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Health & Aged Care News Alert: Health Apps - A Matter of Trust

News Alert 26 May 2017

The Australian Community Attitudes to Privacy Survey 2017 released last week by the Office of the Australian Information Commissioner confirms that health service providers continue to be the most trusted organisations in Australia.  The survey indicates that 79% of the community trust health service providers. However, only 34% trust technology companies and the industry with the lowest level of trust is social media at 12%.

What do these findings mean when considering the place of mobile medical apps or health apps in the Australian community?

Health apps are now commonplace and used with increasing frequency. Further, a close look at the survey results indicates that trust declines with age and yet the Australian Government is encouraging our ageing population to become digitally literate with one reason being to facilitate digital access with regard to healthcare. 

What role therefore does and should an Australian regulator take to ensure patient safety when using health apps? 

The primary concerns about the use of health apps relate to:

  • the type of data that is collected and how that data is used;
  • patient safety if individuals use the results of a health app to make their own (potentially incorrect) health decisions; and
  • an incorrect diagnosis due to incorrect data or a defective device. 

The Therapeutic Goods Administration (TGA) in Australia only regulates a limited number of health apps as medical devices.  Put simply, if a health app has a role in diagnosing or managing illness in contrast to being a source of information then it is likely to come within the definition of ‘medical device’ in the Therapeutic Goods Act 1989. Examples of health apps that satisfy the definition include health apps that measure blood glucose levels and patient body temperature. 

In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) takes a similar position and earlier this year updated its guidance as to whether a health app is a regulated medical device.  Put simply, the test in the UK is whether the health app has a medical purpose.  For instance, an app that calculates medicine doses or gives an individual a percentage risk or score of having a particular medical condition or disease.  The MHRA will not however regulate a health app that does not have a medical purpose if it only provides patient medical education; stores or transmits medical data without change; monitors fitness, health and wellbeing; or uses analytical services that are not being used to process data for a medical purpose. 

The growth in health apps and the evolving landscape of digital health means it should not come as a surprise when the TGA, or another regulatory agency, does move to more closely regulate health apps.  In the meantime, considering the many benefits of health apps to patients and health practitioners it is important that innovators, developers and health practitioners be aware of potential risks that may arise from using health apps (particularly privacy risks) so that trust in health apps may in the future run alongside the level of trust in health service providers.

Karen Keogh, Partner

News Alert 26 May 2017
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