Hacker News Reader

Do most medical device manufacturers carry insurance against lawsuits? If so, historically, how high has the bar been before the insurers pay out? If there is a strong relationship between a device manufacturer getting sued and an insurer losing money then this could be a great contact to try.

View on HN

Yes, but more importantly, medical device makers have broad immunity when their devices go through the PMA process (the most stringent type of FDA approval). Basically, the argument is "hey, the FDA said it was safe".

Then this is where the pressure needs to be applied - at the certification process. It needs to be made a legal requirement to attain certification (if not already), and the certifiers need to follow best practices for vulnerability detection. And it needs to be an ongoing, open process.

Yes, the FDA certification should include something along the lines of "Manufacturer has an ongoing process to evaluate new vulnerabilities and push updates to affected individuals."

It does, at least for new approvals post ~2012. Doesn't help existing devices in the field though.

Reply on news.ycombinator.com