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Author Archives: Bob
Controlling a Computer with EMG
Microsoft has applied for a patent for using finger flexing to control a computer. I’ve talked many times in the past about the use of EEG technology for computer control (brain-computer interface, BCI). As discussed in the RWW article, there … Continue reading
When Open-source can Kill or Cure
The use of open-source software in medical devices has been a topic of discussion for many years. The Economist article Open-source medical devices: When code can kill or cure highlights continuing activity in the academic community and interest by the FDA in developing … Continue reading
Posted in FDA, Medical Devices, Open Source
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Healthcare IT Q&A: R.I.P.
After close to two years of effort (see here) the Healthcare IT Stack Exchange Site is closing for good. HealthCare IT is closing: it simply does not appear that this topic has a strong enough following on our network to support … Continue reading
Design Patterns for EMR/EHR Performance
Healthy Architectures – Using CQRS and Event Sourcing for Electronic Medical Records presents a couple of interesting patterns for the management of healthcare data. The two patterns are: Command Query Responsibility Segregation (CQRS) Event Sourcing (ES) Here’s another article that provides … Continue reading
OTS/SOUP Software Validation Strategies
My last discussion of Off-The-Shelf software validation only considered the high-level regulatory requirements. What I want to do now is dig deeper into the strategies for answering question #5: How do you know it works? This is the tough one. … Continue reading
Building Safety into Medical Device Software
The article Build and Validate Safety in Medical Device Software takes a critical look at the current processes for medical device software and concludes: The complexity of the software employed in many medical devices has rendered inadequate traditional methods (testing) for demonstrating … Continue reading
Posted in FDA, Medical Devices, Software Quality
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SOPA and Internet Censorship
I first heard about this from a system message on the Stack Overflow site. The post Protect intellectual property – but not like this explains their position (in particular, SOPA vs. DMCA) and has a lot of good links to more information. SOPA-Rope-a-dope has … Continue reading
Posted in General
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Validation of Off-The-Shelf Software Development Tools
A reader asked me about OTS software tool validation. He says: It seems to me that the editor and any other tool used to create the software is exactly that, a productivity tool. The end result (compiled binary installed on a … Continue reading
Brain Wave Monitoring Through the Extremities
The recent Time Magazine article Thought Control (subscription required) describes what is essentially another brain-computer interface. What’s novel about this device is that the EEG signal is monitored from dry electrodes on the arm or leg. The BodyWave® Brain Wave Monitoring (pdf) … Continue reading
Finally Launched: Healthcare IT Q&A
The new Healthcare IT Stack Exchange site is now open to the public. Hopefully this thing will take off. So go search, ask, answer, up vote, and (yes) down vote when necessary. Also, don’t forget to tell your friends and colleagues. … Continue reading