Wednesday, September 28, 2011

Opening propriety medical device software up for inspection and review

In the following article, the GNOME director argues for opening up propriety medical device software to review and inspection.  Read the article, and follow the footnotes and links.

Issues raised:
  1. Devices fail and people die - the public wants appropriate assurances that these deaths are investigated and effective corrective and preventive actions are taken.
  2. The public is not completely ignorant of the vulnerabilities of the technology. "Trust us. We are the experts." - may not be a defensible public position for much longer. The public may demand objective, competent, 3rd party assessment of these products.
  3. The FDA is going to have to learn to recognize the difference between "Checking" and "Testing" software, and begin demanding the latter.
  4. With the surge in the use of medical device software, the public interest in regulating the risks to the patient of this technology will only grow over time.
  5. Hacking will continue to grow as a concern.
  1. What is your opinion about using open source software for medical devices?
  2. What if someone created an open source hardware/software implantable defibrillator, that cost 1/20th of a proprietary solution. 

    Why would the insurance companies and the government not mandate their use?

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