The Health Information Technology Policy Committee has said regulations differentiating which data constitutes research and which constitutes operations on the issue of electronic health records will need clarification, FiercegovernmentIT.com reports.
In a letter to National Coordinator for Health Information Technology Farzad Mostashari, the committee recalled a notice of proposed rulemaking for secondary uses of EHR data for research uses could end up perpetuating obstacles to the learning health system.
The letter says current rules define research as activities that contribute to “generalizable knowledge.” The issue at hand is the learning healthcare system will depend on more widespread dissemination of healthcare results.
“Characterizing research as any evaluative activity that contributes to the ‘generalizable knowledge’ arguably no longer serves the interests of either patients or providers,” the letter says. “If data from an EHR is used for treatment purposes or to evaluate the safety, quality and effectiveness of care, such use should not be considered “research” and so require the consent of an institutional review board, or individual patients.”