There was an unprecedented uptake of digital technology in 2020 in the healthcare sector, and 2021 is expected to be no different. In creating these technologies for the healthcare sector, developers should ensure that all applicable regulatory requirements are complied with.
In Australia, software may be regulated by the Therapeutic Goods Administration (TGA) as a medical device if it falls within the definition of “medical device” as set out in section 41BD of the Therapeutic Goods Act 1989 (Cth). Further, from 25 February 2021, changes to the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) will come into effect which seek to clarify some existing requirements around the regulation of software-based medical devices, and introduce new requirements. We provide an update about these changes below.
Software-Based Medical Devices
The definition of “medical device” includes software that is intended to be supplied to be used by a person for one or more of the following purposes:
- the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
- the diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
- the investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
- the control or support of conception.
Based on a strict reading of this definition, a large number of software-based products may be captured and regulated as medical devices.
In order to clarify the boundaries for the regulation of software-based products as medical devices in Australia, to ensure that Australia is aligned with international regulatory frameworks where appropriate, and to reduce or remove unnecessary regulatory burden, including by not regulating products where there is no significant risk to safety, from 25 February 2021, certain software-based medical devices will be either exempted or excluded from the scope of regulation by the TGA.
Exempted software will include certain clinical decision support systems, and the application of the exemption will depend on a number of factors, including the intended purpose and functionality of the systems.
Excluded software will include:
- Consumer health products for prevention, management and follow up that do not provide specific treatment or treatment suggestions (e.g., wearable technology that tracks heart rate for fitness);
- Enabling technology for telehealth, healthcare or dispensing (e.g., software that facilitates telehealth consultations). Although the technology that facilitates telehealth may not be regulated by the TGA, telehealth is nevertheless otherwise regulated in Australia. For more information regarding the Australian position on telehealth regulation and the regulation of telehealth around the world, please see our Global Guide on Telehealth;
- Digitisation of paper-based or other published clinical rules or data (e.g., software that replicates paper-based mental health assessments in electronic format);
- Population based analytics (e.g., software that analyse statistics of a group or population); and
- Laboratory information management systems and laboratory information systems (e.g., software that enables laboratories to automate workflows and manage samples).
New Classification Rules
From 25 February 2021, new classification rules for software-based medical devices will also come into effect. Depending upon the intended purpose of the software, the risks the software poses to individuals and public health, and the audience of the information provided by the software (healthcare professional or patient), the software can be classified as either Class I, IIa, IIb or III. The higher the classification of the device, the higher the level of regulatory scrutiny.
More information regarding the new classification rules can be found on the TGA website at https://www.tga.gov.au/resource/regulatory-changes-software-based-medical-devices.
Finally, there will be amendments to the Essential Principles for medical devices, which set out the fundamental design and manufacturing requirements for medical devices and must be complied with, that will come into effect on 25 February 2021.
Relevant to software-based medical devices, Essential Principle 12.1, which currently requires a medical device incorporating an electronic programmable system to be designed and produced in a way that ensures its performance, reliability and repeatability are appropriate for its intended purpose, and any consequent risks associated with a single fault condition are minimised, will be amended to clarify existing requirements on data management and cyber security.
Essential Principle 13.2(3) relating to how information may be provided with medical devices will be amended to allow such information to be provided electronically.
Lastly, a new Essential Principle 13B will be introduced requiring the current version and build number for the software to be made accessible and identifiable to users of software-based medical devices. This information must be in English but may also be displayed in other languages.
For more information regarding the regulation of medical devices and telehealth in Australia, please contact Greg Bodulovic (Partner) and Stephanie Wang (Senior Associate).