ONC Project Aims to Facilitate Real-World Data Access, Exchange

ONC recently released results from its Coordinated Registry Network for Women’s Health Technology project, a joint effort with the FDA and NIH to facilitate real-world data access and exchange.

The report discusses the findings and lessons learned from the development and testing of the Women’s Health Technologies Coordinated Registry Network FHIR Implementation Guide. This guide offers technical specifications and considerations for implementing a strategically coordinated registry network (CRN), including identifying the actors and technology for data exchange.

The use of real-world data can enhance research, post-market monitoring of approved interventions and technologies, healthcare decision-making, and clinical study design. This kind of data is increasingly stored in registries, which collect granular data at the point of care and information from multiple sources to create a comprehensive dataset for a specific disease or procedure, or to track a medical device’s performance.

However, accessing and sharing this data is typically a difficult task.

“The process of populating and extracting patient data stored in legacy registries to conduct research is often complex. Additionally, a lack of interoperability prevents linkages between legacy registries and other data sources,” Stephanie Garcia, MPH; Jawanna Henry; Danica Marinac-Dabic and Teresa Zayas Cabán wrote in a blog post.

“For example, physicians that conduct medical procedures for removal of fibroids or implantation of devices to treat pelvic floor disorders routinely collect information about the devices they use. By analyzing these data, which can include unique device identifiers across manufacturers, investigators may be able to rule out a manufacturing defect as the cause of a malfunction or conduct long-term follow-up studies about device performance.”

With CRNs, the industry can address the challenges of accessing and using registry data. CRNs can allow researchers across registries study multiple interventions, which will better reflect patients’ experiences in the real world.

The CRN concept relies on an interoperable set of common data elements that can be linked to other data sources, including claims data, EHRs, patient-reported outcomes, and other sources. CRNs also play an important role in patient-centered outcomes research (PCOR), the blog authors noted.

“PCOR aims to produce scientific evidence on the effectiveness of prevention and treatment options with consideration of patients’ preferences, values, and questions when making healthcare choices,” the group said.

“In addition, the technology that enables CRNs supports a broader health IT infrastructure to improve interoperability and reduce the need for duplicative data collection efforts.”

ONC, FDA, and NIH launched the Coordinated Registry Network for Women’s Health Technologies project in 2017. The project aimed to establish a CRN that uses common data elements to assess technologies uniquely affecting women’s health.

Additionally, the project was designed to develop tools to standardize and exchange data across multiple sources using health IT standards like HL7 FHIR.

The project’s Implementation Guide built upon existing specifications, as well as technology such as application programming interfaces (APIs) and mobile applications. This gave users a base from which to tailor the technology to use cases beyond women’s health technologies.

For the project, two women’s health registries tested the implementation guide and provided feedback about the implementation of a CRN. The results showed that the project successfully created an interoperable framework with reusable tools that can facilitate linkage among national clinical registries related to women’s health technologies.

“There is a growing opportunity for registries to leverage health IT standards to reuse clinical data, more efficiently capture data that is critical to research, and share data across complimentary registry partners,” researchers stated in the report.

“This framework has the capability to advance research efforts to develop an interoperable data network infrastructure to maximize efficiency, advance PCOR, and improve patient-centered outcomes.”

This project established a roadmap for building a CRN that FDA will continue to scale, refine, and apply to different clinical areas. FDA will also leverage this project’s infrastructure for other use cases that support future research and regulatory decision-making.

“Overall, the Coordinated Registry Network for Women’s Health Technologies project illustrates the critical nature of partnerships in the generation of real-world evidence and the search for answers to complex and novel research questions that reflect the actual patient experience,” the authors concluded.

“We encourage you to leverage this project’s findings and outputs to support interoperable data sharing for research, post-market surveillance, and clinical care using CRNs.”