Engineering Health Information Systems

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Archive for June, 2010

The “tip of the iceberg”? Should Electronic Health Systems be regulated?

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The U.S. FDA is getting increasingly concerned about the safety of Electronic Health Systems. Earlier this year, I attended a meeting of the Software Certification Consortium (SCC), which involved participation of regulators, academics and practitioners in different areas of critical systems. eHealth systems are certainly seen as an increasing issues. Now the Huffington Post published an article stating that FDA’s voluntary notification system has logged a total of 260 reports of “malfunctions with the potential for patient harm,” including 44 injuries and the six deaths. Since such reports are completely voluntary at this point, it is fair to assume that this is just the “tip of the iceberg”. The article mentions that in the past the vendor community has argued against regulatory oversight of their products, for fear of slowing down adoption.
Notably, some vendors such as Cerner have come to the conclusion that mandatory registration and reporting “is the right thing to do”.
Other jurisdictions, such as Canada seem to be ahead. Health Canada is considering any type of patient management software under a mandatory licensing regime according to the medical devices act.

Written by Jens

June 30th, 2010 at 4:11 pm

Posted in Uncategorized