Newsletter - January 12, 2017
Hacking Risks for Medical Devices with Internet Connectivity
Like any other internet-connected device, medical devices can be hacked, and the hacked device used to harm the individual dependent on it. Imagine someone controlling the pacemaker embedded in your body or the infusion pump giving you life-support. It’s no different from someone pointing a gun to your head, with similar outcome. The possibility no longer just resides in the minds of Hollywood writers but is a really scary concern. Read More
Limitation of Real World Evidence Highlighted by Physician Survey
Data collected from doctors, medical records, insurance claims databases and patient registries regarding use of medical products and disease conditions, called “Real World Evidence”, is often claimed to be reliable, robust and credible enough to support regulatory decisions. The 21st Century Cures Act requires FDA to create a process to use Real World Evidence (RWE) in support of market approval of products. Read More
Hacking Risks for Medical Devices with Internet Connectivity
Like any other internet-connected device, medical devices can be hacked, and the hacked device used to harm the individual dependent on it. Imagine someone controlling the pacemaker embedded in your body or the infusion pump giving you life-support. It’s no different from someone pointing a gun to your head, with similar outcome. The possibility no longer just resides in the minds of Hollywood writers but is a really scary concern. Read More
Limitation of Real World Evidence Highlighted by Physician Survey
Data collected from doctors, medical records, insurance claims databases and patient registries regarding use of medical products and disease conditions, called “Real World Evidence”, is often claimed to be reliable, robust and credible enough to support regulatory decisions. The 21st Century Cures Act requires FDA to create a process to use Real World Evidence (RWE) in support of market approval of products. Read More
