|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.
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).
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.
- 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.
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.