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UPDATE: [Close of Comments on Commerce Cyber Rule]

Client Alert | 1 min read | 01.20.22

On January 12, 2022 the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) issued a federal register notice delaying the effective date of new controls on cybersecurity items and an accompanying new license exception. The rules are now set to take effect on March 7, 2022.

The new controls were published in an interim final rule on October 21, 2021, please see our earlier client alert on this. Broadly speaking, they cover (a) items, including software, for the generation, command and control, or delivery of intrusion software and (b) internet protocol (IP) network communication surveillance equipment. BIS delayed the implementation to give industry additional time to comply with the new restrictions as well as update internal compliance procedures, and to provide BIS itself time to provide additional guidance on the rule. BIS may also consider some modifications to the rule, but is not reopening the comment period and these modifications based on the latest comments will most likely be made, if at all, sometime after the new effective date for the interim final rule.

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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. ...