Are Electronic Health Records Medical Devices?

Abstract

Are Electronic Health Records Medical Devices? While statute (largely) excludes EHRs from the medical device category, commentators have struggled to offer a justification. They have argued that EHRs inform but do not replace clinical decision-making, do not directly interact with patients, and are constantly being upgraded and modified. But all these characteristics are often true of many medical devices. I argue the key aspect of EHRs that render them foreign to the FDA’s jurisdiction is their systemwide interconnectedness. The patient’s EHR affects others. EHRs must work in a certain way, for the integrity of the whole system. EHR data is used for both clinical and quality management research. Alternatively, the safety of EHRs involves greater systematic, upstream regulation - of third-party networks, data formats, and other issues that present collective action problems. This goes far beyond the mandate of the FDA that fails to consider such issues and lacks jurisdiction over many necessary third parties. I argue that the distinction between EHR functions that have a direct and primary effect on the particular patient versus those such as data format and interoperability that present these third-party and systematic considerations should determine the respective jurisdictions of the FDA and health data subagencies.