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Apps to manage healthcare can be a great tool. Indeed, they may help users track symptoms and recognise patterns. Alternatively, they may remind people to take medications or provide resources to people with various health needs. If you want to create a health app, there are many considerations to keep in mind. For instance, in healthcare app development you must make sure you provide accurate information. Furthermore, you must limit your liability, develop your app terms and conditions and privacy policy, comply with all relevant regulations, and correctly handle your users’ personal information. In this article, we look at some of the key considerations you should keep in mind when creating a medical or health app. 

App Terms and Conditions

The App Store and the Google Play Store require you to have a set of terms and conditions for your health app. Your app terms and conditions will set out to users what they can expect from your service. For example, your app terms and conditions will include details about the payments and billing terms. They will also cover who owns intellectual property generated through the mobile app, and what acceptable usage entails. 

When developing a health-related app, you must have clear disclaimers and limitations on your liability. Your terms and conditions will include such disclaimers. For example, you might want to include disclaimers that your app provides information only and does not constitute medical advice. Furthermore, you may include a disclaimer that the information on your app is not tailored to a user’s personal circumstances, therefore, you do not guarantee any particular results. You certainly must make it clear that if a user has a serious medical issue, they should seek specific advice from a qualified medical professional.

There will likely be other disclaimers and limitations on your liability that will vary depending on how your app works. This will also depend on the kind of information or service you provide.

Handling Personal Information

The Privacy Act in Australia creates a national set of guidelines for storing and handling personal information. This Act includes 13 Privacy Principles that set out what obligations a business has when:

  • collecting personal information;
  • engaging in direct marketing; or
  • disclosing personal information to third parties. 

The Privacy Act has rules for how your app handles personal information, and they are quite detailed. These rules can impose a fair amount of administrative work on a business that needs to comply. However, the Privacy Act does not currently apply to all businesses in Australia.

Does My App Need to Comply With the Privacy Act?

Generally, businesses with an annual turnover of less than $3 million do not need to comply with the data collection, storage, and usage regime set out in the Privacy Act. However, there are some exceptions to this small business rule. Businesses that purchase or sell personal information, for example, must comply.

Crucially, a mobile app related to the healthcare industry will likely need to comply. All organisations that provide a health service and hold health information (other than employee records) are covered by the Privacy Act, even if they have an annual turnover of less than $3 million. Examples of providing a health service include: 

  • assessing, maintaining or improving a person’s physical or psychological health;
  • diagnosing or treating a person’s illness, disability or injury; or
  • recording a person’s physical or psychological health for the purposes of assessing, maintaining, improving or managing the person’s health. 

If you think your healthcare app will be providing a health-related service, it is important to speak to an experienced privacy lawyer. This way, you can understand if you need to comply with the Privacy Act, and if so, what practical steps you need to take to ensure compliance. There may also be state health privacy laws that apply to your app. Importantly, if you are covered by the Privacy Act but do not comply, you could face penalties of up to $2.1 million per breach.

Software as a Medical Device

Some software or apps can be considered to be a ‘medical device’ and are regulated as such. Some examples of software that would likely be considered a ‘medical device’ would be:

  • an app that organises and tracks a person’s health information and analyses this information to diagnose diabetes, or provide a percentage risk of the user having diabetes; or 
  • software that analyses skin images to screen for melanoma.

You should speak to a medical regulatory specialist to determine whether they would consider your app as a medical device. If so, seek advice on what additional regulations you need to consider.

Privacy Policy

To list your app on the Google Play or App Store, you will need to have a privacy policy. Your privacy policy will let your users know what kind of personal information you collect from them. This could include their name, email, or payment details. Furthermore, it could include whether you collect any sensitive information. This may include health information, or information on their race, religion, or sexual orientation. 

Your privacy policy will also set out how you store personal information. This includes whether you disclose this information to third parties or whether you send their personal information outside of Australia. Users of a health-related app are likely to be more concerned about how you use their personal information. This is why having a clear privacy policy is key. 

Key Takeaways

Health and medical-related apps can face more challenges than other startups due to the highly regulated nature of the medical industry. If you plan on launching a health-related app, you should make sure that your terms and conditions protect you from liability and include disclaimers as to the service you provide. In addition, you should understand what your data collection and handling obligations are and whether the regime set out in the Privacy Act applies to you. You will also need to understand whether or not your app is a ‘medical device’ that the TGA regulates. A privacy policy and set of terms and conditions for your app are essential in order to be listed with either Apple or Google. 

If you need help with your medical or health app, contact LegalVision’s medical regulatory and online business lawyers on 1300 544 755 or fill out the form on this page. 

Frequently Asked Questions

What is a healthcare app?

A health app is an app that relates to medical or healthcare. This app may help users track symptoms and recognise patterns. Or, they may remind people to take medications or provide resources to people with various health needs. If you want to create a health app, you must make sure you provide accurate information.

Is my health app considered a medical device?

Some software or apps can be considered to be a ‘medical device’ and are regulated as such. One example of software that would likely be considered a ‘medical device’ would be an app that organises and tracks a person’s health information and analyses this information to diagnose diabetes or provides a percentage risk of the user having diabetes. Another would be an app that uses software that analyses skin images to screen for melanoma.

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