The Australian Therapeutic Goods Administration (the TGA) has finally published long-awaited cyber security guidance targeted specifically at: manufacturers developing software for use in medical devices, including artificial intelligence; manufacturers of medical devices which include components susceptible to cyber-based threats; and medical device sponsors in Australia. Further information, including the guidance…
Regulators around the world are increasingly starting to acknowledge that conventional approaches to regulation may act as an impediment to digital innovation in healthcare and are looking to modernise health regulation.
On 19 October the Privacy Amendment (Notifiable Data Breaches) Bill 2016was introduced into the House of Representatives. If passed, the new law will require entities subject to the Privacy Act 1988 (Cth) to notify data subjects and the Information Commissioner of an “eligible data breach”.
The Australian Privacy Commissioner has released a joint report with the Privacy Commissioner of Canada regarding the data breach in 2015 that occurred to a dating website operator’s system