- Devices fail and people die - the public wants appropriate assurances that these deaths are investigated and effective corrective and preventive actions are taken.
- 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.
- The FDA is going to have to learn to recognize the difference between "Checking" and "Testing" software, and begin demanding the latter.
- 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.
- Hacking will continue to grow as a concern.
- What is your opinion about using open source software for medical devices?
- 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?