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During a virtual media briefing this week, the HIMSS Electronic Health Record Association outlined some of the comments it plans to send the Office of the National Coordinator for Health IT about its draft Health Data, Technology and Interoperability Certification Program Updates, Algorithm Transparency and Information Sharing proposed rule,or HTI1.
While some of the rules details are still being parsed, EHRA said it has reservations about the ability of its member IT companies to balance new regulatory compliance with other HHS requirements and has questions about a lack of provider incentives, information blocking rule challenges and more.
The EHR Association has several considerable concerns about the ONC HTI1 proposed rule, particularly regarding the suggested implementation timeframes, the burden compliance would place on both provider organizations and health IT developers and misalignment between ONC and Centers for Medicare and Medicaid Services requirements, the organization said in a statement Thursday.
Need for sufficient time
While recognizing that ONC is under pressure to implementrequirements of the 21st Century Cures Act, EHRA called for some leeway.
In order to do highquality work and ensure that the work were doing is going to be safe to the users of our systems, time frames must be adjusted, said David Bucciferro, special advisor at Foothold TechnologyRadicle Health and chair of the EHR Association.
It often takes at least 1824 months to develop, test and safely deploy new versions of health IT software, he noted.
It really seems like the time frames that were drafted last fall were not adjusted, even though were six to eight months further along, he added It really doesnt give us sufficient time to complete the sizable work that the development teams have to do to make this a reality.
Bucciferro said eight of EHRAs workgroups are putting together an analysis that will highlight the effect those time frames will have on both software developers and providers.
We will encourage ONC to take a closer look at those aspects of the proposed rule that fail to sufficiently consider the burden compliance would place on both provider organizations and health IT developers if adjustments arent made before finalizing, said EHRA in a statement.
Data aggregation challenges
HTI1s insights requirement for maintenance of certification requires software vendors to recruit clients to participate, said Altera Digital Health VP of Government Affairs amp Public Policy Leigh Burchell, an EHR Association representative.
Their impact analysis is not accurate in the rule, and were going to be doing our best to help them understand why thats the case.
Burchell compared the measures the agency suggested to the days of meaningful use, where we have all of these measures for people to check off, but in this case, there is no incentive for providers to participate to be supportive of the things we have to get done.
That puts vendors in the middle of data aggregation, forcing them to get a lot of information from multiple data sources where the agencies in theory, could use other regulatory levers available either within ONC or Health and Human Services to gather that information directly if they wanted to, said Burchell.
For the EHRA members that need to gather and submit this insights data, are we going to be able to have enough clients who are willing to do it
There are also other analytics priorities, like digital quality measures from CMS, that will have an impact on provider workflows, she noted.
The Medicare and Medicaid Electronic Health Record Incentive Programs and ONCs insights program have some duplication, like certification and realworld testing.
Even with realworld testing, clients are not overly enthusiastic about supporting what they need to do there, Burchell said.
EHRA will be asking ONC to delay the start of the first measurement period to January 2025 and to extend the reporting period to one year, with the first report to be submitted midyear 2026, Burchell said, adding that adjusting the proposed reporting time frame will avoid conflict with other regulatory deadlines.
We continue to encourage ONC and CMS to work together to resolve disconnects between the requirements they are imposing on various stakeholders in healthcare, according to a statement from EHRA.
For example, there are frequent misalignments between when ONC expects new certified software versions to be deployed and when CMS requires provider organizations to be using those new versions, with insufficient time allowed by CMS for implementation and testing of new versions.
There are also included within HTI1 proposals that require healthcare providers to collaborate with us in order for us to be able to fully comply, but CMS has not included any requirement that they do so in their own regulations.
Allornothing USCDI requirements
The timeline is aggressive, and the United States Core Data for Interoperability scope is expanding all the time.But the time frame from the final rule to the suggested implementation date of December 2024 does not leave enough time maybe 14 or 15 months, Burchell explained.
Large institutions want nine months to a year from getting the new version of software to do their own testing and training, she said.
EHRA will be asking for a two year deadline following the release of the rule, and an end to the allornothing requirement.
Not every hospital or care environment needs everything that is included in USCDI, said Burchell.
Michael Blackman,chief medical officer at Greenway Health and an EHR Association representative.
The current suggestion is overly broad.We recommended there be some narrowing of that definition so that its quite clear what is predictive, whats not, and where you would need that additional source attribution, he said.
There is an assumption that seems to be that EHRs create the decision support.That is often not the case, he added, noting that many clients use third parties or create their own.
The burden of reporting would result in a lot of duplicative work when sourcing for the same vendors, and the timeline to report by December 2024 is also too tight.
A better scenario, Blackman suggested, is having the thirdparty vendors add the provenance information and the other data requested around the source of the data, as opposed to each EHR individual redoing it, where frankly we often dont even know the answer.
While requesting feedback on decision support is a valid request, he pointed out that most of it comes in passively, and there is often no mechanism forcing consideration.
Adding additional alerts could impose additional cognitive load and burden that is not helpful in the course of seeing patients, he said.
EHRA will be suggesting limiting that feedback requirement to interruptive decision support.