Slashdot Mirror


FDA To Scrutinize Mobile Medical Apps

mikejuk writes "It looks like 'first do no harm' is coming to an app near you. The US Food and Drug Administration (FDA) is seeking input on its proposed oversight of some health-related mobile phone apps. It is almost too easy to create an app that aims to help people detect or manage some condition or other — but should programmers play the role of doctor even in seemingly harmless areas?"

2 of 142 comments (clear)

  1. Bad Summary by microcars · · Score: 4, Insightful
    This only applies to apps that are used to communicate with an external device of some sort.

    It isn't planning to oversee all health apps - just those medical apps that could present a risk to patients if the apps don’t work as intended.
    It specifies the following two categories of mobile medical apps:
    a: those used as an accessory to medical device already regulated by the FDA.
    (For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet)
    b: transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices.
    (For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).
    The FDA wants interested parties including software creators to comment on its proposals during the next 90-days.

    --
    I like microcars
  2. could they go after the 'one secret to trim belly' by decora · · Score: 4, Insightful

    could they go after the '1 secret to trim belly fat' or 'dermatologists hate this woman' ads first?

    those are out and out fraud, but more than that, im sick of looking at them.