The Standard

 Join the Vulcan Interoperability Bridge Webinar | Thursday, June 12 at 1:00 PM ET 

The story of clinical research has always been one of astounding breakthroughs… and barriers. It’s the story of research, regulators and technologists working together, and more recently, the story of equitable access and activated patients empowered to share their experiences. Clinical research is evolving — and it’s happening through the collective efforts of a passionate, deeply engaged community.

On June 12, we invite you to be part of that evolution.

The Vulcan Interoperability Bridge Webinar, hosted by the Vulcan FHIR® Accelerator in collaboration with the FDA, will bring together clinical research sponsors, EHR providers, life science leaders, technology innovators, academic medical centers and more — all working toward a future where HL7 Fast Healthcare Interoperability Resources (FHIR)-based interoperability enables smarter, faster and more connected clinical research.

Behind this movement is a simple truth: we can’t innovate in isolation. This is precisely where Vulcan makes a difference by breaking down barriers. Every delay in data sharing, every barrier caused by disconnected systems, slows the path from discovery to patient benefit.

Community Roundtable Featuring Payer Data Exchange Implementation Guide on May 28 at 4 pm

If you're looking for a real-world take on how the healthcare industry is putting the HL7 Da Vinci Project’s Payer Data Exchange (PDex) Implementation Guide into action, you won’t want to miss this event! The 90-minute virtual community roundtable will feature how organizations are using FHIR-based APIs to improve transparency and value-based care.

How Organizations Are Using PDex in Production Today

After a brief update on the PDex Implementation Guide from Da Vinci’s technical director, attendees will hear about implementation considerations and first-hand implementer accounts from those actively applying PDex to solve real-world data exchange challenges:

• Blue Cross Blue Shield Association + InterSystems will discuss the immense potential of payer-to-payer APIs to increase patient transparency and improve value-based care in light of the high levels of churn of the impacted population, resulting in care gaps and a need to provide patients with longitudinal records of care. Presenters will highlight the relevant Implementation Guides and the workflow issues inherent in the process that are being worked on. 
  
  
• Availity, Healow Insights, and Humana will explore their experience with payer-to-payer data sharing using PDex—including workflow impacts, scaling considerations, and member-centered outcomes. Availity and Humana will share its observations and lessons learned along their payer-to-payer implementation journey through internal development, coordinating with their cohort of payers, and participating in Connectathons. Then Healow will highlight its experiences from two years in PDex production. 

Are you a member of a technical team that’s beginning its journey toward implementing HL7's Fast Healthcare Interoperability Resources (FHIR^®) application program interfaces (APIs)? Then don’t miss an upcoming three-day online educational event offering two technical tracks tailored to your needs. 

Two days of interactive content delivery and demonstrations will be followed by a Connectathon that will provide implementers and developers with the opportunity to test FHIR-based solutions and exchange data with other FHIR interfaces.  

Organizations that want to fast-track implementing HL7 FHIR APIs to automate workflow, maximize efficiency and meet federal requirements of the CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) should encourage their technical teams attend this online event. 

“We designed two tracks for technical team members at provider and payer organizations, as well as technology vendors, who are looking for a crash course on making the most of FHIR,” says Viet Nguyen, M.D., Technical Director of the HL7 Da Vinci Project. (Da Vinci has developed implementation guides for putting FHIR to use in supporting value-based medicine.) 

Clinical Trial Matching...Room for Improvement 

Clinical trials are essential to the advancement of patient care. The outcomes of a trial directly enable the future development of new treatment options for patients. Participants also benefit during the trial – they are provided access to potential treatments that may not be otherwise available to them – sometimes improving their overall prognosis.

Trial sponsors (the party responsible for the clinical trial) make significant investments, including procurement of products and services supporting the clinical trial workflow. According to the Tufts Center for the Study of Drug Development (CSDD), the mean direct cost to conduct a clinical trial per day is approximately $40,000 for Phase II and Phase III trials, and delays to launching a product can cost $800,000 per day.

With a very high percentage of trials delayed due to enrollment, there is much work to do to ensure clinical trials are sustainable and new therapies reach patients faster. Efficiencies gained in clinical trial matching benefit patients and their caregivers, sponsors and service providers.

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For a patient to be matched with the right trial, that patient’s medical history is compared with multiple trials’ criteria.   In concept, this is a simple process, but more information is often needed than is available in the patient’s record (in Part 1 we tell the story of Dr. Smith’s inability to easily obtain her patient’s medication history from his previous health care provider.) If, after a first evaluation, a patient isn’t disqualified, they must often undergo additional screening by their care team or more involved procedures required by the protocol sponsor to fully determine eligibility.

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Introduction

  Questions to Address:

• How can we build interoperability into this process with HL7 Fast Healthcare Interoperability Resources (FHIR®) – automating trial matching by fitting patient data and clinical trial criteria together like puzzle pieces?  

• Two separate-but-related teams within one of the world’s leading health data standards organizations are independently addressing aspects of this complicated puzzle.  Through more standardized patient medical records and machine-readable, digital clinical trial protocols, we can make progress toward a future state where trial matching is more accurate and seamless. You can be part of the journey!  

Early Bird Registration Ends Soon

Time is running out to take advantage of early bird registration discounts for an upcoming three-day online educational event that will offer practical insights on how to implement Health Level Seven's (HL7®) Fast Healthcare Interoperability Resources (FHIR®) application program interfaces (APIs).

Early bird discounts end March 31 for the event, “Strategy to Execution: Better Prior Authorization by Integrating Operations, FHIR and CMS-0057.”

Two days of interactive content delivery and demonstrations will be followed by a collaborative Connectathon testing event on day three that will provide implementers and developers with the opportunity to test FHIR-based solutions and exchange data with other FHIR interfaces.

If you’re looking to fast-track your organization’s efforts to use HL7 FHIR APIs to automate workflow, maximize efficiency and meet federal requirements of the CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F), then don’t miss this virtual, hands-on training and testing event.

Thanks to the dedicated efforts of Gravity Project’s community members, volunteers, and staff, we made significant progress in advancing standards for Social Determinants of Health (SDOH) in 2024 that will shape the future of health data sharing.

Key Achievements

Gravity focuses on developing consensus-based standards that enhance data interoperability for SDOH. Our terminology, technical, and implementation workstreams all made notable progress in 2024 that we can leverage this year.  We provided valuable resources and guidance to help implementers adopt Gravity terminology effectively.

One of our standout initiatives was a six-week discovery project in February 2024, where over 20 cross-sector stakeholders collaborated to explore social care payment and reporting standards. This effort not only resulted in a comprehensive report but also fostered a deeper understanding of the landscape surrounding social care.

March 26 Session Features Demonstration and Lessons Learned from Cognizant and Infor

What’s the most effective way to streamline the exchange of data among providers and payers for a wide variety of purposes? Find out at the next HL7 Da Vinci Project Community Roundtable: “Transforming Healthcare End-to-End Data Conversations.”

This free webinar, to be held at 4 p.m. ET on March 26, will show how two Da Vinci member organizations are working together to transform provider/payer data conversations by applying Health Level Seven's (HL7®) Fast Healthcare Interoperability Resources (FHIR®) application programming interface (API) standard.

In addition to a demonstration, presenters will address the lessons learned so far in using the FHIR Implementation Guides for Coverage Requirements Discovery (CRD), Documentation Templates and Rules (DTR), Prior Authorization Support (PAS), Clinical Data Exchange (CDex), and Data Exchange for Quality Measures (DEQM), including Gaps in Care.  

Join the Vulcan FHIR® Accelerator on March 26 as we kick off a monthly forum inviting open dialogue on the development of a HL7 Fast Healthcare Interoperability Resources (FHIR®) implementation guide (IG) for the exchange of a digital clinical trial protocol. Input across the broader HL7 community will help ensure a more robust and widely applicable IG.

About

The Utilizing the Digital Protocol (UDP) project focuses on developing a FHIR IG for exchange of protocols aligned to ICH M11 (Clinical electronic Structured Harmonized Protocols). UDP is an umbrella project to accelerate exchange of ICH M11 compliant protocols through collaboration and integration of work products across Vulcan, CDISC and TransCelerate.     

Vulcan’s UDP team will:

• Provide regular project updates, offering a touchpoint for stakeholders who want to stay informed.
• Create a platform for discussion, allowing community members to raise questions, share insights, and engage more directly.

HL7, in collaboration with the Argonaut Project, is excited to announce the launch of a new website dedicated to the International Patient Access (IPA) standard:ipa.hl7.org. This site is designed to provide a central resource for healthcare organizations, policymakers and patients to understand, implement and support patient-controlled access to health data using the HL7® FHIR® standard.

A Milestone for Global Interoperability

IPA is a global standard aimed at empowering patients with access to their health records across different systems and countries. By defining a minimal yet meaningful set of FHIR-based profiles, IPA ensures that applications can seamlessly retrieve patient data regardless of geographic or system-specific differences.

The new website serves as a hub for information about IPA adoption, implementation guidance and ongoing development efforts. It provides insights into how healthcare systems worldwide can enable secure, authorized access to patient records through standardized APIs, reducing barriers to interoperability.