Chapter 6 Terminology

Question 1

Regulation

Answer 1

Rules issued by administrative agencies that have the force of law.

Question 2

Standard

Answer 2

A uniform method of defining basic parameters for processes, products, services and measurements.

Question 3

Best Practice

Answer 3

A method or technique that has consistently shown results superior to those achieved by other means.

Question 4

Premarket approval (PMA)

Answer 4

The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Question 5

Serious Injury

Answer 5

An injury or illness that is life-threatening, resulting in permanent impairment of a bodily function or permanent damage to a body structure, or necessitates medical or surgical intervention to preclude permanent impairment of a body structure.

Question 6

MedWatch

Answer 6

The U.S. Food and Drug Administration’s safety information and adverse event reporting system that serves healthcare professionals and the public by reporting serious problems suspected to be associated with the drugs and medical devices they prescribe, dispense or use.

Question 7

Medicare

Answer 7

A federal medical insurance program that primarily servers those under 65 years (regardless of income), people under 65 with certain disabilities, and people of all ages with end-stage renal disease.

Question 8

Medicaid

Answer 8

A federal and state assistance program that pays covered medical expenses for low-income individuals. It is run by state and local governments within federal guidelines.

Question 9

Health Insurance Portability and Accountability Act (HIPAA)

Answer 9

The HIPAA Privacy rule provides federal protections for individually identifiable health information held by covered entities and their business associates and gives patients an array of rights with respect to that information

Question 10

Standard (AAMI)

Answer 10

Voluntary guidelines representing a consensus of AAMI members that are intended for use by health care facilities and manufacturers to help ensure that medical instrumentation is safe for patient use.

Question 11

Technical Information Reports (TIRs)

Answer 11

Reports developed by experts in the field that contain valuable information needed by the healthcare industry.