[Med-privacy] CASPIAN does RFIDs

[pmarshall]

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<http://www.DrugResearcher.com>

<http://www.DrugResearcher.com/news/news-NG.asp?id=3D55533>

Implantable RFID chip decision draws criticism
20/10/2004 - This week=19s announcement of the US approval for an=20
implantable radiofrequency identification (RFID) chip for use in humans=20
as a prescription device has been met with consternation by a consumer=20
group, which fears the technology could infringe civil liberties.

CASPIAN (Consumers Against Supermarket Privacy Invasion and Numbering)=20
has issued a press release pointing out the areas that the US Food and=20
Drug Administration wants to address before giving the go-ahead for=20
widespread use of the technology, developed by VeriChip.

The FDA notes that the VeriChip is indicated for use as way of providing =

a patient with a unique identification number that may be used to access =

a database containing the patient's identity and health information. In=20
this way, it could be used to avoid misprescribing for drugs or medical=20
procedures.

However, while the FDA letter states its classification process provides =

=1Creasonable assurance of the safety and effectiveness of the device,=1D=
=20
CASPIAN takes the opposing view.

The group points out that the FDA has suggested that potential risks to=20
health associated with the device are: adverse tissue reaction;=20
migration of implanted transponder; compromised information security;=20
failure of implanted transponder; failure of inserter; failure of=20
electronic scanner; electromagnetic interference; electrical hazards;=20
magnetic resonance imaging incompatibility; and needle stick.

However, the agency said that it is satisfied that such a device can be=20
marketed safely, without pre-market approval, provided the company=20
sticks to the letter of the approved indication. A copy of the FDA=19s=20
letter to VeriChip can be downloaded here=20
<%20http://www.inpharma.com/pdf/verichip-fda-letter.pdf>.

CASPIAN=19s Katherine Albrecht claims that MRI incompatibility as perhaps=
=20
the most serious issue. An MRI machine uses powerful magnetic fields=20
coupled with pulsed radio frequency (RF) fields. According to the FDA's=20
Primer on Medical Device Interactions with Magnetic Resonance Imaging=20
Systems, "electrical currents may be induced in conductive metal=20
implants" that can cause "potentially severe patient burns," she points=20
out.

"Patients contemplating a VeriChip implant need to know that the FDA has =

raised incompatibity as a potential risk. "If it's a choice between a=20
potentially life-saving diagnostic procedure or a VeriChip implant, I=20
believe most patients would choose the MRI."

In addition to outlining a number of health risks, the FDA letter also=20
cites the risk of "compromised information security" among its concerns, =

and this is another issue that CASPIAN is concerned about.

The VeriChip ID implant, about the size of a grain of rice, uses radio=20
waves to transmit medical and financial account information to reader=20
devices. There is a risk that these transmission could be intercepted=20
and duplicated by others or that the devices could be used to track an=20
individual's movements and location, claims the consumer group.

"Once you're chipped, you can be identified by doorway portal readers=20
without your knowledge," says Albrecht.

=A9 2000/2004=13 NOVIS



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