News & Analysis as of May 7, 2025

Cybersecurity › Data Management › Medical Devices

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Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now. less -

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

Knobbe Martens on 1/23/2025

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

New guidance on AI-enabled device software functions clarifies information FDA expects in marketing applications

Hogan Lovells on 1/15/2025

On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

King & Spalding on 1/13/2025

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

FDA Issues Draft Guidance on AI-Enabled Medical Devices

Orrick, Herrington & Sutcliffe LLP on 1/8/2025

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more

The Impact of the New EU AI Act on the Medtech and Life Sciences Sector

McDermott Will & Emery on 4/16/2024

As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more

EU Emergency Response Update – Key Policy & Regulatory Developments No. 110

Jones Day on 1/15/2024

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

Data Privacy + Cybersecurity Insider - July 2019

Robinson & Cole LLP on 7/5/2019

DHS Warns Businesses of Risk of Iranian-Backed Wiper Malware Attacks - The tension with Iran has generally increased, and it has been reported that the U.S. has launched a cyber-attack against Iran. In retaliation, the risk...more

HIMMS, Chronic Care Management, and the Top 5 Overlooked Items

Dorsey & Whitney LLP on 3/21/2018

Harnessing existing digital health solutions to improve chronic care management was a prominent topic at HIMMS this year (amongst many others, including AI and cybersecurity, both of which we will cover in upcoming blog...more

Clinical trials: Digital technology for recruitment, consent, and data capture

Hogan Lovells on 3/20/2018

The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is...more

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