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Rules issued by administrative agencies that have the force of law: - correct Answers -Regulation
Uniform method of defining basic parameters for processes, products, services, and measurements. -
correct Answers -Standard
A method or technique that has consistently shown results appeared to those achieved by other means:
- correct Answers -Best practice
The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of class lll
medical devices: - correct Answers -Premarket approval (PMA)
An injury or illness that is life - threatening, resulting in permanent impairment of bodily function or
permanent damage to a body structure, or necessitates medical or surgical intervention to preclude
permanent impairment of a body structure. - correct Answers -Serious injury
The US 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 drugs and medical devices they prescribe, dispense or use. - correct Answers -MedWatch
A federal medical insurance program that primarily serves those older than 65 (regardless of income),
people under 65 with certain disabilities and people of all ages with end-stage renal disease: - correct
Answers -Medicare
A federal and state assistance program that pays covered medical expenses for low income individuals.
It is run by state and local governments with federal guidelines. - correct Answers -Medicaid
The HIPAA privacy rule provides federal protections for individual identifiable health information held by
covered entities and their business associates, and gives patients and a rate of rights with respect of that
information: - correct Answers -Health insurance portability and accountability act (HIPAA)
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