The ONC Policy Office Team at HIMSS23 last week provided an overview of what is being proposed in Health Data, Technology, and Interoperability: Certification Program Updates, Information Sharing, and Clarity HTI-1 Algorithm or Rule, addressing data standards during development, defining and establishing guidelines around “trusted” artificial intelligence, reporting requirements for Certified Healthcare IT, etc.
Patient-centered design
While National Coordinator for Health Micky Tripathi said the agency is working to improve interoperability with the goal of working towards health equity during the live release of the proposed rulemaking announcement. on April 11, it’s equally critical of what the industry can expect in terms of certification and enforcement deadlines.
NRPM Connects to 21st Century Cures Act and Biden-Harris Executive Orders – Ensuring a Data-Driven Response to COVID-19 and Future High Consequences of Public Health Threats while also ordering the promotion of racial equality, said Elisabeth Meyers, Deputy Director of the Office, in the Policy Office of the National Coordinator for Health Information Technology.
People who have approached Healthcare IT News by email about the proposed rule quickly agreed that it was in the best interest of the patient.
In particular, the provision of information containment of the proposed rule is in the best interest of the patient – better supporting the access and exchange of electronic health information, Julie Nagy, design director clinical product of the EHR supplier CliniComp said.
“Overall, the proposed rule would result in a better patient experience.”
Meyers joined Jeffery Smith, deputy director of certification and testing in the ONC’s office of policy, and Michael Lipinski, director of the office’s policy and regulation division who led the session, to dive into on HTI-1’s proposed expectations.
Patient data point expansion
After Meyers reviewed the unpublished nomenclature and proposed expectations, she said the ONC would establish a date when the “previous version of a criterion” no longer applies and the new standard is the sole criterion. most acceptable for certification.
“We think this will help establish reasonable transparency timelines because we’re setting them up right now and we’re laying out a model for how it will continue to work over time.” so that developers can plan and look at that cycle and have reasonable expectations of what that cycle looks like,” she said.
The goal is that the rule will help MS Centers “get up to speed,” and if the agency needs to add new functionality, it can tailor adoption to the ONC timeline so developers can update and implement such viable technology in practice. world.
These include:
- United States Core Data for Interoperability Standard Version 3.
- C-CDA Companion Guide.
- US Core Implementation Guide.
- Update the “Minimum Standard” code set.
- SNOMED, RxNorm, LOINC, NDC, etc
- Electronic Case Report § 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 Restriction Criteria in § 170.315(d)(14).
- Demographic and Observational Attestation Criteria of Patient in § 170.315(a)(5).
- Update on Transition Criteria of Care in § 170.315(b)(1).
Notably, USCDI v4 will likely be published before the ONC issues the final interaction rule.
“Our intention is to consider applying the update [interim guidelines] support data elements in USCDI v3 because we recommend applying USCDI v3 in this rule,” according to the ONC.
Meyers noted the timelines and expiration dates as well as how the ONC will add new interoperability criteria to “when they are viable when they are ready and when there is demand” and will seek feedback from industry on whether that timeline needs to be adjusted accordingly. individual measures.
“We really think this will allow us to be more innovative and make sure that you all don’t have to do a major overhaul of all systems across the entire country at once, ” she said.
She reviewed USCDI’s minimal datasets for proposed interoperability expectations and new data layer components.
“Health IT modules certified to the USCDI reference criteria will need to be updated to USCDI v3 by the end of 2024,” according to the review.
The ONC also recommends updates to the vocabulary standards used in several codes – SNOMED CT US March 2022, CDC Racial and Ethnic Codes July 2021, and others – to promote semantic interoperability, accurate quality measurement and public reporting, and research support.
Certified medical IT developers will have until the end of 2024 to adopt the HL7 clinical document architecture or the HL7 Rapid Healthcare Interoperability Resource.
While they wanted to support ONC’s certified health IT program, the developers were concerned about the practicality of the rule, as illustrated by Wayne Singer, Darena’s VP of managed services. Solutions, which provides the FHIR-enabled MeldRx Ecosystem.
“The program is heavily focused on the early stages, putting significant pressure on medical IT developers without steps to ensure full vendor adoption,” he said in an email, citing leads to long-awaited frustration among those engaged in interception.
“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 matters. In fact, a percentage Significant clinical documentation is still captured in unstructured data and too many patient records are exchanged by fax.Spend time, money, and resources on improvements that are not seen by providers. valuable to their workflow becomes extremely difficult for medical IT developers.”
Patient privacy and trust in AI
The rule proposes criteria for restrictions requested by patients on what they consider sensitive data. HTI-1 helps to enable certified medical IT users to implement a data-restricted process to meet patient requests, says Smith.
“These basic transparency requirements are intended to improve the reliability of prediction algorithms and support their widespread use in healthcare,” according to an overview of the ONC policy team.
A predictive decision support intervention is “based on algorithms or models that derive relationships from training data or example data and are then used to produce one or more outputs.” relating to, but not limited to, predicting, categorizing, recommending, evaluating or analyzing”, as the ONC defines it.
While ONCs have had clinical decision support claims for 10 years that EHR users must support, they will now have to support the criteria for what the agency now calls a decision support intervention or DSI , with specific factors related to SDOH, race, ethnicity or language, gender identity and sexual orientation, Smith said.
“It is truly an acknowledgment that decision support is being used in a wide range of clinical and non-clinical use cases and that electronic health records are increasingly central to these use cases.”
Since DSI users will need to provide technical, performance, and real-world testing information, ONC also recommends that certified medical IT developers “use or participate in DSI’s risk management forecast.”
Draft HTI-1 includes technical, governance, and monitoring requirements detailing how health IT developers document, disclose, summarize, test compliance, and report to the ONC that IT developers are making sure DSI is transparent and trustworthy.
The ONC will host a DSI and Algorithm Transparency Proposal virtual session on May 4 to dig deeper into the requirements.
EHR reporting is phased in two years
The Cures Act requires EHR reporting to measure the performance of certified medical IT but also to address information gaps and help the agency understand the use of specific certified medical IT functions.
The measures were developed by the Urban Institute and have four areas with many measurements and are intended to not be detrimental to small hospitals.
Certified health IT developers will be required 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 on their certified medical IT products.
- Their product(s) are certified according to the standard/criteria relevant to the measure.
- The developer has any users of the applicable criteria/criteria associated with the measure.
The initial report on the measures will be phased in over two years, with measures related to individual access, public health exchanges, and applications supported through medical IT. certification to begin, and clinical care communication and additional standard measures will be reported in year two.
The ONC said industry stakeholders can submit comments identified by RIN 0955-AA03 at Regulations.gov. “Attachments must be in Microsoft Word, Microsoft Excel, or Adobe PDF; however, we prefer Microsoft Word. Public templates are also available.”
The agency is providing a series of webinars and sessions so that those responsible for leading readiness and minimizing interception risks for their organizations can handle the nuances.
More information about the proposed rule and the medical IT certification program, including factsheets and webinar schedule, is available on HealthIT.gov.
Andrea Fox is the senior editor of Healthcare IT News.
Email: [email protected]
Healthcare IT News is a publication of HIMSS Media.
