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Pharmaceutical Industry › Food and Drug Administration (FDA) › Cyber Attacks

Nelson Mullins Riley & Scarborough LLP

FDA Issues Implementation Guidance on Cybersecurity Requirements for Medical Device Premarket Submissions

Nelson Mullins Riley & Scarborough LLP on

The U.S. Food and Drug Administration (FDA or the Agency) has issued guidance concerning cybersecurity requirements for certain medical device premarket submissions (the Guidance). The Guidance outlines the implementation of...more

Gardner Law

FDA’s New Draft Guidance on Cybersecurity

Gardner Law on

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - October 2021

Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Robinson+Cole Data Privacy + Security Insider

FDA Announces Playbook for Medical Device Cybersecurity

Robinson+Cole Data Privacy + Security Insider on

On October 1, 2018, the Food and Drug Administration (FDA) issued its “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook” to address continued threats to medical devices that could affect...more

Hogan Lovells

Best practices for managing cybersecurity risks related to IoT-connected medical devices

Hogan Lovells on

Connected medical devices deliver numerous benefits not available before, including improved monitoring of patient welfare and a wealth of vital data. But for all the advantages available through these devices, their...more

Searcy Denney Scarola Barnhart & Shipley

Hacking Gains New Heights with Threat to Big Pharma

Searcy Denney Scarola Barnhart & Shipley on

Cyber attacks have broken free from their initial molds of carting off with consumer credit card numbers or stealing someone’s identity. The act of digitally digging into cyberspace has hit the U.S. Department of Health &...more

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