Machine Learning

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On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The long-awaited draft guidance on Clinical Decision Support (CDS) software sets forth FDA’s proposed approach to regulating CDS, including software that incorporates machine learning (ML) technology. Companies developing ML software for life science applications should consider reviewing FDA’s planned approach to inform their regulatory strategies.
Continue Reading New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

Originally posted on the Sheppard Mullin FDA Blog on June 25, 2019.

In April of this year, the US Food and Drug Administration (FDA) released a discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device (SaMD), which proposed a novel regulatory framework for artificial intelligence (AI)-based medical devices.  The public docket closed on June 3, 2019, and FDA received over one hundred comments from manufacturers, industry associations, and other interested parties. The comments vary in support of FDA’s framework and largely urge FDA to align with external stakeholders that are already developing industry standards and clarify the agency’s expectations under the proposed framework.
Continue Reading Medical Devices – Artificial Intelligence and Reactions to FDA’s Proposed Oversight

Healthcare Information and Management Systems Society (HIMSS) kicked-off its annual global conference this week in Orlando, Florida, addressing leading topics in healthcare information technology. Over 45,000 healthcare and information technology professionals and 1,300+ vendors are expected to attend the week long event.  
Continue Reading HIMSS19 Kicks-Off Addressing Leading Topics in Healthcare Information Technology