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1 projects are tagged with “software”.

Very few medical devices consist solely of electro-mechanical technologies these days. Most have firmware to drive the core therapeutic or imaging modalities. Medical device software (including an algorithm to compute results), and data transfer logic connect the devices to hospital networks and populate enterprise data warehouses. In my experience, writing, testing and debugging medical device […]

If you are building a cloud-based mobile medical app, don’t delay on your privacy and security strategy. With the mHealth Summit kicking off this week, have no doubt that medical devices, privacy and cloud-based mobile apps will be hyped.  The summit will showcase how personal devices and wearables are now integrated into mobile medical apps. But is […]

Toyota’s recent $1.5 million jury awarded loss in an Oklahoma court illustrates it’s pretty much impossible to write software without some third party code creeping in.  IEC62304:2006 calls this “Software of Unknown Provenance” or SOUP, referring to software with unknown safety-related characteristics, or developed under an unknown methodology.  I know the situation very well.  Operating Systems, code libraries […]

Hacking (gaining access to a device through unintended means) commonly has negative connotations, but it need not imply an intent to destroy data or harm hardware. I’ll use the term Hacking in this blog, with the acknowledgement that when malicious intent is involved, a better term is Cracking. Hacking medical devices is not new, but […]