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The anti-circumvention provisions of the Digital Millennium Copyright Act (DMCA) exist to deter circumvention of TPMs (technological protection measures) used to protect and prevent access to copyrighted works.<\/p>\nThe anti-circumvention provisions of the Digital Millennium Copyright Act (DMCA) exist to deter circumvention of TPMs (technological protection measures) used to protect and prevent access to copyrighted works.<\/p>\n
For example, it\u2019s illegal to circumvent a TPM to enable copying of Nintendo Switch games. It\u2019s also illegal to circumvent a TPM to modify a Switch to play pirated games, or indeed anything else.<\/p>\n
The same also applies to people who prefer to repair broken electronic devices rather than buy new ones. The moment a work protected by copyright is made accessible after circumventing a TPM, an offense is committed under the DMCA, albeit with limited exceptions.<\/p>\n
To accommodate instances of circumvention for the promotion of public safety, security, or similarly beneficial activities, the DMCA has some exceptions<\/a> built-in, applicable to schools, libraries, law enforcement, and encryption researchers, for example. <\/p>\n The Librarian of Congress also engages in a triennial rulemaking process to identify additional exceptions, part of a \u201cfail\u2010safe mechanism\u201d to protect the right to make non-infringing use of copyrighted works, under the fair use doctrine.<\/p>\n<\/p>\n As part of the Eighth Triennial Rulemaking Proceeding (pdf<\/a>)<\/em>, in October 2021 the Librarian of Congress adopted the \u2018Medical Device Exemption.\u2019 An analysis of the statutory factors determined that maintenance and repair of medical devices constituted fair, non-infringing uses, that would be adversely affected by the DMCA\u2019s anti-circumvention provision. <\/p>\n The exemption was subsequently renewed in 2024, despite continued opposition from the trade associations Advanced Medical Technology Association (AdvaMed)<\/em> and Medical Imaging & Technology Alliance (MITA)<\/em> whose members manufacture medical devices and rely on TPMs to protect their intellectual property. <\/p>\n From the beginning they argued that the independent service organizations (ISOs) that petitioned in favor of the exemption were primarily commercial and in direct competition with the original manufacturers. Allowing circumvention, they added, would jeopardize both patient safety and privacy.<\/p>\n The associations followed up by filing a lawsuit against the Library of Congress and the Librarian of Congress at a federal district court in Washington, D.C. They argued that the Medical Device Exemption violated the Administrative Procedure Act (APA<\/a>), describing it as describing it as arbitrary and capricious, and contrary to the APA given the Librarian\u2019s failure to respond to critical comments. <\/p>\n The district court determined that the plaintiffs\u2019 APA claims were barred by sovereign immunity because the Library of Congress was not an \u201cagency\u201d under that statute. On appeal the D.C. Circuit vacated that opinion, finding that the Copyright Act and DMCA<\/a> provided for APA review of the Library of Congress\u2019s rulemaking. <\/p>\n The case was referred back to the district court, the plaintiffs amended their lawsuit to include three claims under the APA, and both parties cross-moved for summary judgment.<\/p>\n District Judge Beryl A. Howell\u2019s memorandum opinion published last week examines the Librarian\u2019s determination that the exempted uses were non-infringing fair uses under 17 U.S.C. \u00a7 107. Judge Howell reviewed the Librarian\u2019s application of the four statutory fair use factors and concluded as follows:<\/p>\n The Judge concludes that the diagnosis, maintenance, and repair work of independent service organizations (ISOs) is a transformative use, just as the Librarian observed. By restoring device functionality and not commercializing the protected software itself, that demonstrates a \u201cnovel function going beyond the original purpose\u201d of the software.<\/p>\n \u201cContrary to plaintiffs\u2019 hyperbolic characterization\u2026..the Librarian did acknowledge the commercial nature of the exempted uses but rightly recognized that commercial use is not dispositive,\u201d the Judge notes, adding that the commercial aspect was reasonably outweighed by the transformative use.<\/p>\n The Librarian\u2019s analysis found that this factor also favors fair use. The plaintiffs had argued that software is \u201cessentially a creative work\u201d but the Librarian took the position that software and data in medical devices are used for their \u201cfunctional and informational aspects\u201d rather than their expressive qualities. The court agreed.<\/p>\n \u201cThe Librarian nonetheless reasonably concluded that in this case, the software code itself and the ancillary materials are informative, factual, and functional rather than expressive in nature, favoring fair use,\u201d Judge Howell writes.<\/p>\n The Librarian concluded that this factor favored fair use but was given little weight. If necessary, entire copyrighted works can be used as long as the use was \u201creasonable\u201d relative to the purpose of diagnosis, maintenance, or repair.<\/p>\n Judge Howell says the Librarian\u2019s decision was well reasoned, noting that copying even large amounts can favor fair use when \u201ctethered to valid, and transformative, purpose.\u201d<\/p>\n The Librarian\u2019s analysis found that diagnosis, maintenance, and repair of devices is unlikely to harm the market for the software embedded inside them, because the software \u201chas no independent value separate from being used with the equipment.\u201d<\/p>\n Judge Howell agrees; third party repairers do not \u201cusurp the market of the original work\u201d or act as a substitute. There is no \u201cchilling effect on innovation\u201d as the plaintiffs insist, since they recoup their costs by selling devices while any other unauthorized uses remain prohibited. <\/p>\n The Judge also cited comment from the FDA which noted that both OEMs and ISOs \u201cprovide high quality, safe, and effective medical device servicing\u201d and \u201cthat the continued availability of ISOs to service and repair medical devices is critical to the functioning of the healthcare system in the United States.\u201d<\/p>\n According to the Judge, the anti-circumvention provision of the DMCA is intended to balance copyright holders\u2019 right to prevent circumvention, with the right to access and use material for non-infringing purposes under the fair use doctrine. Not doing so would risk fair-users of information being \u201crelegated to negotiating access on terms set by the monopoly rights-holders.\u201d<\/p>\n The Exemption for medical devices and systems is consistent with copyright law and the DMCA and supported by the Librarian\u2019s thorough and well-reasoned explanations from the Eighth and Ninth Triennial Rulemaking proceedings. The plaintiffs\u2019 arguments to the contrary, challenging both the substance of the Librarian\u2019s reasoning and her procedural thoroughness, were all unsuccessful. <\/em><\/p>\n Consequently, plaintiffs\u2019 motion for summary judgment is denied, and defendants\u2019 cross-motion is granted.<\/p>\n<\/blockquote>\n Judge Howell\u2019s Memorandum Opinion is available here<\/a> (pdf)<\/em><\/p>\n From: TF<\/a>, for the latest news on copyright battles, piracy and more.<\/p>\n![\"librarian-congress-consider\"](\"https:\/\/www.cryptocabaret.com\/wp-content\/uploads\/2025\/07\/librarian-congress-consider.png\")
<\/center><\/p>\nExemption Challenged by Medical Device Manufacturers<\/h2>\n
Summary Judgment in Favor of the Defendants<\/h2>\n
1. Purpose and Character of the Use<\/h2>\n
2. Nature of the Copyrighted Work<\/h2>\n
3. Amount and Substantiality of Portions Used<\/h2>\n
4. Effect on the Market for or Value of Copyrighted Work<\/h2>\n
Judge Howell\u2019s Conclusion<\/h2>\n
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