HCBA Lawyer Magazine Vol. 29, No. 1 | Page 44

CHeCK out MY CliniCAl softWAre tHAt definitelY is not A MediCAl deViCe Health care law section Chairs: TJ Ferrante – Foley & Lardner LLP & Kevin Rudolph – Shriners Hospitals for Children Because of the advancements in technology in the mobile medical applications space, the Cures Act attempted to carve out certain types T of Cds from consideration he Food and Drug Administration (FDA) recently requested public comment on the exclusion of certain software functions from FDA regulation by virtue of the 21st Century Cures Act’s (Cures Act) amended definition of a medical device. FDA sought feedback on the risks and benefits of exempting certain software functions from consideration as medical devices. u September 6, 2018 as medical devices. © Can Stock Photo / pressmaster One particular area that has generated confusion is how the FDA treats clinical decision support software (CDS). CDS is software that is intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of diseases or other conditions. Because of the advancements in technology in the Continued on page 43 qSave the Dates Membership Luncheon at the Hilton Tampa Downtown u October 3, 2018 22nd Annual Bench Bar Conference & Judicial Reception at the Hilton Tampa Downtown u November 9, 2018 YLD Annual Golf Tournament, Temple Terrace Golf & Country Club u December 6, 2018 Holiday Open House at the Chester Ferguson Law Center 42 mobile medical applications space, the Cures Act attempted to carve out certain types of CDS from consideration as medical devices. Section 3060 of the Cures Act removed certain CDS from the definition of a device as long as the CDS: u January 9, 2019 Diversity Membership Luncheon at the Hilton Tampa Downtown u April 13, 2019 Pig Roast/5K 5 Pro Bono River Run, Stetson University College of Law Tampa Campus u May 8, 2019 Law Day Membership Luncheon at the Hilton Tampa Downtown Learn more about HCBA events at www.hillsbar.com. StAy ConneCted SEPT - OCT 2018 | HCBA LAWYER