Cybersecurity Disclosure Under Scrutiny

By | The D & O Diary | November 6, 2013
Cybersecurity Disclosure Under Scrutiny

The threat of a cybersecurity breach is unfortunately one of the ongoing business risks companies face n the current operating environment. For that reason, corporate disclosures of cyber-breach related risks have been a priority of the SEC’s Division of Corporate Finance as well as the agency’s new Chair, Mary Jo White.

FDA Seeks Enhanced Cybersecurity Risk Management Efforts, Including Premarket Submission Requirements, for Medical Device Manufacturers and Hospitals

By | Focus on Regulation | June 19, 2013

Drawing on the increasing use of wireless, Internet- and network-connected medical devices, the Food and Drug Administration (“FDA” or “the Agency”) issued a draft guidance document for comment on June 14, 2013, proposing that manufacturers of medical devices that contain software, firmware, or programmable logic, address cybersecurity risks in premarket submissions.