FDA Supports DMCA Exemption, Including For Cybersecurity

A letter from Suzanne Schwartz affirms that the FDA approves the extension of a copyright-law exemption that lets third parties access software in medical devices for repair or maintenance, but not for modifications that could affect device safety.

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The US Food and Drug Administration is backing the extension of a copyright enforcement policy that allows access to medical device software, including for cybersecurity purposes.

Suzanne Schwartz, director of Office of Strategic Partnerships and Technology Innovation (OST) at FDA, issued a letter in June expressing the agency’s continued support of the Digital Millennium Copyright

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