Secure Product Development Framework News Today

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead...

The last year has seen a multijurisdictional regulatory push for increased cybersecurity standards for medical devices. The new approaches, issued by regulatory authorities in the...

Manufacturers need to document a medical device's intended use and operational environment, as well as plan for misuse, such as a cyberattack.

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing...

Artificial intelligence innovations continue to fuel advances across diverse life science applications, including drug discovery and digital health…

Lawyer Spotlight: Artificial intelligence innovations continue to fuel advances across diverse life science applications, including drug discovery and digital health....

Artificial intelligence innovations continue to fuel advances across diverse life science applications, including drug discovery and digital health.

As we all try to keep up with the Metaverse and as the healthcare system wilts under a data deluge, the convergence of realities in a shared online space is not merely a chance for...

The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA's latest...

The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA's latest...