chapter 3.2 - healthcare law

health-related law

• body of rules for the conduct of individuals & organizations

  • created by federal, state, & local government

  • ensures a minimal standard of action by individuals & organizations

  • interpreted differently & changed over time

  • rules & regulations are interpretations of law

• public law

  • enforces relationships & regulations between government & the public

• private law

  • manages issues between individuals or groups

    • civil law

      • wrongful acts against individuals & organizations based on contractual violations

      • torts

        • type of wrongful acts in civil law that cause harm, which may not have a pre-existing contract

    • criminal law

      • actions that are illegal, based on the court decisions

        • activity must be proven without a reasonable doubt of guilt private law manages issues between individuals or groups

• law vs policy

  • policy is more broad, guidance, decision to address a long term purpose

  • law is an established procedure, standard & system of rules that will have penalty if violated

• health policy

  • laws, rules, regulations, principles, plans, or actions taken to achieve health-related goals in society

  • may address health at all levels → production, delivery, & financing of health care services

  • all levels of government influence health policy

  • can be used to enforce regulation/allocate resource

  • ex) food safety policy, substance abuse policy

health related legislation

• health consumer laws

  • address how healthcare is provided to consumers

    • EMTALA, HIPAA

• antitrust laws

  • protect consumers by ensuring market competition so consumers have a choice for healthcare

    • enforced by federal trade commission & department of justice

• employment-related legislation

  • ensures protection of employer & employees rights in the workplace, including the healthcare industry 

    • ADA, FMLA

HIPAA & the privacy rule - public example

• HIPAA - health insurance portability & accountability act national standards

  • protect a patient’s personal medical records & other personal health info maintained by healthcare providers, hospitals, insurance companies, and health plans

• privacy rule

  • established the first set of national standards for the protection of
    individual health info

    • assure that an individual’s health information was protected
      while allowing the flow of information to provide high-quality health care

    • requires safeguards to protect information and sets limits on the use/disclosure of the health information without the knowledge and consent of the individual

    • 2 exceptions

      • an individual can request a copy of their health record

      • information needed for a police investigation

  • PHI - protected health info

mental health parity & addiction equity act - public example

• mental health & substance use disorder treatment must be offered at the same level & cost as medical/surgical benefits

  •  plans cannot impose annual/lifetime limits on mental health benefits

  • includes group insurance provided by employer of 50+, insurance purchased on the exchange, & Medicaid/CHIP

  • *medicare is not subject to this law

GINA - public example

• genetic info nondiscrimination act

  • prohibits U.S. insurance companies and employers from discriminating based on info derived from genetic tests

  • forbids insurance companies from discriminating through
    reduced coverage or price increases

  • prohibits employers from making adverse employment decisions based on a person’s genetic code

• genetic info

  • an individual’s request for genetic services

  • if someone or a family member participates in a clinical
    trial that collected genetic info

  • the genetic info of a fetus of a pregnant woman or
    an embryo is used is assisted reproductive methods

healthcare provider

• a doctor of medicine or osteopathy who is authorized to practice medicine or surgery (as appropriate) by the state in which the doctor practices

• OR

• any other person determined by the secretary to be capable of providing
  health care services

  • ex) dentists, clinical psychologists, optometrists, chiropractors,
    nurse practitioners, nurse midwives

legal relationship between provider & healthcare consumer

start of provider-consumer relationship

1. care contract

2. informed or statutory consent

3. patient bill of rights

4. standard of care/negligence or malpractice/liability insurance

end of provider-consumer relationship

• not al provider/consumer relationships have negligence or malpractice, may also not be a linear process
  

care contract

• mutually agreed upon relationship between a provider and patient

• contract to care

  • for a designated population is often indicative of an HMO or managed care contract (in-network)

    • physician is contractually required to care for those member patients of a managed care organization

• express contract

  • simple contract & is a mutual agreement of care between the provider & patient

    • may be defined verbally or in writing

    • clearly states terms of agreement

    • physician may define limitations of contract, including parameters of care

• implied contract

  • implied from actions of a patient or provider

    • if physician gives advice regarding medical treatment

    • patient extends their arm in a lab draw chair prior to lab work

informed consent

• based on the patient’s right to make an informed decision regarding a medical or surgical treatment

• legal requirement in all 50 states

• provider is responsible for discussing with patient:

  • diagnosis if it has been established

  • nature of a proposed treatment or procedure, w risks & benefits, any alternatives & risks & benefits of those alternatives

  • risks & benefits of not agreeing to procedure/treatment

• statutory consent

  • if individuals cannot provide informed consent

  • presumes a reasonable person would give consent to the lifesaving procedure

  • ex) heimlich maneuver

• assent

  • affirmative agreement to take part in a clinical investigation

  • not always required by law nor for medical treatment

  • may be required for participation in a clinical study

    • children as young as 7 can provide this, but must be developmentally able to understand what the decision entails

      
      

patient bill of rights

• patient has right to all info from provider regarding testing, diagnoses, & treatments

• patient self determination act of 1990

  • requires hospitals, nursing homes, home health providers, hospices, & MCOs that provide services to medicare & medicaid eligible patients to supply info on patient rights to them upon admission

standard of care & medical malpractice

• standard of care

  • used to determine if a medical practice was negligent or evidence of malpractice

  • reasonable person standard 

    • did someone act with the same care as someone with similar credentials in the same circumstances?

• medical malpractice

  • improper treatment of a patient leading to injury, damage or loss

    • negligence

      • unintentional act or omission of an act that puts the patient’s health at risk

      • failure to act in the same way a reasonable person would in the same circumstances, that may lead to harm

    • intentional tort

      • assault & battery

      • intentional harm

      • invasion or privacy

• patient must show clinician acted w negligence & it results in jury or harm to patient, showing these ways:

  • professional duty to patient

  • breach of duty

  • breach led to injury/harm to patient

  • proven causation between breach of duty & damage

end of provider-consumer relationship

american medical association provides 5 steps for physician to terminate a relationship:

1. giving patient written noticed → certified mail

2. providing patient w specific reason for termination

3. continuing to provide care for a reasonable period of time so patient can find other care

4. providing assistance to patient to find other care

5. offering to transfer all medical records w patient permission

• following this helps prevent being accused of patient abandonment