An update on regulations for digital and connected healthcare devices has been a long time coming.
A lot has already changed in the world of computers and the internet.
Regulations need revisiting to keep up with the times.
The agency also clarifies many of the unclear aspects of the older guidance document.
Medical devices are not known to be built with cybersecurity as an essential consideration.
The agency provides recommendations on how to make medical devices resilient to cybersecurity attacks and maintain consistent cyber defenses.
One notable guideline in this FDA update pertains to leveraging data and code integrity.
This is a timely update in view of the growing prevalence of memory or buffer overflow vulnerabilities.
These attacks overwrite data onto adjacent memory blocks, which can cause the app to behave erratically.
Worse, they can introduce anomalous code and execute it within the rig.
The anomalous code can facilitate data theft or open access to IT systems.
Is the FDA guidance update enough?
The FDA guidance update is a step in the right direction.
It is particularly laudable that policymakers are showing a good grasp of the current threat landscape.
This gap is enough for threat actors to launch attacks and inflict damage.
However, it would be impudent to characterize it as insufficient.
No regulation will ever be foolproof.
source: www.techworm.net
