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Medical Devices › Risk Management › Protected Health Information

Gardner Law

Why Every Manufacturer Needs a Robust Information Security Program

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Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more

Polsinelli

CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices

Polsinelli on

Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000,...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 8, October 2024

Spilman Thomas & Battle, PLLC on

Welcome to our eighth 2024 issue of Decoded - our technology law insights e-newsletter. Thank you for reading. EU AI Act Tightens Grip on High-Risk AI Systems: Five Critical Questions for U.S. Companies - Why this is...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Nutter McClennen & Fish LLP

Code Blue: Cybersecurity Vulnerabilities for Medical Device Makers Require Urgent Care

Nutter McClennen & Fish LLP on

Q: How is the shift of medical devices moving to the Internet of Things affecting the health care industry? A: Connected medical devices routinely record sensitive health information about a patient. This critical...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - April 2018 #4

Robinson & Cole LLP on

“Orangeworm” Targeting Health Care Industry - In what is being called a systematic targeting of large health care organizations, pharmaceutical companies, and IT companies and equipment manufacturers that service the...more

Hogan Lovells

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns

Hogan Lovells on

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more

Bricker Graydon LLP

New cybersecurity threats with potential to impact health care industry identified

Bricker Graydon LLP on

On January 4, 2018, the National Health Information Sharing and Analysis Center (NH-ISAC) posted an announcement regarding the cybersecurity threats Meltdown and Spectre that were recently identified....more

Sheppard Mullin Richter & Hampton LLP

Device Advice: New Guidance From the FDA on Medical Devices and Cybersecurity

Sheppard Mullin Richter & Hampton LLP on

Are medical devices, subject to pre- and post-market regulatory controls, under increasing cybersecurity scrutiny? The FDA recently published recommendations for consideration of cybersecurity management in a product’s design...more

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