SFLC Wants To Avoid Death by Code

foregather writes "The Software Freedom Law Center has released some independent research on the safety of software close to our hearts: that inside of implantable medical devices like pacemakers and insulin pumps. It turns out that nobody is minding the store at the regulatory level and patients and doctors are blocked from examining the source code keeping them alive. From the article: 'The Food and Drug Administration (FDA) is responsible for evaluating the risks of new devices and monitoring the safety and efficacy of those currently on market. However, the agency is unlikely to scrutinize the software operating on devices during any phase of the regulatory process unless a model that has already been surgically implanted repeatedly malfunctions or is recalled. ... Despite the crucial importance of these devices and the absence of comprehensive federal oversight, medical device software is considered the exclusive property of its manufacturers, meaning neither patients nor their doctors are permitted to access their IMD's source code or test its security.'"

Comments

this is Surprising?

[querky]

the software running your pacemaker is probably patented too!

So what

[clarkkent09]

Does a government agency examine the source code which keeps airliners in the air, cars on the road, nuclear plants from blowing up etc etc? If the government is going to evaluate and approve every important piece of code line by line we will pretty soon run out of programmers. But then, chip designs will have to be evaluated too because they can fail as well. Next, mechanical designs, engines, turbines, reactors, better make sure that the government is stocked with experts in all those fields too.

After all, nothing can possibly be safe until it is certified as such by the government. Just ask hundreds of thousands of people who died while the drugs that could have saved them were waiting for the FDA approval. They are pretty safe now.