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Health Information Technologies › Risk Management › Medical Devices

Troutman Pepper Locke

2025 SCOPE Conference Emphasizes AI and Better Technologies to Improve Patient Outcomes

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The 2025 SCOPE Conference (Summit for Clinical Ops Executives), held last week in Orlando, FL, brought together more than 4,500 industry leaders, innovators, and experts in the clinical operations field. ...more

Jackson Lewis P.C.

Cybersecurity Awareness Month: FDA Guidance on Cybersecurity in Medical Devices

Jackson Lewis P.C. on

Cyber incidents are on the rise with no signs of slowing down, particularly in the healthcare industry. To combat this trend, on September 27, 2023, the U.S. Food and Drug Administration (FDA) released guidance on...more

Butler Snow LLP

Cybersecurity: What Businesses Need to Know

Butler Snow LLP on

Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more

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FDA’s New Draft Guidance on Cybersecurity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 In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

Robinson+Cole Data Privacy + Security Insider

Cybersecurity Risks in Medical Devices Discussed at Recent FDA Meeting

Robinson+Cole Data Privacy + Security Insider on

The Patient Engagement Advisory Committee to the Food and Drug Association (FDA) met recently to discuss cybersecurity in medical devices. Medical devices are increasingly connected to the internet, hospital networks, and...more

Troutman Pepper Locke

Health Sector Cybersecurity Guidance Provides Best Practices Applicable Across Industries

Troutman Pepper Locke on

While cyberattacks continue to increase in number, health care organizations face some of the greatest risks. According to the Health Sector Coordinating Council (HSCC) — a coalition of industry associations that operates in...more

McDermott Will & Emery

FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

McDermott Will & Emery on

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more

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