FDA Approves Implantable Medical ID

[Guest guest]

http://www.washingtonpost.com/wp-dyn/articles/A29954-2004Oct13.html

The Washington Post

Thursday, October 14, 2004; Page A01

 

Implantable Medical ID Approved By FDA

 

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 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 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.

 

Related story on Reuters:

http://www.reuters.com/audi/newsArticle.jhtml?type=technologyNews & storyID=64

92915