- it is software that is provided separately to a medical device (such as hardware) but which is intended to operate, or influence the operation of, the hardware; or
- it is intended to be used to provide diagnostic or therapeutic information but it is not intended to drive or influence medical hardware (that is, standalone software).
Wednesday, October 09, 2013
Medical App Regulation Looks To Have Really Become A Hot Topic In The Last Little While.
A few articles appeared in the last week or so.
First we had this.
On 13 September 2013, the Therapeutic Goods Association (TGA) published guidance about Australia's regulatory arrangements for medical software and mobile medical 'apps' on its website.
The TGA first undertook to regulate medical software and apps in 2011, after the United States Food and Drug Administration released draft guidelines on the issue. This is the first time that the TGA has published formal regulatory guidance about medical software and medical apps.
WHAT MEDICAL SOFTWARE DOES THE TGA REGULATE?
Medical software is regulated by the TGA as a “medical device” under Chapter 4 of the Therapeutic Goods Act 1989 (Cth) (the Act).
Generally, medical device software that is intended to control a device, or influence the functions of a device will fall into the same classification as that device itself.
However, the TGA’s guidance about in vitro diagnostic medical devices (published online on 19 September 2013) clarifies that medical software will be a distinct medical device if:
This means that medical software available for use by consumers through smart phones, tablets or computers are likely to be distinct medical devices if the relevant software is intended to be used for a therapeutic purpose such as diagnosing or treating a disease, injury or disability, or for the purpose of controlling conception.
In contrast, software that is limited to merely collating and presenting medical information would not be a medical device and would not fall within the ambit of the TGA’s regulatory mandate.
Lots for here:
Second we have this.
Monday, 30 September, 2013
NEW guidelines from the Therapeutic Goods Administration and the US Food and Drug Administration will do little to slow the proliferation of medical smartphone applications if the “app” retailers ignore them, say concerned Australian experts.
The sale and use of apps and attachable devices for smartphones by doctors and patients is a “huge grey area” and “fraught with traps”, the AMA’s dermatology spokesman Professor Stephen Lee told MJA InSight.
The AMA is so alarmed at the explosion of medical apps, they have fast-tracked discussions on the issue in time for the November Federal Council meeting, Professor Lee, of the University of Sydney, said.
He said the use of apps, particularly by patients looking for a quick diagnosis or risk assessment, was “fraught with traps”.
“For example, [melanoma] apps rely on the patient taking a photo of the right lesion, or the right part of the lesion”, he said. “Is the resolution good enough? If not, then the image could be misleading.”
Research into dermatology apps, published in JAMA Dermatology, found that, as of July this year, there were 229 available, with 51.1% aimed at patients, 41.0% aimed at providers and 7.9% aimed at both. (1)
“The widespread variety and popularity of mobile apps demonstrate a great potential to expand the practice and delivery of dermatologic care”, the authors concluded.
An accompanying invited commentary went further, saying if dermatologists were not using such apps it represented “a practice gap”. (2)
Professor Peter Soyer, a clinical adviser with the Australasian College of Dermatologists, said using such medical apps could be like “playing with dice”.
Much more here with references.
Last (for now) we have.
Posted Tue, 01/10/2013 - 06:06 by Fran Molloy
Last week, another smartphone-enabled medical device, an asthma wheeze monitor, was launched by Australian medical technology company iSonea Limited, backed with a high-profile ad campaign featuring Australian Olympian Cathy Freeman.
The company claims the digital device is a world-first for monitoring wheeze via smartphone technology, and with an estimated 2.3 million Australians with asthma, it’s likely to be a commercial success.
The user holds the AirSonea device against their throat to record breathing sounds, which the smartphone app then transmits to a cloud-based site for analysis by proprietary wheeze detection algorithms and software – a far simpler process than the peak-flow monitors traditionally used to monitor asthma through forced breathing.
The device sounds like a great application of mobile technology to a clinical need, and the company has registered it with Australia’s Therapeutic Goods Administration (TGA) and will seek FDA approval before launching in the US.
The Airsonea joins a rapidly-growing technology niche; according to a Deloitte report, an estimated 247 million people downloaded a health app in 2012, up from 124 million in 2011.
It’s the tip of a growing medical app iceberg, and regulators are trying to get some control back, with the TGA coming out earlier this month [http://www.tga.gov.au/industry/devices-software-mobile-apps.htm ] with clarification on the types of medical apps that could be classified as medical devices.
The statement issued noted that software that manages and presents information, like dosage calculators, would usually be exempt, but apps that incorporate a therapeutic or diagnostic function, such as one analysing clinical data like blood test results, could be considered to be medical devices and would be subject to TGA regulation.
To me, given the scale of the app market, this area can only become more and more complex, especially as the device manufacturers add additional sensors to the various devices.
I would argue that the key to what should be regulated revolves around what potential harm can result either from the app misleading or confusing the user or the app not performing in a reliable trustworthy and transparent way.
To achieve this outcome is by no means easy - as you have to recognise that 50% or people are below average - and being sure the app is safe and reliable in the hands of pretty much all users is a more than considerable challenge.
Developers need to apply the classical ‘first do no harm’ mantra in all they offer the public and to think laterally regarding all the possible risks they need to ensure they address!
Posted by Dr David More MB PhD FACHI at Wednesday, October 09, 2013