The industry struggles with various unknowns that impact efficiency, quality, and as a result, finances. This article reviews some of these challenges and how to overcome them.
It’s important to draw on experience from other sectors.
The agency has realigned information technology, data management and cybersecurity functions, and established a new office reporting directly to the FDA commissioner.
The vulnerability could allow a remote attacker to gain access to highly sensitive systems.
Medical devices and medical software are becoming increasingly connected to hospital networks, other medical devices or the Internet. As a result, manufacturers and developers are required to consider cybersecurity from the very early stages of development. This in turn necessitates comprehensive risk management along the entire lifecycle of a device.
To change the landscape of cyber threats in healthcare, companies must prioritize designing security into devices.
Data, IoT, artificial intelligence, predictive analytics, virtual and augmented reality, and many other technologies will fuel the healthcare system.
Software continues to be a key factor in recalls, and this year the end of some EUAs may also contribute to an increase.
A mere 13% of IoMT leaders believe their organization is in a good place to mitigate future risks related to cybersecurity.
The agency created the new post within CDRH, effective January 1.