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48 Cards in this Set
- Front
- Back
Why was HIPAA designed?
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To protect the privacy of medical information for all Americas, as well as to improve the portability of continuity of health insurance coverage
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HIPAA stands for -
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Health Insurance Portability and Accountability Act
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What happens to copies of date use agreements for research of Limited Data?
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it has to be submitted to the IRB with applications for initial review, exemption or change of protocol.
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What are some consequences of not complying with HIPAA?
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Fines ranging from $100 - $200,00 and 10 years in jail
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Food and Drug Law of 1906
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First law requiring food purity
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Food, Drug, and Cosmetic Act of 1938
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1st law requiring the establishment of drug safety prior to marketing
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Durham-Humphrey Amendment of 1951
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Provides statutory basis and criteria for differentiating prescription and nonprescription drugs
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Kefaufer-Harris Amendments
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Establishes efficacy, safety, and purity of drugs
Obtained informed consent from research subjects |
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Belmont Report of 1979
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Federally funded review that resulted in increased protection for human research subjects, attention to beneficence, and justice for human research
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Dietary Supplement Health and Education Act (DSHEA) of 1994
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Regulation of nutritional supplements and vitamins
- Must be safe for human consumption under ordinary conditions of use |
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FDA Modernization Act of 1997
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Helps streamline clinical research of drugs
- Helped established pharmacy compounding exemption and rules - Pediatric clinical studies - Expedite fast track drugs |
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Institutional Review Board (IRB)
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Helps protect the rights, safety, and well being of all study subjects
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The IRB is made up of what?
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- at least 5 members
- One member w/primarily nonscientific interests - One member that is independent of the institution - Only members that are independent of the investigator and sponsor may vote |
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What is the purpose of the IRB?
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To assure that the appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research
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What type of research requires IRB approval?
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- retrospective chart reviews
- observational studies - experimental studies |
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What is an expedited review?
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A review procedure that consists of a review of research involving human subjects by the IRB chairperson or by one or more experience reviewers designated by the chairperson from among members of the IRB
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When does the IRB use an expedited procedure?
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- To review minor changes in previously approved research during the period covered by the original approval
- Can be carried out by the IRB chairperson or by one of the more experienced members of the IRB |
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What CAN'T the reviewers of an expedited procedure do?
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They can exercise all authorities of the IRB except disapproval
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When can disapproval be accepted?
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When it is reviewed by the entire IRB committee
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What type of research have an expedited review?
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- Research on drugs in which an IND is not required
- Collection of blood samples by fingerstick, heel stick, ear stick, etc. - research that has data that has been collected, or will be collected solely for non-research purposes - Collection of data form voice, video, digital, and image recording made for research purposes - Research on ind. or group characteristics, behavior, research employing survey, oral history, etc. |
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FDA Modernization Act of 1997
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Helps streamline clinical research of drugs
- Helped established pharmacy compounding exemption and rules - Pediatric clinical studies - Expedite fast track drugs |
|
Institutional Review Board (IRB)
|
Helps protect the rights, safety, and well being of all study subjects
|
|
The IRB is made up of what?
|
- at least 5 members
- One member w/primarily nonscientific interests - One member that is independent of the institution - Only members that are independent of the investigator and sponsor may vote |
|
What is the purpose of the IRB?
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To assure that the appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research
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What type of research requires IRB approval?
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- retrospective chart reviews
- observational studies - experimental studies |
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What is an expedited review?
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A review procedure that consists of a review of research involving human subjects by the IRB chairperson or by one or more experience reviewers designated by the chairperson from among members of the IRB
|
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When does the IRB use an expedited procedure?
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- To review minor changes in previously approved research during the period covered by the original approval
- Can be carried out by the IRB chairperson or by one of the more experienced members of the IRB |
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What CAN'T the reviewers of an expedited procedure do?
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They can exercise all authorities of the IRB except disapproval
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When can disapproval be accepted?
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When it is reviewed by the entire IRB committee
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What type of research have an expedited review?
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- Research on drugs in which an IND is not required
- Collection of blood samples by fingerstick, heel stick, ear stick, etc. - research that has data that has been collected, or will be collected solely for non-research purposes - Collection of data form voice, video, digital, and image recording made for research purposes - Research on ind. or group characteristics, behavior, research employing survey, oral history, etc. |
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What is the difference between ED50 and LD 50?
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ED 50 = amount of drug required to produce a specific effect in 50% of animals tested
LD 50 = amt of drug required to cause death in 50% of animals tested |
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What does preclinical studies consist of?
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- Laboratory and clinical studies (LD 50 and ED 50)
- Toxicological signals (establishing basis for pregnancy categories) |
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What happens once the preclinical studies are completed?
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- A New Drug Application is drafted and submitted to the FDA
- This has to be approved prior to human experimentation |
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What occurs during Phase I of the Drug Approval process?
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- Tested on usually healthy young male adults
- Small number of people - Evaluate pharmacokinetic profile to determine a safe dosage - Not structured to detect most adverse effects - Determine the MOA of humans |
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What occurs during Phase II of the Drug Approval Process?
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- Study the drug in patients with the particular disease or condition its supposed to be treating
- Larger group of people tested (80 - a few hundred) - Preliminary data of effectiveness - Identify most common short-term adverse effects |
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What occurs during Phase III of the Drug Approval Process?
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- Tested on hundreds to thousands of patients
- Should be geared to detect differences in efficacy - Collect info on safe usage - Need enough information to weigh benefits and risks |
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What happens to a medication once it gets through the phase III of the DAP?
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A New Drug Application (NDA) is submitted
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What happens during Phase IV of the Drug Approval process?
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This is after the drug has been marketed
- Focuses on special populations - Identify rare, but serious side effects - Sequelae and outcomes of long-term use |
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Drugs that meet unmet medical needs and that are for patients with serious life threatening conditions are called what?
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Fast-tracked drugs
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What is the Purpose of the Investigation Drug Service?
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To ensure that the use of the investigational drugs i conducted ethically, and in application of the rules and regulations
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What is technically considered to be an Investigational Drug?
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Any drug that is not approved by the FDA for use in humans.
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A 3 day process which is a method of evaluation during and on-site visit which traces the health care of a patient while in the hospital
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Tracer Methodology
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What is ORYX?
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A JCAHO initiative that integrates outcomes and other performance measurement data into the accreditation process; a component of the ORYX initiative is the Standardized Core Measures.
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What are the Core Measures of the ORYX?
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1. Acute MI
2. Heart Failure 3. Community-Acquired pneumonia 4. Pregnancy and related conditions |
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What is NCQA? and it what 3 ways does it evaluate healthcare?
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1. Rigorous on-site review of key clinical and administrative processes
2. Health Plan Employer Data and Information Set 3. Comprehensive member satisfaction survey |
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In what key areas does HEDIS has performance measures for?
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Immunization rates
Mammography screening Cholesterol management Customer Satisfaction Other |
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What is NCQA? and it what 3 ways does it evaluate healthcare?
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1. Rigorous on-site review of key clinical and administrative processes
2. Health Plan Employer Data and Information Set 3. Comprehensive member satisfaction survey |
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In what key areas does HEDIS has performance measures for?
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Immunization rates
Mammography screening Cholesterol management Customer Satisfaction Other |