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Cybersecurity Breach Turns Back the Clock - Confidential Information to be Filed in Paper

Client Alert | 1 min read | 01.12.21

On January 6, 2021, the Administrative Conference of U.S. Courts authorized federal district courts to develop policies for accepting “highly sensitive court documents (HSDs),” which would normally be filed electronically under seal, via paper filing. The statement from the Administrative Conference also acknowledged that the recent cybersecurity attack on SolarWinds products compromised the confidentiality of documents filed under seal on the Judiciary’s Case Management/Electronic Case Files system (CM/ECF).

As a result, courts nationwide are issuing notices delineating what constitute HSDs, and how parties must file HSDs, effective immediately. While some courts have yet to issue guidance, a number of other federal courts have issued general orders requiring that HSDs be filed in paper in drop boxes in or outside the courts. Individual courts are left with a split between treating all sealed documents as HSDs, and leaving to the presiding Judge, or if none, the Chief Judge, the determination of whether a document is an HSD. The U.S. District Court for the District of Columbia will take the latter approach and has provided that the HSD determination may consider whether the document contains closely held trade secrets, or confidential government enforcement information.

On a practical level, these orders may require that sealed documents, including bid protests, are filed by the court’s close of business to be considered timely filed, rather than 11:59 p.m., the deadline for electronic filing. The orders also may require more conferences among the parties to reach consensus on what information must be filed under seal, particularly if the presiding Judge or Chief Judge of a District has to decide when the parties fail to agree, as is often the case. We will continue to monitor these developments.

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Client Alert | 7 min read | 09.14.26

AI in Life Sciences: Ten Legal Considerations and Risks of AI Use in Drug Discovery and Development

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage. ...