Researchers have designed a set of guidelines to help protect consumers and assist health app developers understand laws and regulations.
Researchers from the University of Sydney’s Charles Perkins Centre have partnered with the Australian Communications Consumer Action Network to design a guide for developers of health apps.
There are currently more than 250,000 health apps on the market, however app developers might not be aware of all the regulatory requirements and this could be putting users’ health at risk.
Senior author Dr Quinn Grundy from the Charles Perkins Centre said the guidelines will help to minimise the chance of harm by helping developers identify and navigate laws that can be difficult to understand.
"Health apps need to be regulated in order to limit their potential for harm due to, for example, loss of personal health privacy, financial costs, and health harms from delayed or unnecessary diagnosis, monitoring and treatment," says lead author Dr Lisa Parker.
"These guidelines are designed to help app developers navigate the relevant laws and to identify best practices in health app development."
With Governments and health professionals now actively involved in driving or funding app development, and endorsing existing health apps, these issues are becoming increasingly important.
The guide focuses on seven key areas relevant to app developers including;
- Consumer privacy
- Data security
- Promotion and advertising
- Consumer finances
- Medical device efficacy and safety
- Professional ethics
Deputy CEO of the Australian Communications Consumer Action Network, Narelle Clark, said that while apps can provide positive outcomes to users, there are some that can have negative effects.
"Apps can be very convenient and effective tools for a range of consumer benefit, but when they make unjustifiable claims of health outcomes or prey upon vulnerable people by not disclosing costs or misusing private and sensitive information, apps can move into dangerous territory."
Dr Grundy said people who access these apps are often vulnerable and protections need to be in place.
"People download mental health apps, for example, because they are experiencing some sort of distress."
"This means that they might be vulnerable to misleading advertising, stigma due to loss of privacy, loss or waste of their money, or worsening of mental health symptoms that the app may not address.
"Health products, including apps, are typically regulated to protect consumers in this kind of situation."
Dr Parker adds that the researchers hope the guidelines will help ensure apps are developed in line with the law and will provide health benefits to the users.
"We anticipate that health apps developed in accordance with these guidelines are more likely to be legally compliant, but also to protect consumers’ privacy, finances, and to deliver health benefits," said Dr Parker.
While this guide was developed to reflect Australian laws, Dr Parker says it can be adapted to suit other countries.
"We have developed a tool specifically for app developers that outlines the relevant laws for apps distributed in the Australian market. However, other developed countries have similar regulations for health products, consumer privacy or advertising and these guidelines could be adapted to different jurisdictions."
The App Developer’s Guide to Law and Policy was developed in conjunction with the Australian Communications Consumer Action Network. An accompanying journal article provides more information and describes the guide’s development.
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