1. Introduction to Healthcare and Public Health in the US Lecture b Regulating Healthcare This material (Comp1_Unit6b) was developed by Oregon Health and Science University, funded by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology under Award Number IU24OC000015.

2. Regulating Healthcare Learning Objectives Describe the role of accreditation, regulatory bodies, and professional associations in health care in the US. (Lecture a) Describe the basic concepts of law in the United States: the legal system, sources of law, classification of laws, the court system, and the trial process. (Lecture b) Describe legal aspects of medicine involving the Affordable Care Act, professional standards in health care, medical malpractice, Tort reform, and Medicare and Medicaid Fraud and Abuse (Lecture c) Describe key components of the Health Insurance Portability and Accountability Act (HIPAA) and current issues of privacy and patient safety in the US (Lecture d) Discuss the need for quality clinical documentation for the use of the health record as a legal document, communication tool and a key to prove compliance for health care organizations. (Lecture e) 2 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

3. The Legal System in the US Legislative –House of Representatives and the Senate Executive – The president and numerous departments and agencies Judicial –Judges and courts 3 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

4. Balance of Power Separation of powers –Three branches of government –Designed to prevent any one branch from becoming too powerful Checks and balances –Legislative branch makes laws –Executive branch enforces laws –Judicial branch interprets laws 4 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

5. Sources of Law Legislative branch makes statutory laws Executive branch makes administrative laws Laws made by the courts are called common law or case law 5 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

6. The Judicial System: Courts Trial court –Hears evidence and hands down verdicts –Can be federal, state, or local Appellate court –Losing party can appeal –Court usually does not hear new evidence –Reviews case to determine if the law was properly applied to the facts as determined by the trial court 6 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

7. The Judicial System: Jurisdiction Federal courts –Constitutionality of a federal law –Disputes primarily involving federal law –Disputes between citizens of different states State courts –Often called courts of common pleas or county courts City or municipal courts 7 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

8. Comparing Court Systems: An Example US GovernmentState of OhioCity of Cleveland Trial courtsUS District Court for the Northern District of Ohio Cuyahoga County Court of Common Pleas Cleveland Municipal Court Appellate courts US Sixth Circuit Court of Appeals Ohio Eighth District Court of Appeals Highest courtUS Supreme CourtOhio Supreme Court 6.2 Table: Example of court jurisdiction on various levels of government. 8 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

9. Classification of Laws Civil or private law –Relationships between people –Relationships between people and organizations –Relationships between organizations –Includes family, property, inheritance, corporate, contract, and tort law Public law –Relationships between people and the government 9 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

10. Two Kinds of Penalties Civil law—exchange of money between the private parties to the lawsuit Public law—can result in fines paid to the government and/or imprisonment The same action can result in both kinds of penalties 10 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

11. Example: Traffic Accident Drunk driver crashes car, causing serious injury to the driver of the other car Criminal (public) penalty –State vs. drunk driver Civil (private) damages –Injured driver vs. drunk driver 11 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

12. General Classification: Private Law 6. 3 Figure: Two important sub classifications of civil law are contract law and tort law (OHSU, 2010). 12 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

13. Contract Law Contract elements –Offer –Acceptance –Consideration: something of value given in exchange for a promise Express contract –Written or oral Implied contract 13 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

14. Tort Law Intentional torts –Battery –Defamation Negligence –Does not act with a reasonable amount of care –As a result, someone is injured 14 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

15. General Classification: Public Law 6.4 Figure: The two types of Public Law that have the most effect on individuals are criminal law and administrative law (OHSU, 2010). 15 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

16. Litigation: Parties Adversary system –Each party presents his or her case –Facts determined by neutral fact-finder Civil case: plaintiff and defendant Criminal case: government and defendant 16 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

17. Pre-trial Litigation: Discovery Purpose is to fully develop the facts Depositions are one kind of discovery –Sworn testimony recorded by court reporter –Parties –Witnesses –Expert witnesses 17 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

18. Administrative Hearings Sometimes an administrative agency has a system of hearings that is outside the normal court system The agency may or may not have an appellate level Usually reviewable in a court of law 18 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

19. Administrative Hearing Example Social Security Administration (SSA) –Hearing officers –Social Security Appeals Council –Decisions of the SSA appeals board can be further appealed to the US District Court 19 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

20. Regulating Healthcare Summary – Lecture b 3 branches of government: legislative, executive, judicial (the courts) Courts are divided into: –Trial courts and appellate courts –Federal, state, city/municipal courts The courts are neutral arenas where the parties to a dispute face off in an adversarial process 2 main types of law: private and public 20 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b

21. References Administrative Office of the US Courts. The federal court system in the United States. 2010. 3rd ed. http://www.uscourts.gov/uscourts/FederalCourts/Publications/English.pdf. Accessed April 8, 2011. http://www.uscourts.gov/uscourts/FederalCourts/Publications/English.pdf Administrative Office of the US Courts. Understanding federal and state courts. http://www.uscourts.gov/EducationalResources/FederalCourtBasics/CourtStructure/UnderstandingFederalAndStateCourts.aspx. Accessed April 8, 2011. http://www.uscourts.gov/EducationalResources/FederalCourtBasics/CourtStructure/UnderstandingFederalAndStateCourts.aspx Administrative Office of the US Courts. United States Courts. http://www.uscourts.gov/Home.aspx. Accessed April 8, 2011.http://www.uscourts.gov/Home.aspx Centers for Medicare and Medicaid Services. Guidance to laws and regulations: overview. https://www.cms.gov/GuidanceforLawsAndRegulations. Accessed April 10, 2011. https://www.cms.gov/GuidanceforLawsAndRegulations Cornell University Law School Legal Information Institute. Tort. http://topics.law.cornell.edu/wex/tort. Accessed April 10, 2011.http://topics.law.cornell.edu/wex/tort Social Security Online. Information about Social Security's hearings and appeals process. http://www.ssa.gov/appeals. Accessed April 10, 2011.http://www.ssa.gov/appeals The Library of Congress. Law Library of Congress. http://www.loc.gov/law. Accessed April 10, 2011.http://www.loc.gov/law US Citizenship and Immigration Services. Welcome to the United States: A guide for new immigrants. ttp://www.uscis.gov/files/nativedocuments/M-618.pdf. Accessed April 8, 2011. ttp://www.uscis.gov/files/nativedocuments/M-618.pdf USA.gov. Federal executive branch. http://www.usa.gov/Agencies/Federal/Executive.shtml. Accessed April 10, 2011.http://www.usa.gov/Agencies/Federal/Executive.shtml Charts, Tables and Images 6.2 Table: Example of court jurisdiction on various levels of government. 6. 3 Figure: Two important sub classifications of civil law are contract law and tort law. OHSU (2010). 6.4 Figure: The two types of Public Law that have the most effect on individuals are criminal law and administrative law. OHSU (2010). 21 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture b Regulating Healthcare References – Lecture b