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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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