Possible FDA Regulation of Smartphone Applications

While Health Canada is moving ahead with licensing of health IT software as medical devices, the Federal Drug Administration (FDA) in the US is contemplating possible regulation of smartphone applications that monitor vital signs.   The FDA appears to moving cautiously.  According to an article in eWeek.com, “the FDA plans to seek public input before issuing a final document”.  FDA spokesperson Dick Thompson notes that “Some mobile applications are very similar to traditional software applications that the FDA has already classified or regulated, but we believe that further clarifications on mobile applications would be helpful.”

Given the confusion surrounding the Health Canada regulations regarding licensing of health IT software, I wonder if they also apply to smartphone applications?


5 responses to “Possible FDA Regulation of Smartphone Applications

  1. Pingback: ICMCC News Page » Possible FDA Regulation of Smartphone Applications

  2. Good question Mike. I would answer your question with a question. Are smartphones “just another kind of computer” and thus from a legalistic standpoint they could/should be regulated by Health Canada? Or are smartphones something else entirely.

    I also think that we need to be asking the all important question of “What is the value for Health Canada to regulate”? Will patients be better protected? I would like to hear some solid arguments based on evidence as to the benefit of regulation before I support it.


  3. Mark,
    Let’s see … is a smarthphone a computer? It has a processor, various input devices, long term storage, and a display. Hmmm … if it looks like a duck and quacks like a duck then it probably is a duck! Yeah, I think that a smartphone is a computer! Hence, smartphone apps should probably be subject to the same medical device regulations as software running on a laptop.

    As for the value of Health Canada regulation, what they are doing is modeled on what is happening in other jurisdictions. Do you think that an IV pump should be certified as a medical device? If so, why not EMR software that is analyzing physician input and patient date to generate alerts and make recommendations?


  4. There the government goes again. They want to have a hand in everything. I wish they’d stay out of some things. I hope that these apps are not regulated but left in the hands of the people. The government has too much power as it is.

    Also, a free smartphone app that will help you to manage your health and get offers and coupons that will help with the cost of medication is Cardmobili. Cardmobili will enable users to store vital cards in their phone, like membership cards, loyalty cards, and insurance cards.Since I’ve found this app, I’ve been in heaven with it, and i have to let everyone know about it. That is how cool it is. You can check it out for yourself at http://www.cardmobili.com

  5. Pingback: Impact of Potential FDA Regulation of EMRs

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