May 6, 2021 - AI + Robotics, FDA

CTA Publishes New Standard for Healthcare AI

In February, the Consumer Technology Association (CTA) announced a voluntary standard for healthcare products that use Artificial Intelligence (AI). This standard follows the Food and Drug Administration’s (FDA) recently published action plan for regulatory oversight of AI and machine learning-based medical software. FDA ultimately …›

FDA’S PLAN FOR AI/ML-BASED SOFTWARE AS MEDICAL DEVICES: PROGRESS AND CONCERNS

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory oversight. The FDA recently published an AI/ML SaMD action plan, developed in direct response to …›

Podcast: Applying AI and Data Science to the Fight Against COVID-19: The Science and Legal Considerations

In this second of a four-part podcast series on the science, regulatory framework, commercial transactions, and privacy and data security considerations of each unique aspect of the current health crisis, Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and …›

The New ABC's: Artificial Intelligence, Blockchain and How Each Compliments the Other

Artificial intelligence (AI) and blockchain technology are two novel innovations that offer the opportunity for us to move beyond our legacy systems and streamline enterprise management and compliance in ways previously unimaginable. Each technology augments the strengths and tempers the weaknesses of the other. …›

March 5, 2020 - AI + Robotics, FDA, United States

February FDA Updates

As we move into 2020, we’re starting a regular blog series highlighting noteworthy FDA updates regarding regulatory compliance, fraud and abuse cases, and product development issues every month. Our February recap is below. 1. Two Owners of Telemedicine Companies Charged for Roles in $56 Million …›