Is Healthcare Software a Medical Device?

With the increased prevalence of software aimed at improving day to day health, diagnosing illnesses and treating medical conditions, there has been a recent focus on developing regulations to address new types of medical devices.

When is software a medical device? 

In Australia the Therapeutic Goods Administration (TGA) regulates health related software that is a medical device as defined in section 41BD of the Therapeutic Goods Act 1989 (Cth) as follows:

“Any instrument, apparatus, appliance, material or other article (whether used alone or in combination, including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:

    1. Diagnosis, prevention, monitoring, treatment or alleviation of disease;
    2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
    3. Investigation, replacement or modification of the anatomy or of a physiological process; and
    4. Control of conception”

medical indemnity insurance Australia

Don’t be confused, Tego Insurance is here to help

Tego as your medical indemnity insurance providers are experts at understanding the intricacies of Software as a Medical Device (SaMD), and what SaMD means for your business. We all know that technology is significantly changing the delivery of health care in Australia. There is software for all forms of healthcare, from diagnosis to treatment.  

For example- Software that may assist in processing X-ray images or an app that assists patients in making a diagnosis would be considered a medical device and is regulated by the TGA. Let the team at Tego Insurance help you with medical indemnity insurance, medical practice insurance, medical malpractice insurance and more. 

How is software as medical device regulated?

The regulation of SaMD, like the regulation of most technologies, is struggling to keep pace with the ongoing influx of new and updated SaMDs. The current regulation of SaMDs by the TGA is centred on a risk based approach under the Australian Regulatory Guidelines for Medical Devices (Guidelines). As the current Guidelines do not cater to the unique characteristics of SaMDs, many of these medical devices are considered low risk by the TGA.

“In accordance with the Guidelines, all SaMDs are required to be registered on the Australian Register of Therapeutic Goods. In order to be registered the following criteria must be met:

  • Manufacturers of SaMD products must obtain a Conformity Assessment certificate, unless the SaMD is categorised in the lowest risk classification; and
  • The SaMD must satisfy the TGA’s Essential Principles under the Therapeutic Goods Act (Cth) and the Guidelines.”

“The TGA’s Essential Principles, amongst other things, include requirements regarding the safety, purpose, design, construction and transport of medical devices. Following registration on the Australian Register of Therapeutic Goods there are also additional obligations that will be imposed on owners of SaMDs such as the recently introduced Therapeutic Goods Advertising Code (No. 2) which came into effect on 1 January 2019.”

In conclusion 

If you are unsure if your software or app is an SaMD,  the Tego Insurance team with experts in medical indemnity insurance Australia and medical indemnity insurance costs  can provide tailored advice about your duties and obligations and assist you with any future steps. Ultimately it is a matter for each practitioner to decide whether a technology-based model is clinically appropriate.

The Tego Insurance team specialises in technology and health care. If you would like specific advice about your circumstances, please contact us! Tego Insurance offers medical indemnity insurance for medical practitioners. We have a profound understanding of the Australian medical profession and the ever-changing healthcare industry. It’s this expertise that allows us to provide leading cover with more choice, innovation and greater flexibility.

This publication is general in nature and is not comprehensive or constitute legal or medical advice. You should seek legal, medical or other professional advice before relying on any content, and practice proper clinical decision making with regard to individual circumstances. Persons implementing any recommendations contained in this publication must exercise their own independent skill or judgment or seek appropriate professional advice relevant to their own particular practice. Compliance with any recommendations will not in any way guarantee discharge of the duty of care owed to patients and others coming into contact with the health professional or practice. Tego Insurance Pty Ltd is not responsible to you or anyone else for any loss su­ffered in connection with the use of this information.