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Premier submitted comments in response to OSTP's request for information on regulatory reform for artificial intelligence (AI). In its RFI notice, OSTP requested input on opportunities to streamline existing federal statutes, regulations or subregulatory processes that unnecessarily hinder the development, deployment and adoption of AI in domestic markets. In our comments, Premier shared insights from our experience with developing and deploying AI technology in healthcare and recommended that OSTP prioritize the following:
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Ensuring clear federal guidance on patient consent and other requirements to allow for groundbreaking innovation in clinical trials;
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Coordinating across federal agencies to produce clear guidance supporting the industry-wide transition to AI-powered advanced process controls and quality monitoring in drug manufacturing;
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Partnering with federal agencies to establish a clear federal standard for privacy and security to inform good-faith compliance practices;
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Supporting training for the healthcare workforce that combats automation bias and incorporates human decision-making into the use of AI technology in healthcare;
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Evaluating non-regulatory ways to increase visibility into the uses and performance of AI models or software, particularly through data noting whether embedded AI models or software are open source, licensed, or proprietary; and
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Coordinating with HHS to reduce regulatory barriers to AI approval and payment, particularly for software-as-a-service solutions.
Download:
Premier Comments on OSTP AI Deregulation RFI