June 10, 2011
FDA Regulation of EHRs and the Implications for Your Practice
Written by: EHR and EMR Videos
Is greater federal oversight of health information technology on the horizon? Concerns about patient safety related to electronic health records may be prompting the Food and Drug Administration to revisit its existing “enforcement discretion” approach to HIT, under the premise that EHR software can be considered Medical Device Data Systems (MDDS). This podcast discusses some of the pros and cons of regulation, and reviews recent developments that may provide insight into the FDA’s current outlook on this issue, including a new ruling that took effect last month that reclassifies MDDS as Class 1 devices.
Tim Gee, Principal of Medical Connectivity Consulting and a principal with Santa Rosa Consultants
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[...] For at least a couple of years, there’s been talk of the FDA’s stepping in and imposing usability rules on EMRs; observers say the rules would be akin to those they already do on medical devices and supporting software. (See more on this issue from medical device connectivity expert Tim Gee here.) [...]