All posts in category Health IT Regulation

HTI-1 Falls Short with DSI and Predictive Decision Support Proposals

By David Bucciferro, Chair, EHR Association

In other installments of this five-part blog series on the EHR Association’s issues with ONC’s Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing Proposed Rule (HTI-1), we discussed our overarching concerns, as well as concerns with the Insights Condition program, transition to USCDI v3, and Patient Requested Restrictions. In this installment, we examine the considerable issues we have identified with provisions related to Decision Support Interventions (DSI) and Predictive Models.

According to ONC, the existing scope and structure of the Health IT Certification Program are to enhance transparency around predictive decision support, with requirements to make transparent information regarding the authorship, bibliographic, and other kinds of “source attribute” information for evidence-based decision support and linked referential interventions. Noting that AI/ML in healthcare “is often best considered a form of decision support or ‘augmented intelligence’,” ONC says its goal with the proposed rule related to DSI and predictive models is to update the existing decision support criterion to directly include predictive decision support, inclusive of ML technologies.

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by EHR Association on June 8, 2023  •  Permalink
Posted in Health IT Regulation
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Posted by EHR Association on June 8, 2023

https://ehrablog.org/2023/06/08/hti-1-falls-short-with-dsi-and-predictive-decision-support-proposals/

HTI-1’s Insufficient USCDI v3 Transition Timeframe

In other installments of this five-part blog series on the EHR Association’s issues with ONC’s Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing Proposed Rule (HTI-1), we discussed our overarching concerns, as well as specifics concerns with Insights Condition, the proposed requirements related to Decision Support Interventions (DSI) and Predictive Models, and Patient Requested Restrictions. In this installment, we examine issues with provisions related to the transition to USCDI v3.

More Time, Flexibility Needed

While we strongly support ONC’s efforts to advance USCDI in general, the proposed Jan. 1, 2025, development and implementation timeframe between the final rule and USCDI v1 expiration is far too short. It also needs to align with CMS timelines. Thus, we would like to see the deadline for USCDI v3 to be included in upgraded versions moved to the end of the second calendar year following the publication of the final rule (estimated to be Dec. 31, 2025). 

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by EHR Association on June 8, 2023  •  Permalink
Posted in Health IT Regulation
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Posted by EHR Association on June 8, 2023

https://ehrablog.org/2023/06/08/hti-1s-insufficient-uscdi-v3-transition-timeframe/

HTI-1’s EHR Reporting Provision Puts EHR Developers in the Middle

By David Bucciferro, Chair, EHR Association

In previous installments of this five-part blog series, we examined the EHR Association’s overarching concerns with ONC’s Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing Proposed Rule (HTI-1), as well as concerns with the transition to USCDI v3, proposed requirements related to Decision Support Interventions (DSI) and Predictive Models, and Patient Requested Restrictions. In this installment, we focus on our concerns with the HTI-1’s new Insights Condition and Maintenance of Certification Requirements provision.

According to ONC, Insights Condition fulfills a requirement in the 21st Century Cures Act for transparent reporting by creating a program to measure the performance of certified health IT (CEHRT) under a Condition and Maintenance of Certification. The goals of the EHR reporting program are to 1) address information gaps in the health IT marketplace and 2) provide insights on the use of specific certified health IT functionalities. 

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by EHR Association on June 8, 2023  •  Permalink
Posted in Health IT Regulation
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Posted by EHR Association on June 8, 2023

https://ehrablog.org/2023/06/08/hti-1s-ehr-reporting-provision-put-ehr-developers-in-the-middle/

ONC Needs to Address HTI-1’s Burdens on Healthcare Providers, Health IT Developers

By David Bucciferro, Chair, EHR Association

While the EHR Association has long supported the goals of ONC’s proposed rule to advance interoperability, improve transparency, and support further access, exchange, and use of EHI, we have several serious concerns about the impact HTI-1 (ONC’s Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing Proposed Rule) will have on the industry if finalized as proposed. 

Among the most significant are the insufficient implementation timeframes associated with various concepts included in HTI-1 and a failure to accurately consider the significant burden compliance would place on both provider organizations and health IT developers. Vendors need more time than proposed in HTI-1 to accommodate the substantial lift required to deliver safe, compliant, and high-quality versions of their certified products – 18-24 months is the commonly accepted necessary timeframe – while providers need sufficient time to implement, test and become proficient on that upgraded software. 

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by EHR Association on June 2, 2023  •  Permalink
Posted in Certification, EHRA News, Health IT Regulation, Health IT Standards, Interoperability
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Posted by EHR Association on June 2, 2023

https://ehrablog.org/2023/06/02/onc-needs-to-address-hti-1s-burdens-on-healthcare-providers-health-it-developers/

Good Information Sharing Practices Released

By Leigh Burchell (Altera Digital Health), Vice Chair, EHRA Information Blocking Compliance Task Force

The EHR Association is committed to preventing information blocking and supporting efforts to share electronic health information to better patient care. As such, our Information Blocking Compliance Task Force collaborated over the past two years with stakeholders across the industry to address regulatory questions and further information exchange.

Our collaboration has produced “Good Information Sharing Practices,” a collection of best practices for health IT developers. The Practices are a practical list of proactive actions health IT developers can undertake to demonstrate their strong support for access, use, and exchange of health information and compliance with information blocking regulations. These include detailed recommendations on:

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by EHR Association on March 22, 2023  •  Permalink
Posted in Information Blocking
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Posted by EHR Association on March 22, 2023

https://ehrablog.org/2023/03/22/good-information-sharing-practices-released/

Standards will Make or Break Efforts Toward ePA

By Janet Campbell (Epic), EHRA Public Policy Leadership Workgroup Vice Chair

This is part two in a four-part series examining the need for ePA, the barriers presented by the current environment, necessary capabilities, and functionality, and the EHR Association’s policy recommendations. Part one can be read here.

Streamlining the electronic prior authorization (ePA) process will require significant coordination and standardization across multiple domains within individual healthcare organizations, across dozens of health plans covering their patients, and across the health IT tools in use by every participant in the process.

Progress is being made by various stakeholders in terms of standards development. Notably, the Coverage Requirements Determination (CRD), Documentation Templates and Rules (DTR), and the Prior Authorization Support (PAS) implementation guides – all a part of the Da Vinci Project’s efforts to understand functional requirements, build consensus on a technical approach, pilot, and iterate – have resulted in significant progress toward the enablement of highly automated prior authorization workflows.

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by EHR Association on October 13, 2022  •  Permalink
Posted in Certification, ePA, Health IT Regulation, Health IT Standards
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Posted by EHR Association on October 13, 2022

https://ehrablog.org/2022/10/13/standards-will-make-or-break-efforts-toward-epa/

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