Feeds

Medical apps to come under FDA scrutiny

Accidentally killed the user? There's an app for that

Build a business case: developing custom apps

In a move that's sure to be watched closely by medical regulators worldwide, America's Food & Drug Administration (FDA) has issued its final regulatory guidance on regulating medical apps running on smartphones.

The announcement formalises a draft guidance issued in July, the culmination of a long process under which 100 apps have already been cleared over the last decade.

The FDA isn't taking aim at the entire world of medical or near-medical apps, only those which “perform the same functions as traditional medical devices”. In particular its concern is apps that might pose a risk to the patient if they lock up, crash, or simply don't work as intended.

The two examples highlighted by the administration are apps that are built to run as an accessory to regulated medical devices (for example, as diagnostic aids), or apps that try to replicate regulated devices like ECGs to detect heart attacks or abnormal heart rhythms.

Its guidance is designed to distinguish high-risk from low-risk apps, and highlights how the unwary or lazy app maker might find itself caught by surprise by an apparently-innocent app that turns on an LED on the phone:

“If, however, through marketing, labeling, and the circumstances surrounding the distribution, the mobile app is promoted by the manufacturer for use as a light source for doctors to examine patients, then the intended use of the light source would be similar to a conventional device such as an ophthalmoscope”.

However, the guidance reiterates, “we intend to apply this oversight authority only to those mobile apps whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended”.

The regulation won't apply to app stores that merely host the apps. ®

Build a business case: developing custom apps

More from The Register

next story
Just TWO climate committee MPs contradict IPCC: The two with SCIENCE degrees
'Greenhouse effect is real, but as for the rest of it ...'
Adam Afriyie MP: Smart meters are NOT so smart
Mega-costly gas 'n' 'leccy totting-up tech not worth it - Tory MP
'Blow it up': Plods pop round for chat with Commonwealth Games tweeter
You'd better not be talking about the council's housing plans
Arrr: Freetard-bothering Digital Economy Act tied up, thrown in the hold
Ministry of Fun confirms: Yes, we're busy doing nothing
ONE EMAIL costs mining company $300 MEEELION
Environmental activist walks free after hoax sent share price over a cliff
Help yourself to anyone's photos FOR FREE, suggests UK.gov
Copyright law reforms will keep m'learned friends busy
Apple smacked with privacy sueball over Location Services
Class action launched on behalf of 100 million iPhone owners
UK government officially adopts Open Document Format
Microsoft insurgency fails, earns snarky remark from UK digital services head
prev story

Whitepapers

Implementing global e-invoicing with guaranteed legal certainty
Explaining the role local tax compliance plays in successful supply chain management and e-business and how leading global brands are addressing this.
The Essential Guide to IT Transformation
ServiceNow discusses three IT transformations that can help CIO's automate IT services to transform IT and the enterprise.
Consolidation: The Foundation for IT Business Transformation
In this whitepaper learn how effective consolidation of IT and business resources can enable multiple, meaningful business benefits.
How modern custom applications can spur business growth
Learn how to create, deploy and manage custom applications without consuming or expanding the need for scarce, expensive IT resources.
Build a business case: developing custom apps
Learn how to maximize the value of custom applications by accelerating and simplifying their development.