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Popularity of Remote Patient Monitoring Skyrockets — Is it Secure?
A recent report from commercial intelligence platform provider Definitive Healthcare revealed that remote patient monitoring insurance reimbursement claims rose 1,294% from January 2019 to November 2022. It’s likely that a desire to minimize contact during the pandemic drove much of this demand. But remote patient monitoring claims continued to grow even after people resumed face-to-face…
Countdown to Safer Medical Devices
A six-month clock started ticking late last year, counting down to the FDA’s new deadline for updating its public-facing guidance for improving the cybersecurity of medical devices. This requirement became law on Dec. 29, 2022, as part of a $1.7 trillion Omnibus Appropriations Bill that also includes new rules for submitting applicable medical devices to…
Getting Real about Real-Time Location Systems
Real-Time Location Systems, or RTLS, emerged in the 1990s for use by government and military entities. The technology has been adopted in manufacturing, logistics and aerospace applications for years. Now it is coming into its own in a growing variety of other applications, from healthcare consignment inventory management to retail item tracking. It’s time to…
The Hidden Crisis Within Today’s Healthcare Crisis
The Healthcare Crisis of today – or, perhaps more accurately, over the past two years — has been never-ending waves of COVID-19 variants. With “Alpha” starting in 2019 to the current “Omicron” & “BA.2” mutations, our hospital systems have been stretched to the breaking point. This crisis has forced administrators to deal with huge patient…
Thirdwayv Applauds Insulet’s FDA Clearance for the World’s First Tubeless Automated Insulin System with Smartphone Control
Congratulations to Insulet and all the kids who will sleep better now after the company announced FDA clearance of its Omnipod® 5 Automated Insulin Delivery System for people with type 1 diabetes aged 6 years and older. It is the first and only tubeless automated insulin delivery (AID) system in the US with compatible smartphone…
FDA Cybersecurity Playbook is out – so what?
The FDA’s long-awaited playbook on cybersecurity for medical devices is out, and while it covers critical topics related to preparedness and response, we hope it’ll soon be followed by efforts that focus on threat prevention. The Playbook thoughtfully covers fundamental concerns for Healthcare Delivery Organizations (HDOs) in managing cyber attacks on Healthcare and Public Health infrastructure…
Stop by for a visit at Cold Chain Global Forum – Philadelphia, Sept 24
You might ask how “Temperature Control” relates to the “Internet of Things”. Well, if you’re interested in tracking temperature of critical assets automatically and efficiently, the days of manual data logs, inspections and reports are going away quickly. IoT devices that provide real-time information including temperature data can provide much greater value than conventional systems. …
Don’t get nicked by “Z-Shave”
While malware hacks such as WannaCry, Fancy Bear and Petya get widespread news coverage, Z-Shave “Man in the Middle” attacks could be much more relevant to the world of IoT. As Catalin Cimpanu writes in this article, the Z-Shave vulnerability could impact more than 100 million devices that use the Z-Wave wireless protocol! The Z-Shave attack exploits the fact that two wireless “Things” that are designed to talk to each other never…
Come See Us at Internet of Things World
We are excited to be joining the world’s top IoT companies next week at one of this industry’s biggest events. We’ll be showcasing our connected health solution that is enabling what we expect will be the first FDA-approved life-sustaining drug delivery device that can be controlled with a smartphone. A few thoughts come to…
FDA Releases Statement on its Medical Device Safety Action Plan
On April 17, FDA Commissioner Scott Gottlieb released a statement regarding the agency’s latest efforts to enhance and modernize its approach to medical device safety and innovation. Aimed at protecting patients and promoting public health, the Medical Device Safety Action Plan outlines how the agency will encourage innovation to improve safety, detect safety risks…
Recall is a Wakeup call: Abbott Announces Defib Cybersecurity Updates
Today, Abbott announced the latest in what it has described as a planned series of cybersecurity updates for the company’s implantable cardioverter defibrillators (ICDs). The voluntary recall reportedly applies to 382,000 devices in the U.S. alone, 350,000 of which are currently implanted in patients. The FDA said in its simultaneous alert about the firmware…