Explore the insights from this informative “Mastering HTI-1 Decision Support Interventions” webinar, where John Valutkevich and Bob Bryan dissected the transition from traditional (a)(9) Clinical Decision Support (CDS) to the dynamic (b)(11) Decision Support Interventions (DSIs) mandated by the HTI-1 Final Rule.
This summary shares the key takeaways from their discussion, emphasizing the significance of moving from (a)(9) to (b)(11), outlining the integration of Predictive and Evidence-Based categories, and analyzing their implications within the USCDIv3 framework.
Watch the video and keep reading below for a summary.
The shift from the CDS criterion (a)(9) to the DSI criterion (b)(11) under the HTI-1 Final Rule highlights the ONC’s dedication to enhancing healthcare decision-making processes. While (a)(9) previously focused on fundamental data crucial for basic interoperability, the transition to (b)(11) has introduced a broader spectrum of data classes and detailed specifications. This expansion aims to enhance the precision and practicality of healthcare information, facilitating more comprehensive patient records and supporting advanced analytics that improve quality care. An important component of this initiative is the ONC’s two-pronged categorization of DSI, which introduces critical language that delineates AI-driven predictive-based DSIs (PBDSI) from its traditional counterpart evidence-based DSI (EBDSI).
Organizations impacted by the (b)(11) DSI criterion should familiarize themselves with the following DSI distinctions so they can effectively adhere to its corresponding requirements:
PBDSI – Data elements that leverage AI to anticipate patient needs and proactively intervene, including predictive analytics outputs and risk scores.
EBDSI – DSIs grounded in clinical research and guidelines that ensure healthcare practices are aligned with proven effectiveness and best practices so they can properly adhere to their corresponding requirements.
By introducing these two distinct categories, the ONC has given way to essential requirements to help keep up with the rapidly evolving pace of DSI functionality in healthcare. One of these critical requirements is for IT developers supplying EBDSI and PBDSI to support a new list of source attributes (attributes of one’s decision support capability) to empower end users to independently comprehend, evaluate, and manage DSI’s potential risk factors. While source attributes are not new to DSI regulation, the HTI-1 Final Rule has introduced a much more extensive list for IT developers—growing from a previous list of four source attributes to forty. This tenfold expansion in source attributes points to the ONC’s concerted efforts to provide transparency and accountability around the usage of DSI functionality.
For this reason, IT developers supplying PBDSIs must adhere to using these source attributes to establish a comprehensive risk management framework. This framework is essential for conducting risk analysis, implementing mitigation strategies, and ensuring robust governance of their DSIs. It’s worth noting that under the HTI-1 Final Rule, IT developers are only obligated to support PBDSI capabilities on their platforms rather than supply them. This means developers are not obliged to provide a PBDSI but rather configure PBDSIs to operate smoothly on their platforms, enabling users to select them effortlessly while effectively managing the associated source attributes. Regarding EBDSI-specific requirements, developers providing EBDSIs must incorporate mechanisms for gathering feedback from their customer base. Additionally, they must integrate functionality that facilitates exporting this feedback data back to the customer.
For organizations looking for a more comprehensive breakdown of PBDSI and EBDSI requirements check out the full Mastering HTI-1 Decision Support Intervention Webinar here.
Now that we’ve gone over the various requirements for PBDSI and EBDSI, let’s examine how they work together within the context of the USCDIv3 framework.
The relationship between USCDIv3 and the development of DSIs under the HTI-1 Final Rule presents a critical decision point for developers. While the deadline for full compliance with USCDIv3 was extended to December 31, 2025, the rule mandates that evidence-based and predictive DSIs must utilize USCDI data elements to meet their compliance requirements. Notably, specific data elements such as demographics (e.g., sex and gender) are integral components of USCDI version 3, and while not immediately required by year’s end, full support becomes mandatory by next year’s phase-out of USCDIv1. Moreover, developers must decide whether to focus solely on USCDIv1 data for now or proactively integrate USCDIv3 elements into their DSI development plan ahead of the deadline. While full compliance isn’t mandatory until next year, incorporating USCDIv3 early on offers flexibility and aligns with the regulatory framework, potentially streamlining future updates and enhancing interoperability across healthcare systems. Developers are encouraged to weigh these considerations carefully to optimize their DSI development plans effectively.
As healthcare continues to advance, the migration from (a)(9) to (b)(11) within USCDIv3 signifies a crucial step towards enhancing data standardization and interoperability. More specifically, by introducing PBDSI and EBDSI categories, the ONC has set a foundation for integrating AI-driven predictive analytics with established clinical guidelines, fostering more informed healthcare practices. As IT developers navigate these transformative shifts in healthcare technology, it is imperative to stay informed and proactive in their adoption of advanced decision-support interventions. For a more detailed exploration of PBDSI and EBDSI requirements, we invite you to watch the “Mastering HTI-1 Decision Support Interventions” webinar so you can leverage its comprehensive insight to improve your workflow efficacy and streamline your compliance efforts.
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