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HCA 505: Legal and Ethical Issues in Healthcare

Course Description

This course provides a framework for analysis of legal and ethical issues in the provision of healthcare. This course is an overview of health law issues and includes the conceptual foundations for societal, institutional, and individual dilemmas in healthcare delivery and the legal aspects of clinical and financial decision-making. It covers government regulation including legal constraints, liability, negligence, patient rights, confidentiality, as well as, corporate and administrative responsibility. (3 credits)

 

Associated Program Learning Outcome(s)

#3 Explain the role of the administrator in upholding the legal, social, and ethical responsibilities in the healthcare organization as they relate to patient/client rights

 

Student Learning Outcomes (SLOs)

Students who successfully complete this course will be able to:

  1. Evaluate compliance program effectiveness by identifying key organizational attributes, developing a structured discovery process, and applying interviewing techniques in order to form an evidence‑based assessment of an organization’s compliance efforts. 
  2. Analyze the elements of the False Claims Act, Anti‑Kickback Statute, and Stark Law and explain how these federal requirements apply to healthcare industry operations.
  3. Evaluate conflicting regulatory guidance (Coding Clinic vs. MAC/LCDs) and apply primary and secondary sources of law to determine correct coding and compliance actions, including how to investigate, audit, and resolve potential non‑compliance in alignment with federal reimbursement rules. 
  4. Accurately analyze EMTALA requirements and evaluate potential violations by applying federal regulations, case-based reasoning, and investigative methods to real‑world emergency care scenarios.
  5. Apply core healthcare compliance principles by demonstrating ethical employee responsibilities and designing a comprehensive baseline audit program that incorporates regulatory expectations, audit methodology, and professional grade documentation.
  6. Interpret and differentiate federal fraud and abuse laws, including the False Claims Act and Self‑Referral (Stark) Laws.
  7. Perform an in-depth interpretation of the seven elements of a compliance program and the role of the OIG.
  8. Apply HIPAA/HITECH privacy and security requirements to organizational workflows, including modern digital environments such as AI, tracking technologies, and ransomware preparedness.
  9. Evaluate HIPAA/HITECH compliance risks and federal enforcement trends—including Right of Access, tracking technologies, business associates, PHI protection, emergency disclosures, and vendor oversight—to strengthen organizational risk‑management practices.
  10. Evaluate whether a healthcare organization is subject to the Red Flags Rule, analyze identity‑theft threats and their operational impact, and develop core components of an Identity Theft Prevention Program that aligns with federal compliance expectations.

 

Course Activities and Grading

AssignmentsWeight

Discussions (Weeks 1-8)

20%

Assignments (Weeks 1, 2, 4-7)

55%

CYU Quizzes (Weeks 1-3, 5, 6, 8)

0%

Final Project (Week 8)

25%

Team Evaluation (Week8)

0%

Total

100%

Required Textbooks

  • This course uses Open Educational Resources (OER). OER are openly licensed, educational resources that can be used for teaching, learning and research. OER may consist of a variety of resources such as textbooks, videos and software that are no cost for students.

Additional Resources

  • Office of Inspector General, U.S. Department of Health & Human Services. (2023). General compliance program guidance (HHS‑OIG Publication No. 1135). (Source: https://oig.hhs.gov/documents/compliance-guidance/1135/HHS-OIG-GCPG-2023.pdf)
  • Brinson, S. G., Clack, L., Gill, L. M., & Gosa, L. K. (n.d.). Overview of healthcare compliance. University of North Georgia Press. (Source: https://web.ung.edu/media/university-press/overview-of-healthcare-compliance.pdf?t=1661448716344)
  • Journal Articles and other course material, including primary websites, will be provided as required reading within the course.

 

Course Schedule

Week

SLOs

Readings and Exercises

Assignments

1

1

Topic: Corporate Compliance - Healthcare Fraud and Abuse

  • Read and Review: 
    • General compliance program guidance (HHS‑OIG Publication No. 1135): Introduction, pp. 6-9
    • Overview of healthcare compliance:  Introduction to Healthcare Compliance, pp. 1-16
    • Medicare General Overview
    • Brief Summaries of Medicare/Medicaid
    • Fact Sheet - False Claims Act Settlements and Judgments FY2025
    • Department of Justice
    • Search Internet for sample job descriptions for: Compliance Officer, Privacy Officer, and Risk Manager in the healthcare setting.
  • Read assigned materials
  • Review the lecture material
  • Particpate in the Discussions
  • Submit Week 1 - Assignment: Compliance Position Description  Assignment
  • Complete Week 1 - CYU Quiz

2

2,3

Topics: Fraud, Abuse, False Claims Act, and Anti-Kickback Statute

  • Read and Review: 
    • General compliance program guidance (HHS‑OIG Publication No. 1135): Health Care Fraud Enforcement and Other Standards: Overview of Certain Federal Laws, pp. 10-31
    • Overview of healthcare compliance: Ethics and Law, pp. 17-29
    • Reporting Fraud and Abuse
    • Medicare Fraud & Abuse: Prevention, Detection, and reporting
    • What Effect Do the “marketing” Provisions of the HIPAA Privacy Rule Have on Federal or State Fraud and Abuse Statutes?
    • Office of the Inspector General
    • Centers for Medicare & Medicaid Services
    • Department of Justice
    • AHIMA (membership required)
    • The False Claims Act: A Primer. Includes full text of the False Claims Act
    • National Whistleblowers Center
    • Stark Law
    • National Library of Medicine
    • Anti-Kickback
    • Overview: Safe Harbor Regulations
    • Safe Harbors Full Regulations: CFR-2010-title42-vol5-sec1001-952.pdf
    • PowerPoint Tips Introduction 
  • Read assigned materials
  • Review the lecture material
  • Particpate in the Discussions
  • Submit Week 2 - Assignment: Stark and Whistleblower PowerPoint Assignment
  • Complete Week 2 - CYU Quiz

3

4,5

Topics: EMTALA, Ethics and Audit and Sampling Processes

  • Read and Review: 
    • Overview of healthcare compliance:  EMTALA, p. 45
    • Centers for Medicare & Medicaid Services. EMTALA Overview
    • State Operations Manual, Appendix V – Interpretive Guidelines – Responsibilities of Medicare Participating Hospitals in Emergency Cases. Rev 60
    • Search the Internet for further information on EMTALA
  • Read assigned materials
  • Review the lecture material
  • Particpate in the Discussions
  • Complete Week 3 - CYU Quiz
  • Begin Week 4 Audit Program Assignment

4

5,6

Topics: Stark Law and Whistleblowers: Risk Assessment, Addressing Complaints and Mitigating Challenges

  • Read and Review: 
    • General compliance program guidance (HHS‑OIG Publication No. 1135): False Claims Act, pages 17-20.
    • Overview of healthcare compliance: False Claim Act, page 7. Fraud and Abuse, pages 25-27, page 45.
    • The False Claims Act: A Primer
    • Department of Justice
    • National Whistleblowers Center
    • AHIMA
    • Office of the Inspector General
    • Centers for Medicare & Medicaid Services
  • Read assigned materials
  • Review the lecture material
  • Particpate in the Discussions
  • Submit Week 4 - Assignment: Audit Program Assignment

5

7

Topic: Risk Management: Risk Assessment and the Annual Compliance Plan

  • Read and Review: 
    • General compliance program guidance (HHS‑OIG Publication No. 1135):  Compliance Program Infrastructure:  The Seven Elements 32-64, Risk Assessment, Auditing, and Monitoring , pages 55-59, 65-76
    • Overview of healthcare compliance:  Risk Management pages 63-65
    • Tackling AI, cybersecurity, and regulatory challenges
    • Awan, A. T., Gonzalez, A. D., & Sharma, M. (2024). A neoteric approach toward social media in public health informatics: A narrative review of current trends and future directions. Information, 15(5), 276.
    • Enterprise risk management: Readiness assessment tool
    • Collective intelligence in risk management: How organizations leverage collaboration to improve decision‑making.
    • What Is Risk Management & Why Is It Important?
    • Financial risk mitigation techniques for sustainable healthcare operations.
    • United States Sentencing Commission. Guidelines Manual, Current Edition
  • Read assigned materials
  • Review the lecture material
  • Particpate in the Discussions
  • Submit Week 5 - Assignment: Seven Sentencing Guidelines Case Study Assignment
  • Complete Week 5 - CYU Quiz

6

8,9

Topics: Healthcare Information Privacy and Security: Documentation for Breaches

  • Read and Review: 
    • General compliance program guidance (HHS‑OIG Publication No. 1135): HIPAA Privacy and Security Rules, pp. 28-30
    • Overview of healthcare compliance: HIPAA, pp. 22-28, and 41-48. HITECH pp. 92-112
    • Guidance Regarding Methods for De-Identification of Protected Health Information in Accordance with the
    • Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
    • HIPAA administrative simplification: Recent rulemaking and regulatory updates
    • CMS specifications manual for eligible hospitals and critical access hospitals participating in the Medicare Promoting
    • Interoperability Program: Electronic health record reporting period in calendar year 2025
    • FY 2027 IPPS proposed rule aligns with changes to the ONC certification program. HIMSS
    • Health Data, Technology, and Interoperability (HTI‑1) final rule. U.S. Department of Health & Human Services
    • Nationwide privacy and security framework for health information. U.S. Department of Health & Human Services
    • Security guidance for healthcare organizations: Cybersecurity trends and best practices
    • Blue Button. U.S. Department of Health & Human Services
  • Read assigned materials
  • Review the lecture material
  • Particpate in the Discussions
  • Submit Week 6 - Assignment: HIPPA Contingency Planning
  • Complete Week 6 - CYU Quiz

7

8,9

Topic: Healthcare Information Privacy and Security Continued: Monitoring and Investigating in an Electronic Environment

  • Read and Review: 
    • General compliance program guidance (HHS‑OIG Publication No. 1135): Other Compliance Considerations, pp. 76-81, OIG Resources and Processes, pp. 82-85.
    • Overview of healthcare compliance: HIPAA, pp. 22-28, and 41-48. HITECH pp. 92-112.
    • HIPAA administrative simplification: Recent rulemaking and regulatory updates
    • HIPAA administrative simplification: Privacy, security, and breach notification rules
    • General compliance program guidance
    • Risk management and patient safety
    • HIPAA privacy & security training guide
    • Safeguarding your medical information: Protecting your health coverage from fraud and abuse [Fact sheet]
  • Read assigned materials
  • Review the lecture material
  • Particpate in the Discussions
  • Submit Week 7 - Assignment: Training Project Assignment
  • Complete Week 7 - CYU Quiz

8

10

Topics: Identify Theft and Corporate Compliance Plan

  • Read and Review: 
    • Identity theft: Red Flags Rule compliance guidance
    • What to know about medical identity theft
    • HIPAA Security Rule guidance on identity verification and authentication
    • Health Care Fraud and Abuse Control Program Report: Fiscal Year 2023.
    • Cybersecurity guidance for patients: Protecting your health information.
  • Read assigned materials
  • Review the lecture material
  • Particpate in the Discussions
  • Submit Week 8 - Final Project
  • Complete Week 8 - CYU Quiz
  • Complete Week 8 - Team Evaluation
  • Complete Course Evaluation

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COSC Accessibility Statement

Charter Oak State College encourages students with disabilities, including non-visible disabilities such as chronic diseases, learning disabilities, head injury, attention deficit/hyperactive disorder, or psychiatric disabilities, to discuss appropriate accommodations with the Office of Accessibility Services at OAS@charteroak.edu.

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Students are responsible for knowing all Charter Oak State College (COSC) institutional policies, course-specific policies, procedures, and available academic support services and resources. Please see COSC Policies for COSC institutional policies, and see also specific policies related to this course. See COSC Resources for information regarding available academic support services and resources.