During this week’s online media briefing, the HIMSS Electronic Health Records Association outlined some of the comments it plans to send to the Office of the National Coordinator for Health IT on the draft. Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Proposed Rule Sharing Information, or HTI-1.
While some details of the rule are still being parsed, the EHRA said it is concerned about the ability of member IT companies to balance compliance with the new regulation with other requirements. HHS – and have questions about lack of supplier incentives, blocking rules challenges, etc.
“The EHR Consortium has some significant concerns about the ONC HTI-1’s proposed rule, particularly regarding the proposed implementation timeframe, the burden of compliance that would place on both the supplier organization and Medical IT developers and the disparity between ONC and [Centers for Medicare and Medicaid Services] request,” the organization said in a statement on Thursday.
Need ‘enough time’
While recognizing that the ONC was under pressure to implement the 21st Century Healing Act requirements, the EHRA requested some time.
To do “high-quality work and ensure that the work we’re doing will be safe for the users of our systems,” time frames must be, said David Bucciferro, vice president of the EHR Consortium. adjust.
It usually takes at least 18-24 months to develop, test, and securely deploy new versions of medical IT software, he notes.
“It looks like the timeframes drafted last fall are not adjusted, even though we have six to eight months left,” he added. “It really didn’t give us enough time to finish the massive work that the development teams had to do to make this a reality.”
Bucciferro said eight groups that include EHRA members and their customers are putting together an analysis that will highlight the impact those timeframes have on both developers and software vendors.
“We would encourage the ONC to take a closer look at aspects of the proposed rule that fail to fully consider the compliance burden that would place on both the service provider organization and the medical IT developer if the conditions Corrections were not made prior to completion,” EHRA said in a statement.
Data aggregation challenge
The requirement for HTI-1 insight to maintain certification requires software vendors to recruit customers to participate, said Leigh Burchell, representative of the EHR Association.
“Their impact analysis isn’t exactly the rule, and we’ll do our best to help them understand why that is.”
Burchell compared the agency’s proposed measures to “meaningful use dates, when we had all of these measures available for everyone to test, but in this case, there was no incentive for Vendors join to support the things we get done.”
That puts providers in the middle of the data aggregation process, forcing them to pull so much information from multiple data sources that agencies “could theoretically use other regulatory levers available in ONC or [Health and Human Services] to collect that information directly if they want to,” Burchell said.
For EHRA members who need to collect and submit this insight data, “can we have enough customers willing to do so?”
She noted that there are other analytical priorities, such as digital quality metrics from CMS, that will have an impact on supplier workflows.
The Medicare and Medicaid Electronic Health Records Incentive Programs and the ONC insights program have some overlap, such as certification and real-world testing.
Even with real-world testing, customers weren’t too enthusiastic about what we needed to do there, says Burchell.
The EHRA will ask the ONC to delay the start of the first measurement period to January 2025 and extend the reporting period to 1 year, with the first report being sent in mid-2026, Burchell added. Adjusting the proposed reporting timeframe will avoid conflicts with other specified deadlines.
“We continue to encourage ONC and CMS to work together to address the disconnect between the requirements they are imposing on various healthcare stakeholders,” according to a statement from EHRA.
“For example, there is often a discrepancy between when ONCs expect to deploy new versions of certified software and when CMS requires service organizations to use those new versions, in when CMS does not have enough time to roll out and test new versions.There are also other issues in the HTI-1 proposals that require healthcare providers to work with us to we could be fully compliant, but CMS doesn’t include any requirement that they do so in their own regulation.”
Claim all or nothing USCDI
Progress is flexible and the scope of Core Data for US Interoperability is always expanding – but the timeframe from final rule to proposed implementation date of December 2024 is not enough time – maybe 14 or 15 months, Burchell explains.
Large organizations want between nine months and a year from receiving a new software version to conduct their own testing and training, she said.
The EHRA will ask for a two-year deadline after the rule’s promulgation and end the “all-or-nothing claim”.
Not every hospital or care setting needs everything included in USCDI, Burchell said. And for those who don’t need everything in USCDI v3 and only what’s clinically relevant, “they should be allowed to achieve certification by adding only the aspects they need to meet the needs of the user” to ease the burden on software vendors and developers, Burchell said.
Wayne Singer, vice president of managed services for Darena Solutions, the company that provides the FHIR-enabled MeldRx Ecosystem, previously said Healthcare IT News that vendors are concerned about the practicality of the expected minimum USCDI dataset for interoperability.
“We are concerned that it will be difficult for vendors to grasp the new data elements of the ever-evolving USCDI standards and that adding FHIR will further complicate this issue,” he said.
“In fact, a significant proportion of clinical documents are still kept as unstructured data and too many patient records are exchanged via fax. Spend time, money and resources on improvements advancements that vendors don’t see as valuable to their workflows becomes extremely difficult for health IT developers.”
CDS rules are too heavy
Dr Michael Blackman, representative of the EHR Consortium, added that HTI-1’s proposals around prediction rules are unclear and confusing.
“The current recommendation is so broad, we recommend narrowing that definition down so we can clarify what is predictable, what isn’t, and where you will need to credit that additional source,” he said.
“There is an assumption that seems to be that EHR generates decision support, which is often not the case,” he added, noting that many customers use third parties or create their own.
The reporting burden will result in a lot of duplication when sourcing for the same supplier, and the reporting deadline before December 2024 is also too tight.
Blackman suggests a better scenario would be for third-party vendors to “add the required provenance and other data around the data source, as opposed to having the individual EHR redo it, where which we often don’t even know the answer to.”
While asking for feedback on decision support is a valid request, he points out that most feedback comes in passively and often doesn’t have a mechanism to force review.
He added additional warnings can cause “additional cognitive load” and unhelpful burden “during the patient exam”.
The EHRA will recommend limiting that response to support the decision to interrupt. The organization will also require the maintenance of the term CDS, as opposed to a proposed decision support intervention, or DSI.
According to the ONC review at HIMSS23, this change “is really an acknowledgment that decision support is being used in a wide range of use cases of a clinical and nonclinical nature and profile.” e-health is increasingly at the heart of these use cases.”
Andrea Fox is the senior editor of Healthcare IT News.
Email: [email protected]
Healthcare IT News is a publication of HIMSS Media.
