Australia: Using health information for research – key privacy considerations for medical technology companies

Last Updated: 15 May 2016
Article by Marie Feltham
Services: Competition & Consumer Law, Intellectual Property & Technology, People & Workplace
Industry Focus: Life Sciences & Healthcare

What you need to know

  • Medical technology companies are often keen to access health information for research and development.
  • Australia's privacy legal framework places restrictions on the use of health information for such purposes, particularly with respect to consent, de-identification and transfer of information overseas.
  • This article examines these three key issues which medical technology companies should consider before using health information for research, and outlines some suggested strategies and best practices around how those issues can be addressed.

Medical technology companies are keen to access health information for a variety of purposes beyond the delivery of their products and services.

Research and development is one of these purposes. Through research, medical technology companies seek to improve their products and create better outcomes for individual patients. These improvements may also reduce the burden of health funding on government, private health insurers and patients.

However, Australia's privacy legal framework places restrictions on the use of health information for research.

Here are the three key issues that medical technology companies should consider before using health information for research purposes, and some suggested strategies and best practices around how they can be addressed.

  1. Consent

Generally, medical technology companies are permitted to use and disclose an individual's health information if it is related to the dominant reason that the company collected the individual's information in the first place (the primary purpose).

Medical technology companies usually collect health information when delivering their products (and associated healthcare services) to individuals. The 'primary purpose' is therefore to enable delivery of those products and services.

If a medical technology company wishes to use an individual's health information for a secondary purpose, such as research to monitor features and treatment outcomes associated with its product or services, it must obtain the individual's consent to do so.

The Office of the Australian Information Commissioner (OAIC) has identified these key features of consent:

  • an individual must be adequately informed before giving consent
  • the individual must give consent voluntarily
  • the consent must be current and specific, and
  • the individual must have capacity to understand and communicate their consent. 1

To ensure the requirements of consent are met in practice, several measures can assist including:

  • using clear and plain language to explain what the consent is being provided for
  • setting out what will happen to an individual's information, each step of the way, and
  • being specific about what the consent is for, and how long it will last.

There is an important balance for medical technology companies between being specific about how they will use health information, and ensuring that the consent is broad enough to cover future uses (to avoid the need to go through the consent process again).

  1. De-identification

De-identification allows medical technology companies to use health information for research without the need to obtain the consent of individuals.

Personal (including health) information is de-identified if the information is no longer about an identifiable individual or an individual who is reasonably identifiable (section 6(1) of Privacy Act 1988 (Cth)). Handling de-identified information is not governed by the Privacy Act.

But what does 'de-identifying' really look like in practice? There is no simple 'checklist' of identifiers which must be removed in order for information to become de-identified. Removing the obvious personal identifiers such as the name, address and date of birth of an individual is essential, but other steps might also need to be taken to truly de-identify personal information. This might include removing or modifying information about unusual characteristics of an individual (such as occupation, languages spoken, age and unique background medical features).

Also, whether health information is effectively de-identified depends on what other information is available to persons using the information.

For example, information that an unnamed person with a certain medical condition lives in a specific postcode area may not on its own enable the individual to be identified, so would not be personal information. On the other hand, if the information is held by an organisation with specific knowledge that could link an individual to the medical condition and the postcode, it may be personal information.2

The key question for medical technology companies is: how to separate records containing de-identified data for research purposes from records containing personal information associated with treatment of patients?

The OAIC has indicated that the risk of re-identification must be actively assessed and managed to ensure that the risk of re-identification is low. Relevant factors to consider when determining whether information has been effectively de-identified include the cost, difficulty, practicality and likelihood of re-identification.3

In practice, this means that medical technology companies should establish safeguards to separate identifiable information collected and associated with supplying products and services to individuals, from de-identifiable information used in research and development activities. Possible precautions range from implementing protocols to ensure that personnel do not attempt to re-identify information to engaging experts to determine methods of mitigating the risk of linking different sets of information.

  1. Transfer of information overseas

Australian medical technology companies often wish to transfer health information overseas, and in particular to parent companies' global or regional headquarters, so that it can be used in worldwide research projects.

Australian Privacy Principle (APP) 8 governs the disclosure / transfer of personal information by a medical technology company to a different entity (including a related company) offshore. APP 8 makes it clear that before an Australian medical technology company discloses personal information to an overseas recipient, it must take reasonable steps to ensure that the offshore entity will comply with (not breach) the APPs. Usually this can be achieved through appropriate contractual provisions - for example, those which require the overseas recipient to comply with the APPs.

However, generally speaking, a medical technology company will be liable for the acts or omissions of the overseas recipient if those activities breach the APPs. There are limited exceptions to this rule and it is unlikely that these exceptions will be able to be relied upon in the event of a breach by the overseas recipient.

This means that an Australian medical technology company should review its contractual arrangements to ensure that overseas entities undertake to comply with the APPs, and that overseas entities indemnify them in the event of breaches, before the Australian company releases personal information offshore.

Key takeaways

A medical technology company seeking to use health information for research and development purposes should:

  • be mindful of the obligation to obtain an individual's consent to use their health information for such purposes, and ensure consent is appropriately obtained
  • consider whether health information can be suitably de-identified for use in research and development, which includes assessing the risk of re-identification, and
  • ensure its contractual arrangements with overseas parties include undertakings for those parties to comply with the APPs and to indemnify the Australian company for any breach, before transferring any health information to those overseas parties.


1 OAIC, Australian Privacy Principle Guidelines (1 April 2015), paragraph B.34.
2 Ibid, paragraph B.92.
3 OAIC, Privacy business resource 4: De-identification of data and information (April 2014).

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.