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DoD Previews New Third-Party Cyber Certification Requirements

Client Alert | 1 min read | 06.17.19

The Department of Defense is moving closer to a third-party certification to ensure compliance with its standard cybersecurity requirements – what is being called the “Cybersecurity Maturity Model Certification” (CMMC). While still in the early stages of development, the CMMC would likely require all contractors subject to DFARS 252.204-7012 to obtain a certification issued by an independent third party stating that the contractor has sufficiently implemented its required cybersecurity controls. Holding this certification would be a “go/no-go” condition to compete for relevant DoD work. Although NIST SP 800-171 is the default cybersecurity standard currently required under -7012, DoD is also exploring the creation of a new standard that would govern the certification. DoD is projecting that the CMMC will start appearing in solicitations as early as Fall 2020, but much work remains to be done – including potential revisions to -7012 – and will no doubt be informed by extensive industry engagement. 

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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 .  ...