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31 March 2022MedtechAlex Baldwin

Medtech groups say ‘unlawful’ DMCA exemption should be waived

Medical device companies have asked a US federal judge to eliminate an exemption that allows the bypassing of technological protections for copyrighted software if it is in service of using or repairing medical devices.

The Medical Imaging & Technology Alliance (MITA) and the Advanced Medical Technology Association (AdvaMed) asked the US District Court for the District of Columbia to “set aside” the rule and declare it “unlawful and void” in a short complaint submitted last week.

In a follow-up motion on Tuesday, March 29, the groups requested a summary judgment for the lawsuit and provided a 48-page accompanying memorandum arguing why the rule should be considered unlawful.

Specifically, the rule, 37 C.F.R. § 201.40, provides a waiver to the Digital Millenium Copyright Act (DMCA) and was introduced by the Library of Congress for situations where circumventing technological measures “when necessary” in servicing or repairing certain medical devices is justified.

MITA and AdvaMed claim that the rule was granted “solely for the commercial benefit” of two unnamed “independent service operators”, which they claim “freeride on the creative labours of device manufacturers”.

The groups challenge the rule in relation to bypassing technological protective measures (TPMs) in sophisticated devices such as magnetic resonance imaging (MRI), machines, computerised tomography (CT) scanners, ultrasound systems, X-Ray machines and defibrillators.

The reasoning for the Library of Congress granting the exemption, the groups claimed, was to “reduce the cost of machine servicing contracts and thus serve a separate executive-branch policy”.

“In approving the exemption, moreover, the Library failed to address numerous substantial comments that called into question the underlying fair-use analysis. The exemption is thus unlawful many times over,” MITA and AdvaMed said.

Both companies have asked the district court to grant a summary judgment and enter a final judgment setting aside the exemption, declaring it unlawful and void, and enjoining the Library of Congress from enforcing the exemption.

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