Medical Ethics, Legal and Reulatory Issues 3% Flashcards
Government agency that approves and regulates medication and medical devices
FDS (food and drug administration)
FDA issue ___and ___if there is a problem with a medication or medical device
recall and alerts
Dr. can use medications or medical devices for for off label use if…
it is in Dr. best judgement that it would be in the best interest of the pt.
FDA enforces compliance by ….
surprise inspections
For Off Label and Investigational Use…..
Base use on firm scientific rationale
Sound medical evidence
Maintain records of the product’s use and effects
What are some basic guidelines for protecting sensitive pt information?
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
A government agency that protects employees from dangers in the work place
OSHA
OSHA requires employer to provide you with ___
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.)
____protects individual’s medical information and other sensitive information.
HIPAA
HIPAA applies to …
physician, insurance company, health care clearing houses, and business associates
What is the definition of protected health information?
medical information coupled with anything that would identify the pt (photo, name, SSN)
Rule of HIPAA: we have to release the least amount of information necessary for some one to …
do what they need to do with pt
You can share pt (PHI) pt health information if…
the other health care intity is coordinating care (pharmacy, consulting physician)
HIPAA gives individuals the right to …
review their records and to request corrections
___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.
EMTALA (emergency medical treatment and labor act)
What does the book “Preferred Practice Patterns” issued by AAO provide?
Guidance and recommendations for management of diseases.
Most doctors follow because its based on sound clinical data.
The informed consent must include and have documented in chart…
risks, complications, and benefits, alternatives (including doing nothing) and an opportunity for questions and answers.
It is ___responsibility to assess whether pt understands informed consent discussion
doctors
(doctor can ask if there is medical POA. If not court can appoint Healthcare surrogate)
Person you appoint to make healthcare decisions for you
POA (power of attourney)
Court appointed person to make health care decision when you become unable to make them for yourself
Health care surrogate
Health care proxy used in combination with living will about end of life decision (ex: heart stopped or started, nutrition or not if vegatiative)
Advanced directives
