ONC's Office of Policy team at HIMSS23 last week provided an overview of what's being proposed in the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency and Information Sharing, or HTI-1 rule, addressing data standards in development, defining and setting guidelines around "trustworthy" artificial intelligence, reporting requirements for certified healthcare IT and more.

Patient-centric by design

While National Coordinator for Health IT Micky Tripathi said the agency is working to move the needle on interoperability with an eye toward health equity during the live announcement of the notice of proposed rulemaking on April 11, it's just as serious about what the industry can expect for certification timelines and enforcement.

The NRPM connects to the 21stCentury Cures Act and Biden-Harris executive orders – Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats, and orders advancing racial equity – said Elisabeth Myers, Deputy Director of the Office of Policy Office of the National Coordinator for Health Information Technology.

Those that reached out to Healthcare IT News by email about the proposed rule were quick to agree that the rule was in the best interest of patients.

In particular, the information blocking provision of the proposed rule is in the best interest of the patient – better supporting the access and exchange of electronic health information, said Julie Nagy, director of clinical product design for EHR vendor CliniComp.

"Overall, the proposed rule will result in a greater patient experience." 

Myers was joined by Jeffery Smith deputy director of the certification and testing division in ONC's office of technology and Michael Lipinski, director of the office's regulatory and policy affairs division led the session, to dive into HTI-1's proposed expectations.

Expanding patient data points

After Myers reviewed the editionless nomenclature and proposed expectations, she said ONC would establish dates when a "prior version of a criterion" is no longer applicable and the new standard is the only acceptable criterion for certification.

"We think that this will help to set reasonable transparent timelines because we are setting them now and we are setting out a paradigm for how that will continue to work over time so that developers can plan and look at that cycle and have reasonable expectations about what that cycle looks like," she said.

The goal is that the rule will help Centers for MS "keep a pace," and, if the agency needs to add new functionality, it can align adoption to ONC's timeline for developers to be able to update and implement that feasible technology in the real world.

Those include:

• United States Core Data for Interoperability Standard Version 3.
• C-CDA Companion Guide.
• US Core Implementation Guide.
• “Minimum Standards” Code Sets Updates.
• SNOMED, RxNorm, LOINC, NDC, etc.
• Electronic Case Reporting § 170.315(f)(5).
• Clinical Decision Support § 170.315(a)(9).
• Standardized API for Patient and Population Services § 170.315(g)(10).
• *New* Patient Requested Restrictions Criteria in § 170.315(d)(14).
• Patient Demographics and Observations Certification Criterion in § 170.315(a)(5).
• Updates to Transitions of Care Criterion in § 170.315(b)(1).

Of note, USCDI v4 is likely to be published before ONC issues a final interoperability rule. 

"It is our intent to consider adopting the updated [interim guidelines] that supports the data elements in USCDI v3 since we propose to adopt USCDI v3 in this rule," according to ONC.

Myers noted timelines and expiration dates, and how ONC will add new interoperability criteria to "when they are feasible when they are ready and when there is a need" and will be looking for feedback from the industry about whether that timeline needs to be adjusted for individual measures.

"We really think that this will allow us to be more innovative and to make sure that all of you aren't having to do a massive overhaul of all the systems across all of the entire country all at the same time," she said.

She reviewed the USCDI minimum data sets for interoperability expectations proposed and the new data class elements.

"Health IT Modules certified to criteria that reference USCDI would need to update to USCDI v3 by the end of 2024," according to the overview.

ONC also proposes vocabulary standards updates used in several code sets – SNOMED CT US March 2022, CDC Race and Ethnicity Code Set July 2021, and several others – to promote semantic interoperability, accurate quality measure and public reporting, and to support research.

Developers of certified healthIT would have until the end of 2024, to adopt HL7 clinical documentation architecture or HL7's Fast Healthcare Interoperability Resources.

While they want to support ONC's certified health IT program, developers are concerned about the practicalities of the rule, as illustrated by Wayne Singer, VP of regulatory services for the Darena Solutions, which offers the FHIR-enabled MeldRx Ecosystem. 

"The program is heavily focused on the initial stages, placing considerable pressure on health IT developers without steps to ensure adequate provider adoption," he said in an email, citing the long-awaited disincentive for those engaging in information blocking.

"We are concerned it is hard for providers to embrace the new data elements of the constantly evolving USCDI standards, and adding FHIR further complicates it. In reality, a significant percentage of clinical documentation is still captured in unstructured data, and far too many patient records are exchanged by fax. Committing time, money and resources to enhancements that providers don't find valuable for their workflows becomes extremely challenging for health IT developers."

Patient privacy and trust in AI

The rule proposes criteria for patient-requested restrictions on what they perceive is sensitive data. HTI-1 helps to enable a user of certified health IT to implement a process to restrict data from use in response to a patient request, Smith said.

"These baseline requirements for transparency aim to improve the trustworthiness of predictive algorithms and support their widespread use in healthcare," according to the ONC policy team overview.

Predictive decisions support intervention is "based on algorithms or models that derive relationships from training or example data and then are used to produce an output or outputs related to, but not limited to, prediction, classification, recommendation, evaluation or analysis," as ONC defines it.

While ONC has had a clinical decision support requirement for 10 years that EHR users are required to support, they will now have to support criteria for what the agency now calls decision support interventions, or DSI, with specific elements related to SDOH, race, ethnicity or language, gender identity and sexual orientation, said Smith. 

"That is really an acknowledgment that decision support is being used across a range of use cases that are both clinical and non-clinical in nature and the electronic health record is increasingly central to these use cases."

Because users of DSI will need to provide technical, performance and real-world testing information, ONC also proposes that certified health IT developers "employ or engage in risk management of predictive DSI." 

The draft HTI-1 includes technical, governance and oversight requirements that detail how health IT developers are to document, disclose, summarize, conform to testing and report to ONC that IT developers are ensuring transparent and trustworthy DSIs.

ONC will host a DSI and Algorithmic Transparency Proposals virtual session on May 4 to take a deeper dive into the requirements.

EHR reporting phased over two years

The Cures Act requires EHR reporting to measure the performance of certified health IT but also to address information gaps and help the agency understand the use of specific certified health IT functionalities.

The measures were developed by the Urban Institute and there are four areas with multiple measurements and in an effort not to disadvantage small hospitals. 

Developers of certified health IT would be expected to report (as required by each measure) every six months if they meet the following criteria:

• They have at least 50 hospital users or 500 clinician users across their certified health IT products. 
• Their product(s) are certified to the criterion/criteria associated with the measure.
• The developer has any users of the applicable criterion/criteria associated with the measure.

Initial reporting of measures will be phased over two years, with measures related to individual access, public health exchange and the applications supported through certified health IT to start, and clinical care information exchange and additional standards-adoption measures to be reported in year two.

ONC says industry stakeholders may submit comments identified by RIN 0955-AA03 at Regulations.gov. "Attachments should be in Microsoft Word, Microsoft Excel, or Adobe PDF; however, we prefer Microsoft Word. A public template is also available."

The agency is offering a series of webinars and sessions so those that are charged with leading readiness and minimizing info-blocking risks for their organizations can get a handle on the nuances. 

Further information about the proposed rule and the health IT certification program, including fact sheets and a webinar schedule, is available on HealthIT.gov.

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