CDS Coalition Calls for Comments on Draft Industry Guidelines by July 1, 2017
The CDS Coalition has developed the attached voluntary guidelines for use by clinical decision support, or CDS, software developers to guide the design of such software. The purpose of these guidelines is to ensure that software, as much as possible, leaves the user firmly in control of the clinical decision-making. As explained more in the guidelines themselves, we have been also influenced by some recent legislation that articulates the dividing line between FDA regulation and the practice of medicine.
The coalition is comprised of large and small software developers, including those traditionally from the medical space as well as those new to the area. The coalition also includes hospitals and other users of such software, as well as those who make pharmaceutical products and medical devices that are guided by the software. But we recognize that there is a vast universe of organizations out there impacted by CDS, and so we would like to solicit comments from all those affected.
Our plan is to collect comments through July 1, 2017, and then make appropriate revisions. After that, we plan to present these guidelines to FDA for their feedback.
If you have any questions or concerns, please let me know. Please direct your comments to me, Brad Thompson, at bthompson@EBGlaw.com.
We would very much appreciate hearing your thoughts.