In the wake of serious data breaches and hacks targeting hospitals, the US Food and Drug Administration (FDA), in collaboration with Mitre, has released a new to help organisations prepare for a device breach. Sally Turner looks at the role of cybersecurity in the medical device market.
In May, the FDA approved an innovative AI-driven algorithm to support clinical decision-making at the point of care. But, regulatory standards are only in the early stages, with FDA head Scott Gottlieb writing recently about setting transparent standards to accelerate the entry of AI advances into the med tech space. What are the dangers of holding back on strong AI regulation in healthcare, and what benefits could effective regulation provide?