Health Law Online Courses
This course will cover advanced topics in the law governing development and approval of devices, drugs, and biologics under the jurisdiction of the U.S. Food and Drug Administration. The course will review regulatory obligations for both manufacturers and providers conducting FDA-regulated clinical research. The course will also cover enforcement of non-compliance and how organizations develop compliance infrastructure to manage the highly detailed FDA regulations. LAW 958 is a preferred prerequisite but is not required.
This course explores advanced concepts in health care compliance. This course will present a complex health care compliance scenario each module which the student must analyze and comment upon. The scenarios will cover a broad array of regulatory subject matters which must be analyzed in the context of compliance program principles.
This course explores advanced concepts in health care privacy and security and is designed as a continuation of Health Care Privacy & Security Law (LAW 918).This course will present a complex compliance privacy and security scenarios each module which the student must analyze and comment upon.
This course will cover practical techniques in responding to suspected non-compliance as well as liability exposure in how investigations are handled. The course will also discuss resolution of identified non-compliance and methods for discharging an organization's legal obligations to correct non-compliance, including self-disclosures and refunds. Additionally, the course will cover responding to government inquiries and audits. LAW 910 or LAW 839 are preferred prerequisites but are not required.
This course covers the business and legal issues that arise in health care transactions and the business and regulatory environment surrounding transactions. Topics covered will include organizational operations, the contents and role of organizational documents, and the application of tax laws to transactions. Students will analyze organizational documents and prepare presentations on issues presented by transactions. (LLM only or with permission.) THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
This course is designed to give students practical experience drafting, revising, and analyzing contracts. Students will be placed in teams and will negotiate and draft a health law contract. (LLM only or with permission.) THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
This course is designed to provide practical experience in drafting operational policies from compliance regulations. Having clear policies and procedures is an essential element of an effective compliance program. The course will explore liability associated with how policies are drafted as well as non-compliance with an institution's policy commitment. The course will teach skills and techniques for turning complex regulations into accessible policies for the workforce. LAW 910 or LAW 839 are preferred prerequisites but are not required.
Enterprise Risk Management (ERM) provides a comprehensive framework for making strategic decisions, taking into consideration concepts of both value creation and value protection. The approach looks at strategies for managing risk, uncertainty and growth and their relationship to total value. This course will cover the specific skills and techniques necessary to manage risk across increasingly complex organizations and to align business strategies with goals and culture.
This course covers federal physician self-referral law, commonly known as the Stark Law, and fraud and abuse law. Students will learn about the statutes, regulations, and advisory opinions that define the parameters of physician referrals and anti-kickback laws, analyzing case studies for fraud and self referral issues. Students will also familiarize themselves with the laws, regulations, and government regulatory actions designed to combat false claims and other types of fraudulent activities. (LLM only or with permission.) THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
Students explore the general principles and techniques of financial management and accounting as applied to health care organizations. Considerable focus is placed upon definition, history, and methods by which providers of health care services are reimbursed by third parties.
This course will progress from the basics of a compliance program, including the compliance operations and the Code of Conduct, to specific issues facing the healthcare industry such as anti-kickback, Stark, False Claims Act, and civil monetary penalties; conflicts of interest and governance; tax; coding and billing; privacy, technology, data, and security; and the link between regulatory issues and quality of care. Students will be assigned projects to show them how to implement in a practical setting the various laws, regulations, and standards as well as understand the enforcement environment. THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
Fundamental principles of contract law, illustrated primarily through a study of cases drawn from the health care industry are discussed and explored in this course. Students will learn how to draft and interpret contracts commonly used in the health care setting. THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
The role of the legislative branch of government in health care is explored through a review of major government health programs and policies Students will learn how health policy gets formulated, evaluated and assessed prior to being voted into law and will then explore the process of new policy implementation. Issues to be explored will be drawn from the wide array of health matters in which governments are involved. THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
This course covers the types of health care payors and the relationships between them, including HMOs, PPOs, CMPs, Medicare and Medicaid, and other managed care arrangements. Topics will include utilization review, ERISA, agency doctrine, and payor operational and contracting issues. Students will become familiar with managed care contracts and analyze health care plans and policies. (LLM only or with permission.) THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
This course will cover health information law and policy as it pertains to data security and privacy of electronic health records in the United States. Students will examine how individual health information is collected, maintained, and transferred in this electronic information age, and the ramifications when such information is improperly protected, stolen, and misused.
This course details the regulation of health insurance companies in the United States with a focus on the changes brought about by the Affordable Care Act (ACA). Although the ACA is federal legislation, its implementation is reliant on the states. This course will address how the current regulatory system will adapt to the new federal health care scheme.
This course exposes students to emerging issues impacting the health care industry. Each issue has the potential to impact providers, health care organizations, health care attorneys, and consumers. The summer 2015 HLSS course will focus on leadership, management, and strategy in the health care context. This course is structured over 14 weeks, in which we alternate between reading weeks, where students are given reading material to introduce them to each issue, and synchronous classroom lectures by national experts on each subject. At the end of the course, each student is asked to write a reflective paper on one of the issues presented and describe the impact that they believe it will have on their practice or the delivery of health care in general. This course is graded pass/fail. THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
This course will cover the law of protecting human subjects in clinical research. Federal agencies require institutions conducting research to have a study approved by an Institutional Review Board (IRB), obtain informed consent from the human subject, and self-disclose to the government various events. The course will review the regulations governing IRBs, the content of informed consent forms, the monitoring of research studies, and the disclosure of unanticipated events and significant non-compliance. The course will look at enforcement cases as well as tort liability. Financial relationships between investigators and sponsors will also be covered. LAW 958 is a preferred prerequisite but is not required.
This course is designed to expose students to the legal issues that arise from the relationship between and among patients and health care providers. Areas of focus include: conflicts between cost effective and high quality health care, access to care, individual and institutional liability, public and private regulation, accreditation and licensure, hospital/medical staff relationships, patient rights, with a special focus on informed consent, and other legal issues in the acute care setting. THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
This course provides an overview of the legal research process. The student will learn basic legal research skills with a focus on online legal sources. Students will search for health law cases, statutes, regulations and law journal articles. They will learn how to use citators to verify that a case or statute is still good law and also learn the proper form for citation of legal authorities. (MJ only or with permission.) THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
This foundational course introduces students to the sources and functions of law in our society. The course begins with an explanation of the structure of the American court system. Students then learn to read and brief cases, synthesize cases, and develop basic legal writing and analysis skills. Through multiple short writing assignments, students learn to construct a legal office memorandum, the final course requirement. The course utilizes health law cases and problems and provides students with background for future health law studies. (MJ only or with permission.) THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
Students investigate issues arising from advances in biological science and technology and learn about their impact on the legal rights and of patients, health providers, and government policy makers. Issues explored range from legal and ethical dilemmas in the treatment of individuals to broader societal issues addressing the allocation of health care resources. THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
In this course, students will explore the regulatory and civil practice laws governing electronic health information. The course will include a brief overview of the political and social forces behind the digitization of electronic health information. Students will learn the relevant legal definitions and terms associated with electronic health information and the obligations imposed upon healthcare providers who create, manage and store electronic health data. The course will include in depth analysis of the statutory requirements governing e-health information, such as the Federal Rules of Civil Procedure and the HITEC Act of 2009. Materials will include relevant journal articles, statutes, and case law. Upon completion of the course, students will understand the issues faced by healthcare providers with the explosion of electronic health data, the legal obligations of healthcare providers, and how to develop a legally sound e-health information program. THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
In this course students will take an in depth look at both the substantive and procedural law of medical negligence litigation and alternative dispute resolution. The primary methodologies used in ADR, arbitration, and mediation are reviewed through a series of case examples. THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
This course serves as an introduction to the growing area of health law known as "life sciences." The theme for this course centers on the research and development of pharmaceutical drugs and devices and the role of the FDA in regulating this process. Topics covered will include genomics, personalized medicine, the FCPA, basic patent and intellectual property issues, and financing. Students will learn to analyze the FDA approval process. (LLM only or with permission.) THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
Each LL.M. student must write a paper of publishable quality. The paper, written under the guidance of a faculty advisor, should integrate a number of issues covered in the health law curriculum. It is expected that each LL.M. paper will make an important contribution to health law literature. Students' papers will be considered for publication in Loyola's Annals of Health Law. (LLM only.) THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
This course provides students with working knowledge of the business side of medicine; specifically medical record documentation, coding and billing. Non-compliance with rules and regulations on medical record documentation can result in refunds to health insurers, civil penalties, criminal proceedings, and/or exclusion from federal health care programs. Poor medical record documentation also puts patients at risk. This course will provide students with an in-depth knowledge of the legal role of the medical record, specifically in the context of obligations for the organization of the medical record and its support for reimbursement of services. Medical records must meet all State and federal legal, regulatory and accreditation requirements along with the Medicare Conditions of Participation. Upon completion of this course, the student will have an understanding of the components of the medical record, the types of coding used by different providers, the methods of reimbursement based upon the provider type and risks associated with non-compliance. (Meade, Morris)
MJ students who do not complete their thesis projects within the grace period must register for this course in order to get credit for completing the thesis.
Students are expected to complete a thesis project of substantial depth that explores a specific area of health law and integrates a number of legal subjects covered in the M.J. curriculum. The project is completed in close cooperation with a faculty advisor. Students are required to present their thesis to faculty and fellow students during graduation weekend. (MJ only.) THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
This course is designed to introduce students to the laws, agencies, and other bodies that license, regulate and discipline physicians. Topics covered will include licensing proceedings and hearings and health care entity policies addressing these issues. (LLM only or with permission.) THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
This course explores the role of law and government regulation in the area of public health. The public health process (measurement, problem definition, strategy, design, implementation and evaluation) is explored in reference to current issues that are both timely and expositive of the ways in which law and regulation shape public health practice on the state and federal level. Topical areas for analysis and discussion are drawn from the primary environments of public health, biological, physical, social, individual behavior, and national/international health systems. Students are required to work on group projects, and are required to write a research paper. THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
Students utilize case studies for learning and applying knowledge related to the key roles and responsibilities of the health care risk manager. Through the readings and case study analysis students will learn to identify legal, ethical, administrative, and risk management issues and to reach resolutions for the problems presented. They will also understand how principles of risk management have changed since the 1998 IOM Report which called for increased focus on systemic failures and moving away from a culture of blame and shame. THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.
Students will review basic writing mechanics including grammar and punctuation. They will enhance their writing skills by editing passages, producing written assignments, and doing focused writing exercises. Students will also learn to develop sound arguments by practicing the art of logical flow. The goal is to help students to produce clear, well-organized, grammatically correct prose. This course will also focus on how to approach the master's thesis. THIS CLASS IS ONLY AVAILABLE ONLINE AND WITH PERMISSION.