Chapter 6

3. A federal medical insurance program that primarily serves those older than 65.
5. A uniform method of defining basic parameters for processes, products, services and measurements.
9. Reports developed by experts in the field that contain valuable information needed by the healthcare industry.
10. A method or technique that is consistently shown results superior to those achieved by other means.

1. Voluntary guidelines representing a consensus of AAMI members that are intended for use by healthcare facilities and manufacturers to help ensure instruments are safe for use.
2. Rules issued by administrative agencies that have the force of law.
4. A federal and state assistance program that pays covered medical expenses for low-income individuals.
6. The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of class III medical devices.
7. The FDA safety information and adverse event reporting system that serves healthcare professionals and the public by reporting serious problems.
8. Provides ferderal protections for individually identifiable health information held by covered entities and their associates.
11. A injury or illness that is life-threatening resulting in permanent impairment of a bodily function or permanent damage to a body structure.