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EU Member States Approve EU-U.S. Privacy Shield

Client Alert | 1 min read | 07.08.16

Today, the European Union (EU) Member States in their function as the Article 31 Committee approved the final version of the EU-U.S. Privacy Shield, the new framework for transatlantic data transfers. It is set to replace the U.S.-EU Safe Harbor which the European Court of Justice invalidated in October 2015. Today’s vote by the Article 31 Committee, which was an important prerequisite for the formal adoption, paves the way for the European Commission’s adequacy decision, which is expected to take place early next week. The European Commission stated that, “Both consumers and companies can have full confidence in the new arrangement, which reflects the requirements of the European Court of Justice. Today’s vote by the Member States is a strong sign of confidence.” The European Commission also noted that during the adoption process it consulted as broadly as possible, “taking on board the input of key stakeholders, notably the independent [Member State] data protection authorities and the European Parliament.” The Commission likely hopes its final consultations and changes will satisfy potential opponents to the new program.

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Client Alert | 9 min read | 10.21.26

Artificial Intelligence in Life Sciences: Reliability of AI-Generated Evidence in Drug Discovery and Development

The life sciences sector is uniquely vulnerable to the inherent risks of AI-generated evidence in drug development and discovery. This client alert focuses on five core challenges: hallucinations, skewed predictions from unrepresentative training data, the opacity of AI reasoning, input sensitivity that undermines reproducibility, and adversarial manipulation of training data. To address these risks, companies should use experimental validation and human oversight as the common legal and regulatory safety net. This entails among other measures auditing AI outputs, characterizing training data, and structural oversight. Companies also should prepare for evolving frameworks and guidance from the U.S. Food and Drug Administration (FDA) and the European Union (EU) that address use of AI in drug discovery and development .  ...