What FDA Expects From Medical Device Cybersecurity Efforts

By Jae Kim and Raymond Williams (April 27, 2022, 5:17 PM EDT) -- In recent years, the threat of cybersecurity attacks has evolved in the minds of the public and regulators from a theoretical novelty to a tangible reality. There have been numerous institutions in various industries coming under attacks by malicious actors, sometimes resulting in data breaches and significant monetary penalties.

In the health care sector, cybersecurity incidents can have an adverse clinical impact on patients, particularly if personal medical devices or interconnected medical devices are rendered inoperable or become compromised.

On April 8, the U.S. Food and Drug Administration issued a new draft guidance on cybersecurity, "Cybersecurity in Medical Devices: Quality System...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!


Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!