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Code Red: The FDA’s Artificial Intelligence/Machine Learning Action Plan Poses Potential Risks for Medical Device Makers

Q: The FDA’s stance on a regulatory framework for artificial intelligence and machine learning (AI/ML) software as a medical device is continuously evolving. Could you explain the history? A: Artificial intelligence (AI) is...more

European Court of Justice Strikes Down Privacy Shield

The European Court of Justice (ECJ) struck down the Privacy Shield – the legal mechanism that allowed many small and medium sized companies to transfer personal data from the European Union to the United States without...more

Preparing for the Inevitable: It’s Time to Begin Planning for the CCPA

The California Consumer Privacy Act of 2018 (“CCPA”), the most comprehensive privacy law in the United States, is scheduled to take effect on January 1, 2020. Though the CCPA protections only apply to California residents, it...more

Changes to Massachusetts Law on Security Breaches

On April 11, 2019, significant revisions to Massachusetts’ data breach law – Chapter 93H – take effect. The revised statute requires more detailed notifications to both the Commonwealth and affected consumers, and mandates...more

Happy GDPR Eve! Are You Ready?

Happy GDPR Eve! Tomorrow is the effective date of Europe’s extensive, new and much talked about regulation, the General Data Protection Regulation (GDPR). GDPR is an ambitious regulatory framework that seeks to rebalance the...more

GDPR Compliance: Think It Doesn’t Apply to You? Think Again: Insights from Nutter’s Seth Berman

Seth Berman, a partner in Nutter’s Litigation Department and a leader of the firm’s Privacy and Data Security practice group, addressed upcoming GDPR compliance standards in Nutter Insights. Seth discussed how broadly the...more

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