Darena Solutions Launches First (b)(11) DSI Solution with ONC Health IT Certification

MeldRx by Darena is the first certified (b)(11) Decision Support Interventions (DSI) module available as a plug-and-play solution for EHRs to meet and exceed the new HTI-1 mandates before December 31, 2024.

ST. LOUIS, Oct. 8, 2024 Darena Solutions announced that its FHIR-based healthcare data platform, MeldRx, has achieved certification of the (b)(11) DSI module as defined under the ONC Health IT Certification Program, via Drummond Group LLC, an Authorized Certification Body (ACB). In addition to the previously certified (g)(10) FHIR APIs, MeldRx now also meets the certification requirements for the (b)(11) DSI module. The stamp of approval designates MeldRx to deliver the required functionality, enabling providers and hospitals to meet various regulatory requirements that involve the use of certified EHR technology.

The DSI certification criterion was incorporated into the HTI-1 final rule on March 11, 2024, marking the first major update to Clinical Decision Support (CDS) requirements since 2012. This update introduces modern functionalities, including the use of large language models, configuration requirements, additional source attributes, and comprehensive feedback, significantly increasing the complexity of compliance. EHRs are required to meet these new certification mandates by December 31, 2024. MeldRx's expanded certification ensures that it continues to deliver the necessary functionality for providers and hospitals to comply with the updated regulatory requirements.

The certification of MeldRx as the first (b)(11) DSI solution is a remarkable achievement for the industry. By integrating MeldRx into Aura, our enterprise EHR, we enhance its ability to provide comprehensive evidence-based and predictive solutions - Matthew Prete, CTO at Sigmund Software

Matthew Prete, Chief Product and Technology Officer at Sigmund Software shared, "In the ever-evolving landscape of healthcare, navigating regulations, mandates, payer requirements, and the rapid advancement of AI technologies can be incredibly challenging. Sigmund Software understands the complexities of compliance and the necessity for powerful decision-support systems. The certification of MeldRx as the first (b)(11) Decision Support Interventions (DSI) solution is a remarkable achievement for the industry. By integrating MeldRx into Aura, our enterprise EHR, we enhance its ability to provide comprehensive evidence-based and predictive solutions that meet the latest regulatory standards."

"With the new HTI-1 mandate and advancements in AI, we've built an EHR-agnostic platform that not only ensures (b)(11) DSI compliance but also empowers developers to integrate their AI-driven solutions into EHRs seamlessly. By streamlining the registration and integration process, MeldRx enables app developers to bring their innovations to healthcare organizations, enhancing clinical decision-making and improving patient care.," said Wayne Singer, Senior Vice President of Regulatory Affairs at Darena Solutions."

To earn the certification, Drummond tested MeldRx to ensure compliance with applicable standards and certification criteria set by the U.S. Department of Health and Human Services (HHS). With more than 20 years of testing experience across various industries, Drummond brings a high level of technical expertise to this process. Since becoming an ONC-ACB in 2010, Drummond has conducted more than 3,000 health IT tests and certifications.

MeldRx is ONC Health IT compliant and has been certified by an ONC-ACB in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services.

Vendor: Darena Solutions LLC

Product: MeldRx

Criteria Tested: 170.315 (b) (10-11); (d)(1-3, 7, 9, 12-13); (g)(1, 4-5, 7, 10)

Holds Certificate No: 15.04.04.1322.Blue.02.00.0.200807

Date Certified: 08/07/2020

Mandatory Disclosures: The cost that an organization might pay to implement MeldRx's capabilities is available here.

ABOUT DARENA SOLUTIONS LLC

Darena Solutions simplifies healthcare interoperability and regulatory compliance for EHRs, providers, and payers. Our flagship product, MeldRx, offers a fully managed, scalable, FHIR-first backend as a service. It supports standalone apps, SMART on FHIR apps, multiple EHR integrations, and consumer-mediated data exchange. Its flexibility makes MeldRx an ideal fit for use cases ranging from internal projects to developing new apps. Darena also helps EHRs stay on top of regulatory requirements for the Cures Act, HTI-1, and MIPS, and enhance their offerings with FHIR. By opening data-sharing channels and boosting EHR capabilities with custom apps - including AI apps, DSI apps, CDS hooks, and more, Darena empowers healthcare organizations to achieve true interoperability and gain insights to improve patient outcomes. For more information, connect with us on LinkedIn or visit our website at http://www.darenasolutions.com.

ABOUT DRUMMOND GROUP LLC

Drummond Group LLC is a global software test and certification lab that serves a wide range of vertical industries. In healthcare, Drummond tests and certifies Controlled Substance Ordering Systems (CSOS), Electronic Prescription of Controlled Substances (EPCS) software and processes, and Electronic Health Records (EHRs) – designating the trusted test lab as the only third-party certifier of all three initiatives designed to move the industry toward a digital future. Drummond was founded in 1999 and is an ONC-Accredited Certification Body (ACB) and an Authorized Test Lab (ATL) and continues to build on its deep experience and expertise to deliver reliable and cost-effective services. For more information, please visit http://www.drummondgroup.com.