FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...

A key section of the recently passed 21st Century Cures Act explained to the US Food and Drug Administration (FDA) which categories of software should be exempt from medical device regulations. Most ...

The US Food and Drug Administration’s (FDA) final guidance on clinical decision support (CDS) software goes against the statutory language laid out in the 21 st Century Cures Act, according to a legal ...

Sony BMG Music settled charges that it violated the law when it sold CDs without telling customers that they contain software that limited buyers' ability to play the music and kept track of listening ...

Computers, whether through simple decision trees or complex neural networks, are increasingly playing a larger and larger role in helping healthcare providers make treatment decisions. As the role of ...

In a settlement that will cost the music giant more than $1.5 million, Sony BMG has agreed to stop distributing CDs secretly embedded with software alleged to make the discs vulnerable to hackers. By ...

The saga of U.S. FDA regulation of clinical decision support (CDS) software has spanned six years since the passage of the 21st Century Cures Act, yielding two FDA draft guidances and a final guidance ...