Modern technology has given rise to new legal questions. How does FDA regulate machine-learning computers that are changing so rapidly – given that the approved product may be drastically different than the product that ends up on the market? These questions arise from a lack of understanding of the complex nature of AI/ML-based SaMD, the opaqueness of the regulatory framework, and a dearth of relevant case law.
A review of common risks and pitfalls of incorporating artificial intelligence in medical devices and an overview of the regulatory framework.
The agency is seeking solutions to rapidly address public health needs related to the pandemic.
Companies developing technologies that integrate AI need to consider regulatory concerns, community demographics, fitting into existing workflows, technical proficiency of both the hospital personnel and consumers.
With the rapid growth of life tech discoveries, there is a need to adapt the patent and regulatory frameworks governing the approval, use, and protection of such discoveries.
Artificial intelligence and machine learning are proving to be meaningful weapons in our arsenal during the coronavirus crisis.
The Chinese government is investing heavily in the development of new technologies that leverage AI. This includes solutions to address the COVID-19 outbreak.
Pharma and Tech Working in Sync to Enhance Health.