An Overview of Clinical Decision Support Software from a Regulatory Affairs Historical Perspective

Clinician Decision Support (CDS) tools, as the US federal government describes them, have existed as long as documents have supported medicine. A joint report by the FDA, the FCC, The Office of National Coordination of Health IT was published in 2014. It gives the following as examples of CDS: computerized alerts and reminders for providers and patients; clinical guidelines; condition-specific order sets; focused patient data reports and summaries; documentation templates; diagnostic support; and contextually relevant reference information. The development of user-friendly software applications allowed CDS to yield more valuable information than for example static clinical guidelines, or diagnostic supporting information, on a laminated card. Some of the software would be for lower risk clinical applications. The software might simply perform calculations for a clinician so that they did not have to do it manually; the calculations are well understood and straightforward to describe. Similarly, the software might provide clinical reference information that eliminates the need to maintain a library of physical books. Some of the software applications are for moderate risk information like an application that analyzes patient physiological signals to generate alerts for potential cardiovascular conditions. None of the successful early clinical applications would use highly complex calculations in part because the hardware to perform the calculations did not exist. Medicine did not generate enough interest in software applications to drive the hardware development needed to push CDS software to the next level. However, a perhaps unlikely source did drive the necessary technological breakthroughs: the gaming industry. Server farms grew and the availability of the new computing power provided clinical software algorithm developers and data scientists the opportunity to consider developing more powerful software applications. 

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