Can i see the code?

Some time ago, Karen Sandler (Executive Director of the GNOME Foundation) was diagnosed with Hypertrophic cardiomyopathy , which, if not taken into medical details, significantly increases the likelihood of death from heart problems. She was recommended the installation of a pacemaker. Feeling legitimate curiosity, Karen asked what kind of software worked in him and if she could look at his code before entrusting him with his life. After many shrugs, confused looks and translations of arrows, the cat was finally taken out of the bag.

It turned out that all medical devices ( in the USA? ) Are certified by the FDA(Food and Drug Administration), which never reviews the source code until there is some problem with the device that is clearly related to the software. Instead, the FDA relies on the manufacturer’s report, which, of course, can say anything. In addition to the general standards for text formatting, there are no special requirements for this document.

This is explained as follows: each medical device is unique, the FDA is simply not able to develop some general requirements for all devices without missing something important, and creating such rules for each individual device is too long and expensive. Also, the FDA, of course, I’m not familiar with the hardware device of the equipment being created at the level of its manufacturer, which means that he (and only he) can decide how the software should be built, what tests it should pass and when it should be recognized as fit for installation in real devices .

We all know that any software contains bugs. Software Engineering Institute says the average is 1 bug for every 100 lines of code. How many lines are there in a pacemaker software? Studies show that 98% of such device crashes that happen due to software bugs could easily have been avoided with the proper level of code testing. The lack of necessary tests, code review and other quality assurance mechanisms leads to deaths of people and there is no (or almost no) legislative mechanism to combat this.

The thought of Karen is simple. The role of software in our lives has changed. From simple tasks such as editing text or games, modern software has grown to something that significantly affects all aspects of our lives, right up to the very fact that we have it. So, we must have freedom of access to the code of such software, so as not to let it commit irreparable on time.