cognitive cybersecurity intelligence

News and Analysis

Search

FDA issues guidance on predetermined change control plans for AI/ML-enabled device software functions – Commentary

IntroductionIn more detailDescription of modificationModification protocolImpact assessmentAuthorised PCCPsCommentIntroductionOn 3 April 2023, the Food and Drug Administration (FDA) issued a draft guidance for industry,(1) for manufacturers whose medical devices use machine learning (ML)…

Source: www.lexology.comRead more

Subscribe to newsletter

Subscribe to HEAL Security Dispatch for the latest healthcare cybersecurity news and analysis.

More Posts

MediSecure cyber security incident

The Australian Government is responding to a cybersecurity incident involving former prescription delivery service, MediSecure. The national prescription delivery service, Fred IT Group’s eRx Script