FDA approves "The Chip", a step to the future, or to The End?

http://story.news.yahoo.com/news?tmpl=story&cid=562&ncid=738&e=4&u=/ap/20041013/ap_on_hi_te/fda_implantable_chip said:

FDA Approves Use of Chip in Patients

26 minutes ago

By DIEDTRA HENDERSON

WASHINGTON - Medical milestone or privacy invasion? A tiny computer chip approved Wednesday for implantation in a patient's arm can speed vital information about a patient's medical history to doctors and hospitals. But critics warn that it could open new ways to imperil the confidentiality of medical records.


The Food and Drug Administration (news - web sites) said Wednesday that Applied Digital Solutions of Delray Beach, Fla., could market the VeriChip, an implantable computer chip about the size of a grain of rice, for medical purposes.


The news pleased investors. On Wednesday, Applied Digital shares were up $1.45, or 68.4 percent, at $3.57 on the Nasdaq Stock Market — near the middle of their 52-week range of $1.94 to $5.


With the pinch of a syringe, the microchip is inserted under the skin in a procedure that takes less than 20 minutes and leaves no stitches. Silently and invisibly, the dormant chip stores a code that releases patient-specific information when a scanner passes over it.


Think UPC code. The identifier, emblazoned on a food item, brings up its name and price on the cashier's screen. At the doctor's office the codes stamped onto chips, once scanned, would reveal such information as a patient's allergies and prior treatments, speeding care.


The microchips have already been implanted in 1 million pets. But the chip's possible dual use for tracking people's movements — as well as speeding delivery of their medical information to emergency rooms — has raised alarm.


"If privacy protections aren't built in at the outset, there could be harmful consequences for patients," said Emily Stewart, a policy analyst at the Health Privacy Project.


To protect patient privacy, the devices should reveal only vital medical information, like blood type and allergic reactions, needed for health care workers to do their jobs, Stewart said.


An information technology guru at Detroit Medical Center, however, sees the benefits of the devices and will lobby for his center's inclusion in a VeriChip pilot program.


"One of the big problems in health care has been the medical records situation. So much of it is still on paper," said David Ellis, the center's chief futurist and co-founder of the Michigan Electronic Medical Records Initiative.


As "medically mobile" patients visit specialists for care, their records fragment on computer systems that don't talk to each other.


"It's part of the future of medicine to have these kinds of technologies that make life simpler for the patient," Ellis said. Pushing for the strongest encryption algorithms to ensure hackers can't nab medical data as information transfers from chip to reader to secure database, will help address privacy concerns, he said.


The U.S. Department of Health and Human Services (news - web sites) on Wednesday announced $139 million in grants to help make real President Bush (news - web sites)'s push for electronic health records for most Americans within a decade.


William A. Pierce, an HHS spokesman, could not say whether VeriChip and its accompanying secure database of medical records fit within that initiative.


"Exactly what those technologies are is still to be sorted out," Pierce said. "It all has to respect and comport with the privacy rules."


Applied Digital gave away scanners to a few hundred animal shelters and veterinary clinics when it first entered the pet market 15 years ago. Now, 50,000 such scanners have been sold.


To kickstart the chip's use among humans, Applied Digital will provide $650 scanners for free at 200 of the nation's trauma centers.


In pets, installing the chip runs about $50. For humans, the chip implantation cost would be $150 to $200, said Angela Fulcher, an Applied Digital spokeswoman.

Fulcher could not say whether the cost of data storage and encrypted transmission of medical information would be passed to providers.

Ultimately, the company hopes patients who suffer from such ailments as diabetes and Alzheimer's or who undergo complex treatments, like chemotherapy, would have chips implanted. If the procedure proves as popular for use in humans as in pets, that could mean up to 1 million chips implanted in people.

The company's chief executive officer, Scott R. Silverman, is one of a half dozen executives who had chips implanted. Silverman said chips implanted for medical uses could also be used for security purposes, like tracking employee movement through nuclear power plants.

Such security uses are rare in the United States.

Meanwhile, the chip has been used for pure whimsy: Club hoppers in Barcelona, Spain, now use the microchip to enter a VIP area and, through links to a different database, speed payment much like a smartcard.

___

On the Net:

VeriChip: http://www.4verichip.com/index.htm

HHS: http://www.hhs.gov/

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WayneLigon said:

I doubt it'll be implantation unless they find a way to make it really quick and easy to both implant and take out.

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Umbran said:

The current chips used in animals are implanted by injection, just under the skin. One quick zap between the shoulder blades, takes all of about 45 seconds. It's in the space between the skin and the muscles, so taking it out should not be terribly difficult.

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Top Stories - washingtonpost.com


Implantable Medical ID Approved By FDA

Thu Oct 14,12:57 AM ET Top Stories - washingtonpost.com


By Rob Stein, Washington Post Staff Writer

A microchip that can be implanted under the skin to give doctors instant access to a patient's records yesterday won government approval, a step that could transform medical care but is raising alarm among privacy advocates.


The tiny electronic capsule, the first such device to receive Food and Drug Administration (news - web sites) approval, transmits a unique code to a scanner that allows doctors to confirm a patient's identity and obtain detailed medical information from an accompanying database.


Applied Digital Solutions Inc. of Delray Beach, Fla., plans to market the VeriChip systems -- the chips, scanners and computerized database -- to hospitals, doctors and patients as a way to improve care and avoid errors by ensuring that doctors know whom they are treating and the patient's personal health details.


Doctors would scan patients like cans of soup at a grocery store. Instead of the price, the patient's medical record would pop up on a computer screen. Emergency room doctors could scan unconscious car accident victims to check their blood type and medications and make sure they have no drug allergies. Surgeons could scan patients in the operating room to guard against cutting into the wrong person. Chips could be implanted in Alzheimer's patients in case they get lost.


"In hospitals today, many deaths occur because people aren't able to communicate timely enough their medical information or because of wrong information," said Scott Silverman, the company's chief executive. "With VeriChip, you'll be able to have accurate information even if a patient can't talk. It's a way to modernize our antiquated system of medical records."


The approval was immediately denounced by privacy advocates, who fear it could endanger patient privacy and mark a dangerous step toward a Big Brother future in which people will be tracked by the implants or required to have them inserted for surveillance, identification and other purposes.


"Once the technology is out there and is available, it raises the very real possibility that people in a position to require or demand it will begin to do that," said Katherine Albrecht, who has campaigned against such devices. "It would obviously be possible to inject one of these into everyone. In the post-9/11 world, we are already racing down the path to total surveillance. The only thing missing to clinch the deal has been the technology. This may fill that gap."


The VeriChip technology was developed to track livestock and has been implanted in about 1 million cats and dogs to identify lost or stolen house pets. But the technology has a variety of other potential uses, and the company has already sold about 7,000 chips for human use, about 1,000 of which have been implanted.


Mexico's attorney general announced in July that he had one of the devices injected into his arm, as had about 160 of his lieutenants, to control access to high-security offices. In bars in Amsterdam and Barcelona, patrons can have the chips implanted to allow them to enter exclusive areas and keep track of their tabs.


The company is investigating other applications, including using the chips as "electronic dog tags" for soldiers, creating "smart guns" with built-in scanners that ensure they can be fired only by someone with a corresponding implant, and enabling stores to verify a customer's identity before accepting a credit card.


"That same scanner in a Wal-Mart that is used to bar code your goods can be used to identify you when you present your credit card to make sure someone hasn't stolen it and your identity," Silverman said.


Spurred by South Americans seeking ways to trace kidnap victims, the company has also developed a device that allows satellites to pinpoint a chip's location, but it has no immediate plans to market that gadget.


The company hopes the FDA (news - web sites) approval, however, will speed the proliferation of the chips for medical and other uses.


"We believe that this application is going to drive acceptance of the product," said Angela Fulcher, vice president for marketing and communications. "If you have a chronic disease, where getting information to health care providers quickly may mean life or death, that population is going to be more accepting of this technology."


The company hopes to kick-start use of VeriChips by donating about 200 of the $650 scanners to trauma centers. The chips, which are the size of a grain of rice, will cost about $200 apiece. The devices are injected with a syringe under the skin of the upper arm in a quick, painless procedure.


The accompanying scanners and software ensure that the personal information unlocked by the 16-digit code is only available to those designated by the patient, Silverman said.


"Even if people access your unique identification number, which would be extremely difficult to do, it doesn't give them access to your database. We're confident in the security measures we've taken," Silverman said.





Opponents argue that the medical benefits are marginal at best. Patients can already wear bracelets that alert doctors to their identities and special medical needs, and few medical errors are actually caused by patients being misidentified, they say. But the potential for abuse is great, they caution.

"Over the long haul, any place where there's a surveillance camera today, five or 10 years from now will have these . . . readers. You'll walk into a 7-Eleven, and they'll take your picture and scan your number," said Richard M. Smith, an Internet security and privacy consultant in Boston. "If we start carrying these tags it makes a perfect way, either by private security companies or the government, to keep track of us."

Marc Rotenberg, executive director of the Electronic Privacy Information Center in Washington, said he was concerned that people might be forced to get the implants.

"When you put an identification tag under a person's skin, you make it impossible for a person to remove the tag, much like branding cattle," Rotenberg said. "The most likely applications would involve prisoners and parolees, and perhaps, one day, persons in the United States who are not citizens. I think there needs to be some legislation put in place to prevent abuse."

Silverman dismissed the concerns, saying abuse would be technologically difficult and the benefits would far outweigh any theoretical risks.

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BOZ said:

yeah, we're screwed. just a matter of time, i suppose.

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