FDA and Electronic Health Records

Electronic health records (EHRs) have been a hot topic in health care reform over the past several years. Many believe that EHRs hold promise for reducing costs, improving the quality and efficiency of care, and reducing medical errors. As numerous stakeholders in the healthcare industry gear up to meet the “meaningful use” requirements contained within the Affordable Care Act (ACA) and HITECH Act, some questions surrounding the regulation of EHRs has arisen. Specifically, stakeholders are wondering whether EHRs will be classified as a ‘medical device,’ and if so, under what standards would the Food and Drug Administration (FDA) regulate them.

These issues are critical because both the Recovery Act and the ACA contain billions of dollars in funding provisions to create and implement health information technology (HIT) and EHRs. Further regulation of EHRs would likely delay the full implementation of such provisions and initiatives. Consequently, Jeffrey Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health (CDRH) at the FDA, gave a bit of insight on these questions at a recent conference. Speaking at the first annual PharmEHR Summit in Philadelphia, Dr. Shuren told participants that the FDA “could change its traditional hands-off approach to EHRs, but he acknowledged that the potential of FDA regulation raises serious clinical issues and is a “political hot potato.” He further noted that, “as of right now, FDA not regulating EHRs, and it may turn out that we won’t,” he said.

The two-day PharmEHR Summit brought together executives from the FDA, EHR vendors, and pharmaceutical and device companies to discuss the impact of EHR adoption on drugs and devices from a regulatory, liability and marketing perspective. Panels dealt with the role of the EHR in clinical trials and delivering drug safety alerts to physicians. Janet Woodcock, M.D., Director for the Center for Drug Evaluation and Research (CDER) at FDA, provided the opening keynote for the Summit, in which she focused on the FDA’s perspectives and goals related to EHRs and improving drug safety and efficacy.

Glen Tullman, CEO of Allscripts, discussed EHR functionality and adoption now and over the next two years. Edward Fotsch, M.D., CEO of PDR Network noted that, “EHRs are in the middle of physician workflow and have a profound impact on pharmaceutical regulatory and marketing issues, from automated drug Alerts to convenient access to patient financial assistance programs for drugs.”

Accordingly, Dr. Shuren acknowledged that the FDA will issue new rules about software either later in 2011 or in 2012, “adding that the agency already regulates certain types of software and is also developing rules for the development of medical mobile apps.” An article covering the conference noted that, “FDA regulation could mean that EHR vendors would face review of their manufacturing processes and design controls, as well as FDA testing to show a system does what it claims to do.” In the meantime, the Office of the National Coordinator for Health IT (ONC) is leading “an assessment of the role the federal government should play in addressing EHR safety, and the Institute of Medicine is conducting a study on the topic.”

Despite ONC’s role, Dr. Shuren recognized that, “interoperability issues of EHRs must be addressed and device integration standards developed,” regardless of whether FDA decides to regulate EHRs. Dr. Shuren noted that such standards must be developed because “EHRs touch all kinds of medical devices that FDA has been regulating for a long time, and they impact the functioning of those technologies.” Moreover, he added that regulation of EHRs is needed because they are “becoming increasingly complex and interconnected.” While these EHRs may work well in a “vacuum,” Dr. Shuren acknowledged that, “interoperability can present problems.”

For example, he noted that PACS [picture archiving and communication system] interfaces with the EHR and the wrong image is conveyed or it is flipped. Additionally, Dr. Shuren recognized that EHRs and software also requires frequent upgrades and small changes such as a security patch may have serious unintended consequences. While EHRs will almost certainly need some kind of regulation by the FDA, Dr. Shuren recognized the positive impact and potential EHRs will have because they can “become a data source for medical devices.” However, “the potential for the EHR to uniquely identify the device has been unrealized.

Dr. Shuren noted that FDA “can’t yet link the device with a patient’s experience with that device.” Accordingly, he noted that the FDA is “working on rules for Unique Device Identifiers, which would likely use bar coding to feed specific information about a device into a patient’s electronic record. He said it is expected to improve adverse event reporting, document medical device use, bolster anti-counterfeiting efforts, support hospital IT systems and provide better claims data for third-party payers.”

Ultimately, the prospect of FDA adding another layer of regulations and bureaucratic tape to the EHR process will be troublesome for many stakeholders already invested in bringing EHRs into their practices and institutions. While more oversight and standards for EHRs are necessary and desirable to ensure proper safety and interoperability, more regulations could cause delay in implementation and could scare off sources of private funding that will help stimulate this initiative.

Given FDA’s current resources and staffing issues, particularly with its approval of other devices, EHRs would probably be more effectively managed through ONC for now, with FDA providing advice until they are more capable of handling such a large issue. Stakeholders would almost certainly be more interested in FDA and CDRH first addressing problems with the PMA and 510(k) approval process, before FDA decides to endeavor into EHRs.