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Regulation of Medical Apps – iPhones & other Smart Devices

The number of medical Apps on both the Apple and Android platforms is increasing and mobile technology is increasingly being embraced by healthcare professionals, especially since the pandemic.

With the increase in medical software programs and medical technology, such as robotics and diagnostic software, it’s important the manufacturers are aware of the regulatory requirements (Regulation of Medical Apps) which applies to medical & healthcare industry software and apps, including smartphone apps.

App developers should be aware that some software intended to run on a mobile device may be classified as a medical device and therefore be subject to regulation.

In July 2011 the US FDA released a draft guide for mobile medical applications here. In January 2012 the European MEDEV issued a guide on the qualification and classification of stand-alone software (which includes Apps).

There are some examples of Medical Apps that have been subjected to regulation:

  • US FDA – in 2011, after initially removing the App from Apple’s AppStore because of regulatory concerns, the FDA granted the diagnostic radiology App, Mobile MIM, 510(k) clearance.
  • UK MHRA – In January 2012 the Mersey Burns App is the first App registered with the MHRA as a Class I medical device. This is a clinical tool for estimating burn area percentages and determining fluids to be prescribed.

TGA regulations – Medical Apps / Medical Software Programs

Although the Australian TGA does not have a specific guidance document for Apps, the situation here seems reasonably clear. Part 2, Section 13 of the Australian regulatory guidelines for medical devices (ARGMD) includes a section on software as active medical devices. This guide states that “software that is used as a diagnostic or therapeutic tool” is a separate medical device. Examples included are an oncology image-processing tool and radiation planning/treatment software. This is applicable to software that is standalone (i.e. not part of another medical device) and includes Apps. According to classification rule 4.1 (see ARGMD), such software would be regulated as a Class 1 medical device.

The difficulty is defining “diagnostic or therapeutic tool” and therefore whether or not medical device regulations would apply to an App. The term “tool” implies that the App would have to process data (however input) and produce a result that is either fully or partially relied on to make a diagnostic or treatment decision. An App that is intended to record and/or store medical data without processing the data, would not seem to be a diagnostic or therapeutic tool and therefore not subject to medical device regulation. However, this is a grey area with a spectrum of risk associated with the possible range of types of medical Apps. For this reason it is recommended that developers of medical Apps consult their regulatory authority to determine whether or not medical device regulations apply to their App.

By Tony Gould

Executive Consultant – PharmOut

Ex Chief Auditor with the Therapeutic Goods Association (TGA), Canberra