images for entire health care facilities. The category would also include the medical image workstation, which generally consists of a computer, video monitor, and storage device. The computer often utilizes software related to data communications, file management, image processing (e.g., edge enhancement), measurement, and special image displays (e.g., 3D surface and volume rendering).
Currently, some stand-alone software products (e.g., some decision support systems) also fit the definition of a medical device as described in draft policies developed in the 1980s (FDA, 1989). Other software products are not covered if they are intended only to serve traditional library, accounting, communications, or educational functions and are not used to diagnose or treat patients.
As this report was being drafted, the FDA was exploring new policies that would allow the agency to assess the risks of software devices and decide which might be exempt from certain regulatory requirements. It was also planning to hold a workshop to obtain public suggestions and comments on how the health risks of medical software devices might be assessed and how policies might be defined. In addition, the CDRH had established a Computer Aided Diagnosis (CADx) Working Group to develop guidelines for agency reviewers of CADx software devices.
The task for this committee was to develop an evaluation framework for clinical telemedicine—not to develop policy recommendations. The committee recognized, however, that policies related to licensure, malpractice, and other matters need to be considered in an evaluation framework because they may affect the availability, acceptability, effectiveness, and cost of telemedicine services.
By providing an overview of policy issues, this chapter along with Chapters 2 and 3 has attempted to provide background and context relevant to the task of developing an evaluation framework for clinical applications of telemedicine. The next chapter considers existing and planned evaluations of telemedicine.