Health Care Law

Law

-represents a set of governing rules to protect citizens

-defines rights and obligations fo nteh gov and its citizens

-fluid and constantly evoloving

Private Law

Conflcts between private parties aka civil laws

-tort and contract

-preponderance

tort law

-wrongful conflict which causes harm and seeks compensation for the harm suffered

-intentional or lack of action

-most malpracticce cases

Contract Law

An agreement between 2 or more parties that creates some type of obligation to act or refrain from acting

Public law

Conflicts between private parties and government, or two agencies of government

-criminal and civil laws apply

-follows the constitution

Criminal Law

Conduct injurious to public order

-plantiffs always the gov

-punishment may be fined or improisioned

-state/federal statues alwasy est. crim law

-jury decision must be unanimous

-only defendant may appeal guilty verdicy

-defendant is either guilty or not guilty

-beyond reasonable doubt

-substancive, felony, misdemeanor, procedural

Substansive

an egregrious act

Procedural

what went wrong with the standard procedure

Misdemeanor

fined and up to a year in jail

Felonies

more serious=more time in prision

Preponderance

-almost positive it happened

-can be overturned if more evidence shows up

-burden of proof for civil law

Beyond reasonable doubt

-burden of proof for criminal law

Civil law

-both parites can be anyone

-the loser cannot be imprisioned

-est. both through state and federal statutes and court decisions

-In some systems a majority vote of or unamious decision of jury

-either party may appeal

-plantiff and defendant may be partially right/ at fault

-preponderance

Health info

data generated and collected as a result of delivering care to a patient

-primary use: clinical care

-protected under HIPAA- federal law

secondaery uses of health info

-evidence in legal cases

-public health reporting

-population health management

-3rd party reimbursement

-quality improvement

-patient safety

-research

HIPAA definition of health info

t is any information, whether oral or recorded

in any form or medium, that: (1) is created or

received by a health care provider, health

plan, public health authority, employer, life

insurer, school or university, or health care

clearinghouse; and (2) relates to the past,

present, or future physical or mental health or

condition of an individual; the provision of

health care to an individual; or the past,

present, or future payment for the provision of

health care to an individual”

Purposes of health records

-facilitates care and treatment

-supports decisions and communication

-documents services

-udebtufues quality and efficacy in care

-supports education

-facilitiates operational needs of a facility

-provides evidence

Primary data source

-clinical care

-serves as both legal and medical document that provides proof of care and serves as a business record

Secondary Data

Data taken from primary source and used for other purposes

-owenership of secondary data sources belong ot hte entity that created it

Privacy and security rules protection

-not one singular act

-access, use, and disclosure

Access

right of an indicidual to inspect and obtain a copy of his or her own health info that is contained in a designated record set

Use

sharing, employment, application, utilization, examination, or analyssi of individually identifiable health info within an entity that maintains such info

Disclosure

release, transfer, provision of, access to, or divulging in any other manner of info outside the entity holding the info

Protected Health info

any information that is oral or recorded in any for that is created or recieved by a health entity and relates the any past, present, or future moemnt of physical or mental health of an individual

ePHI

an electronic form transmitted or stored electronically

Health information technology for economic and clinical health act (HITECH), 2009

-part of the american recovery and reinvestment act of 2009

-promotes creation of a national info infrastructure through adoption and meaningful use of EHRs, and sharing health info via health information exchanges (HIE)

21st Century Cures Act (Cures Act) 2016

seamless healthcare data sharing and exchange between patients, providers, and payers while protecting patient access and privacy roghts

-implemented info blocking rules

Privacy

Right to be left alone from undue, unwanted intrusions in privat light

-no consitutional right but there is laws, cout decisions, accredidation bdoies, and professional orginizations

-courts must balance right to individuals privacy and publics right to know

Confidentiality

-from sharing private thoughts with someone in confidence

-often defined as a status accorded to data and infor indoicating that it is sensitive for some reason and needs to be protected from theft, diclosure, or improper use. only authorized people can access it

Confidentinal relationships

-spouses

-attorney and client

-clergy and parishioner

-physcian and patient

Security

physical and electronic protection of info that perseres these concepts

-data, info, and system

data security

sum of measures that safe gaurd data and computer programs from undesired occurences

ex:

-unauthorized ppl accessing data

-physical damage (water, fire, etc) .

-electrical failure or sabatoge

Information Security

Protecting info and info system from unautherized access, use, disclosure, disruption, modification, or destruction in order to provide, integrity, confidentiality, and availability

Systems safegaurd

all of the safeguards including hardware, software, personnel policies, info practice, disaster preparedness, and oversight. Protects system and info it store

Cybersecurity

-focuses on protectign computer systems from unauthorized access or beign potehrwise damaged or amde inaccessible

HIPAA Safe Harbor Bill

Reduces penalities and sanctions for providers who have adopted cybersecurity practices within 12 months of experiencing a data breach

Custodian of health records

a person responsible for care, custody, control, and proper safekeeping and disclosure of health records for persons or instiutions that prepare and maintain healthcare records

-federela and state rules of evidence requries someone in the orginzation to be the custodian

Stewardship

an organizations data or info governance plant tha provides a framework to amnage data and info as a corporate asset

data governance

overall administration throguh clearly defines procedures and plans that ssure the availability ,integrity, security, and usability of strucutured and unstructured data available to an organization

Info governance

policies, procedures, and multidisciplindary arragnement t amnage and optimize an organization;s information for its immeadiate and future needs including regulatory, legal, risk, environmenal, and operational requirements

Data stewardship

accountability for managemnet and oversight of data from a variety of sources, data usage, and security policies, and rules for its collection, storage, and retrieval

Information stewardship

focuses on day to day management of info and integration of data for organizational decision making an to achieve business outcomes

Healthcare professional obligations

adhere to

-laws

-standards of practice

-professional codes of ethics

-interpretative guidelines

Professional code of conduct

-reglects the values and prinicples defined b the profession as appropriate behavior in a professional setting

-guiding principles which a profession governs the conduct of its members

-used as a benchmakr for what constitutes acceptable practice in malpractice, negligence, or other litigous situations

-fluid and mirrors what is acceptable in society

Social determinants of health

-elements contributing t the overall health adn wellbeing of a specific population

ex:

-access and quality pof education adn health care

-neighborhood and environment

-economic stability

-social and community context

Ethics

standards of behavior that develop as a result of one’s concept and right or wrong

-stem from moral values so it can be influenced by background

-derived from generally agreed upon principles and guidelines

Morals

what is right and wrong in human behavior

-unique to the individual

professional ethics

professional use of morals

Moral dilemmas

occur when there is a conflict between ethics and morals

Values

attitutdes and character traits that enable people to be an aact inw ays that develop their human potential

-enable ability to puruse adopted ideals

-can become habits which create system

Ethical dilemmas

the difference of what you haev to do adn what is right to do

Ethical principles

autonomy, beneficence, nonmaleficence, Justice, Double effect principle, Best interest standards, Veracity

Autonomy

-independeence, self-determination, and freedom

-concept is at forefront of informed consent decisions

-must demonstrate competence to maintain

-challenfes includepaternalism and right-to die

-dilemma can exist when balancing rights of invidiuals and orther

Jack Kevorkian M.D

-patholigist who publicly championed right to die for terminally ill patients

-assisted over 100 death durign the 19902

-arrested multiple times, eventually convicted of second degree murders after injecting letal injection to a patient on TV

-His actions sparked national debate about PAS

Beneficence

-Qualities of kindness, mercy, and charity ,duty to always do good

-doing good, preventing harm, helpign others

-doing good requires knowledge of beliefs, cultures, values, and preferences of paatient

-people, often beliveing they know whats best for eachotehr, make decision that are in the patients best interest

Nomaleficence

-avoid causing harm

-constant in clinical practice

-Hippocratic Oath

Justice

-obligation to be fair in distribution of benefits and risks

-requries that no one be favored over another

-does not require that each one be treated the smae

-wjat one considers fair may conflict with anotehr’s opinion

distributive nad comparitve

Distributive justice

Fair distribution of burdens and benefits using independent standards

-requires one in position of authority to provide service due to others

-many medical issues involved in rationing healthcare

Criteria

-need

-effort

-ability to pay

-conterivution

-equity

-merit

Comparitive justice

-balancing competing needs with no independent standard ot amek comparision

-group with greater need or itnerest may recieve more resources than those wiwth lesser need

Doible effect principle

Recognizes tha tehtical choices may result in untoward outcomes

Harm vs. benefit analysis

Harm vs. benefit analysis

-Is the untoward poutcome secondary or unintended?

-Is that outcome outwighted bt an intended positive outcome?

Veracity

always tell the truth

-provides confidence in healthcare workers

-patients must truthfully inform health care provider of all relevant info

-health care provider must discliose facts to patient to enable patient to decide care

Best interest standards

-involves considering a patient’s situation as a wholem including theirn medical, psuchological, and social factors when a patient cannot give consent

-may base decision on past evidence of person’s wishes

ex advancce directives and previosu statements

Fidelity

-faithfulness, loyalty, and devotion to one’s obligations

-operating within acceptable practice constraints

-related to accountability

Compassion

-deep awareness and sympathy for antoher’s suffering

-moral value expected of caregivers

Ethical theories

-Utilitarism

-Deonology

-Right-based

-Virtue-based

Utilitarism

Best option in ant decision is based on what provides the greatest advantage or benefits the greatest number of people

Deonotology

Duty based individuals should be ehtical beacsue it is their duty

Right-based

Primary goal of decision making should be maintaining the rights of every indivdual

Virtue-based

Seekign the good life

-an individuals postiive more principles lead to them to do positive things

Nine step ethical deicison making model

1. Cleaerly define the proble,

2. Determine facts of situation

3. Determine who takeholders rare, values at stake, and oblications and interests of each stake holder

4. Determine abilable options and evaluate them

5. Make a decision

6. Justify decision made by identifying reasons that support decision

7. implement decision

8. evaulte outcome

9. repeat process agian as changes occur and results are moniterized

Medical ethics commitee

-provides a standardized approach to ethical decision amking in teh healthcare organizaton

-members analyze ehtical decisions and make recommendtions

-must take into considerationt he mission and vision of the healthcare organization as well as any applicable laws and regualtions

-Quinlan Case established

Karen ann quinlan

• 21 y/o female who was on alcohol and drugs at a party

• Found unconcious by her parents 

• Taken to the hospital and never woke up 

• Was said to be in a persistant vegitative state 

  • NJ did not have a law describing what brain dead is

• Parents wanted her to be removed from teh ventilator and feeding tube

  • Physcians refused

  • Went to court

  • Court used Roe v Wade

    • Autonomy to make a decision 

    • She did not have advance directive and her parents are chosed to be a surrogate for her decision making

• Decided that self determination is allowed (even by surrogate)

• Removed her from the ventilator and she lived on her own for 9 months

  • She was 60 pounds and so rigid that they couldn’t do ivs

  • Brain death got a legal definition in this time 

• Even though roe v wade was oveerturned this still stands since it includes self-determination 

Cnsequences of unethical behavior

-verbal or written warning

-poor performance evaluations

-disciplinary actions

-suspension

-termination

-unethical behaior can have same reprocussion as illegal behavior

Ethical challeges of using AI in helathcare

-patient privacy

-informed consent

-data ownership

-Data bias and fairness

-transparency and accountability

Bioethics

-when ethical issues arise as a result of advancements in tech leading to disease detection, medication interventions, and enhanced treatements

-often subeject of much debate as the fields of biology adn tech intertwine

-delemmas often are seen as beginning and end of life stages of treatement

Constitution

-supreme law of the land takign precedence over all otehr laws

-established branches of gov

-certain limits on what federal and state govs can do (vill of rights adn amendments)

Constitutional law

Due process requires fair treatment by government and private industry that receive significant funds

(substansive and procedural)

Substansive due process

Protects individuals legal rights and garuntees law are fair, reasonable, and not arbitrary

Procedural due process

government cannot take a person’s life, liberty, or property without fair legal processes and procedures

Sources of law

1. Constitution

2. Statutes

3. Administrative law

4. Common Law

Statutes

-Written laws emanating from a legislative body (ex.CMS,HIPAA)

-May be amended, repealed, or expanded by action of legislature

-legilature that enacted statue has power to adopt an amendment

-May declarre void by court because it does not comply with state or federal constitution

Codes

compilation of statutes

Administrative law

-executive branch enforeces law enacted by legislative body through the development of rules and refulations

US code of federal regulation

-permanent location of administrative rules

-monitor status of propsed regulations that may affect organizations

-submit comments on proposed regualtions

-every regulation must have and enabling statute

-Updated annually

Formal federal rulemaking process

-includes trial type hearing

-its use is limited

OInformal federal rulemaking process

-more common

-rules msut be published witha. notice adn comment period for itnereted partied(notice of proposed rulemaking NPRM)

-Required wating period before rule is published

Federal Register

daily us gov publication that reports all changes to regulations

-all proposed new rules, proposed changes to rules, and final rules must be published in it

Administrative procedures act

describes the different procedures under which federal administrative agencies must operate

-Department of healtha dn human services ,centers for medicare adn medicaid services ,social security administration, FDA, and CDC

Common Law

body of principles that has evolved and continues to evolve adn expanf from judicial decisions that arise during the trial of an actual court case. This results in case law

Case Law

the resultign court decision from a common law case that establishes a precedent that can be relied on for future cases

Common law principles

res judicata and stare decisis

Res Judicata

-the thign decided

-what has previosuly been decided or acted on by the court cannot be further litigated

-you cannot be tried for the same case twice

Stare Decisis

-let the decision stand

-a decision is rendered in a lasuit involving a particular set of facts, anotehr lawsuit involving identical or substantially similar situation is to be resolved in he same manner as the first lawsuit

-Precedent

-lower courts are bound to higher courts

-soemtimes courts decide that the precedent no longer adequately serves society’s needs

Supreme courts

hears appeals from teh appellate courts or from trial courts

-final decision making

-only hears cases granting certiorari

Appellate courts

-Hears appeals on final judgements of the state trials courts to determine whether error in law or procedure occured

-no testimony or exhibits reviewed

-decides whether reversal or modification in verdict is warrented

Trial courts

-burden of proof

-discovery process occurs

-trials conducted where judge and/or jury hear testimony, view exhbit and interview witnesses and try to reach verdict

Municipal courts

local jurisdictions handle minor cases

Petition for writ of certiorari

Process by which a party submits a request for the supreme court to hear a case

-thousands a year adn the court only hears 80 cases max

Circuit courts

-12

-same as appellate courts ins tate system

-12 regional districs

-13th hears national appeals depending on subject matter