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  3. |Plugging the "Gaps" on Transfers of U.S. Sensitive Emerging Technology: New and Permanent Dual-Use Export Control Statutory Authority Becomes Law

Plugging the "Gaps" on Transfers of U.S. Sensitive Emerging Technology: New and Permanent Dual-Use Export Control Statutory Authority Becomes Law

Client Alert | 1 min read | 08.16.18

The Export Control Reform Act of 2018, included within the National Defense Authorization Act (NDAA) for Fiscal Year 2019, became law on August 13, 2018, and provides “modern” and permanent statutory authority for the U.S. Export Administration regulations (EAR), which control the export, re-export, and transfer of U.S. origin “dual-use” items. As a result of the effort to strengthen control over foreign investment in the United States (contained in a companion statute within the NDAA), the law directs the Commerce Department to establish an inter-agency process, subject to a public notice and comment period, for the identification of “emerging and foundational technologies” that are essential to the national security of the United States, and requires the imposition of licensing requirements (even if unilateral) at least for transfers of such technologies to U.S. arms embargoed countries, which includes China. With respect to potential technologies likely to incur heightened scrutiny, a Commerce Department industry event in May of this year highlighted U.S. advancements vis-a-vis Europe and China in the areas of artificial intelligence (particularly autonomy, and human-AI interaction), 5G technology, and robotics, among others.

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Client Alert | 7 min read | 09.14.26

AI in Life Sciences: Ten Legal Considerations and Risks of AI Use in Drug Discovery and Development

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage. ...