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 …›
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 …›
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 …›
In this third installment of a six-part Patent Law Course offered by Morrison & Foerster and GSAS Harvard Biotech Club, MoFo partner and head of the firm’s China Life Sciences Group Janet Xiao taught a class on the value, protection, and legal issues involved …›
The increase in AI-related patent filings in the past few years has given rise to unique questions about the current patent system. In particular, the question of whether an AI system can or should be named as an inventor on a patent application has …›
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. …›
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 …›
The European Patent Office has denied two patent applications on the grounds that an AI system cannot be listed as the inventor. For the first time, the European Patent Office (EPO) has issued a ruling on its approach to patent applications that designate artificial intelligence …›
The year 2019 saw relatively few developments in the digital health space. Although progress has been slow, FDA did make headway on two initiatives: (1) addressing the unique challenges of regulating artificial intelligence and machine learning (AI/ML) in medical applications, and (2) implementing changes …›
Between 2013 and 2016, the number of Artificial Intelligence (AI) related patent applications in the life sciences and medical sciences grew by about 40%*, and, with continuing advances in technology, has likely increased substantially since 2016. Although this finding may not come as a …›