Former FDA Official Weighs in On Harms Associated with Medical Device Right to Repair

As the U.S. Copyright Office concludes its review of exemptions to Section 1201 of the Digital Millenium Copyright Act (DMCA), Peter Pitts, president of the Center for Medicine in the Public Interest and former Associate Commissioner of the U.S. Food & Drug Administration (FDA), expressed his concerns with renewing an exemption for these products that was authorized by the Librarian of Congress in 2021.

Mr. Pitts explained that the Independent Service Operators’ (ISOs) who requested the exemption exist “outside the FDA-mandated quality control ecosystem” and noted that they are not required to follow the same regulations and guidelines as original equipment manufacturers (OEMs), allowing for more vulnerability in the space.

Pitts also highlighted that granting this exemption would make it “impossible to know when ‘repair’ turns into installing new software or changing delicate (and regulated) systems configurations.”

Additionally, he calls attention to the blurred lines that would be caused as a result and highlights that the grant of proposed exemptions for medical device repair “continues an open season on patient safety, provider confidence and healthcare cybersecurity.”

As right to repair continues to percolate among state and federal policymaker discussions, officials need to understand the broad implications on patient safety and cybersecurity that could occur as a result of proposals and laws that bring in medical devices to the conversation. Lawmakers must look at the facts and understand that ISOs need to be regulated and the right to repair should stay far away from medical devices.

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