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Healthcare applications are considered as promising fields for wireless sensor networks, where patients can be monitored using wireless medical sensor networks (WMSNs). Current WMSN healthcare research trends focus on patient reliable communication, patient mobility, and energy-efficient routing, as a few examples. However, deploying new technologies in healthcare applications without considering security makes patient privacy vulnerable. Moreover, the physiological data of an individual are highly sensitive. Therefore, security is a paramount requirement of healthcare applications, especially in the case of patient privacy, if the patient has an embarrassing disease. This paper discusses the security and privacy issues in healthcare application using WMSNs. We highlight some popular healthcare projects using wireless medical sensor networks, and discuss their security. Our aim is to instigate discussion on these critical issues since the success of healthcare application depends directly on patient security and privacy, for ethic as well as legal reasons. In addition, we discuss the issues with existing security mechanisms, and sketch out the important security requirements for such applications. In addition, the paper reviews existing schemes that have been recently proposed to provide security solutions in wireless healthcare scenarios. Finally, the paper ends up with a summary of open security research issues that need to be explored for future healthcare applications using WMSNs.

Background to the Debate: In 2004, the United States Food and Drug Administration approved a radiofrequency identification (RFID) device that is implanted under the skin of the upper arm of patients and that stores the patient's medical identifier. When a scanner is passed over the device, the identifier is displayed on the screen of an RFID reader. An authorized health professional can then use the identifier to access the patient's clinical information, which is stored in a separate, secure database. Such RFID devices may have many medical benefits--such as expediting identification of patients and retrieval of their medical records. But critics of the technology have raised several concerns, including the risk of the patient's identifying information being used for nonmedical purposes.

The Food and Drug Administration (FDA) is issuing a final rule to amend the Federal performance standard for diagnostic x-ray systems and their major components (the performance standard). The agency is taking this action to update the performance standard to account for changes in technology and use of radiographic and fluoroscopic x-ray systems and to fully utilize the International System of Units to describe radiation-related quantities and their units when used in the performance standard. For clarity and ease of understanding, FDA is republishing the complete contents, as amended, of three sections of the performance standard regulations and is amending a fourth section without republishing it in its entirety. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA).

The Food and Drug Administration (FDA) is classifying the implantable radiofrequency transponder system for patient identification and health information into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

In the autumn of 1997, the United States Center for Devices and Radiological Health published a draft guidance document on the use of IEC 60,601 standards in the evaluation of pre-market submissions for electromedical devices. One year later, an important legislative reform act caused this draft to be withdrawn because it allowed the Food and Drug Administration (FDA) to formally recognize standards covering all types of medical devices and not just those related to electrical products. This article discusses the benefits to manufacturers of this new FDA policy and the associated guidance documents that FDA has made available.

Part I of this article provided advice on how to minimize the safety risks when using electromedical equipment and safety features to incorporate into its design. Part II will provide further hints for safe design and compliance with safety legislation, in particular, concerning colours for indicator lights and wiring, power-supply cord sets, power inlets, connectors, and internal-powered devices.

The clinical diagnostic market represents a unique opportunity for the introduction of biosensors on a widespread commercial basis. To date, however, very few successful biosensors have been launched in this field or any other, despite many promising ideas. The need for biosensors in this field must be analyzed more critically, to assess in which direction the developing biosensor technology can be most effectively aimed and which areas need a more focused approach from basic research in bioelectronics. The diagnostics market is already a highly competitive field; from an industrial perspective, some of the critical issues that need to be taken into consideration when evaluating biosensor projects are: costs per test, regulatory requirements, quality control, instrumentation design, and test parameter selection.