Explain the standards of the Health Insurance Portability and Accountability Act (HIPAA) and discuss HIPAA-related terminology (including covered entities, protected health information, business associate, permission, de-identify, and limited data set).
Protected health information (PHI):
Limited data set:
Health Information Technology for Economic and Clinical Health (HITECH) Act.
- Contains provisions that increased enforcement of privacy & security of electronic transmission & health info
- made business associates directly liable for compliance w/HIPAA
- Prohibited sale of PHI w/out pt's authorization
Describe the important features of the Genetic Information Nondiscrimination Act (GINA), the Food, Drug, and Cosmetic Act, and the Controlled Substances Act.
- Modified HIPAA
- Increased protection for individuals
- Prohibits genetic discrimination on health coverage & employment
- became law in 2008
Food, Drug, and Cosmetic Act of 1937
FDA is responsible for safety, effectiveness, security, & quality of drugs, cosmetics, & food.
Controlled Substances Act of 1970
- DEA oversees manufacturing, importation, possession, use, & distribution of certain drugs & chemicals.
- 5 schedules if medications: arranged from greatest to least abuse potential
Patient Protection and Affordable Care Act (PPACA) 2010
- provide Americans w/affordable health insurance
- attempted to reform healthcare system; reduce healthcare spending
Clinical Laboratory Improvement Amendments (CLIA) 1988
- Established quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results.
- regulates laboratory testing
federal agencies involved:
Food & Drug Administration (FDA)
Centers for Medicare & Medic
Occupational Safety and Health Act 1970
- sets workplace standards
- conducts inspections to ensure employee safety
- employees must comply w/all of OSHA's regulations
Needlestick Safety and Prevention Act 2000
- reduce risk of HC workers exposure to bloodborne pathogens standard
- required OSHA to update bloodborne pathogens standard
- revised standards apply to all employees w/anticipated occupational exposure to blood or other potentially infectious materials
Good Samaritan Laws
State laws that provide legal protection for those assisting an injured person during an emergency.
Persons responding must:
Not be paid for care given
Not act negligibly/recklessly
Patient Self-Determination Act (PSDA)
Requires most healthcare institutions to inform pts of their right to make decisions; facilities policies respecting advance directives
Uniform Determination of Death Act (UDDA),
Guide for state lawmakers to create their own laws that define death.
Uniform Anatomical Gift Act (UAGA)
a law permitting a person of legal age and sound mind to give all or any part of his/her body upon his/her death or gives the right to another.
- purpose to make organ donations easier
National Organ Transplant (NOTA)
Established national registry of organ matching
Describe compliance with public health statutes related to communicable diseases and to wounds of violence, abuse, neglect, and exploitation.
HC providers have a responsibility to report specific info to various authorities:
Births & deaths
Sexually transmitted infections (STIs)
Specific injuries related to violence
Abuse, neglect, & exploitation
Describe compliance with reporting vaccination issues
- Vaccine Information Statement (VIS)
- If a pt has an unusual side effect to file a report w/Vaccine Adverse Event Reporting System (VAERS)
National Childhood Vaccine Injury Act 1986:
- Created National Vaccine Injury Compensation Program (VICP)
Discuss how compliance programs work, examine common compliance concerns in healthcare, follow protocol in reporting an illegal activity, and correctly complete an incident report.
A program w/in a business that detects & prevents violations of state & federal laws.
- an effective compliance program helps protect the organization from fines & lawsuits
any care that results in physical harm, pain, or mental anguish
Electronic health record (EHR)
Electronic health record (EHR)