Bio-Hacking & The Law.
Pacemaker Cybersecurity Risk Prompts Calls for TGA to Lose Litigation Immunity.
In the wake of a massive recall of pacemaker devices in the US, Australian personal injury lawyers are considering how the TGA (Therapeutic Goods Administration) is to be accountable for the therapeutic goods that gain access to the Australian market.
Currently the TGA is immune to litigation or any civil action for the products and devices that are allowed into the Australian market. Learn more This raises concerns amongst the medical and legal professions alike as to how fit the TGA is to assess the new wave of medical devices that are wirelessly accessible.
The TGA currently licences medical manufacturers to produce and market medical devices on Australian soil. The fees from the manufacturing licences fund the activities of the TGA, the scope of the licence allows the TGA to investigate the manufacturer and the devices or goods that are being produced. However if the TGA licences a device to be marketed in Australia that has a flaw or defect they are immune to prosecution on regulatory failure.
As medical devices become increasingly connected through wireless systems the risk of hacking these devices is on the increase. Australians who are affected by malfunctioning medical devices or implants can still take civil action against the manufacturer. Large civil suits such as the Dow Corning class action [The Age] on breast implants are still possible, however these proceedings are often drawn out and difficult often due to international law.
Quantum Computers Explained
With the rise of quantum computing cyber security fears [Link] the TGA must be able to accurately predict whether wireless medical devices will be vulnerable to the next wave of computing. Should the TGA fail to vet incoming technology effectively it could lead to thousands of Australians vulnerable to biohacking.
The legal ramifications of failure to stop defective medical devices sold in Australia could be far reaching. We are left with the pertinent question. Is the TGA willing to shoulder responsibility for decisions made under its auspice? Is divorcing the TGA from the governmental umbrella that currently shields it give consumers recourse should those decisions be negligent?