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- Contact the FDA, or other regulatory bodies. - Contact the customers. They'll likely have standing to sue (they were sold a defective product). - Class-act

- Contact the FDA, or other regulatory bodies. - Contact the customers. They'll likely have standing to sue (they were sold a defective product). - Class-action attorneys may be interested for this reason. - Did you know you can pay a very, very modest amount of money to file a press release saying anything you want? - Contact some investors. Short sellers will have a vested interest in making sure the information gets widely publicised.

droopyEyelids 12y ago
I believe this comes closest to the proper answer. Eventually, we need technology literate courts, and a law that criminalizes failure to fix disclosed vulnerabilities. Until that day, the process you describe best achieves the same result.
- eitally 12y ago
  I agree, and -- generally speaking -- OEMs take FDA compliance for Class III medical devices very seriously. If there is a regulation violation that could put patients at risk, the FDA would not hesitate to shut down production and force a fix, whether it's hardware or software. (Speaking from the perspective of an IT guy at an electronics manufacturing company who is well versed in CFR 11 and medical validation.)
duaneb 12y ago
What is legality regarding the investors shorting?
- jacquesm 12y ago
  Since it's on HN you could technically argue that it is now publicly known. If you short the stock past this point you may well be in the clear.
  - fiatmoney 12y ago
    There's no requirement for information to be "publicly known" to trade on it. You have to be an "insider" for it to be insider trading - ie, there has to be some relationship of trust (eg an employee or officer, or in some circumstances people they "tip off").
- fiatmoney 12y ago
  It's not insider trading; you have no relationship with the company that establishes a responsibility to keep their secrets (might be a different story if you, eg, paid an insider for the information). For that matter the device as it's handed to the public is public information. It's no different than discovering your hamburger is poisoned and shorting McDonald's.
chrisBob 12y ago
I agree that the FDA would be a good place to start. I only know people on the Drug side, so I am not sure who to have you talk to about devices. I would start with Josh Simms who is in charge of Cardio Devices in the Division of Manufacturing and Quality at 301-796-5540, or maybe someone in the Office of Device Evaluation. Mark Feliman at 301-796-5630 is in charge of Cardiac Electrophysiology Devices, but I think he works more on the approval side. The appropriate contact info for all of CDRH can be found here: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm127854.htm#OIR http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalPr...

droopyEyelids 12y ago

I believe this comes closest to the proper answer. Eventually, we need technology literate courts, and a law that criminalizes failure to fix disclosed vulnerabilities. Until that day, the process you describe best achieves the same result.

eitally 12y ago
I agree, and -- generally speaking -- OEMs take FDA compliance for Class III medical devices very seriously. If there is a regulation violation that could put patients at risk, the FDA would not hesitate to shut down production and force a fix, whether it's hardware or software. (Speaking from the perspective of an IT guy at an electronics manufacturing company who is well versed in CFR 11 and medical validation.)

duaneb 12y ago

What is legality regarding the investors shorting?

jacquesm 12y ago
Since it's on HN you could technically argue that it is now publicly known. If you short the stock past this point you may well be in the clear.
- fiatmoney 12y ago
  There's no requirement for information to be "publicly known" to trade on it. You have to be an "insider" for it to be insider trading - ie, there has to be some relationship of trust (eg an employee or officer, or in some circumstances people they "tip off").
fiatmoney 12y ago
It's not insider trading; you have no relationship with the company that establishes a responsibility to keep their secrets (might be a different story if you, eg, paid an insider for the information). For that matter the device as it's handed to the public is public information. It's no different than discovering your hamburger is poisoned and shorting McDonald's.

chrisBob 12y ago

I agree that the FDA would be a good place to start. I only know people on the Drug side, so I am not sure who to have you talk to about devices. I would start with Josh Simms who is in charge of Cardio Devices in the Division of Manufacturing and Quality at 301-796-5540, or maybe someone in the Office of Device Evaluation. Mark Feliman at 301-796-5630 is in charge of Cardiac Electrophysiology Devices, but I think he works more on the approval side. The appropriate contact info for all of CDRH can be found here: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm127854.htm#OIR http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalPr...