The American Medical Association recommends that physicians disclose uncertainties about the risks of implants, add extra layers of security to protect patient privacy and support ongoing research regarding the implantation of RFID devices in human beings.
By Beth Bacheldor
Copyright RFID Journal LLC 2008, Used With Permission
July 17, 2007—The American Medical Association (AMA) has officially established a code of ethics designed to protect patients receiving RFID implants. The recommendations focus on safeguarding a patient’s privacy and health, and are the result of an evaluation by the AMA’s Council on Ethical and Judicial Affairs (CEJA) regarding the medical and ethical implications of RFID chips in humans, as well as a follow-up report recently released. The latter discusses the possible advantages and specific privacy and ethical issues of using RFID-enabled implantations for clinical purposes.
Entitled “Radio Frequency ID Devices in Humans,” the report is presented by Robert M. Sade, M.D., who chairs the CEJA. It acknowledges that RFID’s use in health care “represents another promising development in information technology, but also raises important ethical, legal and social issues.” The report adds, “Specifically, the use of RFID labeling in humans for medical purposes may improve patient safety, but also may pose some physical risks, compromise patient privacy, or present other social hazards.”
The AMA’s report identifies three specific recommendations: The informed-consent process must include disclosure of medical uncertainties associated with these devices; physicians should strive to protect patients’ privacy by storing confidential information only on RFID devices utilizing informational security similar to that required for medical records; and physicians should support research into the safety and efficacy of RFID devices implanted in human beings, and examine the role of doctors regarding the nonmedical uses of the technology.
The recommendations now serve as ethical guidelines for physicians and caregivers, explains Steven Stack, M.D., a member of the AMA’s board of trustees, and are officially part of the AMA’s medical ethics code. While not law, the AMA’s code of ethics has long served as a standard of conduct defining the essentials of honorable physician behavior.
“The AMA is the largest professional organization representing the interest of physicians and patients in the U.S.,” Stack says, “and the AMA’s code of ethics is the most widely accepted guidance for physicians’ professional, ethical practices.” In fact, he adds, courts and governments often use the AMA’s ethics codes as guidelines.
Central to the AMA’s recommendations is that RFID implantable devices still need to be researched. The report indicates such implants may present physical risks to patients, because the devices can migrate under the skin and become difficult to extract. It goes on to say the risks may be minimized “by constructing RFID tags from materials that permit surrounding tissue to encase the device.” Furthermore, the document cautions that RFID tags may electromagnetically interfere with electrosurgical devices (medical tools that use electrical currents for cauterization during surgery) and defibrillators, and that more research needs to be done regarding whether RFID tags might also affect the efficacy of pharmaceuticals.
From a privacy perspective, the AMA notes, RFID device security has not been fully established, so physicians “cannot assure patients that the personal information contained on RFID tags will be appropriately protected.” Beyond just storing unique ID numbers on the tags, the association suggests the medical community also consider computer encryption and digital signatures to protect the data.
Moreover, the report recommends that RFID tags not be implanted or removed without the prior consent of patients, as per the AMA’s policies regarding informed consent. More specifically, patients—or those acting as the legal guardians of patients—should be informed of the potential risks and benefits associated with RFID tags, as well as who will be granted access to the data contained on those tags, and the purposes for which this information will be used.
Shortly after the AMA released its report, VeriChip Corp., a maker of implantable RFID tags, applauded the association’srecommendations, saying they could help improve the acceptance of RFID implantable devices in the health-care industry. VeriChip manufactures the VeriMed system, which features a glass-encased passive RFID tag that can be injected into a patient’s arm.
A hospital or medical staffer carrying a handheld interrogator can read a VeriChip’s unique 16-digit identifying number, then link that patient’s identity to such medical-record details as allergies, medications taken and blood type. The VeriMed system is the only human-implantable radio frequency transponder system cleared by the U.S. Food and Drug Administration (FDA) for the purpose of patient identification and health information.
VeriChip could not be reached by press time to comment on some of the AMA’s concerns regarding RF interference, privacy and security. In the past, however, the company has claimed that when its glass-encased tag is inserted just under the skin, a small amount of scar tissue forms around it, preventing the chip from moving or migrating. In addition, VeriChip has stated that any patient data associated with the 16-digit number is stored in a secure online database, accessible only by authorized health-care workers.
Stewart Brand is a cofounder of Global Business Network and the Long Now Foundation. Best known for founding, editing, and publishing the Whole Earth Catalog (1968-1985; National Book Award, 1972), he also has a long-standing involvement in computers, education, and the media arts.
From 1987 to 1989 Stewart ran a series of private conferences on “Learning in Complex Systems,” sponsored by strategic planners at Royal Dutch/Shell, AT&T, and Volvo. In 1988 he joined the Board of Trustees of the Santa Fe Institute, an organization dedicated to multi-disciplinary research in the sciences of complexity. In 1987, Stewart wrote The Media Lab: Inventing the Future at MIT (Viking). It became a QPB Selection, won the Eliot Montroll Award, and has been translated into Japanese, German, Italian, and Spanish. From 1974 to 1985, Stewart founded, edited, and published CoEvolution Quarterly. He also served as editor-in-chief of the Whole Earth Software Catalog (Doubleday) from 1983-1985. During this time, Brand organized the first “Hackers’ Conference,” which was televised nationally and has since become an annual event. He also founded The WELL (Whole Earth ‘Lectronic Link) a computer teleconference based in the San Francisco Bay Area. It now has 10,000 active users, and is considered a bellwether of the medium.
After receiving his degree in biology from Stanford in 1960 and spending two years as a US Infantry officer, Stewart became a photojournalist and multimedia artist, performing at colleges and museums. In 1968, he was a consultant to Douglas Engelbart’s pioneering Augmented Human Intellect program at SRI, which devised now-familiar computer interface tools. In 1972, for Rolling Stone, he wrote the first article about the computer lifestyle, entitled “Fanatic Life and Symbolic Death Among the Computer Bums,” chronicling the fringes of computer science at Xerox PARC, the Stanford Artificial Intelligence Laboratory, and MIT. That article became part of his book, Two Cybernetic Frontiers (Random House, 1974), which also introduced anthropologist/ philosopher Gregory Bateson to a wide audience. In 1974 he organized a “New Games Tournament,” which generated three books and became a genre in experiential education.
In 1994, eight years of research by Stewart into how buildings change over time (a form of organizational learning) came together in a richly illustrated book, How Buildings Learn: What Happens After They’re Built. Referred to as “a classic and possibly a work of genius,” the book has been used as a text by computer systems designers as well as building preservers, architects, and many lay building users.
Since co-founding The Long Now Foundation with Danny Hillis in 1996, Stewart has been involved with its growing number of projects. The 10,000-year Clock project aims to build a monumental timepiece inside a mountain in eastern Nevada; the first working prototype went on permanent display at the Science Museum in London. The Rosetta Project set about micro-etching 1,000 languages on a 3-inch nickel disk and wound up building the world’s largest website of living languages. Long Bets is another web project, this one to make a permanent repository and forum for “accountable predictions,” where each Prediction accumulates votes and discussion and can become a bet with real money at stake. The All Species Inventory was spun off as its own foundation, with the aim of discovering and cataloging every life form on earth within the current human generation. Another project, called Long Server, is attempting to help solve the very difficult problems in long-term preservation of digital materials. Stewart’s book, The Clock of the Long Now: Time and Responsibility, investigates the advantages of taking the very long term seriously, including some new ways to think about the future.