So why is the medical device lobby suing the Library of Congress?

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来源: FierceBiotech

In 2021, the Library of Congress exempted independent service providers from copyright laws that would have barred them from accessing restricted software and manuals necessary to repair sophisticated medical devices, such as CT and MRI machines or surgical robots.

It turns out the U.S. Library of Congress isn’t just the country’s oldest federal cultural institution, nor simply the home of a lovely Beaux-Arts reading room on Capitol Hill. The 223-year-old library has also, in the past decade, become a battleground over the right to repair.

The issue that found its way into the appeals court of the D.C. circuit this week starts as far back as 1998, with the passage of the Digital Millennium Copyright Act (DCMA). Among other things, the DMCA made it a crime to circumvent digital protections designed to limit access to a copyrighted work—such as data encryption, password locks and other means. This, ultimately, can include connecting with the custom software that helps operate an MRI machine, for example.

However, the DMCA also granted authority to the Library of Congress to set exceptions to that rule by working with the U.S. Copyright Office—and it has done so, notably in 2015, when the library said researchers could legally access implanted medical devices and examine their software for potential cybersecurity flaws as well as to allow patients to access the data generated by their implants.

In October 2021, in the midst of the COVID-19 pandemic, the library put forward another series of exceptions (PDF), including one that would allow third-party service providers to access the copyrighted firmware and instruction manuals for high-tech medical devices so that they could diagnose a malfunction or provide maintenance and repair.

Enter the Medical Imaging and Technology Alliance (MITA), a division of the National Electrical Manufacturers Association that represents dozens of medtech companies, including the makers of CT, MRI and ultrasound scanners, as well as the developers of other types of diagnostic equipment. They were joined in a lawsuit by AdvaMed, the trade association for the broader medical device industry.

The two groups first sued the Library of Congress and its chief Carla Hayden, the librarian of Congress, in February 2022, claiming that the software protections employed by medical device manufacturers are essential to safeguard patients and their privacy—and that the library’s rule would allow independent service providers to simply “piggyback” off the work done by the device’s original developers.

Moreover, they said the Library of Congress had run afoul of the laws that restrict how government agencies may propose regulations.

Though the Library of Congress has long been seen as a part of the government's legislative branch, MITA and AdvaMed contended that the library was acting as part of the executive branch when it put forward exemptions—and would therefore have to follow the rules of the Administrative Procedure Act (APA), which requires agencies to take public comments through the Federal Register and wait before regulations go into effect.

Because the library didn’t do so, they claimed the move violated the Constitution’s separation of powers and that the entire exemption should be tossed out.

But when MITA and AdvaMed’s complaints were heard in D.C. federal court earlier this year, they were denied. The district court said this past March that the librarian of Congress did not exceed her authority and that the library’s actions are ultimately exempt from the requirements of the APA.

Today, the medical device lobby’s appeal was heard in the Court of Appeals for the D.C. circuit, with about a half-hour of oral arguments focused solely on the rulemaking authority of the Library of Congress and whether it should be treated as a member of the executive or legislative branch. Indeed, medical devices, imaging machines, surgical robots or repairs of any kind were not mentioned by either side or the court’s panel of three judges.

The attorney representing MITA and AdvaMed described the Library of Congress as a unique fixture in government that at times has functioned as part of the legislature and at others as part of the executive branch—and that with its feet in both branches of government, it would fall under the APA when exercising its rulemaking authority.

The lawyer for the U.S. government, meanwhile, said the APA defines what constitutes an agency on an entity-by-entity basis and that the entirety of the Library of Congress’ actions should determine where it lands—and, specifically, that the appeals court had previously ruled that the library is not an agency subject the APA.

The judges’ opinion in the case is pending.

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