By Mick Meaney由米克meaney
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The American Medical Association (AMA) has released a report highlighting the risks of human implantable RFID microchips.美国医学协会（ AMA ）曾发表了一份报告，强调风险植入人体的RFID微芯片。

The report contains safety and privacy warnings - as the chips have never been thoroughly tested, despite in 2004 the Food and Drug Administration (FDA) giving the go-ahead for the use of human implantable chips, causing outrage among medical professionals and privacy advocates.该报告包含了安全和隐私忠告-作为筹码，从来没有过彻底测试，尽管在2 004年，美国食品和药物管理局（ F DA）给予方能首肯，为使用人的植入式芯片上，造成了愤怒的医疗专业人员及隐私权拥护者。

Medical sales of RFID chips have been poor as a result.医疗销售RFID芯片已经穷人，作为结果。

VeriChip, the company manufacturing the chips, have been putting their own spin on the new report claiming that it will “enhance marketing efforts”.通过VeriChip ，该公司生产的芯片，已经把自己的自旋对新的报告，声称它会" ，增强市场营销的努力" 。

However, the AMA will consider the future use of RFID, if proven secure and efficient.然而，或将考虑未来使用的RFID ，如果被证实在安全和效率。 They will then encourage the widespread use across the global health care sector.然后将鼓励广泛使用横跨全球卫生保健部门。

The full report:报告的全文：

REPORT OF THE COUNCIL ON ETHICAL AND JUDICIAL AFFAIRS * CEJA Report 5-A-07 安理会的报告对党风廉政建设和司法事务*切娅报告5 - - 07

Subject: Radio Frequency ID Devices in Humans主题：无线电频率身份证装置在人体

Presented by: Robert M. Sade, MD, Chair主办：罗伯特英语教育署高级助理署长，医学博士主持

Referred to: Reference Committee on Amendments to Constitution and Bylaws (Richert E. Quinn, Jr., MD, Chair)是指：参照委员会关于修改宪法和章程（ richert体育奎因前些日子，医学博士主持）

INTRODUCTION 导言

Radio frequency identification (RFID) tags are computer chips connected to miniature antennae that can be used to transmit information electronically via a proximate RFID reader.  The use of these devices in health care represents another promising development in information technology, but also raises important ethical, legal and social issues. 无线电频率识别（ RFID ）标签是计算机芯片连接到微型触角，可以用来传输信息，以电子方式近距RFID阅读器。使用这些装置在医疗，代表另一种有前途的发展，在信息技术领域，而且也引起了一些重要的伦理，法律和社会问题。 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. 具体来说，使用RFID标记技术在人类医疗用途，可改善患者安全，但也可能会造成一些物理风险，妥协病人隐私，或者目前的其他社会危害。

This report responds to Resolution 6 (A-06), “RFID Labeling in Humans,” which called for study of the medical and ethical implications of RFID chips in humans.  This report focuses on ethical issues in the use of RFID chips, specifically in regard to their implantation for clinical purposes. 本报告响应第6条（ a - 06 ） ， "的RFID标记技术在人类通知" ，要求研究的医学和伦理影响的RFID芯片在人类中，这个报告的重点是有关伦理问题，在使用RFID芯片，特别是在对于他们植入的临床用途。

BACKGROUND 背景

Radio frequency identification devices utilize wireless technology to communicate data via signals in the radio frequency range of the electromagnetic spectrum.  Data are stored in a microchip attached to an antenna, and packaged so that they can be attached to or embedded in products, animals, or people. 无线电频率识别装置，利用无线技术，使数据传送通过信号的无线电频率范围内的电磁波谱的数据被存储在一个微型芯片附在天线和包装，使他们能够附着或嵌入在产品，动物，或人。

The two main types of RFID tags are passive and active.  Passive tags contain no internal power supply. 两种主要类型的RFID标签是无源和有源被动标签没有内部供电。 They convert the radio frequency energy emitted from a reader device into signals that transmit stored data for a distance of a few feet.  These passive devices currently have restricted amounts of data storage and are of limited functionality, because the information they contain cannot be modified. 它们转换成无线电频率能量排出的一个读者装置到信号传输储存数据的距离只有几英尺远，这些被动元件，目前已受限制的数据量存储，并有限的功能，因为他们的资料包含不能随意修改。

In comparison, active RFID tags contain an internal battery, which provides increased reliability, longer transmission ranges, on-tag data processing and greater data storage. 相比之下，有源RFID标签含有内置电池，提供更高的可靠性，更长的传输范围内，对标签的数据处理和更大的数据存储。

¹ While their capacity to process data internally allows for expanded capabilities in the future, their greater transmission range presents a more substantial threat to data confidentiality and patients’ privacy. ^一日 ，而他们的能力以及处理内部数据允许扩充能力，在未来的日子，他们更大的传输范围，提出了更加实质性的威胁，数据保密和病人的隐私。

In October 2004, the US Food and Drug Administration (FDA) approved the first RFID tags specifically intended for human implantation. 2004年10月，美国食品和药物管理局（ FDA ）批准了第一个RFID标签专门用于人体植入。

² Approved RFID devices are currently limited to passive units, intended for identifying patients. ²核可RFID设备目前只限于被动的单位，为查明患者。 Active RFID chips may be approved in the future. 主动式RFID晶片可能获批准在未来。

Human-implanted passive RFID devices that identify patients may also contain essential biometric and medical information.  The tags are primarily intended for patients with chronic diseases, such as coronary artery disease, chronic obstructive pulmonary disease, diabetes mellitus, stroke or seizure disorder, or are implanted into patients with medical devices such as pacemakers, stents, or joint replacements.  These devices are approximately the size of a grain of rice, and are implanted under the skin via a hypodermic-type needle in less than one minute. ³ 人体植入无源RFID装置，以查明患者也可能含有必需的生物统计和医学信息。标签主要用于治疗慢性疾病，如冠心病，慢性阻塞性肺疾病，糖尿病，中风或扣押紊乱，或正植入病人的医疗器械，如心脏起搏器，支架，或更换关节。这些器件是大约大小相当于一米粒，并植入皮肤下经皮下型针，在不到一分钟³

INFORMATION SYSTEMS 信息系统

RFID tags may promote the timely identification of patients and expedite access to their medical information.  As a result, these devices can improve the continuity and coordination of care with resulting reduction in adverse drug events and other medical errors. RFID标签可促进及时查明患者，并加快进入他们的医疗信息，作为一个结果 ， 这些器件可以改善的连续性和协调服务，由此产生减少药物不良事件和其他医疗差错。 ⁴ RFID tags also may improve efficiency within the health care system.  In conjunction with improved medical record management, these devices may facilitate access to patient records, medication lists, and diagnostic tests. ⁵ To be maximally effective, however, the information in these devices must be adequately integrated into present clinical information and communications systems, laboratory databases, and pharmacy systems. ^四 ， RFID标签，也可提高效率，在卫生保健体系。结合改善病案管理，这些装置可以便利获得病人的病历，用药清单，和诊断测试⁵必须最大限度地有效的，然而，信息在这些设备必须充分整合到目前的临床资料和通讯系统，实验室数据库，以及药房系统。 ^{1 一} Appropriate processes also must be developed to inscribe, read and archive data stored on RFID tags.  As new designs enter the marketplace, the emergence of competing standards may present problems for hospital staff if a patient’s ID tag proves incompatible with the interrogation devices employed by the hospital. 适当程序，也必须制定报名，阅读及存档数据存储在RFID标签，至于新设计进入市场，出现了相互竞争的标准，可目前的问题，医院工作人员如果病人的身分证明，标签不符合讯问设备受雇于由医院。 ^{1 一}

Physical risks to patients 物理患者的危险

These devices may present physical risks to the patient.  Though they are removable, their small size allows them to migrate under the skin, making them potentially difficult to extract.  However, this tendency may be minimized by constructing RFID tags from materials that permit surrounding tissue to encase the device.  In addition, RFID tags may cause electromagnetic interference, which may interfere with electrosurgical devices and defibrillators. ¹ Finally, it has not been determined whether RFID tags might affect the efficacy of pharmaceuticals. 这些装置可以，目前的身体危害病人，虽然他们是可拆卸的 ， 其体积小，让他们迁移皮肤下，使它们有可能难以提取，但这种倾向的原因可能降到最低构建RFID标签，从材料，允许周围组织寓设备。此外， RFID标签可能造成电磁干扰，它可能会干扰电设备和去纤颤器。 ^一日最后，它尚未决定是否RFID标签可能会影响疗效的药品。 ^{1 一 ,6 6}

PATIENT PRIVACY AND SECURITY 病人的隐私和安全性

The primary concerns surrounding human RFID labeling pertain to their potential impact on patient privacy and security.  Physicians must assure patients that their medical information will be held in confidence (see Opinion E-5.05, “Confidentiality”).  Moreover, maintenance of privacy is required to protect patients from embarrassment, potential social discrimination, loss of health care coverage, or other detrimental consequences (see Opinion E-5.059, “Privacy in the Context of Health Care”). At this time, the security of RFID devices has not been fully established.  Physicians, therefore, cannot assure patients that the personal information contained on RFID tags will be appropriately protected.  In light of these security concerns, the FDA currently requires RFID transponders to store only a unique electronic identification code to be read by the scanner. 首要关心周围人的RFID贴标属于自己的潜在影响，对病人的隐私和安全。医师必须保证病人，他们的医疗信息将先后在信心（见民意电子5.05 ， "保密" ） 。此外，维修的隐私是需要为了保护患者的尴尬，潜在的社会歧视，失去医疗保险，或其他不利后果（见民意电子5.059 ， "隐私语境中的保健" ） 。在这个时候，安全的RFID设备没有得到完全建立起来。医师，因此，不能保证患者的个人资料，载于RFID标签将获得适当的保障。针对这些安全问题中， FDA目前要求的RFID转发器向商店只有一个独特的电子识别码，以阅读扫描器。 ^{2 二} This identification code can then be used to access patient identity and corresponding health information stored in a database. To protect confidentiality and privacy, the medical community should advocate for the adoption of other protections, such as computer encryption or digital signatures. 这个识别码可以用来查看病人的身份和相应的卫生信息存放在一个数据库中，为了保护其机密和隐私问题，医界应倡导采取其他的保护措施，如计算机加密或数字签名。 Ultimately, the medical community should undertake appropriate efforts to prevent unauthorized access to patients’ information contained on RFID tags (see also E-5.07, “Confidentiality: Computers,” AMA Policy Database). 最终，医界应进行适当的努力，以防止未经授权的访问，以病人资料载于RFID标签（也见电子5.07 ， "保密：电脑" ，或政策数据库） 。

INFORMED CONSENT 知情同意

To properly respect patient autonomy, RFID tags should not be implanted or removed without the prior consent of patients or their surrogates (see E-8.08, “Informed Consent,” and E-8.081, “Surrogate Decision Making”).  During the consent process, decision-makers should be informed of the potential risks and benefits associated with RFID tags, including the many uncertainties regarding their efficacy.  Patients are also entitled to know who will be granted access to the data contained on RFID tags and the purposes for which this information will be used. 妥善尊重病人自主权， RFID标签不应被植入或撤销未经事先征得病人或其代理人（见电子8.08 ， "知情同意原则" ，和电子商务8.081 ， " 代决策" ） ，在同意过程，决策者应清楚了解这一潜在的风险和益处，相关的RFID标签，其中包括了许多不确定性，就其疗效，病人也有权知道是谁，将获准进入该数据对RFID标签和用途，其中本信息会被如何利用。 ^{7 七日}

FURTHER CONSIDERATIONS 进一步的考虑

It seems likely that utilization of RFID devices for medical purposes will expand. 看来，有可能利用RFID器件作医疗用途将会扩大。 ^{4 四} The medical profession must continue to monitor the efficacy of these devices.  If RFID tags are proven to benefit patient care significantly, the profession should advocate for widespread adoption of RFID technology, and for policies that make RFID tags available to all patients who would benefit (see Opinion E-2.095, “The Provision of Adequate Health Care”). However, if objective evidence demonstrates negative consequences that outweigh the benefits in relation to health care, the medical profession will bear an important responsibility to oppose the use of RFID labeling in humans. Finally, physicians should be aware of emerging non-medical applications of human-implantable RFID devices.  For instance, active RFID technologies might be considered for the tracking or surveillance of individuals who pose a threat to others.  Although this is only one of many possible uses of RFID technology in the future, it alerts the medical profession to the need for continuous assessment of the appropriate role of physicians participating in RFID labeling of human beings.  Indeed, certain uses could constitute an infringement upon patients’ individual liberties, placing physicians in a position to act as patient advocates by promoting the use of other, less intrusive alternatives, when available. 医学界必须继续监测疗效的这些设备，如果RFID标签已被证明可以造福病人护理显着，医学界应倡导广泛采用RFID技术，并制定政策，使RFID标签提供给所有的病人将受益（见民意电子2.095 ， "提供充足的卫生保健" ） ，不过，如果客观证据表明消极后果会大于益处与保健，医学界将承担着重要责任，反对使用RFID标记人类最后，医生应该知道，对新出现的非医学应用中的人为植入RFID设备。举例而言，主动式 RFID 的技术可能被视为为跟踪或监视个人构成威胁别人，虽然这只是其中一个原因许多可能用途的RFID技术，在未来，它会提醒医学界需要不断评估适当的角色，医师参与在RFID标记的人，事实上，某些用途，可能构成侵犯病人的个人自由，配售医师在一个位置，以作为病人主张通过推广使用其他侵扰程度较低的替代品，当可用。 ^{4 四}

CONCLUSION 结论

RFID technology has the potential to improve patient care as well as patient safety.  However, the safety and efficacy of human-implantable RFID devices has yet to be established.  Therefore, the medical community should support further investigations to obtain the data necessary to make informed medical decisions regarding the use of these devices.  The medical community should also be sensitive to potential social consequences of RFID devices, such as non-medical applications in law enforcement. RFID技术，有潜力，以改善病人护理，以及病人的安全，但是，安全性和有效性的人植入RFID设备还没有建立起来，因此，医界应支持进一步的调查，以获取必要的数据，以作出明智的医生决定如何使用这些设备。医学界也应该敏感，潜在的社会后果RFID装置，如非医学中的应用，在执法。

RECOMMENDATION 推荐

The Council on Ethical and Judicial Affairs recommends that the following be adopted and the remainder of the report be filed. Radio frequency identification (RFID) devices may help to identify patients, thereby improving the safety and efficiency of patient care, and may be used to enable secure access to patient clinical information.  However, their efficacy and security have not been established.  Therefore, physicians implanting such devices should take certain precautions: (1) The informed consent process must include disclosure of medical uncertainties associated with these devices. 安理会对伦理和司法事务建议根据以下通过并在余下的报告将提交法庭。无线电频率识别（ RFID ）设备可能有助于确定病人，从而提高了安全性和效率，病人护理，并可能被用来能够安全地进入病人的临床资料，但其疗效和安全都没有建立起来，因此，医师植入这种装置应该采取一些防范措施： （ 1 ）知情同意过程必须包括披露医疗的不确定性与这些设备。

• 2. Physicians should strive to protect patients’ privacy by storing confidential information only on RFID devices with informational security similar to that required of medical records. 医师应尽力保护病人的隐私所储存的机密资料，不仅对RFID设备与信息安全的类似要求的病历。

(3)  Physicians should support research into the safety, efficacy, and potential non-medical uses of RFID devices in human beings. (NEW HOD/CEJA Policy) （ 3 ）医师应支持研究的安全性，疗效以及潜在的非医疗用途的RFID设备在人的人。 （新方法/切娅政策）

Fiscal Note: Staff cost estimated at less than $500 to implement. 财政注：员工成本估计低于500元执行。

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