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Recent Machine Learning Studies in Medical Imaging Applying FDA Principles

Medical imaging is one of the most promising fields for use of AI tools, as pattern recognition and large data sets can enhance human diagnosis (e.g., by radiologists) or even compete with them. A review of AI methodologies...more

FDA Updates Cybersecurity Guidance

(May 30, 2023) Going forward, medical device approval will require the device maker to provide cybersecurity information to the FDA. Congress made this change by adding Section 524B to the Federal Food, Drug, and Cosmetic...more

Measuring the Reach of GDPR, How Far Is Far Enough?

It’s generally recognized that the General Data Protection Regulation (GDPR) can apply to entities outside the European Union. However, scant court rulings guide non-European controllers and processors on this question. The...more

Lessons From the Complaint Against Uber’s Former Chief Security Officer

On August 20, 2020, former Uber Chief Security Officer Joe Sullivan was charged with obstruction of justice and misprision of a felony for knowingly concealing a hack of Uber in 2016. Based on Sullivan’s complaint,...more

Legal Alert: Good News for Software Patents?

Federal Circuit’s Enfish Decision and PTO Guidelines Should Give Hope to Patentees - In the last few years, U.S. Courts have drastically changed their interpretation of the law governing patent eligibility, 35 U.S.C. §...more

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