The Cyberlaw Clinic has filed a petition on behalf of a coalition of medical device researchers as part of the Copyright Office and Library of Congress’ rulemaking for exemptions to copyright’s anti-circumvention law. Every three years the Librarian of Congress, at the recommendation of the Register of Copyrights, considers exemptions to the general law against circumventing technological measures that prevent the public from accessing copyrighted works. These exemptions are granted in cases where the law against circumventing technological measures around copyrighted works unduly impedes on lawful uses of those works. (For more on anti-circumvention law, see the Chilling Effects FAQ.)
This petition (PDF) is filed on the behalf of researchers who study the security and effectiveness of implantable medical devices, including Hugo Campos, Jay Radcliffe, Karen Sandler, and Benjamin West. Each of these researchers studies the security and effectiveness of implantable medical devices, including pacemakers, implantable cardioverter defibrillators, insulin pumps, and continuous glucose monitors. This research sometimes requires researchers to reverse engineer these devices in order to study their source code and outputs, and the petition here seeks to make sure these researchers are allowed to do this even when the device manufacturers encrypt, password-protect, or require proprietary tools in order to access this information.
As the petition notes, this sort of critical security research and reporting is clearly a fair use of any copyrighted works a device manufacturer may own around these devices. Ensuring robust independent research into the security of these devices is also an essential part of how the public understands medical device safety, security, and effectiveness. Independent researchers in the past have shown how pacemakers can be susceptible to attacks from radio transmitters and how to fix it, how similar vulnerabilities exist with insulin pumps, and how greater patient access to device information can help improve therapy and treatment. Research like this has lead the U.S. Government Accountability Office to urge the Food and Drug Administration to devote more resources to studying the safety and security of devices, and the FDA in turn has begun examining the security of devices more critically as part of its approval process. As these devices continue to grow in sophistication and use, independent researchers will need to have a strong role in auditing their safety, security, and effectiveness. An exemption here will ensure that such research is allowed to continue.
The petition is available here, and was drafted by Clinical Fellow Andy Sellars with Cyberlaw Clinic students Evita Grant (HLS ’16) and Megan Michaels (HLS ’16). The Copyright Office will be hosting all petitions filed during this rulemaking on its website, and our friends at EFF have begun gathering these petitions here. After evaluating and consolidating these requests, the Copyright Office will later issue a notice of proposed rulemaking with all proposals the Copyright Office and Library of Congress will consider for this cycle, and the public will be invited to comment more of whether such exemptions should be granted.