FDA to scrutinize mobile medical apps
FDA to scrutinize mobile medical apps
Written by Sue Gee   
Thursday, 21 July 2011

The US Food and Drug Administration (FDA) is seeking input on its proposed oversight of some health-related mobile phone apps.

It's hardly surprising that health-related apps are popular on the mobile phone platform. The smartphone is a device you carry around with you and its in-built camera can easily double as a monitoring device. It all provides excellent opportunities for some clever programs. It 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 roll of doctor even in seemingly harmless areas.




The FDA has now drawn up a set of draft guidelines for reviewing a subset of medical mobile apps. 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:

  1. 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)
  2. 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.

Given the rise in all sorts of "quack" mobile phone apps that take some alternative approaches and medical apps lanuched with no real field testing there is an argument that the FDA should take app medicine more under its control - unless of course you happen to be building a medical app at this moment. Regulation is good when you are the consumer and usually bad when you are the producer. So now is the time to get involved.

More information:

Draft Guidance: Mobile Medical Applications



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Last Updated ( Thursday, 21 July 2011 )

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