1. Home
  2. |Insights
  3. |DSS Initiative to Adopt a More Holistic Evaluation of FOCI Boards

DSS Initiative to Adopt a More Holistic Evaluation of FOCI Boards

Client Alert | 1 min read | 09.19.18

On August 31, 2018, the Defense Security Service (DSS) issued a white paper suggesting an initiative to expand the considerations it evaluates in reviewing nominations and performance of Outside Directors or Proxy Holders (OD/PHs) serving on Boards of Directors of FOCI-mitigated entities. Specifically, DSS intends to evaluate nominees for OD/PH positions not just on their personal backgrounds but also in the context of the entire Board, suggesting that it considers OD/PH Board members to be able to contribute experience beyond a national security background. While many companies already consider such factors when identifying nominees for OD/PH positions, the new initiative suggests DSS will be seeking such justifications in the review process and hints that it may require specific OD/PH training and on-going internal or external reviews of FOCI Boards and OD/PH performance. One bit of good news is a suggestion that the strict prohibition on an OD/PH having any prior relationship with the FOCI-mitigated entity may be relaxed.

Insights

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 .  ...