This Is A Useful Major Review Of Just Where Digital Health Is In Australia. Valuable Stuff I Believe!

This appeared last week:

Digital Health in Australia: 2021

Gilbert + Tobin

Australia, Global, USA January 22 2021

Market overview and transactional issues

Key market players and innovations

1.       Who are the key players active in your local digital health market (eg, healthcare providers, research partners, government and academic institutions and investors) and what are the most prominent areas of innovation?

Key players include:

• the Australian government (funds 42 per cent of all health services, including 78 per cent of research), especially the Department of Health, the Therapeutic Goods Administration, the Medical Research Future Fund (MRFF) and the Australian Digital Health Agency (ADHA), which is responsible for the National Digital Health Strategy and operates MyHealth Record;
• state and territory governments (fund 27 per cent of all health services), which among other things operate Australia’s public hospitals, including emergency departments and ambulance services;
• private healthcare businesses, including operators of private hospitals, day surgeries, primary and referred care clinics and imaging and pathology services;
• healthcare professionals;
• developers and suppliers of digital heath systems;
• private health insurers (fund 9 per cent of all health services);
• venture capital and private equity funds;
• academic institutions, especially the Commonwealth Scientific and Industrial Research Organisation and universities;
• a range of cross-sector innovation and commercialisation bodies, including ANDHealth, the Digital Health Cooperative Research Centre and MTPConnect; and
• industry associations, including the Medical Software Industry Association, the Medical Technology Association of Australia and the Australasian Institute of Digital Health.

The industry has delivered innovations across both infrastructure and capabilities, with the key publicly funded innovation being the launch of MyHealth Record, an online platform that aggregates an individual’s key health information and provides interoperability between clinical information systems across the health sector. It is estimated that 65 per cent of public hospitals have deployed electronic medical records (EMR) systems, with an 85 per cent deployment rate in the most populous state, and most states and territories have strategies for further deployment of electronic health records, including medical imaging systems, medication management systems (eMeds), patient administration systems (PAS) and laboratory information systems (LIS).

Key areas of focus include telehealth and virtual health services (including for mental health and aged care), AI, interoperability, health informatics, and e-referral and booking capabilities.

The covid-19 pandemic has been a catalyst for accelerated investment in digital health and greater coordination between governments and between private and public sector participants. The Australian government estimates that it delivered 10 years of reform in 10 days with the introduction of whole-of-population access to telehealth under Medicare.

Investment Climate

2.       How would you describe the investment climate for digital health technologies in your jurisdiction, including any noteworthy challenges?

Participants in the healthcare industry (government and private) are increasing their adoption of digital health technologies in order to improve health outcomes, meet the needs of their stakeholders and respond to various health system issues (eg, increasing rates of chronic conditions, emphasis on prevention, management and in-home care, focus on value-based healthcare, declines in private health insurance, crisis in aged care, inequality in access to health services, hospital waiting times and budget pressures). Over the past decade, the private health sector has led the developments in the digital health industry. However, federal, state and territory government-funded investments have significantly increased over the past few years. The covid-19 pandemic, the 2019–2020 bushfires, the Royal Commission into Aged Care Quality and Safety and the Productivity Commission’s report into Mental Health have all accelerated appetite for investment in digital health technologies.

However, the key challenge in the Australian digital health industry remains funding and access to capital to drive commercialisation of innovations. This has been particularly relevant in respect of foreign investment given recent temporary restrictions implemented in the Australian foreign investment regime in response to the covid-19 pandemic. However, several such restrictions are anticipated to fall away on 1 January 2021.

There are pages and pages more at this link:

https://www.lexology.com/library/detail.aspx?g=3c1783e8-7c39-4f03-a191-f944658ec92e

This – very long document – provides a excellent outline of the commercial, legal and IP environment within he Australian Digital Health environment as I reckon is mandatory reading for any who plan to operate in the sector.

I passing Gilbert and Tobin (G+T) have produced to much shorter document recently.

See here:

At a glance: data protection and management of health data in Australia

Gilbert + Tobin

Australia January 6 2021

Data protection and management

Definition of `health data'

What constitutes ‘health data’? Is there a definition of ‘anonymised’ health data?

Health data includes:

·         information or an opinion about an individual’s health or any health services provided, or to be provided, to the individual;

·         any personal information collected to provide or in providing a ‘health service’ to an individual (including organ donation); and

·         genetic information about an individual that is in a form that could be predictive about the health of an individual (or relative of the individual).

The concept of ‘providing health services’ is very broad and can capture a range of services that may not be front of mind when thinking about health – for example, information collected by a gym on an individual in connection with a gym class, or Medicare billing information held by an insurance provider or debt collector.

Anonymised health data is not defined, although the Australian Privacy Principles (APP) Guidelines state that ‘anonymity’ means that an individual dealing with an entity cannot be identified. Critically, health data that may be anonymous in the hands of one entity may not be anonymous in the hands of another. The ability of an entity to link a data set with other information is relevant to whether data is truly anonymised.

Data protection law

What legal protection is afforded to health data in your jurisdiction? Is the level of protection greater than that afforded to other personal data?

Given the sensitivity of health information, its collection, use and management is regulated by the Privacy Act.

Health data is treated more strictly than personal information under the Privacy Act. Health data is a subset of ‘sensitive information’ and consent is required for its collection.

Generally, an organisation can collect health data from a person if:

·         the person provides their consent (express or implied); and

·         the information is reasonably necessary for the organisation’s activities.

Implied consent arises when consent can be inferred from the circumstances and conduct of the person providing the health information. This is a higher test than that imposed on other personal information.

APP 11 requires entities to take reasonable steps to protect personal information (including sensitive information, such as health information) it holds from misuse, interference and loss, and from unauthorised access, modification or disclosure. According to the Office of the Australian Information Commissioner (OAIC)’s APP Guidelines, ‘reasonable steps’ will depend on the circumstances in each particular case and may include governance, culture and training, internal practices, procedures and systems, ICT security, access security, and destruction and de-identification.

In addition, the handling of health information is also subject to certain state-based legislation, which differs from the Privacy Act in some aspects, but the differences are relatively minor.

Vastly more here:

https://www.lexology.com/library/detail.aspx?g=0f16f60d-811f-4f3b-bb5f-df9f7cebb2e2

and also here:

At a glance: intellectual property for digital health in Australia

Gilbert + Tobin

Australia January 6 2021

Intellectual property

Patentability and inventorship

What are the most noteworthy rules and considerations relating to the patentability and inventorship of digital health-related inventions?

Patentees of digital health-related inventions, which often require computer implementation in one form or another, need to navigate the patentability requirement in Australia. While abstract ideas and computer-implemented inventions are not regarded as patentable subject matter in Australia, patents directed to other aspects of digital health-related inventions such as hardware, telemetry and diagnostic tools may be patent-eligible.

Patent prosecution

What is the patent application and registration procedure for digital health technologies in your jurisdiction?

The Australian patent system provides the same application process across all technologies, including digital health. There are no specific provisions for digital health technologies. IP Australia (incorporating the Australian Patent Office) is responsible for pre-grant examinations, pre-grant oppositions, re-examinations and amendments to patents and patent applications. As in other jurisdictions, the process of filing to grant can take more than 18 months.

For patentees looking for a faster filing-to-grant process, Australia has a unique patent protection system in the form of innovation patents (until they are phased out – the last opportunity to file is 25 August 2021). Innovation patents confer the same exclusive rights as standard patents, and the remedies for infringement are also the same (that is, injunction and monetary relief). Innovation patents last for eight years and are similar to the utility model in other jurisdictions. For a patentee, an innovation patent may be especially advantageous because it can be granted quickly (there is no capacity for pre-grant opposition in the context of innovation patents). Further, as there is no ‘inventive step’ hurdle as there is with standard patents, so long as the invention at issue is materially different to relevant prior art, it can be obvious, which may be significantly less burdensome to the patentee. Together, these features mean that the innovation patent as a mechanism has been a particularly useful form of patent protection for many digital health technologies, which tend to operate in a rapid innovation environment.

More here:

https://www.lexology.com/library/detail.aspx?g=0fd44da4-d417-4181-bfb8-c4e3fb5cb7f0

There is a lot of good reading here – so dive in!

David.

Disclaimer: I have no affiliation with G+T other than knowing personally some of their present and past lawyers. D.