Articles, PSQH May 27, 2010

Regulate HIT Tools as Medical Devices? Yes and No

by Barry P Chaiken, MD

The Food and Drug Administration recently announced it is reconsidering its previous decision to exclude health information technology (HIT) tools from regulation as medical devices. When last evaluated in the late 1990s, this decision made common sense. At that time HIT consisted of rudimentary clinical documentation systems, electronic reference materials, and administrative applications. As even these tools were not well integrated with each other and into clinical workflow, they represented more of a digitization of paper-based activities rather than something truly transformational.

Today, HIT functionality far outstrips what was even dreamed about 10+ years ago. In addition, applications function in an integrated manner truly providing the clinician with a clinical experience much different than that offered using paper-based clinical documentation or simple clinical decision support tools.

The role of physicians, nurses, and other healthcare professionals is changing. These providers are becoming more dependent upon the clinical content within the HIT tools, often deferring to “decisions” made by these tools. Such examples include differential diagnosis, prescribed diagnostic and therapeutic treatments, choice of drug, and drug dose calculations. Although the previous rationale for not considering such HIT tools medical devices was based upon the intermediation of the provider between the recommended clinical activity and actual actions taken on behalf of the patient, the strong reliance on these very sophisticated HIT tools today puts this premise into question.

The FDA must study in detail the quality and safety issues inherent in integrated HIT applications before rushing to regulate HIT tools as medical devices. An uninformed effort to regulate HIT tools as medical devices may cause more harm than good. Applying the same standards used for medical devices to HIT tools makes little sense as HIT is neither a standalone application nor strictly a medical device. They are integrated applications that can impact quality and safety in ways far dissimilar to standard medical devices.

Regulation of HIT tools as medical devices is currently premature. Although HIT tools do directly impact patient care and therefore surely require some level of regulation, such regulation cannot be done without the requisite understanding of how HIT works within clinical workflow. The regulations must be constructed to advance HIT use while simultaneously protecting patients.

Excerpts from: Regulate HIT Tools as Medical Devices? Yes and No. PSQH, May/June, 2010