legal issues in healthcare week 1

8/11/2019 Legal Issues in Healthcare WEEK 1

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LEGAL ISSUES IN

HEALTHCARE:

REGULATION AND

COMPLIANCE

HCS/430

Dolly Ireland, MSN,

RN, CAPA, CPN


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Objectives

Week 1 Relate the general nature, sources, and functions of

the law to the healthcare industry and environment.

Identify the governmental and other agencies that

impact the healthcare industry, and the regulatory

scheme they administer.

Analyze the regulatory issues and trends that

impact the healthcare industry. Examine the function and process of individual and

organizational licensure, accreditation, certification,

and authorization.


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Legal Environment of theHealthcare Industry


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Healthcare and Law

Without a moral structure for ones actions, people would

be free to pursue their own self-interests. Because what

is illegal is almost always unethical, it is important to

have a basic understanding of the law as it applies to themedical world.

Applied Ethics:Adhering to ethical

standards and codes of

conduct

Bioethics:Result of modern

medical advances and

research


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The legal system

Federal Government:

U.S. Tax Court U.S. Bankruptcy Court

3 Branches:Legislative

Executive

Judicial

Separation between the threebranches created system of:

Checks and Balances

State Government:

Traffic and small claims Medical licensing acts

3 cou rt levels:

Trial

Appellate

supreme

Federalism

Checks and Balances


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Legislative Branch

The Constitution Executive Branch

Judicial BranchThe

Supreme

Court

President

Congress

Other Agencies

The Cabinet

House of Representatives

435 members from states

Senate

100 members, 2 each state

Circuit Court of Appeals

District Courts


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Sources of LawLaws ( enforceable rules) prescribed by

government authority:

Constitutional

Statutory

Regulatory

Common (case)


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ConstitutionalConsists of both the U.S. Constitution

and the constitutions of the individual

states.U.S. constitution sets up the

government, defines the power to act,

and sets limits on the governmentspower. *(individual rights such as free

speech).


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StatutoryStatutes are laws passed by legislativebodies, either Congress or a statelegislature.

Called Statutory or Legislative LawConsist of:Rules and regulations created by Congress, State

legislators, local governments, or constitutionallawmakers.Inviolable rights, privileges, or immunities secured andprotected for each citizen by the Constitution.


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Regulatory

Legislators can authorize agencies to make laws.

They pass a statute called enabling legislation.

This statute creates an agency and authorizes it to pass laws

regarding specific issues.

The Food and Drug Administration is a federal agency that

can pass rules governing the sale of food and drugs.

Rules or Laws made by agencies are called: REGULATIONS


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Common Law (Case Law)

Made by judges when they apply previous courtdecisions to current cases.

Based on judicial interpretation of previous lawswhich leads to a common understanding of how alaw should be interpreted.

Evolves on a case by case basis so it is also

called case law.

Legal principle of stare decisisor let the decision standcomes from basing decisions on past case decisions.


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Laws

Functions:

Keep the peace

Shape moralstandards

Promote social

justice

Resolve disputes


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LawsDivided into Private and Publiclaws.

Private:

1. Tort2. Contract

3. Property

4. Inheritance5. Family

6. Corporate

Civil (private) law concerns relationships either

between individuals or between individuals and

government. Involves all law that is not criminal.Examples: divorce, child custody, auto accidents,

slander, libel and trespassing.

In a civil law case there must be a

preponderance of evidence to receive a guilty

verdict.Civil law includes tort law and contract law.

Healthcare employees most frequently involved

in tort and contract cases.MEDICAL MALPRACTICE LAWSUITS FALL WITHIN

THE CATEGORY OF THE CIVIL LAW OF TORTS


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TortA tort is a wrongful act committed against

another person or property, resulting in

harm, and is compensated by money

damages.

Torts:

Intentional(and quasi-intentional)

Unintentional


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Intentional (quasi-intentional)

Intentional:

Assault

BatteryAggravated battery

False imprisonment

Fraud

Embezzlement

Quasi-intentional:

Defamation of

Characterslander, libel

Invasion of Privacy

Breach ofconfidentiality

Abandonment


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UnintentionalNegligence occurs when a patient is

injured as a result of a healthcare

professional not following thestandard of care.

Only professionals can be sued for

malpractice: physicians, nurses,lawyers, accountants, pharmacists,

physical therapists.


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Negligent Torts

Altering or Tampering with a medical record

Failure to adequately assess or monitor apatients condition

Failure to notify a physician about changes ina patients condition

Failure to maintain a safe environment

Failure to dispense the correct medication

Failure to document in a timely manner

Failure to follow policies and procedures


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Key Elements to Medical

MalpracticeRelationship

Breach of Duty

Damages

Causation


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Contract LawA breach or neglect of a legally bindingagreement between two parties.

Insurance

Sales

Business

Real estate

Services (healthcareBreach of contract refers to the failure, with legalexcuse, to perform any promise or to carry out any ofthe terms of a contract.


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Contracts (2 types)Expressed:

Agreement that clearlystates all the terms. It can

be entered into orallyorin writing.

Each state identifiescontracts which must be

in writing.Property

Mortgages

Deeds

Implied:

Agreement is shownthrough inference by

signs, inaction, orsilence.

Termination generallyoccurs when treatment

has ended and the feehas been paid.


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Public Law (Criminal)

Felony

Punishment of death or

prison in state/federalprison>1yr

Murder, rape, sodomy,robbery, larceny, arson,

burglary, tax evasion, &

medicine without a

license.

Misdemeanor

Less serious

offenses-punishmentof fines or prison in

jail up to 1 year.

Traffic violations,

disturbing the peace,

and minor theft.


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Administrative LawA branch of public law, covers

regulations that are set by government

agencies.In the healthcare field, federal and state

agencies, under authorization from

Congress or state legislatures, havecreated a multitude of rulesand

regulations.


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Judicial System

Federal

State

There are 5 conditionswhich the federal court

system has jurisdiction

over to hear a case, if

the case is not one of

these it must be tried in

state court.


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Multilevel Review Federal

1. District (municipal)

2. Court of Appeals(circuit courts)

3. U.S. Supreme Court

Case is tried at the lowest levelcourt first, if decision appealedor challenged then the nexthigher court examines thedecision.

State

State courts from lower tohigher are divided into:

1. district or municipaltrial courts

2. state court of appeals

3. states highest courtfor final appeals.

The lower state courts hearcases such as small claims andtraffic violations.


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Agency Power and Procedures

Regulations Federal regulation is one of the basic tools government uses to

carry out public policy. Agencies create regulations (also known as"rules") when Congress provides the authority to do so.

Public Participation in Rulemaking

The public plays an extremely important role in the rulemakingprocess by commenting on proposed rules. Your comments canhelp shape the decisions the Department makes. Learn more aboutregulations and how you can make your voice heard by reading theHHS Regulations Toolkit.

Regulatory Agenda and Plan Each fall and spring, the Department publishes a list of all

regulations under development or review called the RegulatoryAgenda. In the fall, the Department also publishes a RegulatoryPlan, which summarizes priorities for the coming year.
http://www.hhs.gov/regulations/rulemaking-tool-kit.htmlhttp://www.hhs.gov/regulations/rulemaking-tool-kit.html


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Top HHS RegulationsAfford able Care Ac t

The Department uses regulations and guidance to implement parts of theAffordable Care Actthat deal with private and public health insurance.

Health Info rmation Priv acy (HIPAA)

HIPAA provides protections for personal health information and gives

patients a variety of rights. Learn more about health information privacy.

Human Research Protect ions

If your institution is engaged in human subjects research (not otherwise

exempt, and supported by HHS), your institution must have an Office for

Human Research Protections-approved assurance of compliance with the

HHS regulations for the protection of human subjects.

Health Inform ation Techno logy

The Health Information Technology for Economic and Clinical Health

(HITECH) Act provides HHS with the authority to write regulations and

guidance to support development of a nationwide health informationtechnology infrastructure.
http://www.healthcare.gov/law/resources/regulations/index.htmlhttp://www.healthcare.gov/law/resources/regulations/index.htmlhttp://www.hhs.gov/ocr/privacy/hipaa/understanding/index.htmlhttp://www.hhs.gov/ohrp/humansubjects/index.htmlhttp://www.healthit.gov/policy-researchers-implementers/health-it-legislation-and-regulationshttp://www.healthit.gov/policy-researchers-implementers/health-it-legislation-and-regulationshttp://www.healthit.gov/policy-researchers-implementers/health-it-legislation-and-regulationshttp://www.healthit.gov/policy-researchers-implementers/health-it-legislation-and-regulationshttp://www.healthit.gov/policy-researchers-implementers/health-it-legislation-and-regulationshttp://www.healthit.gov/policy-researchers-implementers/health-it-legislation-and-regulationshttp://www.hhs.gov/ohrp/humansubjects/index.htmlhttp://www.hhs.gov/ocr/privacy/hipaa/understanding/index.htmlhttp://www.healthcare.gov/law/resources/regulations/index.htmlhttp://www.healthcare.gov/law/resources/regulations/index.html


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Review of Existing Regulations

HHS is committed to identifying and reviewingexisting regulations in order to:

eliminate those that are obsolete,unnecessary, burdensome, or

counterproductive

modify others to increase their effectiveness,

efficiency, and flexibility


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Adjudication

Legalprocess by which an arbiterorjudgereviews evidenceand argumentationincluding

legal reasoningset forth by opposing parties or

litigantsto come to a decision whichdetermines rights and obligations between the

parties involved. Three types of disputes are

resolved through adjudication: Disputes between private parties, such as individualsorcorporations.

Disputes between private parties and public officials.

Disputes between public officials or public bodies.
http://en.wikipedia.org/wiki/Lawhttp://en.wikipedia.org/wiki/Arbitrationhttp://en.wikipedia.org/wiki/Judgehttp://en.wikipedia.org/wiki/Evidence_(law)http://en.wikipedia.org/wiki/Logical_argumenthttp://en.wikipedia.org/wiki/Reasoninghttp://en.wikipedia.org/wiki/Litiganthttp://en.wikipedia.org/wiki/Individualhttp://en.wikipedia.org/wiki/Corporationhttp://en.wikipedia.org/wiki/Public_officialhttp://en.wikipedia.org/wiki/Public_bodyhttp://en.wikipedia.org/wiki/Public_bodyhttp://en.wikipedia.org/wiki/Public_officialhttp://en.wikipedia.org/wiki/Corporationhttp://en.wikipedia.org/wiki/Individualhttp://en.wikipedia.org/wiki/Litiganthttp://en.wikipedia.org/wiki/Reasoninghttp://en.wikipedia.org/wiki/Logical_argumenthttp://en.wikipedia.org/wiki/Evidence_(law)http://en.wikipedia.org/wiki/Judgehttp://en.wikipedia.org/wiki/Arbitrationhttp://en.wikipedia.org/wiki/Lawhttp://en.wikipedia.org/wiki/Law


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Judicial ReviewDoctrine under which legislativeand/or executiveactions

are subject to review (and possible invalidation) by the

judiciary. A specific court with judicial review power may

annul the acts of the state when it finds them incompatible

with a higher authority (such as the terms of a writtenconstitution). Judicial review is an example of check and

balancesin a modern governmental system (where the

judiciary checks the other branches of government). This

principle is interpreted differently in different jurisdictions,which also have differing views on the different hierarchy of

governmental norms. As a result, the procedure and scope

of judicial review may differ from country to country and

state to state.
http://en.wikipedia.org/wiki/Legislaturehttp://en.wikipedia.org/wiki/Executive_(government)http://en.wikipedia.org/wiki/Judiciaryhttp://en.wikipedia.org/wiki/Constitutionhttp://en.wikipedia.org/wiki/Separation_of_powershttp://en.wikipedia.org/wiki/Separation_of_powershttp://en.wikipedia.org/wiki/Separation_of_powershttp://en.wikipedia.org/wiki/Separation_of_powershttp://en.wikipedia.org/wiki/Constitutionhttp://en.wikipedia.org/wiki/Judiciaryhttp://en.wikipedia.org/wiki/Executive_(government)http://en.wikipedia.org/wiki/Legislature


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Regularcitizens can

participate! Go

to HHS.gov tofind out how to

make yourcomments.


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Agencies impacting Healthcare

HHS

NIH

CDC

FDA

ACF

AHRQ

EPA

GAO

CMS

HRSA

IHS

Library of Congress

NHTSA

OSHA

NCQA

JCAHO

ALAPHABETSOUP!!


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legal issues in healthcare week 1

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