With more and more advanced technology supplementing and, in some cases, supplanting traditional medical staff, one has to wonder just who is responsible when a high tech medical machine or computer program malfunctions.

The answer is somewhat complicated. In some cases, harm is caused by errors or negligence on the part of the medical staff. In other cases, as demonstrated in a string of radiation therapy accidents, the tools medical professionals use can be the root cause of injuries or deaths. In such incidents, the fault would lie with the manufacturer of the medical device. But now, with computer programs and Artificial Intelligence algorithms taking the place of traditional medical staff, finding the correct answer has become more difficult.

Another difficult to answer question is: who is even responsible for regulating the increased usage of software in medical treatments? According to an article at legalexaminer.com, the FDA will likely ultimately have the power to regulate AI usage in medical devices, but even then there are challenges and difficult classifications that will have to be made. Certain rules, like how to even track the reliability of AI software have yet to be written or finalized.

Whatever happens, the next few years will be interesting as rules and laws catch up to rapidly advancing high tech healthcare treatments.