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Final Rule on Supply Chain Risk Fails to Provide Additional Guidance, Protection, or Relief from Uncertain Application

Client Alert | 1 min read | 11.02.15

On October 30, DoD published a final rule (a) requiring evaluation of supply chain risk when acquiring information technology that is either a covered National Security System ("NSS"), part of a covered NSS, or in support of a covered NSS; and (b) authorizing DoD to exclude primes or subs from a particular procurement if they fail to mitigate identified supply chain risks adequately. DoD made relatively modest changes to the 2013 interim rule (e.g., removing the flow-down requirement applicable to subs at any tier) but largely rejected industry input (e.g., declining to identify specific standards or controls to mitigate supply chain risk and declining to create a mechanism for challenging exclusion from a particular source selection).


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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 .  ...