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The U.S. Department of Commerce is soliciting comment on possible restrictions on “connected vehicle” components obtained from “foreign adversaries.” On March 1, 2024, the department’s Bureau of Industry and Security (BIS)...more
I. OVERVIEW - The U.S. Food & Drug Administration (“FDA”) has increased its focus on mitigating cybersecurity risks in medical device software. On June 24, 2021, the FDA issued two documents that are important not only...more
On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when manipulation or repair of a medical device becomes...more
In a release aptly labeled “A Starting Point for IoT Device Manufacturers” the National Institute of Standards and Technology (NIST), an arm of the Department of Commerce, recently added to the discussion with the...more
Connected devices already are making headway into business and consumer markets. “Smart” speakers, video doorbells, remote programmable thermostats and other devices are increasing in popularity in homes across the United...more
Protection of industrial control systems is crucial to the security of our country. The National Cybersecurity Center of Excellence (NCCoE) has announced a project for which it is seeking comment: Detecting and Protecting...more
The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more
In recognition of the increasing prevalence of connected medical devices, and the potential cybersecurity vulnerability of the same, the U.S. Food and Drug Administration (FDA or the Agency) issued on October 18, 2018 a draft...more
On 4 February 2017, the Cyberspace Administration of China issued a draft of the Network Products and Services Security Review Measures (“Draft Measures“) for public comment: the Draft Measures remain open for comments until...more
Last week at the PacSec security conference held in Tokyo, a new device capable of fully infiltrating radio-controlled drones was unveiled by researchers. This new device exploits a vulnerability in the frequency-hopping...more
On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance on cybersecurity risks associated with medical devices, and addressed steps that device manufacturers should take to mitigate such risks. The...more
The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity. Recognizing the growing importance of cybersecurity for medical devices and the potential public...more
On January 22, 2016, the Food and Drug Administration (“FDA”) released draft guidance regarding postmarket management of cybersecurity risks in medial devices. This guidance comes over a year after the FDA issued similar...more