MA:C4-Healthcare Laws

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).

Covered entities:
Protected health information (PHI):
Business associate:
Permission:
De-identify:
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
Act reasonably
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
Specific diseases
Sexually transmitted infections (STIs)
Specific injuries related to violence
Abuse, neglect, & exploitation
Table4.3

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)
- Lifts

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

Abuse

any care that results in physical harm, pain, or mental anguish

Advance directives

Advance directives

Breach

Breach

Claims clearinghouse

Claims clearinghouse

Coding system

Coding system

Communicable diseases

Communicable diseases

Dependent adults

Dependent adults

Discrimination

Discrimination

Egress

Egress

Electronic health record (EHR)

Electronic health record (EHR)

Electronic transaction

Electronic transaction

Exploitation

Exploitation

Harassment

Harassment

Neglect

Neglect

Precedence

Precedence

Privileged communication

Privileged communication

Retaliation

Retaliation

Retribution

Retribution

Whistleblower

Whistleblower