Safety Communications > Battery Performance Alert and Cybersecurity Firmware Updates for Certain Abbott (formerly St. Jude Medical) Implantable Cardiac Devices: FDA Safety Communication

As a heart patient myself, I’m intrigued by the cyber-security aspects of these implantable devices. I think we’re going to see a lot in this area in the short-term.

~TJK

“Cybersecurity

Many medical devices—including Abbott’s ICD and CRT-D devices—contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits. As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect how a medical device operates.”

Source: Safety Communications > Battery Performance Alert and Cybersecurity Firmware Updates for Certain Abbott (formerly St. Jude Medical) Implantable Cardiac Devices: FDA Safety Communication

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Alexa, Fitbit and Apple Watch are your digital snitches – CNET

Alexa is always listening…..

~TJK

 

Source: Alexa, Fitbit and Apple Watch are your digital snitches – CNET

WEARABLE TECH

Your Alexa and Fitbit can testify against you in court

In today’s digital world, Big Brother may be on your wrist, in your room — or inside your heart.

BY 

  • MARGUERITE REARDON

reMarkable Tablet

Hi REMARKABLE eWriting Tablet Thingie people,

ReMarkable, £579

I’m very impressed with the concept and initial execution (you’ve shipped a viable product….Bravo!). That being said, there is a lot of promise here (untapped promise). Things like OCR, indexing, interfaces to external apps, an embedded web browser (even if only text), etc. etc. etc. There are so many ways you could go with this.

 

Is there a road map as to where you *actually are going* (or attempting to go). Not just exploring your options, but going with intent. I know that you don’t promise anything that you’re not sure of, but give us an idea. Is there a document online outlining this?
 
Before I drop $500+ on a tablet of this sort that only does some of what I’d need to ditch my paper notebooks, I’ll want to know what to a bit about the plan. Will earlyadopters be rewarded or will they be left holding a pricey beta device once the more polished/functional version comes out in 6 months or a year? Thanks and keep up the good work.
 
~TJK

Open Source

The open-source model has been crucial…and this article outlines that nicely.

 

Mozilla’s radical open-source move helped rewrite rules of tech

A gamble 20 years ago unleashed the source code for the browser that became Firefox. The approach is now core to Facebook, Google and everyone else.

New Proposed Auditing Course: Considerations for an eData Quality Audit Program

We’ve submitted this course proposal for the April SQA Quality College in Anaheim. Feedback has been good, but even if it isn’t picked up for this venue…it will eventually happen *somewhere*:

Instructors: Timothy J. Kuhn and Conrad Kawaguchi

Target Audience: Seasoned Auditors with little eData/CSV experience or CSV professionals with little auditing experience.

 Course Objectives

• Establish and differentiate between the eData Audit Function and the Operational CSV Quality Roles.

• List the considerations for the GxP eData Audit Program (Contributing to other GxP Audits, Independent Focused Data Integrity Audits, etc.)

• Explore the various roles that the eData Auditor may serve as part of an audit (SME, Co-Auditor, Audit Lead)

• Define and list the desired skill set for the eData Audit Team

• Break down the various types of audits and risk areas for each: GLP Labs, Central Clinical Labs, Central Readers (eCG, Imaging, etc.), ePRO (Electronic Patient Reported Outcomes – AKA Diaries), Acquisition Due Diligence, GMP Manufacturing Sites and Vendors, PV, eSystem Validation, Databases, IT Infrastructure, Cloud Providers, Software Providers, SaaS vendors, Pharma, Device, Combo Product, and others.

Course Description: Electronic Data (eData) is pervasive in the GxP world and auditors in that GxP eData space need to understand what is most important in these areas. This course will explore considerations in establishing an eData audit program, give auditors with little Technology/eData/Computer System Validation(CSV)/IT saavy the understanding needed to assess the eData/eSystems they encounter in the course of their existing GxP audits, and expand the understanding of eData auditors beyond the software vendor audit so as to know what is most important in GxP audits. The course will demonstrate “what to look for” for a variety of audits, both technology-focused and more conventional areas in which technology has “encroached”.

 

~TJK

Equifax Breach

Equifax says a giant cybersecurity breach compromised the personal information of as many as 143 million Americans — almost half the country.

 

http://money.cnn.com/2017/09/07/technology/business/equifax-data-breach/index.html

 

 

NIH: Robotic Exoskeleton Could Be Right Step Forward for Kids with Cerebral Palsy

This is very cool!

#VeryCool

Robotic Exoskeleton Could Be Right Step Forward for Kids with Cerebral Palsy
09/05/2017 09:55 AM EDT
https://na01.safelinks.protection.outlook.com/…

More than 17 million people around the world are living with cerebral palsy, a movement disorder that occurs when motor areas of a child’s brain do not develop correctly or are damaged early in life. Many of those affected were born extremely prematurely and suffered brain hemorrhages shortly after birth. One of the condition’s most […]
Robotic Exoskeleton Could Be Right Step Forward for Kids with Cerebral Palsy
09/05/2017 09:55 AM EDT

More than 17 million people around the world are living with cerebral palsy, a movement disorder that occurs when motor areas of a child’s brain do not develop correctly or are damaged early in life. Many of those affected were born extremely prematurely and suffered brain hemorrhages shortly after birth. One of the condition’s most […]

More than 17 million people around the world are living with cerebral palsy, a movement disorder that occurs when motor areas of a child’s brain do not…
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