Like the US, Australia is experiencing the proliferation of mobile medical apps (software applications that can be executed on a mobile platform) which seek to provide a number of functionalities, many of which operate between traditional disease management and health and wellness. Some of these new apps assist consumers with their health and wellness management, whilst others provide healthcare providers with tools to improve and facilitate the delivery of patient care.

United States

The US Food and Drug Administration (FDA) released the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff on 25 September 25 2013.

The US Guidance explains how the FDA intends to regulate select software applications intended for use on mobile platforms

The FDA defines a “mobile medical app” as a mobile app that meets the definition of “device” in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and includes an application that:

• is used as an accessory to regulated medical device, for example a remote display to a medical monitor; or
• transforms a mobile platform into a regulated medical device, for example an attachment to a blood glucose strip.

The intended use of the mobile app determines whether it meets the definition of a “device”.  As stated in 21 CPR 801.4, intended use may be shown by labelling, claims, advertising materials, or oral or written statements by manufacturers or their representatives.  When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.

The FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were not to function as intended.

Mobile medical apps that meet the definition of a device must follow the regulation required for the particular class of device classification.

The FDA will apply regulatory oversight in respect of applications which allow the user to input patient-specific information and, using patient-specific formulae or algorithms, output a patient-specific result, diagnosis or treatment recommendation to be used in clinical practice or to aid in making clinical decisions.

There are three categories:

1. mobile apps which are not medical devices;
2. mobile medical apps which may be medical devices and for which the FDA intends to exercise enforcement discretion (meaning that the DFA does not intend to enforce requirements under the FD& C Act;  and
3. mobile medical apps which are the focus of FDA’s regulatory oversight (mobile medical apps);  

The US Guidance does not consider the following as medical apps:

• mobile apps containing only medical reference materials or educational tools for medical training, which do not contain patient specific information;
• mobile apps that are intended for general patient education and facilitate patient access to commonly used reference information, treatment, or prevention of a disease;
• mobile apps that automate general office operations in a healthcare setting and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation;
• medical apps which are generic aids, for example a magnifying glass;  and
• mobile apps that perform the functionality of an electronic health record system.

Examples of mobile apps which may meet the definition of medical devices but which the FDA intends to exercise enforcement discretion because they pose lower risk to the public include:

• mobile apps that help patients with diagnosed psychiatric conditions by providing a “skill of the day” behavioral technique or messages which can be accessed to decrease anxiety;
• mobile apps that us GPS location information to alert asthmatics of environmental conditions;
• mobile apps which use video and video games to motive patients to do their physical therapy exercises at home;  and
• mobile apps which advise on interactions between herbs and drugs.

The following are examples of regulated mobile apps:

• mobile apps that transform a mobile platform into a regulated medical device, such as mobile apps which use a sensor or electrode to measure blood oxygen saturation;
• mobile apps that connect to an existing device type for the purposes of controlling its operation, function or energy source, for example, a mobile app which controls an infusion pump or a cochlear implant;
• mobile apps that display, transfer, store or convert patient-specific medical device data from a connected device, for example, a device which connects to a nursing central station and displays medical data to a physician’s mobile phone.

Manufacturers of mobile medical devices are subject to the requirements described in the applicable device classification regulations.

Australia

The Australian Therapeutic Goods Administration (TGA) regulates the quality, safety and performance of medical devices and uses a regulatory framework that includes software for therapeutic purposes which falls under the definition of a “therapeutic good” under the Therapeutic Goods Act 1989 (Cth)(Act).

In Australia, whether or not a mobile health and medical app is a “medical device” and “therapeutic good” (and regulated as such) depends principally upon:

1.   functionality; and
2.   the claims made in relation to the product

Therapeutic goods includes goods that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be for “therapeutic use” (as defined) and includes medical devices, subject to stated exceptions.

Section 41BD of the Act states that:

A medical device includes:

(a) any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
        i.  diagnosis, prevention, monitoring, treatment or alleviation of disease;
        ii. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
        iii. investigation, replacement or modification of the anatomy or of a physiological process;
        iv. control of conception; and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or
(b). an accessory to an instrument, apparatus, appliance, material or other article covered by paragraph (a).

The Medical Technology Association of Australia (MTAA) in its submission on Apps Purchases by Australian Consumers on Mobile and Handheld Devices dated January 2013 recommended the “regulation of smartphone medical apps that are intended by the developer to cure, treat, monitor or diagnose a medical condition.”

In that paper the MTAA mentions that the TGA has stated that it will regulate health apps for smartphones as the need arises.

Please contact Alison Choy Flannigan with any questions.

Alison Choy Flannigan, Partner
E: alison.choyflannigan@holmanwebb.com.au
P: +61 2 9390 8338

This article is provided for general information purposes only and should not be relied upon as legal advice.