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Cloud Computing Corrective Actions

Foley & Lardner LLP

FDA Clinical Investigations: New Guidance on Electronic Systems

Foley & Lardner LLP on

On October 2, 2024, the U.S. Food and Drug Administration (FDA) released guidance in a question and answer format regarding the use of electronic systems, electronic records, and electronic signatures in clinical...more

Morgan Lewis

Mine, Yours, and Ours: Gating Issues in the Use and Commercialization of Data

Morgan Lewis on

Many companies are actively exploring how to better use, commercialize, and productize (make into a standalone product) the data that they collect or is collected on their behalf. A gating issue for these companies is...more

Orrick, Herrington & Sutcliffe LLP

Don't Wait for It; Recent HIPAA Enforcement Action Signal More to Come in Phase 2 Audits

Officials at the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) have recently selected a vendor to conduct the second wave of HIPAA audits. These so-called "Phase 2 Audits" are set to commence...more

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