NISPOM Revised to Incorporate DSS and GCA Requirements
Client Alert | 1 min read | 08.08.18
On August 1, 2018, DoD published the National Industrial Security Program: Industrial Security Procedures for Government Activities (“Volume 2”), which finally replaces the 1985 Industrial Security Regulation much as the original National Industrial Security Program Operating Manual (NISPOM) had replaced the Industrial Security Manual applicable to contractors. Volume 2 prescribes security practices applicable to U.S. government activities and includes an extended discussion of facility security clearances (FCLs), including examples of documentation that sponsoring agencies can use to justify an FCL, an exception for continued FCL processing even if it cannot be completed in time to qualify the company for participation in a procurement action, and uniform criteria for identification of key management personnel for various business structures. Volume 2 also establishes detailed procedures for DSS oversight of contractor investigations of compromised information, DSS processing of limited access authorization, and DSS requirements for international security programs including foreign government and contractor access to U.S. classified information.
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Client Alert | 9 min read | 10.21.26
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 .
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