Background
In a first-of-its-kind trial, clinician-scientists from NUH and NUS Medicine leveraged Japan's first surgical robot to remotely perform a gastrectomy on a simulated organ at Nagoya, Japan, from a surgeon cockpit at the Advanced Surgery Training Centre at NUH.
The Singapore surgeons' movements were transmitted, directed and replicated by a robotic operation unit located in Japan via a dedicated international fiber-optic network.
This pre-clinical trial, involving a series of complex gastrectomy procedures conducted by both the Singapore and Japan teams, aimed to prove that long-distance robotic telesurgery for technically demanding procedures can be safely conducted using a robotic system connected by high-speed fiber-optic communication. The successful collaboration marks a critical step towards making remote surgeries an accessible option to patients in the near future.
Navigating the regulatory landscape
As the healthcare industry continues to innovate and unlock the potential of technology — recently with the increasing adoption of telemedicine and now, telesurgery — there will be legal implications.
Key issues to consider include the following:
- Which country's health regulatory laws would apply to the telesurgery?
- What qualifications must the surgeon have?
- Will the surgeons and/or healthcare service providers be required to obtain any licenses or registrations to perform the telesurgery? If so, from which country?
- Who will be held liable for any complications arising from the telesurgery?
- What are the data privacy considerations that may arise from the telesurgery?
- What are some ways to mitigate the risks and potential liabilities from telesurgery (for example, informed consent or disclaimers)?
- For manufacturers of the surgical robots, what are the applicable requirements for such apparatus?
- From a medical technologies perspective, will there be any issues regarding software as a medical device?
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