In a February 6, 2018 letter to Food and Drug Administration (FDA) Commissioner Scott Gottlieb, HIMSS offered comments to the FDA’s Clinical and Patient Decision Support Software Draft Guidance. In this letter HIMSS leveraged its members’ expertise to provide feedback on how clinical decision support (CDS) software helps providers, and ultimately patients, identify the most appropriate treatment plan for their disease or condition.
HIMSS supports FDA’s efforts to develop a risk-based oversight framework for such CDS software or hardware that takes into account critical factors such as risk relative to intended use and the cost/benefit of any proposed oversight, with the intent of ensuring patient safety.
In the draft guidance, FDA delineates between CDS that warrants FDA oversight as a medical device, and CDS that under provisions of the 21st Century Cures Act, does not require FDA oversight. HIMSS recommends that FDA specifically define the CDS technologies that meet the medical device standard. Given that CDS is an overarching term for a wide variety of technologies, HIMSS recommends the FDA use the term, “Regulated CDS Devices” to define the CDS technologies that meet the medical device standard.
HIMSS notes that for regulator purposes, “medical device” should not cover software or hardware that (with very limited exceptions) provides CDS technology that simply transmits or allows other parties to read information originally sent from medical devices, electronic health records, or technologies that are widely used in other industries.
HIMSS feels that it is critically important for FDA to share more details regarding the logic applied to determine if a specific technology meets the device criteria per FDA’s interpretation of 21st Century Cures provisions. As there will be innovations that build on current technologies, in some cases such refinements and improvements could result in an entirely new technology, HIMSS notes that more specificity is necessary for the entire community to understand where FDA’s current thinking on a technology is while simultaneously ensuring a degree of flexibility moving forward.