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

Posted in EEG, Microsoft | Tagged | 1 Comment

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 | 4 Comments

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

Posted in General | Tagged | 1 Comment

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

Posted in EMR, Programming | Tagged , , | 2 Comments

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

Posted in FDA, Software Quality | Tagged , | 8 Comments

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

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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

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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

Posted in FDA | Tagged , | 12 Comments

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

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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

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