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The FDA was given the authority to review the effectiveness and safety of a new drug before it could be marketed.


A) Food and Drugs Act, 1906
B) Prescription Drug User Fee Act, 1992
C) Kefauver-Harris Drug Amendments, 1962
D) Food, Drug, and Cosmetic Act, 1938

E) A) and C)
F) None of the above

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This made additional resources available to the FDA, and resulted in a shortened approval process for new drugs.


A) Kefauver-Harris Drug Amendments, 1962
B) Food and Drug Administration Modernization Act, 1997
C) Orphan Drug Act, 1983
D) Prescription Drug User Fee Act, 1992

E) A) and B)
F) None of the above

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The ACA of 2010 has provisions to allow the development of generic-like versions of biologics.

A) True
B) False

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All technological innovations used in the delivery of medical care increase costs.

A) True
B) False

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Thanks to technology, HIV/AIDS has become a chronic disease.

A) True
B) False

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Which department of the DHHS supports research on health care quality, cost, and access?


A) National Institutes of Health
B) Agency for Healthcare Research and Quality
C) Institute of Medicine
D) American Health Quality Assocation

E) B) and C)
F) C) and D)

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What is the main application of quality-adjusted life years?


A) They are used as a measure of health benefits
B) They are used to determine how long on an average a person is likely to live if a given technology is indicated for a health condition
C) They are used to evaluate the ethical dimension of technology
D) They are used as indicators of the economic worth of technology

E) All of the above
F) A) and C)

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The United States controls the diffusion of medical technology through central planning.

A) True
B) False

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Generally, at the start of medical treatment


A) benefits exceed costs
B) cost-efficiency is minimum
C) costs exceed benefits
D) safety is not a major concern

E) None of the above
F) B) and C)

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In the US, both patients and practitioners generally equate high-quality care with high-intensity care.

A) True
B) False

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At a fundamental level, medical technology deals with


A) production of new equipment to provide more advanced health care.
B) the application of scientific knowledge for improving health and creating efficiencies.
C) using discoveries made in basic sciences to deliver health care.
D) new drugs, devices, and biologics.

E) B) and C)
F) A) and C)

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In technology assessment, what role do clinical trials play?


A) They are used for experimentation with potentially useful drugs
B) They are used for establishing the rights of participants
C) They are used for determining cost-effectiveness
D) They are used for evaluating efficacy and safety

E) A) and C)
F) B) and C)

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D

The most stringent requirements of premarket approval regarding safety and effectiveness apply to _____ devices


A) Class I
B) Class II
C) Class III
D) Class IV

E) C) and D)
F) B) and D)

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The asynchronous form of telemedicine uses _____ technology.


A) store-and-forward
B) access-when-needed
C) delayed-access
D) forward-and-retrieve

E) B) and C)
F) None of the above

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Benchmarking of HTA organizations should be linked with


A) cost effectiveness of medical technology
B) coordination of HTA efforts across various organizations
C) standardization of HTA methods
D) evaluation of economic worth

E) A) and D)
F) A) and C)

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C

What was the purpose of certificate of need (CON) laws.


A) Monitor the diffusion of new technology.
B) Control the flow of federal funds for private projects
C) Control new health service programs
D) Control new construction and modernization projects

E) B) and C)
F) A) and D)

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What is the main intent of the Stark laws?


A) Require that personal health information be kept confidential
B) Require demonstration of cost-efficiency of new technology
C) Prohibit self-referral by physicians to facilities in which they have an ownership interest
D) Disclosure of potential harm from a procedure or device

E) B) and D)
F) All of the above

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At the flat of the curve,


A) marginal benefits are zero
B) marginal costs are the highest
C) additional medical treatment is harmful
D) maximum cost-efficiency is achieved

E) All of the above
F) C) and D)

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A

What is the main advantage of interoperability within an electronic health records (EHR) system?


A) Information can be transmitted over the Internet.
B) Information can be safeguarded.
C) Information can be coordinated with clinical practice guidelines.
D) Information can be shared between physicians, pharmacists, and hospitals.

E) A) and B)
F) A) and C)

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What is the main function of the National Institutes of Health?


A) Conduct and support research on health care quality, cost, and access
B) Establish medical subspecialties in US medical schools
C) Provide specialized training for medical specialists
D) Conduct and support biomedical research

E) None of the above
F) All of the above

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