ACI Comments on Medical Device Exemptions Under DMCA

When Congress passed the Digital Millennium Copyright Act (DMCA) in 1998 they established a rulemaking process that gives the Library of Congress the power to make exceptions to certain provisions of the legislation. Most notably, Section 1201, the provision that prohibits people from circumventing technological tools used by copyright owners to prevent access to their material.

However, in 2021 the Library of Congress approved an exemption to Section 1201 that gives third parties access to copyrighted software involved with the diagnosis, maintenance or repair of medical devices.  

Now, the U.S. Copyright Office is conducting its ninth triennial rulemaking proceeding under the DMCA, where stakeholders can apply for new exemptions and the Library of Congress can review and renew previous exemptions. In response, the American Consumer Institute (ACI) submitted a comment outlining the reasons why the exemption should not be renewed, specifically highlighting how temporary exemptions for medical devices could “jeopardize patient safety.”

ACI noted that the potential copyright exemption could “undermine the maintenance and repair standards laid out by the FDA for the equipment employed in patient care.” In addition, they also emphasized how the continuation of the exemption from 2021 would undermine the need for certain industries, like the medical sector, to have oversight and accountability.

Read the full letter below:

The American Consumer Institute (“ACI”) hereby submits this comment opposing the petition to renew the 2021 exemption governing, “Computer programs that control medical devices or systems, and related data files, for diagnosis, maintenance, or repair of the device or system.”

ACI is a nonprofit (501c3) educational and research institute with the mission to identify, analyze and protect the interests of consumers in selected policy and rulemaking proceedings related to information technology, health care, retail, insurance, energy, postal and other issues.

Often, rulemakings decisions, like this one, can yield more costs than benefits to consumers if not appropriately considered. We would therefore like to the urge the Librarian to seriously consider how the exemptions for medical devices could jeopardize patient safety during this ninth triennial rulemaking mandated by the Digital Millennium Copyright Act.

This year, ACI established the Safe Repair Project. A new initiative to keep American consumers and patients safe from potentially dangerously and incorrectly repaired medical equipment. Our goal aims to educate and advocate for sensible policy solutions that ensure patient safety remains at the forefront of the right to repair debate.

The exemption undermines the maintenance and repair standards laid out by the U.S. Food Drug Administration (FDA) for the equipment employed in patient care. Medical devices are regulated by the FDA because they are intricate and sensitive machines that require precision and expert training to conduct necessary repairs. The FDA requires specific technical requirements, specifications and expertise when manufacturing these regulated products.

However, independent servicers (ISOs) are neither regulated nor monitored, and not required to adhere to the FDA’s Quality System Regulations or report adverse repair events. We have strong federal regulations on the manufacturers in this market, but none related to third-party servicers. This gap puts patients at serious risk.
Moreover, because these unregulated repair shops have no obligation to uphold the highest repair standards or report adverse incidents, we are potentially exposing patients to poorly serviced or malfunctioning medical devices.

While our organization’s mission is rooted in consumer sovereignty — the freedom for consumers to make their own choices and the importance of giving consumers better information to make those choices – there are certain industries that require oversight and accountability to maintain the public interest. A decision to continue the exemption from 2021 from the Librarian would undermine that system.

Repairs by unregulated ISOs increase patient risk and a continued exemption would only serve to undermine the quality and safety standards that patients and medical professionals rely on to ensure patient safety.

If your loved one needed an emergency diagnostic evaluation, you certainly would want that equipment to be maintained by a licensed professional with the same knowledge and training required by the FDA. Patients deserve better.

Thank you for your consideration of our comments.

Respectfully submitted,

Steve Pociask
President and CEO
American Consumer Institute Center for Citizen Research
4350 Fairfax Drive, Suite 725
Arlington, VA 22203
[email protected]
(703) 282-9400

https://www.regulations.gov/comment/COLC-2023-0004-0039