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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

2 Responses to 'The “tip of the iceberg”? Should Electronic Health Systems be regulated?'

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  1. I wonder how strictly patient management software is defined.

    Very few of the healthcare information systems I work with would be considered patient management systems. Certainly in community health the word ‘patient’ isn’t used. Patrons are referred to as ‘clients’ because most of them are quite healthy. Now that I’m working in BI … I wouldn’t consider these systems as patient management systems either.

    Glen McCallum

    5 Jul 10 at 6:55 pm

  2. Hi Glen,
    Health Canada’s definition of Patient Management Software is quite strict. They define two risk categories of PMS (Class I and Class II).

    Class II PMS is “software that is used for the purpose of monitoring a physiological condition, state of health, illness or congenital deformity and is involved in data manipulation, data analysis, data editing, image generation, determination of measurements, graphing, flagging of results, identifying a region of interest or performing calculations”

    The definition goes on to state that: “only calculations that directly impact diagnosis and/or treatment of a patient merit a Class II designation for the software in which they are utilized. Calculations and manipulations, which are used to perform only administrative functions such as determining time between appointments, do not result in a Class II software classification.”

    “patient management software used only for storing, acquiring, transferring or viewing information or images is considered a Class I medical device.”

    Check out the detailed definition here:

    ITAC Health has issued an FAQ about this issue to the vendor community:


    6 Jul 10 at 9:10 am

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