FDA Regulation of EHRs and the Implications for Your Practice.

FDA Regulation of EHRs and the Implications for Your Practice.

Date: June1, 2011

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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Bio: Tim Gee is acting Principal and founder of Medical Connectivity Consulting, and a principal with Santa Rosa Consultants, where he focuses on Patient Care Device Integration (PCDI) and Point of Care Technology. He has more than 20 years of health care experience in the areas of workflow automation and the integration of medical devices into information systems, and is a member of the HIMMS Medical Device Security Working Group.