FDA/FCC on Wireless Medical Devices
…concern for the proliferation of devices using radio technology as well as reliance on consumer grade communication devices.
About: whyman
Profile:
William A. Hyman, ScD, PE, is a Professor of Biomedical Engineering at Texas A&M University (College Station) and President of the ACCE Healthcare Technology Foundation. His primary areas of professional activity are in medical device design and regulation, clinical engineering, system safety and human factors. He is an editor of the Journal of Clinical Engineering and has served as a consultant for the FDA, the National Science Foundation, the National Institutes of Health, NASA and medical device companies, and he is a member of the Dallas District FDA/Industry Coalition.
Website
http://biomed.tamu.edu/faculty_detail.asp?lname=%27Hyman%27
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Progress (?) on Clinical Decision Support
“Expert System or One Guy’s Opinion”
The 25 Elements of “Meaningful Use”
Number 13’s implementing decision support rules is perhaps one of the issues that is closer to the core interests of readers here.
FDA Posts New Draft Guidance on Computer-Assisted Detection Devices
While designers of such systems like to say it is “just an aid” and thereby in part try to avoid responsibility for the quality of the output, the likely reality is that it will be relied upon, and therefore a high level of performance should be assured.
What (if anything) can the recent Sidekick problem teach us?
Let’s always pause long enough to do some risk management thinking…
Canada Posts “Medical Device Data System” Rule
Any software that receives and manipulates patient data is a medical device.
