for us, but it's also very challenging for our clients," she said on earlier this month at a HIMSS24 media briefing that covered a number of regulatory compliance issues. 

Last year, the EHRA asked the Office of the National Coordinator for Health IT and the Centers for Medicare and Medicaid Service to better coordinate on regulatory misalignment to address regulatory burdens last year on interoperability and artificial intelligence transparency rules. 

"They give us the deadline of when we have to have it available, but they also are telling us, and CMS is reinforcing through their rulemaking when we have to have it out to our clients," Burchell said at the briefing.

"It's really a six-month difference between the two sets of deadlines," she said, noting that EHRA is currently engaging with federal agencies on the merits of a "flex-year approach" to reduce the pressure of annual deployments required under Health Data, Technology and Interoperability: Certification Program Updates, Algorithm Transparency and Information Sharing, or HTI-1, and other interoperability rules.

"What we have recommended, particularly to CMS, is that they return to a structure where there's a flex-year approach in which there's more flexibility as to when that software can be deployed, when they can start using it, or when they have to start using it," Burchell said. 

"We've heard this from our clients."

HTI-1's decision support intervention certification is a particularly concerning requirement that includes having to conduct safety-enhanced design testing with healthcare provider clients before certification by Dec. 1.

"So that's a big lift," she said. 

"What we have to do, even just for transparency on the DSI requirement, is really, really substantive because we essentially – all of us – have to conduct an inventory of all of the interventions," many of which are not developed by EHR vendors, Burchell pointed out.

"In many, many cases, we're not necessarily the source, and so we've got to get to the source more than we are now."

As a result, she said that EHRA asked ONC to offer a six-to-12-month enforcement discretion period on HTI-1's DSI intervention requirements. 

At the briefing, EHRA said it is also working with states to set realistic frameworks and timelines for data segmentation, governed by privacy and other drivers.

Josh Mast with Oracle Health, who chairs the EHR Association’s public policy leadership workgroup, said in the last two years, the organization has started to see, "a big uptick" of activity since the Supreme Court's Dobbs decision. 

EHRA is providing education at the state level on the IT development processes that would be required to meet individual state requirements to restrict abortion care or allow it. 

"Ideally, you don't want to be chasing down 50 different requirements in 50 different places when we can try and align as much as possible and create more of a strategy at the either industry level, or leveraging what ONC and others are doing at the federal level," he said.

One example is a New York legislative proposal to segment data to protect certain data from information-sharing requirements.

"A lot of it is trying to set a realistic framework for what is currently available in the technology segmentation and what a realistic timeline is for the development of those capabilities," said Mast.

THE LARGER TREND

In January, Healthcare IT News asked Micky Tripathi, ONC National Coordinator for Health Information Technology, what he thinks certified health IT owners need in order to clear regulatory hurdles like DSI and electronic case reporting, during a discussion about the agency's 2024 interoperability roadmap.

EHR vendors have been concerned, despite a reduced scope of work to deliver on HTI-1 requirements initially proposed in the draft rule, that delivering "AI nutrition labels" on decision support will be daunting, given the time frame allotted.

"We believe it's totally reasonable for them to be able to create that in a year," Tripathi responded. 

"Because again, it's just transparency functionality, it's not anything about the AI tools themselves."

ON THE RECORD

"Even though they did shrink the scope from the proposed rule, it is still a very substantive [DSI] program that they are imposing," Burchell said at the stakeholder briefing.

Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.