Medical Ethics, Legal and Reulatory Issues 3%

Question 1

Government agency that approves and regulates medication and medical devices

Answer 1

FDS (food and drug administration)

Question 2

FDA issue ___and ___if there is a problem with a medication or medical device

Answer 2

recall and alerts

Question 3

Dr. can use medications or medical devices for for off label use if…

Answer 3

it is in Dr. best judgement that it would be in the best interest of the pt.

Question 4

FDA enforces compliance by ….

Answer 4

surprise inspections

Question 5

For Off Label and Investigational Use…..

Answer 5

Base use on firm scientific rationale
Sound medical evidence
Maintain records of the product’s use and effects

Question 6

What are some basic guidelines for protecting sensitive pt information?

Answer 6

Shred written credit card info
Don’t repeat credit card numbers
Do not transmit credit card numbers via unsecured email
Must have plan for reported suspected security breaches
Must notify those whose info was breached

Question 7

A government agency that protects employees from dangers in the work place

Answer 7

OSHA

Question 8

OSHA requires employer to provide you with ___

Answer 8

initial and ongoing training and testing on bloodborne pathogens, needlestick safety, hazard communications(labeling of containers), fires safety, and emergency preparedness (and Hep B vaccines, counseling, testing a following sharps injury at no charge to you.)

Question 9

____protects individual’s medical information and other sensitive information.

Answer 9

HIPAA

Question 10

HIPAA applies to …

Answer 10

physician, insurance company, health care clearing houses, and business associates

Question 11

What is the definition of protected health information?

Answer 11

medical information coupled with anything that would identify the pt (photo, name, SSN)

Question 12

Rule of HIPAA: we have to release the least amount of information necessary for some one to …

Answer 12

do what they need to do with pt

Question 13

You can share pt (PHI) pt health information if…

Answer 13

the other health care intity is coordinating care (pharmacy, consulting physician)

Question 14

HIPAA gives individuals the right to …

Answer 14

review their records and to request corrections

Question 15

___says that if you are in active labor or you have a medical emergency and you go to a medicare participating hospital that offers emergency services they provide you with stabilizing tx and at least a medical screening regardless of your ability to pay.

Answer 15

EMTALA (emergency medical treatment and labor act)

Question 16

What does the book “Preferred Practice Patterns” issued by AAO provide?

Answer 16

Guidance and recommendations for management of diseases.
Most doctors follow because its based on sound clinical data.

Question 17

The informed consent must include and have documented in chart…

Answer 17

risks, complications, and benefits, alternatives (including doing nothing) and an opportunity for questions and answers.

Question 18

It is ___responsibility to assess whether pt understands informed consent discussion

Answer 18

doctors
(doctor can ask if there is medical POA. If not court can appoint Healthcare surrogate)

Question 19

Person you appoint to make healthcare decisions for you

Answer 19

POA (power of attourney)

Question 20

Court appointed person to make health care decision when you become unable to make them for yourself

Answer 20

Health care surrogate

Question 21

Health care proxy used in combination with living will about end of life decision (ex: heart stopped or started, nutrition or not if vegatiative)

Answer 21

Advanced directives