AMA on implantable ID chips, patenting procedures

Technology demands review, revision of ethics code

The American Medical Association has spoken out on two medical technology-related ethics issues, affirming that it is unethical to patent medical procedures and cautioning that the use of implantable radio frequency identification devices should come with a strong dose of caution to the user.

The AMA House of Delegates took action on the ethics questions at its annual meeting in June.

Patents too restrictive, delegates rule

The AMA's Council on Ethics and Judicial Affairs (CEJA) proposed that the AMA soften its opinion that the use of trade secrets, confidentiality agreements, and patents unethically limits patient access to the protected procedures.

CEJA said its investigation into patents suggests there are legitimate reasons to patent some procedures, and that the patent application process provides adequate public disclosure of the procedures. CEJA proposed that patents on procedures be permitted under the AMA ethics code, so long as they are not used to limit access; but the House of Delegates decided to let the 1995 ethics rule stand unchanged.

In other action, the AMA established its first code of ethics relating to implantable radio frequency identification devices (RFIDs), or "chips."

RFIDs bear an identifying number unique to the wearer that is revealed when scanned by a handheld scanner or "interrogator." The ID links to a potentially huge amount of medical and personal information, including allergies, medical conditions, blood type, and history. Currently, the VeriChip manufactured by VeriMed (Delray Beach, FL) is the only RFID approved by the U.S. Food and Drug Administration for implanting in humans for the purpose of identification.

In the ethics council's report, CEJA Chairman Robert M. Sade, MD, notes that RFIDs represent "another promising development in information technology," but cautions that they "also raise important ethical, legal, and social issues."

The CEJA report states that while use of RFID identification may improve patient safety, it also may pose physical risks and threats to privacy.

The AMA recommends that physicians who consider the implantable chips — which are inserted just below the skin, usually on the patient's arm — disclose the medical uncertainties associated with the devices.

Doctors also should work to protect privacy by storing confidential information only on RFID devices that are as secure as electronic medical records. The AMA expressed concerns that the devices might migrate under the skin and be difficult to remove; VeriMed has stated that the method for insertion ensures they stay in place.

"Physicians cannot assure patients that the personal information contained on RFID tags will be appropriately protected," the AMA cautions. The chips should not be implanted or removed without prior patient consent, the delegates said.