The draft provides suggestions on device design, labeling and documentation that should be included in premarket submissions.
Hackers and their ability to access systems remotely and disrupt healthcare organizations are a key concern.
A look at the pros and cons of connected medical devices.
As medical technological capabilities increase along with the proliferation of embedded systems and IoT, cybersecurity is becoming a very real risk for the medical industry. While securing the whole medical device industry may seem like an insurmountable task, the combination of education, regulation and technology is a good first step toward protecting our most critical infrastructure from attack.
As standards around interoperability emerge, now may be the time to look at the benefits of connected technologies.
Why does anyone want to hack a medical device or steal medical data? The risk may appear low, but unfortunately this is not the case.
The Healthcare Supply Chain Association releases a laundry list of areas in which device companies and providers must increase security of devices and networks.
There are too many unique needs on the part of both manufacturers and providers. More collaboration is needed.
Next month cybersecurity experts from FDA, medical device companies and other healthcare organizations with gather to talk strategy and best practices for designing and evaluating secure technologies.
Throughout 2018, device and diagnostic manufacturers have opportunities to address challenging market trends and turn internal change into ways of increasing business and goodwill from providers who purchase their technology.