Friday Dec 02, 2022

The Right to Repair of Medical Equipment is Not an IP Issue –


“Common sense tells us that illegal hackers are not waiting for legal access to repair documentation, nor that they would be in the least constrained by the threat of litigation for copyright violations.”

How does it make any sense that fixing something, which you bought and paid for, is a violation of the manufacturer’s copyright? It’s not, and here’s why.

Fixing things is legal under multiple sections of Copyright Law. Repair doesn’t modify books, music, videos or licensed software, so it’s absurd that copyright law is even being used to restrict repair.

The Section 1201 Exemption Process is Transparent

Apparently, the U.S. Copyright Office agrees. They recently granted a broad new set of exemptions to Section 1201 of the Digital Millennium Copyright Act (DMCA) for repair, including the repair of medical equipment.

A recent blog post by Peter Pitts, President of the Center for Medicine in the Public Interest, argues that the Copyright Office was wrong to exempt medical device repair from copyright peril under Section 1201 of the DMCA, writing:

The unintended consequence of the Copyright Office’s ruling [on the right-to-repair] is that what was once an illegal activity that was hard to track is now a legal activity that is hard to track and increases threats not only to patient safety but to patient privacy.

As declared above, this piece doesn’t argue points of copyright law, but rather of how Right to Repair as a legislative movement is dangerous and ill-conceived. Even if you agree with Pitts that manufacturers of medical equipment should be allowed a repair monopoly (which, it’s worth noting, the Food and Drug Administration [FDA] does not agree with [see p.  2, Executive Summary]), why should the Copyright Office be regulating repair of medical equipment at all?

17 U.S.C. § 1201 (known as “Section 1201”) is designed to protect copyrighted works from piracy and makes it a crime to bypass a digital lock set up to protect copyrighted content like music, video games or movies. But some manufacturers have exploited that provision to lock customers into their own expensive, inaccessible repair services, by locking repair functions, too.

Every three years, the Copyright Office allows for exemption requests to be made under Section 1201. This process, set up by Congress, has been in place since 1998 and includes multiple rounds of hearings and opportunities for discussion and testimony. The recent ruling by the Copyright Office granted exemptions for technicians to break digital locks for purposes of repair of equipment as diverse as tractors, gaming consoles, servers and ventilators.

There is nothing mysterious or behind the scenes about this process: it’s as regular as clockwork. Pitts suggests that the process was hidden and swept under the rug of the Federal Register, stating: “The U.S. Copyright Office’s announcement, deep inside the Federal Register and written in very user unfriendly dense government jargon, landed not with a bang, but with a whimper. On purpose. Hiding in plain sight. This terrible ruling offered without a comment period or any other appeals mechanism, will have a profoundly negative impact on America’s public health.”

The Copyright Office report to Congress itself shows otherwise.

Under Section iii of the Register’s Recommendations (see pages 224-231), there are extensive references to the engagement of major medical device trade associations AdvaMed, MITA, ACT and directly by Phillips as a manufacturer. In the text of the report, the Register explains her …….


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