A New Dawn or New Nightmare: Will Transactional Data Reporting Reduce, or Merely Shift, GSA Schedule Contractors' Compliance Burden?
Client Alert | 1 min read | 06.23.16
Despite competing concerns expressed by both contractors and the IG, on June 23, 2016, GSA published a final rule proceeding with a pilot program imposing substantial monthly transactional data reporting obligations on contractors but relieving them from the burden of both commercial sales practices data submissions and the monitoring of commercial sales to tracking customers, as well as from the threat of price readjustments and possible FCA liability under the Price Reduction clause. The pilot program will initially apply to new contracts (and existing contracts where contractors elect to participate) under select GSA Schedules accounting for approximately 43 percent of GSA Schedule purchases, including Schedule 70 (Information Technology) and 00CORP (Professional Services), and continue for at least one year as GSA evaluates its ability effectively to collect and use transactional data and price analysis to assure better pricing for GSA Schedule customers.
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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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