EHR vendors ask FDA for revisions to clinical decision support software guidance

In a letter, the HIMSS EHR Association expresses concerns and asks for answers on matters like automation bias and how the sector would move away from antiquated systems. This week, the U.S. Food and Drug Administration received a letter from the HIMSS Electronic Health Record Group, a national trade association of EHR developers with 30 member businesses, highlighting issues with the regulatory body's clinical decision support software final Guidance. Section 520 of the Federal Food, Drug & Cosmetic Act was modified by the 21st Century Cures Act to exclude some medical software functionalities, such as specific decision support software, from the definition of device. While noting that its members have contributed, the EHR Association stated in a letter dated December 6.