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DoD's Proposed Counterfeit Electronic Parts Rules Are Short on Details

Client Alert | 1 min read | 05.22.13

Following up on its publication of an instruction on counterfeit parts on May 16, DoD issued a long-expected proposed rule on counterfeit electronic parts avoidance, detection, and liability, with comments due by July 15. As discussed on our blog, the rule -- which applies only to CAS-covered prime contractors but will have a much broader impact on subcontractors and suppliers -- requires that business systems include DoD-approved avoidance and detection systems, but leaves the details of the newly required systems to be fleshed out, it would seem, by DCAA and/or DCMA, and, while it imposes potentially unlimited liability for counterfeit parts, it has an exceedingly narrow "safe harbor." 


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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 .  ...