Medical Device Manufacturers Sue Library of Congress Under DMCA Exemption

Shannon Flynn

Shannon Flynn is a freelance blogger who covers education technologies, cybersecurity and IoT topics. You can follow Shannon on Muck Rack or Medium to read more of her articles.

The right to repair is a contentious topic that has spent a lot of time in the news over the last couple of years. Consumers believe they should have the right to repair devices they own, while many manufacturers contest this. When discussing repairing an automobile or a smartphone, the law should side with the consumer – but where does the right to repair fall when dealing with medical devices?

A new lawsuit brought against the Library of Congress by a trade association of medical device manufacturers could change how DMCA gets applied moving forward.

DMCA Section 1201 and the Triennial Review

Congress passed the Digital Millennium Copyright Act (DMCA) in 1998. It has evolved into a seemingly comprehensive tool for copyright protection in the intervening decades. Unfortunately, people have found ways to exploit it. Many of its sections and processes operate contrarily to one another, making it difficult for even those versed in DMCA law to keep track of all the potential loopholes and exploits.

On paper, Section 1201 of the DMCA seems like a straightforward process to prevent the law from being circumvented. Section 1201 explains that attempting to “circumvent a technical measure” would also be considered copyright infringement in very broad terms. It also creates a tool for people to obtain exemptions to this section of the DMCA. Every three years, people are allowed to apply for exemptions.

2021 provided the latest opportunity for exemption applications. Some of the approved exemptions included an expansion on an exemption from six years ago which allowed for the circumvention of technological protection measures (TPMs) on medical devices. The initial exemption limited this sort of circumvention to partially or wholly implanted devices, but petitioners in 2021 sought to expand the exemption to include any medical devices.

For medical professionals, this exemption makes a lot of sense. It allows medical professionals to access data on their patients’ devices, regardless of any TPMs in place. The medical device industry doesn’t see it that way.

Medical Device Manufacturers vs. the Library of Congress

In response to the expansion of the exemption, medical device trade associations launched a lawsuit against the Library of Congress. This suit claims the exemption puts patients at risk, leaving the door open for cyberattacks that could compromise the integrity of medical devices.

The suit goes on to explain that, whether the Library of Congress was acting as an executive agency or not, the exemption violates the separation of power principles as outlined in the Administrative Procedure Act (APA).

To an outside observer, the whole situation is a bit of a mess. Some argue that because medical device manufacturers are already locking down their devices with TPMs, thus using DMCA to block any competition or competitive services, the manufacturers are abusing copyright law for their own ends.

These exemptions are simply calling them out on their abusive practices. But when someone brings it into the light, they respond by bringing a lawsuit against the Library of Congress.

Looking Forward

Currently, the medical device trade associations that brought the lawsuit against the Library of Congress are waiting to respond to their request for summary judgment, while the government has responded by requesting the option to file a motion to dismiss the case. It may be some time before any results emerge. If the medical device manufacturers come out victorious, it could set a dangerous precedent.

Giving industries the ability or incentive to sue to have these exemptions overturned could allow companies across the country to exploit a loophole in DMCA and copyright laws to lock their competitors out of the marketplace actively. This lawsuit could impact how Section 1201 of the DMCA is used moving forward. For anyone who owns the intellectual property in a competitive industry, this is a scary thought.


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