|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:
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.
Draft Guidance: Mobile Medical Applications
|Last Updated ( Thursday, 21 July 2011 )|