Can I see the code?
Karen Sandler (Executive Director of the GNOME Foundation) was diagnosed with a hypertrophic cardiomyopathy, which greatly increases the probability of death from heart problems some time ago. She was recommended to implant a cardiostimulator. Karen got very curios and asked a few questions such as: “What kind of the software is running in it? Can she take a look at the code, before she will trust it with her life?”, but no one could give her clear answers.
It turned out that all medical devices get certified by FDA organization (Food and Drug Administration) in the USA, which has never conducted the review of source code until some problem may happen to the device’s software. Instead, FDA relies on the manufacturer's report, which includes all the information about it. In addition, this document meets the general standards that are required in this case.
All this is explained in the following way: each medical device is unique, FDA simply cannot work out some general requirements for all devices without missing something important, and as well it cannot make such rules for each device separately, because it is too long and expensive. In addition, FDA is not familiar with the hardware device technology that is created at the level of its manufacturer, therefore, only the maker can decide how software should be built, what tests it must pass, and so on.
We all know that any software contains bugs. According to the Software Engineering Institute every 100 lines of code include one bug on the average. How many lines are in the cardiostimulator software? Studies show that 98% of the device failures happen due to bugs in the software, and on the other hand they could be easily avoided with the proper level of code testing. Lack of required tests, code reviews and other quality assurance mechanisms are leading to the deaths of people, and there is not any legal mechanism to struggle against it.
Karen’s idea is very simple. The role of software has changed in our lives. From simple tasks such as text editing or gaming, the modern software has grown to something that greatly affects all aspects of our lives. So, we should have the free access to the software code in order to prevent something that could be irreparable.
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