Vol. 8 Issue 2
A Chip Below Their Shoulders
Are ID implants a viable, ethical way to slow Alzheimer's wandering?
Radio frequency identification (RFID) may seem like something borne out of The Jetsons or the latest sci-fi thriller.
But this identification technology isn't as futuristic as it sounds. In fact, RFID has existed for several years (dating back to the late 1940s) and is gaining popularity in its use in credit cards, toll booths, passports and subway systems. It's also become more common among pet owners who have their animals imbedded with RFID chip implants to make it easier to identify Fido should he get lost or "petnapped."
More recently and more controversially, RFID is being tested by healthcare providers in an attempt to protect Americans living with Alzheimer's disease who are at risk for wandering.
While there are positives associated with this usage, some argue that RFID implants are a violation of human rights, especially in the case of a person with Alzheimer's who cannot give his consent to the procedure due to his cognitive condition.
Protecting The Patient
In February 2007, officials with Alzheimer's Community Care an organization based in West Palm Beach, FL, that cares for more than 2,000 Alzheimer's patients and caregivers throughout a three-county radius (Palm Beach, Martin and St. Lucie) partnered with neighboring RFID technology manufacturer VeriChip to begin a 2-year pilot program using the company's latest RFID device the VeriMed microchip.
Said to be about the size of a grain of rice, the VeriMed chip is inserted by syringe into a patient's upper arm and contains a 16-digit personal identification number (PIN). This allows ED personnel to access an existing database that provides a host of information identifying the individual and listing his healthcare diagnoses, medications, allergies, etc.
To date, about 100 patients and caregivers with Alzheimer's Community Care have undergone successful RFID implants with another 100 expected to be implanted by February 2009.
"They say that you have innovation out of necessity," said Mary M. Barnes, president and CEO of Alzheimer's Community Care. "The area we serve has the highest incidence rate of Alzheimer's in the world, so we've seen this program as a great opportunity to serve our community with our expertise in this specialty area."
Through the pilot, the chips have come without cost to patients and caregivers. However, they have not come without controversy or debate.
The Case Against RFID
According to an ABC News report that ran in August, certain privacy groups are arguing the VeriMed and other related instruments, "strip Alzheimer's patients of their dignity."
"I don't think that because it's useful in animals is a reason why we should do it in human beings," Katherine Albrecht, founder of Antichip.com, a Web site that openly refutes the use of such materials in humans, told ABC.
Additionally, Wisconsin and North Dakota have banned human implanting of RFID devices without consent, while California is considering doing the same.
Officials with the ethics advisory panel of the Alzheimer's Association, an entity that claims to be the leading voluntary health organization in U.S. Alzheimer's research, believe these chips should not be of a permanent nature or implanted into those with Alzheimer's. Nor do they endorse any such product or service.
"While intended to ensure the safety of the person with Alzheimer's, [tracking devices] may be perceived as infringement on personal autonomy," the association's official statement reads. The panel [feels] that using these devices is acceptable so long as they do not violate the expressed wishes of a competent individual."
Instead, the ethics panel suggests caregivers and healthcare providers discuss issues related to wandering risks, such as establishing protocol on how to quickly access medical records when needed, immediately after an Alzheimer's patient's diagnosis is made.
According to the statement, "The manner in which an individual chooses to provide access to medical records is a personal decision best made by the individual."
Piloting For Protection
But Barnes and other officials with Alzheimer's Community Care don't necessarily agree, stating that diagnosing and caring for an individual with the disease is not a clear-cut issue. Plus, they argue that the vast majority of their patients, if not all of them, are beyond early-stage dementia and require a power of attorney or legal guardian to make their healthcare decisions.
"Anyone who's had a family member with Alzheimer's knows that the issue of ethics is a moot point," Barnes explained. "When you're a caregiver, you know how vulnerable these patients are in acute settings. They don't know what they're suffering with. We found ourselves morally responsible to get into a project like this because we are advocates for care and safety, and cannot miss a beat when it comes to this disease and our patients."
Still, Barnes acknowledged that facilities and families need to be comfortable in using the technology.
"If people out there think the chip isn't ethically appropriate, that's their individual choice," she added. "It's a free country."
That's why the program has been strictly voluntary per the approval and consent of the individual's caregiver, Barnes said.
"And not everybody elects to have the procedure done," she said. "But it has been so popular that we were able to meet our initial goal of getting 100 patients on board in 1 year within a matter of months."
However, Barnes along with Patricia Oram, chief operating officer with Alzheimer's Community Care, insist that no client was persuaded or coerced into participating to meet the program's goal.
"We've looked at this project as being another choice, not the only choice, for families and patients to consider when determining their healthcare," Oram said. "We see this as an appropriate, convenient method for us to ensure patient safety."
Those patients and families considering participation meet with Ann Moyer, RN, family nurse consultant with Alzheimer's Community Care and lead nurse on the VeriMed project, in their homes or resident facilities.
Moyer explains the program in its entirety and gets signed consent before a physician can implant the patient's chip, which is inserted below the shoulder on the right arm so facilities know where to look for it.
"Our talks tend to go very smoothly because people at that point are strongly considering the chip," she said. "We wouldn't try to talk someone into it if they weren't comfortable. I go there also to answer any questions they may have or address any anxieties they may have."
The implant takes just a few seconds to insert and requires no more healing time than a general needle stick would, Moyer said.
"The area on the arm is numbed and the chip is inserted with a syringe comparable to one that would be used to draw a pint of blood," she said. "There are no allergic reactions that have to be considered."
Once implanted, the patient's chip number, which is determined during manufacturing, is entered into an online database that is accessible only to those facilities who've agreed to tap into the VeriChip network. Approximately 15 hospital EDs throughout the three aforementioned counties are currently participating, Barnes said. Those who participate are equipped with an electronic wand to read chips and are given access to an online patient database.
Although some 100 participants currently have chips, the system hasn't been put through an actual test because no Alzheimer's client has wandered since undergoing the procedure.
If someone were to wander and taken to a participating ED, the chip would only be activated if scanned with an electronic wand provided by VeriMed, officials said.
"But the benefit is that we can also give our caregivers as much peace of mind as we can," Barnes said. "They deal with so many changes in their lives, just with the disease progressing. If we can do anything to make the family stronger, that's what our job is. With the chip, they know their loved ones can get the care they need if they end up in an ED."
This should also help skeptics realize the product is about information retrieval, not placing tracking devices into human beings, said Oram.
"We originally thought it was like a GPS system, but we quickly learned that it isn't," she said. "It's a passive device that's more of a means of having medical information readily accessible when providers are in a medical situation where they can't communicate with the patient."
Addressing HIPAA, Security Concerns
Like all new healthcare innovations, the VeriMed chip could eventually affect HIPAA and other patient privacy/security measures. But, this currently isn't an issue, said Clyde Hewitt, principal consultant with Forsythe Solutions Group, an independent national service technology consulting company.
"HIPAA does not come into play unless the organization is a covered entity as defined by Health and Human Services, meaning it has to bill insurance companies using electronic invoice," said Hewitt. "The VeriChip implementation is not currently covered by insurance, so there will be no insurance claims. But I qualify that statement with the term 'yet.' And that doesn't relieve those facilities using the chip of other security requirements."
Hewitt said facilities have to consider state disclosure laws related to patient privacy and what legal protocol calls for should a facility lose personally identifiable information.
"The chip itself contains no personal identification," he said. "But, in terms of general security, you have to consider how the numbers are designed and how easily it could be for someone to look up people just by their numbers."
Patient numbers are randomly generated, making the assignment of numbers more secure and less likely of opening the person to ID theft, said Allison Tomek, vice president of investor relations with VeriChip.
While Hewitt agrees random numbers make the technology safer, he still worries that scanners could one day be strong enough to read the chip from further distances, thereby possibly allowing unwarranted individuals to access the numbers.
But Tomek says this is also a non-issue.
"The chips can only be read by a scanner that's within 3-6 inches," she said. "Even if another device could pick up a chip number [in the future], it wouldn't be worth anything unless you have access to the database."
The database itself is also guarded, Tomek adds. "We use a secure, password-protected database, but we wouldn't want to compromise the integrity of the system by discussing it."
Alzheimer's Care officials agree there are valid questions concerning the frequency in which this patient population's healthcare information changes and how quickly updates could be entered into the database.
Barnes said the organization has assembled a professional review committee to recommend protocol as well as appropriate staff and patient education procedures should the program become increasingly popular.
"I see this [chip], long-term, as a potential benefit," Hewitt concluded. "It's definitely ahead of it's time now, but the time is coming fast."
Joe Darrah is associate editor at ADVANCE.