National Health Law Bulletin – April 2021

29 April 2021

We are delighted to welcome you to the HWL Ebsworth Health Law Bulletin.

The health law practice of HWL Ebsworth is one of the premier legal service providers to the Australian health industry, dedicated to assisting clients with all aspects of their legal needs. Within the national practice group we have a team of partners and lawyers who have market-leading expertise in all aspects of health law and policy including assisting health practitioners and public and private health facilities in civil claims, disciplinary proceedings and coronial inquests and providing advice on regulatory and compliance issues such as clinical governance, privacy, Medicare and ethics. Our team also has extensive experience with advising on clinical protocols, medical practice management and industrial relations as well as providing corporate and commercial advice to health industry participants.

As part of our focus on the health industry, our bulletin addresses a range of topics designed to provide you with an insight into legal and other developments across the nation.


A snapshot of AHPRA’s recent changes and updates

The Australian Health Practitioner Regulation Agency (AHPRA) is the organisation responsible for implementing the National Registration and Accreditation Scheme in Australia.  More recently, we saw some important updates from the regulatory body.

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Cyber incidents in the health sector – what should you do if a cyber incident occurs?

February 2021 marked the three year anniversary of the introduction of the Notifiable Data Breaches Scheme (NDB Scheme) in Australia. This milestone is an important reminder for health service providers to familiarise themselves with their privacy and cyber security obligations.

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Commonwealth Government consulting ahead of changes to Privacy Act

The Commonwealth Government is currently consulting with the public in relation to potentially broad changes to Australia’s key piece of privacy legislation, the Privacy Act 1988 (Cth) (Act). Any changes to the manner in which personal information can be handled will be relevant to businesses with health or medical information; however there is also the potential for amendments with respect to specific health matters.

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Can an opinion provided by a medical practitioner within an expert report, for the purposes of court proceedings, be subject to a conduct complaint?

The NSW Court of Appeal considered an application for judicial review of the Health Care Complaints Commission’s (HCCC) decision to not take further steps in relation to a complaint made against a psychiatrist arising from his diagnosis of a delusional disorder within an expert report. The Court of Appeal dismissed the application seeking leave to appeal.

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Nouri v Australian Capital Territory – end of the road for wrongful birth case

The High Court of Australia has refused an application for special leave to appeal from the decision of the ACT Supreme Court Court of Appeal in Nouri v Australian Capital Territory [2020] ACTCA signalling an end of the road in this wrongful birth case.

On 26 November 2018, Justice Elkaim found against the plaintiffs on the basis that although they had established negligence on the part of the defendants, the plaintiffs failed to establish causation. Crucially, they failed to prove that they could have terminated the pregnancy at 30 weeks had they known of the foetus’ medical condition.

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Medicare v Professional Services Review – What is the difference?

Medicare is the public health insurance scheme which is implemented by providing subsidies for medical treatment via the Medicare Benefits Scheme (MBS) and the Pharmaceutical Benefits Scheme (PBS). It is part of the Commonwealth Health Department.

Medicare routinely audits the claims made by doctors under both the MBS and PBS. Where there has been non-compliance, Medicare will usually require repayment of benefits directly from the practitioner who holds the relevant provider number.

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Obligations to notify APHRA

Do you know what your professional obligations are if you were convicted of an offence punishable by imprisonment? Or what if your Medicare billing privileges were restricted?

Many health practitioners are not aware of their legislative obligation to notify the Australian Health Practitioner Regulation Agency (AHPRA) when a relevant event occurs as required under Section 130 of the Health Practitioner Regulation National Law (NSW) (National Law).

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Case Review: Medical Board of Australia v Arulanandarajah [2021] VCAT 85

The case involves a finding by the Victorian Civil & Administrative Tribunal (The Tribunal) that Dr Arulanandarajah engaged in professional misconduct when he sexually assaulted a co-worker whilst in a drunken state after celebrating his 35th birthday.

The Tribunal reprimanded and suspended Dr Arulanandarajah’s registration for a period of three months.

The decision involved a determination as to whether the conduct amounted to professional misconduct

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Changes to regulation of software-based medical devices

Through rapid advances in computing technology, software has expanded from our personal devices and televisions, and into our medical devices. Software products can now inform, drive, and even replace clinical decisions and directly provide therapy to individuals, drastically changing their risk profiles in medicine and healthcare.

To better address such use of software in the field and align Australia’s regulatory position with international guidance and the European Union position, regulatory requirements specific to software-based medical devices have been incorporated in the Therapeutic Goods (Medical Devices) Regulations 2002 (Regulations).

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