The rise of smartphone health and medical apps

Health and medical smartphone apps can help improve the management of acute and chronic conditions and provide more personalised medical treatment.

With the proliferation of mobile telecommunications devices, the smartphone apps market has created an ‘app economy’ heavily impacting on many industries. Healthcare is one of these industries, with the potential value of developing innovative smartphone apps to improve the management of acute and chronic conditions and provide more personalised medical treatment being realised internationally.

Smartphone apps within the healthcare industry fall into two main categories:

1. Health apps
2. Medical apps

Health apps do not require approval in Australia from the Therapeutic Goods Administration (TGA). These apps relate to the general health and wellbeing of the individual and involve non-invasive monitoring programs such as monitoring calorie intake.

By contrast, medical apps can be utilised for the purpose of providing diagnostic tools and remote monitoring, and can include sensor-based applications. There are far fewer medical apps than there are health apps.

Medical apps that make certain diagnostic or treatment claims (as opposed to just providing information) may be classified as medical devices, in which case they would require approval from the TGA before they could be marketed and sold.

Medical apps can be designed to operate in collaboration with other devices, with the purpose of providing a medically beneficial outcome, for example:

• Sanofi Aventis’s sensor-based iBGStar Diabetis monitoring app that measures blood glucose;
• An insulin pump, where the app controls the delivery of insulin;
• A blood pressure cuff, where the app controls the inflation and deflation of the cuff;
• The AliveCor iPhone ECG, where the app allows for the measurement, storage and display of ECG signals; and
• The Mobisante MobiUS, which allows for the miniaturisation of ultrasound devices and attaches a probe to show images on a smartphone screen.

While numerous health and medical apps are available through marketplaces such as iTunes, certain medical apps (and particularly those that would be classified as a medical device) would more likely be privately distributed to relevant patients.

The market for health and medical apps

In 2011 the global smartphone market for both medical and health apps was worth US$718 million and it is estimated by research2guidance that in 2012 that market was worth US$1.3 billion. The US Food and Drug Administration expects there will be 500 million smartphone users downloading healthcare-related apps worldwide by 2015.

Despite this substantial growth, the market has likely got a long way to develop yet. This seems especially the case in relation to medical apps in Australia, as we are yet to see a medical app registered or approved as a medical device on the Australian Register of Therapeutic Goods (ARTG).

By way of contrast, in the US there are approximately 75 ‘mobile medical apps’ that have received clearance from the FDA under section 510(k) of the Federal Food Drug and Cosmetic Act.

Medical apps have the potential to risk public health where they are used for diagnostic and treatment purposes. For this reason, regulatory bodies oversee the safety and effectiveness of medical apps.

In Australia, the TGA’s medical device regulatory framework provides for the regulation of medical device software, so a medical app with a therapeutic purpose would be held to the same level of scrutiny as other medical devices.

This would cover any app that is intended to be used for the:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease;
• Diagnosis, monitoring, treatment, alleviation of an injury or disability;
• Investigation, replacement or modification of the anatomy or of a physiological process; or
• Control of conception.

In the US, the FDA is in the process of forming a specific policy to better regulate mobile medical apps.  Once this is settled, Australian policy may take guidance from it and follow suit.

Developing and marketing smartphone health or medical apps

In Australia, any development of health or medical apps must be carried out with regard to four key areas: regulatory compliance, intellectual property, privacy and data collection, and marketing claims.

When developing the app, consideration needs to be given to:

• Compliance with the medical device standards in the Therapeutic Goods Act 1989 (Cth) and the Therapeutic Goods Advertising Code;
• The name and branding of the app;
• Copyright ownership in the app’s underlying software code;
• The patentability of the app;
• The protection of the ideas underpinning the app prior to and during development;
• Data security;
• Privacy policies and the collection of sensitive information; and
• Ensuring that all claims made regarding the app comply with the Australian Consumer Law and are not unsubstantiated or likely to mislead or deceive consumers.

The health and medical claims that are permitted to be made about the app will depend on the registration status of the app under the TG Act. If registration as a ‘medical device’ in Australia is possible, more substantial claims will be permitted and this may give the app a distinct advantage over its competitors.

With such a rapid increase in the use of medical apps, there will be an increase in the need to address the concerns associated with this technology, including the accuracy of information, diagnosis and treatment, says Eric Wicklund of Government Health IT. According to David Brill at the The Medical Observer, there is concern that some medical and health apps may make unsubstantiated claims, especially those purporting to be diagnostic. In those circumstances, the TGA would be able to take regulatory action as if the app were a medical device.

The legal consequences of making unsubstantiated claims regarding treatment by using a medical app have been tested in the US. In one particular case the Federal Trade Commission commenced an action against three individuals for making unsubstantiated claims in relation to the treatment of acne with coloured light emitted from a smartphone.

The individuals falsely claimed the treatment was supported by a study in the British Journal of Dermatology. The matter settled with the individuals paying a civil penalty and being barred from making claims about other medical devices without competent and reliable scientific evidence.

What next?

There is clearly a booming market for health and medical apps. Medical apps that make certain diagnostic and treatment claims will require approval from the TGA in Australia and will be held to the same level of scrutiny as other medical devices. Those that can stand up to that scrutiny have the potential to provide lucrative revenue streams that, not so long ago, would not have been envisaged.

While there are clear advantages to being the first on the market, this should not be at the expense of neglecting the need for proper regulatory compliance, and the appropriate development and marketing of a health or medical app. It remains to be seen who will be the first to obtain registration of an app as a medical device in Australia, but it cannot be far away.

Michael Sutton is a Senior Associate with DibbsBarker, a commercial law firm that advises the medical and pharmaceutical industry.  He is a Certified Licensing Professional, specialising in technology licensing and competition and consumer law. Megan Fraser is a Lawyer at DibbsBarker, focusing on intellectual property and technology.

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