Data Privacy and Confidentiality Controls for AI-Assisted Submissions in the US in 2023 Data Privacy and Confidentiality Controls for AI-Assisted Submissions in the US in 2023 The integration of artificial intelligence (AI) into regulatory submissions has revolutionized the way pharmaceutical and biotechnology companies interact with regulatory authorities. As organizations leverage AI technologies for submission automation, understanding the stringent data privacy and confidentiality controls is imperative for compliance with FDA regulations and ensuring the secure handling of sensitive information. This guide outlines a systematic approach to implementing data privacy and confidentiality controls for AI-assisted submissions in the United States. Step 1:…