Although the medical device industry operates within a stringent regulatory environment, the
growing deployment of connected, intelligent medical devices (CIMDs) in the healthcare …

FEATURE to the desire to make a political statement (eg, denial-of-service attacks on the
Boston Children's Hospital13 and Hurley Medical Center in Flint, MI14). Healthcare …

Managing Risk lems that previously were unseen with older devices. 1 Devices that rely on
off-the-shelf software, particularly commercial operating systems (eg, versions of Microsoft …

Medical devices (MDs) are becoming increasingly networked. Given, that safety is the most
significant factor within then MD industry and the radical shift in MDs design to enable them …

The integration of the Internet of Medical Things (IoMT) and Artificial Intelligence (AI) into
clinical routines is significantly impacting organisational preparedness at the point of care …

The newly adopted EU AI Act represents a pivotal milestone that heralds a new era of AI
regulation across industries. With its broad territorial scope and applicability, this …

Approaches to Cybersecurity for use of security assurance cases to demonstrate confidence
in IEC/TR 80001-2-2 security capabilities. 6 80001-2-2 has been a commonly used resource …

Healthcare is a rapidly growing industry that is continuously expanding with technological
advances. Similar to many other critical industries, healthcare faces an onslaught of daily …

11 Horizons Fall 2017 got to automate as much as we can, and we're simply being told to do
it far ahead of what we are ready for. I think that's the root cause of this problem. It's not just a …

Regulation of medical devices has been one of the most notable regulatory initiatives of the
European Union. The need to ensure that medical devices are of a high quality is self …