Australia: Major legislative changes to affect those managing health information – what does 2016 have in store?

Services: Corporate & Commercial, Intellectual Property & Technology
Industry Focus: Life Sciences & Healthcare

What you need to know

  • At the end of 2015, new legislation came into force which has brought a number of changes to the eHealth system.
  • At around the same time, the Government released for consultation a draft Bill to introduce a mandatory data breach notification regime that could be wide-reaching, and significant for all healthcare providers (whether they participate in the eHealth system or not).
  • Healthcare providers should ensure they are well informed about the recent changes to the eHealth regime, as well as the additional obligations they may soon face with respect to mandatory data breach notification.

As 2015 drew to a close, important legislative changes came into effect and future legislative changes were released for public consultation, all of which will have a significant impact on the way that healthcare providers handle health records.

Here are our thoughts about what the first months of 2016 will bring for healthcare providers in the areas of eHealth and mandatory data breach notification.

eHealth

The Health Legislation Amendment (eHealth) Act 2015 commenced on 27 November 2015. It amended a number of Acts which establish the eHealth system in Australia, most importantly the Personally Controlled Electronic Health Records Act 2012 (PCEHR Act), which is now the My Health Records Act 2012.

Background

The PCEHR system commenced in 2012. It allowed individuals to register for an electronic record which contained their health information, and for healthcare providers to upload and access the health information in that record.

The PCEHR system was an "opt in" system. Only 1 in 10 Australians voluntarily registered to use the PCEHR system.

The new My Health Records Act aims to increase participation and improve the implementation of the eHealth system.

What has changed?

1. A new name and new governing body

The PCEHR system has been renamed the "My Health Record" system. Replacing the National e-Health Transition Authority, the Australian Commission for eHealth (ACeH) will be responsible for the governance, operation and ongoing delivery of eHealth in Australia. ACeH will be more representative of the healthcare industry, and will include healthcare providers.

2. Move to an opt-out system

The Government is hoping to transition to an opt-out model, which means that each Australian will have a My Health Record unless they opt out.

To achieve this, the Government will commence opt-out trials in North Queensland and in NSW's Nepean - Blue Mountains region from mid-March 2016.

The Government will be able to implement the opt-out system nationally, without the need for any further legislation, if trial results support such a move. Before this occurs, there will be an independent evaluation of the trials and consultation between the Minister for Heath and the state and territory health ministers in 2017.

3. Participation agreements

To reduce the regulatory burden on healthcare providers, the registration process is simplified and participation agreements (between healthcare providers and the System Operator, the Secretary of the Department of Health), have been removed. As the issue of copyright in health records will no longer be covered by participation agreements, the Copyright Act 1968 (Cth) has been amended so that the sharing and use of health records in the eHealth system does not infringe any copyright in those health records.

4. New penalties

New criminal penalties and more severe civil penalties have been introduced. This new penalty regime is designed to better protect the sensitive information contained in the My Health Record, and to provide a graduated framework for responding to inappropriate behaviour and use of the My Health Record system.

Criminal penalties, including imprisonment, may be imposed for unauthorised collection, use or disclosure of information from the My Health Record system, where the person knows or is reckless as to whether the collection, use or disclosure is unauthorised. Potentially criminal behaviour will be referred to the Director of Public Prosecutions to make an independent decision about whether to pursue criminal penalties through the courts. Civil penalties include fines of up to $108,000 for individuals and $540,000 for corporations.

5. Mandatory data breach notifications

The mandatory data breach notification requirements under the My Health Records system now extend to include healthcare providers. Healthcare providers are required to provide a notification to the System Operator or Australian Information Commissioner (OAIC) if they become aware of unauthorised access to certain eHealth information.

Outside of the eHealth space, we may soon see even more changes with respect to mandatory data breach notifications, which we explore in more detail below.

Mandatory data breach notification

Mandatory data breach notification is a legal requirement for agencies and organisations to notify individuals when a breach of security leads to the disclosure of their personal information.

What are the current requirements?

Currently, mandatory data breach notification requirements only apply to healthcare providers that participate in the My Health Records (eHealth) system (as set out above).

Under the Privacy Act 1988 (Cth):

  • Australian Privacy Principle (APP) 11 requires entities to take reasonable steps to secure personal information they hold from misuse, interference and loss, and from unauthorised access, modification or disclosure
  • organisations are not required to notify individuals whose personal information has been compromised following a data breach
  • the OAIC does not have specific powers to deal with data breaches, and
  • the OAIC administers a voluntary data breach notification scheme, and has published guidelines about how organisations should manage data breaches and assess the risk of harm to individuals following a data breach.

What is going to change?

On 3 December 2015 the Australian Government released an exposure draft of its mandatory data breach notification bill: the Privacy Amendment (Notification of Serious Data Breaches) Bill 2015. Public consultation on this draft legislation will continue until 4 March 2016. Further information about making submissions is available here.

The proposed Bill will amend the Privacy Act to require entities bound by the Privacy Act to notify the OAIC and affected individuals of serious data breaches. Importantly, this will include healthcare providers other than those participating in the My Health Records system.

The key aspects of the regime proposed in the Bill are:

  • where there are 'reasonable grounds' to believe that a 'serious data breach' has occurred, entities must notify the OAIC and take reasonable steps to notify affected individuals
  • if an entity suspects but is not certain that a serious data breach has occurred, it has 30 days to assess whether notification is required
  • otherwise entities must notify as soon as practicable after they become aware or ought reasonably to have become aware of a serious data breach
  • a breach is "serious" if it gives rise to a "real risk of serious harm" to the affected individual
  • "harm" includes physical, psychological, emotional, economic and financial harm, as well as harm to reputation, and
  • if an entity fails to notify a serious data breach, the OAIC has discretion to direct the entity to provide notification, and to use its enforcement powers including imposing civil penalties of up to $1.7 million (for serious or repeated breaches).

Healthcare providers should watch this space

Importantly for health services providers, the Bill also provides that the Government may prescribe situations as serious data breaches which must be notified. The Explanatory Memorandum contemplates that this power might be used to protect "particularly sensitive information such as health records...which should be the subject to the highest level of privacy protection".

It is likely that in the future, if health records are compromised, the holder of those records must notify the OAIC and individuals affected, regardless of the risk of harm.

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 Mondaq.com.

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

Authors
 
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”

Mondaq Advice Centre (MACs)
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (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 www.mondaq.com

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 Mondaq.com’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.

Disclaimer

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.

Registration

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 unsubscribe@mondaq.com 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.

Cookies

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.

Links

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.

Mail-A-Friend

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.

Security

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 webmaster@mondaq.com.

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 EditorialAdvisor@mondaq.com.

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 enquiries@mondaq.com.

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