FDA approves microchip for medical use in humans

Economic and privacy concerns raised by critics

October 14, 2004|By Lou Dolinar | Lou Dolinar,NEWSDAY

The Food and Drug Administration gave permission yesterday for humans to get a digital upgrade - receiving implantable electronic tags for computerized medical information.

Human patients can now join 1 million pets, many cattle herds and assorted wildlife that already carry these implantable chips, but there are questions about how useful such a system would be and whether the security precautions are stringent enough.

A comparative handful of people have gotten the chips on an experimental basis, but the FDA's decision paves the way for widespread medical use, according to Applied Digital Solutions, the company that makes the VeriChip and received approval for its device. The Delray Beach, Fla., company uses radio frequency identification technology similar to external devices such as E-ZPass electronic toll collection.

Under the implant procedure, the doctor administers a local anesthetic to a patient and then uses a special injector to place the rice-sized identification capsule under the collarbone or into the triceps. The injector can also remove the device.

The chip itself contains no patient information, just 256 characters of memory, a radio transceiver and a tiny antenna. A scanner checks the code and then pulls up patient data through the Internet, displaying it on a computer screen. Records could be anything from simple warnings about drug allergies - analogous to a medical ID bracelet - to complete medical histories. The records could be updated like any other computer record on central networks, without touching the patient.

The FDA approval was needed because the device accesses medical records; versions of it are already in use in people to provide ID codes that unlock doors at secure facilities, among other uses.

FDA spokeswoman Kathleen Quinn said the agency looked primarily at medical safety issues, such as the potential for infection and irritation at the site of the injection.

Critics say there are economic and privacy concerns.

"I don't see how it can be effective until all emergency vehicles and centers have the readers," said Richard M. Smith, a privacy and Internet security consultant based in Boston.

In addition, the medical profession would have to agree to standards for the storage and access of computerized records, something doctors have resisted.

"There's a lot of infrastructure that needs to be put into place," he said.

Applied Digital cracked the pet market by donating scanners to hundreds of animal shelters and veterinary clinics. In the 15 years since, it has sold 50,000 such scanners. Initially it plans to donate 200 scanners, which cost $650, to the nation's trauma centers.

The chip costs about $50 for pets, and costs for humans should be $150 to $200, a company spokesman said. Costs and plans for the database and network were unclear.

The second concern is that the existing chip, because it is both small and limited in memory, has relatively little security and is adapted from products the company sells to identify lost pets, track cattle herds, and monitor fish and other wildlife.

"We did take into account privacy issues when we took this action," Quinn said, but she declined to be more specific.

Currently, the two biggest deployments of the internal devices are outside the United States.

In Mexico, at least 160 top federal prosecutors and investigators began receiving chips in their arms in November in order to get access to restricted areas inside the attorney general's headquarters, at a cost of about $150 per chip.

In Barcelona, Spain, the VIP Baja Beach Club serves its clients chips with drinks, providing access to VIP lounges and incidentally acting as a debit account for bar tabs.

Newsday is a Tribune Publishing newspaper.

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