UBC Successfully Implemented REMS Administration Software During HL7® FHIR® Connectathon

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Feb 22, 2024, 08:00 ET

BLUE BELL, Pa., Feb. 22, 2024 /PRNewswire/ -- United BioSource LLC (UBC), a leading provider of Risk Evaluation and Mitigation Strategies for biopharma, recently participated in the Health Level Seven (HL7 ^®) International Fast Healthcare Interoperability Resources (FHIR ^®) Connectathon, 16 – 18 January 2024.

With a focus on enabling healthcare interoperability through FHIR, Connectathon participants meet several times a year to work alongside vendors, peers, healthcare providers, and administrators, to rapidly learn to implement the standard and validate their conformance to the specification and mature implementation guides.

During Connectathon, UBC successfully implemented the Risk Evaluation and Mitigation Strategies (REMS) administration software, including the CDS Hooks Services and SMART App Launch as described in scenario 1 and 2 against an EHR test system.

"Connectathon participation is a critical component to advancing interoperability, and we are thankful for UBC's efforts, as we were able to experience the workflows first-hand. The process allows us to fine-tune the standards so we can efficiently integrate REMS into workflows, share data across stakeholders, and reduce burden on staff and patients," said Kelee Petzelt, REMS Use Case Coordinator, Point of Care Partners/CodeX.

"The business value derived from this technology is best understood from the workflow of a prescriber," said Natalie O'Donnell, SVP, Head of Safety & Risk Management, UBC. The technology enables the prescriber, within their normal Electronic Health Records (EHR) system workflow, to be notified of a REMS and its applicable elements to assure safe use at the appropriate time – in this use case, when ordering a medication for a REMS covered drug.

In addition to being notified, the prescriber is also presented with an application user interface, still within their EHR and without the need for additional logins, etc., to supply the information required for the Elements to Assure Safe Use (ETASU), in this case a patient enrollment.

"A key component of this use case, championed by the U.S. Food and Drug Administration, is automating interoperable exchange of standardized REMS data," said Saneel Vasram, Program Director, CodeX. "The shared CodeX vision and community-driven effort to reduce REMS clinical workflow burden, technical implementation effort and improved quality of REMS data is integral to optimizing safe medication use and health outcomes."

Within the just-in-time prompt and in workflow user interface, most if not all the data can be supplied directly from the EHR to the REMS form and the prescriber data entry will be eliminated or severely reduced. "This creates enormous value for a REMS implementation by reducing burden to prescribers, patients, and indirectly pharmacies, as their patients will be more likely to arrive at the pharmacy with the proper ETASU documentation in place," said Ms. O'Donnell. The streamlined process will improve compliance and therefore overall safety.

About UBC
United BioSource, LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. Underpinned by our scientific expertise, data and analytics, and innovative technologies, we offer our customers flexible solutions generating the relevant real-world data necessary to make more informed decisions earlier, meet stakeholder requirements, and, ultimately, drive better patient outcomes. For additional information, visit www.ubc.com.

About CodeX
As an HL7^® FHIR^® Accelerator, CodeX is a community on a mission to leverage standards to unlock the power of real-world clinical data so that patients can have the care and research journeys they deserve and should expect. CodeX advances FHIR standards in clinical specialty domains such as cancer, genomics, and cardiovascular health across a wide breadth of use cases that includes real world endpoints for cancer clinical trials, cancer clinical trial matching, registry reporting, etc. With tremendous strides forward in vendor adoption, early use in routine patient care, and an expanding domestic and international community, CodeX is looking for new members as we bring clinical health interoperability to the next level. Get engaged by reaching out to [email protected]. Learn more at https://codex.hl7.org/.

SOURCE UBC