FDA Approves Implantable Chip Used to Access Medical Records

Laurie Barclay, MD

October 25, 2004

Oct. 25, 2004 -- On Oct. 13, the U.S. Food and Drug Administration (FDA) approved the VeriChip, a computer chip implanted subcutaneously to facilitate medical record access. Advocates of the chip, produced and marketed by Applied Digital Solutions Inc. (ADS) in Delray Beach, Florida, believe it will improve rapid access to vital medical information on unconscious or uncommunicative patients, but some privacy experts have voiced confidentiality concerns.

The VeriChip, which is about the size of a pen point, is implanted in the subcutaneous tissue in the triceps area, where it is invisible to the naked eye. Using the FDA-approved inserter, "chipping" under local anesthesia is painless and only takes a few minutes.

"The beauty is that you even don't know it's there," Richard Seelig, MD, ADS medical director and vice president of medical applications, told Medscape. "There's no visible evidence that there is an implanted chip and therefore there's no stigma to the person, but it's there when the individual needs it."

When activated by a hand-held scanner, the radiofrequency identification (RFID) chip emits radio waves read by the scanner as a unique, 16-digit patient identification number. The healthcare provider would then use that number to access a computer database containing medical information previously entered and regularly updated by the patient, such as health conditions, allergies, and medication use.

"My primary concern with the VeriChip RFID technology is with security," Richard M. Smith, a computer security and privacy expert from Brookline, Massachusetts, told Medscape. "An RFID device that only sends out an ID number is not appropriate for protecting financial transactions and medical information. The potential exists for building a device which will clone the ID number embedded in such an RFID device."

Other applications of RFID chips are to limit access to a secure building to only "chipped" individuals, or to prevent unauthorized individuals from making withdrawals from financial accounts. In 2002, the FDA determined that it would not regulate financial, security, or other uses of the VeriChip, such as identification of livestock and lost pets, but it prevented marketing for medical use until approval was obtained.

For approximately 15 years, the ADS subsidiary Digital Angel Corporation has been manufacturing implantable RFID microchips, and it has sold more than 30 million "Home Again" chips for use in pets. For the last two years, VeriChip has been marketed primarily internationally for its security application; for example, the attorney general of Mexico and some of his staff use the chip for access to their secure government facilities.

"Through a managed database, VeriChip can act as a portal to medical records, medical device information, personal information, and insurance information within milliseconds at the point of treatment, such as in a doctor's office, an emergency room, a hospital, or an ambulance," ADS Chairman and CEO Scott Silverman said during a news conference. "We [also] believe that VeriChip has the potential in the military to in essence be a replacement for a dog tag, such as a modern identification device, and not only be identification but now also provide medical records in the field in a triage situation in the event of an emergency."

Approval of the VeriChip as a class II medical device on Oct. 13 allowed immediate marketing, subject to FDA-specified controls to reduce potential risks by identifying performance and safety testing, and by appropriate labeling. In a letter from the FDA to ADS granting this approval, potential health risks associated with the VeriChip device were described as adverse tissue reaction, migration or failure of the implanted transponder, compromised information security, failure of the inserter or scanner, electromagnetic interference, electrical hazards, magneticresonance imaging incompatibility, and needle stick.

"The information that we looked at in the application had to do with making sure that the chip was provided sterile, that the biocompatibility issues were adequately addressed, that there wasn't undue interference between the reader and other electromagnetic devices," Donna-Bea Tillman, PhD, FDA director of the Office of Device Evaluation, Center for Devices and Radiological Health, told Medscape. "So there were a number of those kinds of preclinical issues that we looked at in the review of this system. There was not any clinical data provided as part of this approval process."

Although the FDA is not aware of any formal studies planned by ADS, and the FDA has not requested any, the FDA has a medical device safety information and adverse event reporting system, so that the manufacturer and healthcare institutions would presumably report to the FDA any adverse events that occurred with the VeriChip.

"There are theoretical health risks, but in our clinical experience, both in the animal kingdom and in a study group, none of those types of issues have literally or figuratively surfaced," Dr. Seelig said. "The animal use experience extends for at least 15 years, and the volume is about 30 million applications in almost every level of the animal kingdom. We expect it to function at least as long as it does in cat or dog life spans, which is about 13 to 14 years, and in the filed applications for the animal kingdom there really haven't been any reported failures."

ADS has addressed the potential risk of migration by using a patented form of polypropylene on one half of the chip capsule, which then fixates to the surrounding tissues. Because the weight of the mass of this chip is only about 1/2000th of an ounce, the biomass of foreign material is minimal and unlikely to cause foreign body reactions.

"Then again, with any implant of any size, there's always going to be somebody who's going to have a foreign body reaction even to the most innocuous, biocompatible materials," Dr. Seelig said. With large implants, such as pacemakers, orthopaedic hardware, or mesh hernia repair, the foreign body reaction incidence is well under 2%, and he predicts that incidence with the VeriChip would be much less than that.

"When we did our review, one of the areas we did ask the company to provide some information about was in terms of ensuring confidentiality of information in the database," Dr. Tillman said, adding that the system approved by the FDA was simply the chip, the reader, and the inserter, and that the database itself was not part of the application.

"Traditional FDA approval focuses on 'safety and efficacy,' but the safety concerns, historically, concern the physical safety of a device," Peter P. Swire, a professor at the Moritz College of Law of Ohio State University in Columbus, told Medscape. "The risks with VeriChip are not at the physical level -- I have no reason to think the small chip is likely to create physical risks. Instead, the risk is that a person's medical information will be used improperly over time. The FDA process is not suited for examining those problems."

Unauthorized persons can access information on the chip, according to Mr. Swire, which exacerbates the potential for improper use of medical data. Similar problems exist with new biometric passports, because the biometric information is broadcast "in the clear" rather than in encrypted formats that avoid transmitting the information to unauthorized readers.

"Unless good controls are established on new chip technologies, this sort of overbroad transmission could very easily develop for chipped information," said Mr. Swire, who is also a John Glenn Scholar in Public Policy Research.

"I am concerned that readers can be placed anywhere, allowing third parties to track people via implanted VeriChips withouttheir knowledge or permission," Mr. Smith, the computer security and privacy expert, said. "This same problem will exist for other RFID tags that we will be carrying around in the future embedded in items like credit cards, car keys, cell phones, and clothing."

Although some opponents of the chip cite possible use of the chip to track an individual's location, Mr. Smith notes that GPS and RFID are different technologies: "They aren't really related except they both can provide location information about an object," he said. "The smallest GPS reciver than I'm aware of is about the size of a half of deck of cards. They can't really be implanted in people because of their size and the fact that they need a battery."

Dan Mullen, president of the Association for Automatic Identification and Mobility (AIM) in Warrendale, Pennsylvania, told Medscape that the VeriChip uses similar technology to the companion animal tagging systems currently in use. Concerns about tracking location or unauthorized reading of the ID number are more theoretical than practical.

"With the amount of speculation and hype about RFID, based primarily on a lack of understanding of the technology, one of AIM's goals is to better educate the public about what RFID is, what it can and cannot do," Mr. Mullen said. "As a very low power, passive tag, [the VeriChip] is not capable of generating a strong enough RF signal to be read except through near contact and with fairly precise reader orientation.... Because these implantable transponders could not be covertly interrogated, the individual must consent to it being read."

According to Dr. Seelig, the read range of the VeriChip is three inches. It is a passive RFID chip, meaning that it lacks a power supply and requires activation by the external multiplex scanner. Electrons emitted by the scanner activates the capacitor in the chip, which reads the housekeeping security and ID number from the infrared circuit and then sends it back to the scanner.

"Once that interrogation is over,which lasts less than one tenth of a second, the chip then goes back to sleep," Dr. Seelig said. "Because there's no power and because the actual size of it is so tiny, there's no capability of at-distance reading and therefore no at-distance tracking."

Assume a scenario in which a chipped individual were mugged and rendered unconscious by a thief who had stolen a scanner, which Dr. Seelig said is unlikely because all the scanners are registered, and logs track which scanner accessed which patient's information at which period of time. Even if the thief scanned the individual and obtained the identification number, he would have to be registered with a hospital's Web database or health registry and know that person's four-digit ATM-type of password corresponding to their 16-digit number before he could access their medical records.

"It's not like a thief could just automatically scan somebody and say, oh, I know now that person has terminal cancer and is HIV-positive," Dr. Seelig said. "Concerns about safekeeping of medical information are not different with utilizing VeriChip than they would be with the safeguarding or the maintenance of security of medical records as they now exist, whether they be in your manila folders or whether they are in currently available electronic medical records systems."

Mr. Mullen explained that privacy concerns regarding VeriChip are the same as ethical concerns regarding photo driver's licenses, birth certificates, passports, signatures on credit cards, and other means of personal identification: "An RFID transponder offers no more or less capabilities to track purchases, preferences, or behaviors than do credit, club, or loyalty cards. But it would be wise to require a photo ID in conjunction with the use of any implantable method of ID," he said.

Is there a concern that the chip could be removed, stolen, and put into someone else as a form of identity theft?

"I guess that's certainly a science fiction type of question and a very hypothetical question, so the hypothetical answer is yes," Dr. Seelig said. "But the penalty for carving or attempting to carve a chip out of somebody is much greater than for just stealing a wallet and getting a credit card number. The laws of this country call that assault with a deadly weapon, or even attempted murder."

Features of the VeriChip that may discourage theft and implantation into someone else are fibrotic ingrowth because of the polypropylene material on the outside of the capsule. If the capsule is removed, some of the chipped patient's tissue is likely to adhere to the capsule despite repeated washings, causing a foreign body reaction in the new host.

Other reasons why stealing the chip would be futile is that it contains only a number. If a thief appeared at a medical facility and attempted to represent himself as the owner of the chip, the anthropomorphic information within the database corresponding to that access number would include height, weight, hair color, skin color, and password.

"All these would have to match up exactly with the individual who is in front of them. In the most abstract way, it's conceivable, but in a practical way, the answer to your question is no," Dr. Seelig said. "Finally, if I have a pacemaker, who would want to represent themselves as having a pacemaker? My information is something that I want to share with practitioners if there was a medical emergency, and in fact that is why I would have the chip implanted."

Now that the FDA has approved the VeriChip, ADS is providing scanners free of charge to 200 trauma centers nationwide to use when patients present with compromised levels of consciousness, difficulty breathing, postictal states, or other conditions preventing communication. The suggested retail price of the scanners, which are powered by four AAA batteries, is $650. ADS is embarking on an education program to encourage emergency providers to scan for a chip in the customary location in the upper arm whenever vital signs are done on an unconscious person.

The intended market for VeriChip is for patients with chronic illnesses, such as diabetes, Alzheimer's disease, congestive heart failure, other cardiac conditions, or stroke, requiring transference of information that the patient is unable to communicate during an emergency. Another potential application is for patients with implanted medical devices with significant technical settings, such as orthopaedic hardware, pacemakers, and infusion pumps, or for patients receiving complex medication regimens such as chemotherapy.

In the future, the implantable RFID platform can be used for biosensing capabilities of parameters including temperature, heart beat, and ultimately glucose, lactic acid, or transaminases, to be monitored by the patient or others.

"Those sensors have yet to be developed, but once they are developed, it's theoretically possible to link them to our RFID communication package under the skin," Dr. Seelig said. "With the proper communication package externally, warnings or alerts theoretically could be sent to whomever that individual designates, whether it be family or physician."

According to Dr. Seelig, ADS will comply with whatever future regulations are imposed by statutory bodies in the financial and security domains, just as they have complied with FDA regulations in the medical domain. Some privacy advocates are concerned that healthcare organizations, potential employers, or even the government could require use of the chip.

"Regardless of what VeriChip is or isn't, we wouldn't be viewed any differently than any other mandate that the government puts in place," Dr. Seelig said. "The present reality is that this is a medical device, and as such, permission has to be given by the patient for [use of] that device to go forward."

Reviewed by Gary D. Vogin, MD


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