A key goal of the federal health information technology program has always been to use interoperable electronic health-record systems to quicken the pace of clinical innovation.
To that end, the Food and Drug Administration's Center for Drug Evaluation and Research is sponsoring pilot projects that would link previously "siloed" systems for gathering and storing clinical information. There is currently one set of electronic record-keeping systems for patient care and another for clinical research.
“Streamlining clinical research at the source may open up opportunities to improve clinical trial design and execution, speed the cycle of clinical research and get medicines to market faster,” the FDA said in a notice, published last week in the Federal Register, soliciting comments and pilot project applicants.
The EHR systems used by clinicians and what the FDA calls electronic data capture, or EDC, systems, which are “now ubiquitous for the capture of clinical trials data,” and the underlying data models of both systems have been “widely disparate,” the FDA notice said.
The demonstration projects the FDA is looking to support should assess and report the value and challenges of linking EHR and EDC systems, the agency said. The FDA did not identify any funding available for these projects.
Still, the FDA aspires to use common interoperability standards to link the systems so that clinicians in the normal course of their workflow could use their EHRs to “auto-populate” researchers' electronic study forms.
Direct connections between the systems might also reduce duplication of effort from data re-entry and reduce transcription errors incurred by moving data from one system to another. And, according to the regulator, the use of standards-based technology could “facilitate the inspection and reconstruction of clinical investigations by the FDA.”
Doug Fridsma, president and CEO of the Bethesda, Md.-based American Medical Informatics Association, said the standards for data collection and interoperability used by EHR vendors and developers of EDC systems differ and need to be harmonized.
“There's going to have to be some retooling of some of these older standards,” Fridsma said.
Fridsma is the former chief science officer at the Office of the National Coordinator for Health Information Technology at HHS. He worked on standards and interoperability issues.
Both sides need to move away from the historic paradigms of documents as the basic structure of health information exchange used by both EHRs and EDC, according to Fridsma.
Instead, they should use an approach focused more on specific data elements.
“This announcement is a tremendous opportunity for some of these developers of standards to really come together” with this common approach, he said. Fridsma suggests the Fast Healthcare Interoperability Resources, or FHIR (pronounced “fire”), a more "datacentric" initiative gaining ground with EHR developers, should be explored.
Fridsma said the FDA project also offers an opportunity for the agency and its pilot participants to think horizontally, on other data needs, such as for disease surveillance by state and local public health agencies and the Centers for Disease Control and Prevention or for developing precision medicine therapies, work spearheaded by the National Institutes of Health.
“The learning healthcare system is going to need engagement across that entire spectrum,” from patients to clinicians to researchers, Fridsma said. “If they (the FDA) can do that and bring those worlds together, this could be tremendously helpful,” he said.