Devices

Senate Bipartisan Bill on Device Cybersecurity

U.S. Senators Jacky Rosen (D-NV) and Todd Young (R-IN) have introduced their bipartisan Strengthening Cybersecurity for Medical Devices Act that would mandate FDA to review and update medical device cybersecurity guidelines and suggestions to ensure devices are protected from possible hacking and cyberattacks. Text of the legislation has not yet been made available.

Specifically, the bill would require FDA, in consultation with the Cybersecurity and Infrastructure Security Agency (CISA), to review guidance for industry and FDA staff regarding medical device cybersecurity and make appropriate updates at least every two years. “The bill also requires FDA to share information publicly regarding federal resources for health care professionals, medical device manufacturers, and health systems to identify and address cyber vulnerabilities, and access support,” Rosen said in a release. “Additionally, the bill requires a GAO report examining medical device cybersecurity vulnerabilities and recommendations for improving federal coordination to support cybersecurity for medical devices.”

In March, Rosen and senator Bill Cassidy (R-LA) introduced their bipartisan Healthcare Cybersecurity Act, which would direct CISA to collaborate with the Department of Health and Human Services on improving cybersecurity in the health care and public health sector.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome