Sunday, July 25, 2010
What can I say here? We all obviously think turning off automatic alarms is a bad thing. What would have been a better solution to the problem? A timeout on the override? Getting people in the chain of command to actually understand the risks of turning safety features off in the name of production? Better Maintenance logs across departments and system replacements (testimony clearly indicates that area had problems)? Is your system designed to minimize false alarms?
What do you think after watching Mr. Williams' testimony?
One off-the-wall closing thought: "This is the Seventh Sign: You will hear of the sea turning black, and many living things dying because of it." -- White Feather, a Hopi of the ancient Bear Clan.
SFLC makes a case for why Safety Critical systems should all have their source code available for public review. They are promoting Free and Open Source Software (FOSS) be mandated for medical devices, and all devices in general; myself I want to see Toyota's source code to look for the race condition [unfortunate terminology in this case] of unintended acceleration that I believe exists.
I covered the issues related to the FDA's promotion of FOSS in medical devices previously: FDA says commercial software kills, but Open Source won't? and 200,000 Infusion Pumps ordered destroyed by FDA, due to software defects and other problems.
Philosophically I agree with SFLC's position, and in Utopia it would work out well that all devices have Free Open Source Code. However in the real world of cooperate greed where only the bottom line of next quarter is all that maters, I do not see medical device manufactures, or automotive manufactures, giving up what they would consider 'Trade Secrets' so that their competition could use them. A more workable solution would be an independent auditing agency, which still must be held to the highest standards to prevent such things as cooperate kickbacks. Nor would we want the agency to be funded by the people that are having their code audited.
Also just because a project is FOSS does not mean it is secure. One only has to take a look at the recent events of the Unreal IRC Server Project.
"We found out that the Unreal126.96.36.199.tar.gz file on our mirrors has been replaced quite a while ago with a version with a backdoor (Trojan) in it.".
This incident demonstrates that the entire chain of custody from the Source Code to the code on the device must be traceable, so that the code that is really being run, is the code that came from the legitimate sources of the project.
Unreal had this to say about addressing the issue, to give some ideas of what needs to be done:
Posted by Syzop on June 14, 2010, 3:36 pm EDT
After receiving many questions of what we are doing with regards to the hack incident, here's my reply:
First, we now PGP/GPG sign releases. Our GPG key is firstname.lastname@example.org (0x9FF03937). When downloading UnrealIRCd you will be given instructions on how to verify the integrity of the file.
Second, we're now isolating/shielding the main site from the rest, and making parts unmodifiable, to prevent catastrophes in case of a break-in.
Third, we added several methods of detection when files and other data is modified.
Fourth, we'll only serve the files from the main site for now. While the mirror admins did not have any blame in this, it does mean we only have to protect our own site(s).
And finally we did some other things which I won't mention here.
In short: we've really tightened security since the break-in to make sure this will never ever happen again. As you may understand, we really can't afford a repeat of this incident.
On an unrelated side note, I find the claims in various media that this security incident indicates that Linux and Open Source cannot be trusted and that Microsoft and closed-software is better really silly. It lacks any foundation. A hacker, once in, could just as easily have inserted the backdoor in Windows software. In fact, it is *THANKS* to it being Open Source that this backdoor got noticed, though - I fully agree - much too late.
Hash Deep is helpful to find development files that have changed unintentionally, due to either simple disk corruption or malicious intent. On Embedded Devices themselves I run CRC checks of the code. SRecord is a big help in this area.
Returning back to SLFC's paper. SFLC points to the case of Riegel v. Medtroni in February 2008, stating:
"Since the FDA is a federal agency, its authority supersedes state law. Based on the concept of preemption, the Supreme Court held that damages actions permitted under state tort law could not be filed against device manufacturers deemed to be in compliance with the FDA, even in the event of gross negligence."...
"It is clear that medical device manufacturers have responsibilities that extend far beyond FDA approval and that many companies have failed to meet their obligations," William H. Maisel said in recent congressional testimony on the Medical Device Reform bill.50 "Yet, the U.S. Supreme Court ruled in their February 2008 decision, Riegel v. Medtronic, that manufacturers could not be sued under state law by patients harmed by product defects from FDA-approved medical devices ... . [C]onsumers are unable to seek compensation from manufacturers for their injuries, lost wages, or health expenses. Most importantly, the Riegel decision eliminates an important consumer safeguard - the threat of manufacturer liability - and will lead to less safe medical devices and an increased number of patient injuries."
Here is part of that actual US Supreme Court Decision, that I took from Cornell:
"The Riegels contend that the duties underlying negligence, strict-liability, and implied-warranty claims are not pre-empted even if they impose " 'requirements,' " because general common-law duties are not requirements maintained " 'with respect to devices.' " Brief for Petitioner 34-36. Again, a majority of this Court suggested otherwise in Lohr. See 518 U. S., at 504-505 (opinion of Breyer, J.); id., at 514 (opinion of O'Connor, J., joined by Rehnquist, C. J., and Scalia and Thomas, JJ.).6 And with good reason. The language of the statute does not bear the Riegels' reading. The MDA provides that no State "may establish or continue in effect with respect to a device ... any requirement" relating to safety or effectiveness that is different from, or in addition to, federal requirements. §360k(a) (emphasis added). The Riegels' suit depends upon New York's "continu[ing] in effect" general tort duties "with respect to " Medtronic's catheter. Nothing in the statutory text suggests that the pre-empted state requirement must apply only to the relevant device, or only to medical devices and not to all products and all actions in general." --- Justice Scalia, Opinion of the Court; RIEGEL v. MEDTRONIC, INC. (No. 06-179)
451 F. 3d 104, affirmed.
Not being a lawyer, it seems to me that the Court just gave medical device manufactures a free pass to make defective products because there is no longer a threat of liability? We have all seen the End User Licenses Agreements (EULA) for software that all say, using lots of Lawyer Weasel Words, "No mater what this software does to you and yours. It is not our fault. To bad for you." Is this where hardware is now?
Thursday, July 15, 2010
Before getting into that I need to point out that some might consider my view biased. In a past life I designed Coal Mining equipment, and I'm still involved with Mine Safety and Health Administration (MSHA) and the Coal Ming section of CDC/NIOSH. See our A Technology Review of Smart Sensors with Wireless Networks for Applications in Hazardous Work Environments booklet for example. A bit outdated now, written before most people had heard of wireless sensors or energy harvesting. Now with that out of the way, lets move on...
The major design goal of any moving vehicle is to keep its weight down. Right now each and every car out there has to carry the weight of its own pollution control system around. That takes energy in and of itself.
Putting the pollution control system at the power plant has no issues of weight so they can be far more effective. Since the electric car no longer has to consume energy to move around its own pollution system there is an over all savings of resources.
What is more importantly overlooked is the resources consumed in making the pollution control system for every existing gas powered vehicle.
Resources such as Palladium and other metals are used to make Catalytic Converters, which takes significant energy in the manufacturing process. There are may other resources also consumed to manufacture these pollution control systems.
Something else most always over looked in the discussion of hybrid vehicles just moving the pollution form the tail pipe to the smoke stack, is Regenerative Braking.
In both conventional and hybrid/electric vehicles energy is used to get the vehicle moving, in other words the fuel is converted in to kinetic energy. However there is a significant difference in how energy is used to get the respective vehicle types stopped.
A conventional vehicle uses friction heating to dissipate the energy that was used to get the vehicle moving in the first place. Applying the brakes causes the brake pads to engage to slow the vehicle to a stop by dissipating the kinetic energy as heat through friction. That heat goes into the environment, and is totally wasted.
On the other hand, a properly designed hybrid or electric vehicle will use Regenerative Braking to return the kinetic energy back into stored energy in the systems batteries or capacitors. There will be some small amount of energy lost to the environment, due to the system not being 100% efficient.
The bottom line is that the existing vehicles waste nearly 100% of their stopping energy, while a electric vehicle will recover significant amounts of their stopping energy, which will approach 100% recovery as technology advances.
One final thought. Did auto and oil companies gang up to kill the electric car? Check out 2006 documentary film "Who killed the electric car?".
Sunday, July 4, 2010
If you happen to be in the Youngstown Ohio area on July 8th 2010, you might want to stop into the seminar being giving on how to get grants from the Government for your high-tech start-up adventure:
"Show Me the Money! Obtaining Government Funds for High-Tech Start-Ups and Small Businesses. Learn innovative ways to pursue pgovernment funding, new rules on earmarks and how they affect small businesses, legislative opportunities to advance your organization, and what agencies are looking for in grant applications."
- Thursday, July 8th, 2010
- 12:00pm - 2:00pm
- The Butler Institute of American Art
- The Parlor Room
- 524 Wick Ave., Youngstown, Ohio, 44502
While I personally would like to see such pork gone, so that we all end up with lower taxes, we might as well take advantage of the supposedly "free" money ("free" in the Orwellian sense that it was taken by force from you and I in the form of taxes), to take advantage of the programs offered, until we can vote their creators out of office.
While in the area you might want to stop by Youngstown State University. YSU recently held their 2010 Sustainable Energy Forum. The areas leaders are hoping to invent a "Tech. Belt", 134 miles long from Cleveland to Pittsburgh. They see Sustainable Energy as a key component. After all when you stop to think about, the key to survival at any level of abstraction is energy, right down to the energy we each get from our food.
They covered the usual suspects:
- Energy Efficiency
- Fuel Cells and Electric Vehicles
- General Topics: Liquid Fuels, Advanced Material, etc.
- Landfill / Digester Gas
- Wind and Solar
Alas world changing ideas don't come from the mainstream, but from the obscure people working in their workshops, working on ideas that many say would not work at all, ever. Our own industry is a good example. Fellow from IBM once said that there was only the need for a few computers world wide, ever. Unil a few people working in garages and such started to play with the first microprocessors, and we all know how that turned out.
To see what is happening in the fridges of Science take a look at the 17th annual Natural Philosophy Alliance conference recently held in Long Beach California.
You can get the Conference Proceedings, 650 Pages, to see what is happening on the bleeding edge of Wired Science.
Is all of that valid, not at all likely, will something there change the world, maybe it just might... Our Consensus Reality is made up of what we believe is possible...