Regulating Medical Devices In The ‘Internet Of Things’

Any device that can collect its own data and communicate via a network is now part of the billions of gadgets collectively known as the Internet of Things (IoT).

In the Healthcare space, common uses include fitness products like FitBits, automated security systems and stock inventory. But we can be certain we are just beginning to see that health technology, especially IoT is advancing rapidly. With this emergence, issues arise around the adequacy of regulation which in turn is concerning healthcare professionals.

Tego Insurance, Your Medical Indemnity Insurance Provider

As medical indemnity insurance providers in Australia, we want you to know the latest about the state of technology and the healthcare industry. With the rapid growth of all kinds of IoT devices, it is important that you know the regulations or lack thereof that exist. We provide- 

  • Medical Malpractice Insurance 
  • GP medical indemnity Insurance
  • Medical Indemnity Insurance 
  • Doctors Indemnity insurance 
  • Medical Practice Insurance 
  • And more

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In Australia, software can be listed as a medical device if it undergoes a review of its safety and effectiveness by experts. The Therapeutic Goods Administration  (TGA) fee for a Class III device is around $A100,000. While it’s unknown exactly how many people are using DIY open-source technology in Australia, we know from the University of Melbourne study that it is being used by parents for their children.

The University of Melbourne, with collaborators from Royal Children’s Hospital and Diabetes Australia, are finalising a two-year research project exploring this issue.

They are investigating the perspectives and attitudes of key stakeholders including the healthcare professionals who provide care to children, parents who are using the new technology, lawyers, medical indemnity insurers and software developers.

Tego Insurance Wants You to Be be Up to Date

As medical indemnity insurance providers in Australia, we will cover your practice with medical indemnity insurance, medical malpractice insurance, doctors indemnity insurance, medical practice insurance, GP medical indemnity insurance, and more. If you are a health practitioner with Tego, your medical indemnity insurance comes with 24/7 medico-legal advice and support to guide you through the risks of telehealth and informed consent.

This publication is general in nature and is not comprehensive or constitutes 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. 

All content on this page has been written in a generic way, and has not been presented with any knowledge of your personal objectives or financial needs.