As medical devices evolve to better treat and monitor patient health, cybersecurity remains a top priority. As per FDA guidance, “medical device security is a shared responsibility…”
Recent advances and increased application of computer-aided decision making, including artificial intelligence (AI) and machine learning (ML), have caught the attention of consumer protection organizations and regulatory agencies.
The FDA first drafted guidance on CDS software in 2017, but finalizing it has not been a priority for the agency since. That’s set to change next year.
The FDA has announced updated software guidance for Software in a Medical Device (SiMD) or Software as a Medical Device (SaMD).
The digitization of medical records should lead to streamlined access for patients, efficiency upgrades for providers, and economic opportunity for developers. These benefits exist in theory, but not in practice—due to cybersecurity concerns and the associated costs.
Around the middle of August, a security research firm named Unit221B reached out to T-Mobile with some really, really bad news.
The FTC voted 3-2 to move forward with a new version of an antitrust lawsuit against Facebook, filed on August 18.
In this post, we breakdown the most high-profile lawsuit taking place in the United States this summer: the prosecution of Elizabeth Holmes and Theranos.