A bipartisan Senate Bill to Limit FDA Control Over Electronic Medical Records, S. 2977 Medical Electronic Data Technology Enhancement for Consumers Health Act or the MEDTECH Act was introduced on December 4, 2014. The bill provides that EHRs are not “devices” under the Food, Drug, and Cosmetic Act: “Electronic patient records created, stored, transferred, or reviewed by health care professionals or individuals working under supervision of such professionals that functionally represent a medical chart, including patient history records, but excluding diagnostic image data.” The bill also excludes from the FDA device definition basic office software and patient data management software.
Bill Text and Status: https://www.govtrack.us/congress/bills/113/s2977
As part of the Federal Drug Administration’s charge “to protect the public health,” in March of 1997, FDA issued regulations (21 CFR § 11.10) that provide criteria for the FDA’s acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. The FDA issued guidance explaining that the rule did not include persons who use computers to print out records.
Synopsis courtesy of Marilyn Singleton, MD, JD @MSingletonMDJD