Bob on Medical Device Software

August-9-2014

14:24

left-right-brainIBM Unveils a ‘Brain-Like’ Chip With 4,000 Processor Cores. The TrueNorth chip mimics 1 million neurons and 256 million synapses that IBM calls “spiking neurons.”

…the chip can encode data as patterns of pulses, which is similar to one of the many ways neuroscientists think the brain stores information.

IBM Research: Neurosynaptic chips provides more information on the low power system architecture and potential applications:

Neurosynaptic-chips

This is similar to Qualcomm’s Brain-Inspired Computing effort.

July-20-2014

2:25

I had been reading about “internet of things” (IoT) connectivity standards groups (links below) when I came across Bridget Moorman’s post Connectivity Standards Adoption Over Time.

I made an off-the-cuff comment because of the contrast I saw between the way other industries approach standards vs. the medical device industry.  Bridget and Tim kindly responded with informative feedback.

Standards are hard, so I guess it’s not easy for anyone.

 

June-3-2014

16:09

apple-healthkitThe reality of healthcare interoperabilty is going mainstream: Apple Launches HealthKit To Share Vital Stats With Nike, Mayo Clinic:

The problem Apple will run into: No one agrees on how to measure even very simple health metrics, …

TL;DR:  iOS 7.1 to iOS 8.0 API Differences (search for ‘HealthKit’ on the page).

UPDATE (8/18/14);  Apple – iOS 8 – Health

April-6-2014

1:39

health-it-catagoriesThe Food and Drug Administration Safety and Innovation Act (FDASIA) required the FDA to develop:

a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.

Here’s the report: FDASIA Health IT Report (warning: PDF).

It looks like EMR/EHR vendors (administrative and health management functionality) don’t have to worry about FDA regulatory oversight. The medical device category (of course) does:

FDA would focus its oversight on medical device functionality because, in general, these functions, such as computer aided detection software and remote display or notification of real-time alarms from bedside monitors, present greater risks to patient safety than health IT with administrative or health management functionality.

 

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