By William Hyman – The 21st Century Cures Act addressed what kinds of medical software are medical devices (and therefore subject to regulation by the FDA), and what kinds are not medical devices (and therefore not regulated by the FDA, but subject to CPSC and FTC).
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By Suzanne Schwartz MD MBA – Virtually every aspect of our lives – including our health – has gone digital. Medical devices from insulin pumps to implantable cardiac pacemakers are becoming more interconnected and, like computers and the networks they operate in, can be vulnerable to security breaches.
By Bakul Patel – Imagine an intensive care unit for newborns. An interface on a device called a pulse oximeter is sending data on changes in the newborns’ blood oxygen level to a hospital computer system that simultaneously gathers data from EKGs that are monitoring the electrical activity of their hearts.
By Scott Gottlieb MD – When people think about personalized medicine, they often think of genetic testing and sequencing of the human genome. But the concept of personalized medicine is much broader. It includes the re-imagination of healthcare delivery.
By Sarianne Gruber – More and more medical devices are becoming smarter, and close to 15% are already smart and are on the network. The challenge with connected ‘smart’ medical devices is their vulnerability to cybersecurity attacks.
By Sarianne Gruber – More and more medical devices are becoming smarter, and close to 15% are already smart and are on the network. The…
By Rachel Beavins Tracy – After the mega-merger era of 2015-2016, the passage of the 21st Century Cures Act and a new administration in the White House, many in the medical device industry are wondering what changes are on the horizon for 2017.
By William A. Hyman – Readers in this space are well aware of cybersecurity threats, and the need for affirmative security activities to prevent threats from becoming crises. Risk assessment is part of this agenda…
By Tim Needham – Medical device and biomedical/clinical engineering teams are relying more and more on their provider’s IT infrastructure department to perform job duties.