Medical devices, such as pacemakers and insulin pumps, are increasingly utilising software to enhance their functionalities. Yet, this advancement raises concerns about the transparency and safety of the code running in these devices. Patients have no way of knowing what code is operating inside their bodies, a situation that has sparked a debate about the right to access and examine this code.
The medical device industry argues that the intricacy of the code and the potential for misuse makes it unsafe for patients to have access. On the other hand, patient advocates contend that they should have the right to know what is running inside their bodies, particularly given the increasing number of cybersecurity threats.
In the United States, the Digital Millennium Copyright Act (DMCA) prohibits unauthorised access to copyrighted software, including medical device code. However, the US Copyright Office has granted a three-year exemption for researchers to examine the software in medical devices, a move seen as a step towards greater transparency.
The debate is far from over, with both sides presenting compelling arguments. As medical device software continues to evolve, so too will the discussion around the transparency and accessibility of the code that powers it.
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