Health Law Courses

Administrative Law (3 cr.) D/N 647 considers the role of administrative agencies in the scheme of government, constitutional limitations on agency action, and analysis of agency functions; emphasizing informal procedures and placing formal procedures of investigation, rule-making, and hearings in perspective. P: Completion of or concurrent enrollment in Constitutional Law (DN620) or permission of instructor.

Advanced Research in Health Law (2 cr.) D/N 662 provides a vehicle for students to conduct research, prepare a major paper and present a talk on a health law topic in order to complete their advanced writing requirement and/or the required major research paper for the concentration in health law.

Antitrust and the Health Care Industry (2 cr.) D/N 866 focuses on antitrust issues that are relevant to health care providers, including such areas as hospital and physician mergers, virtual mergers and joint ventures; exclusive contracts and other medical staff exclusion issues; covenants not to compete; physician collective bargaining with, and exclusion from, managed care plans; antitrust defenses such as state action, nonprofit, learned profession, efficiencies, failing business, etc.; and federal and state health care antitrust regulatory efforts, including health care collaborative guidelines.

Bioethics and Law (2 or 3 cr.) D/N 838 examines how the law in bioethics is shaped by the interplay of ethical principles, medical considerations, and social forces. Topics that will be covered include: the refusal of life-sustaining treatment, physician-assisted suicide, organ transplantation, abortion, the balance between individual liberty and protection of the public health, access to health care, and rationing of health care. An important theme of the course will be to consider the extent to which individuals have--and should have--control over medical decision making.

Business and Legal Aspects of Health Care Organizations (2 cr.) D/N 859 addresses the business and legal aspects of various health care organizations, including hospitals, nursing homes, physician-professional organizations, physician-hospital organizations, managed care organizations, and integrated delivery networks. Areas of law discussed include the corporate and tax aspects of not-for-profit organizations, antitrust law, state insurance regulation, corporate practice of medicine, Medicare and Medicaid fraud and abuse rules, and professional and corporate liability.

Corporate Compliance Overview (3 cr.) D/N ___ This introductory overview course emphasizes the areas of corporate and regulatory law that impose requirements on corporations including health care provider organizations as well as pharmaceutical and medical device companies. The course emphasizes the importance of corporate compliance for these organizations, and gives and overview of relevant regulatory authorities and their underlying theories and rationales. This course examines the pertinent government regulations, guidance documents and enforcement initiatives forming the framework for corporate compliance. The course will focus on the process of compliance which should be established internally irrespective of the regulatory authority involved. The course will also examine on the various requirements of financial disclosures and conflict of interest in the health care arena.

Drug Innovation and Competition Law (2 or 3 cr.) D/N 635 provides and understanding of the processes by which pharmaceutical exclusivity is obtained and challenged on a global scale. The course examines the interplay between patents, data package exclusivity, pediatric exclusivity, and orphan drug exclusivity; and surveys the procedural and substantive aspects of US Hatch-Waxman litigation, drug reimportation/parallel trade, and exceptions to exclusivity. Finally, it addresses the influence of public policy on the evolution of pharmaceutical exclusivity law.

Elder Law (2 cr.) D/N 720 Study of legal issues and programs particularly affecting elderly persons: topics selected from such areas as nursing home law; mental health, guardianship, and civil commitment; age discrimination; Social Security and other income assistance programs; Medicare, Medicaid, National Health Insurance, health and drug issues; consumer protection; and housing problems of the elderly.

ERISA Retirement Plans: Formation and Structure (2 cr.) D/N 656 focuses on the formation and structure of qualified retirement plans, such as defined benefit pension plans and 401(k) defined contribution plans. The course looks at the technical requirements under the Internal Revenue Code, as well as plan design issues. The course also reviews ongoing reporting and disclosure compliance issues imposed under ERISA and the Internal Revenue Code.

Food and Drug Law (2 or 3 cr.) D/N 888 surveys statutes and regulations dealing with the production, distribution, and sale of food, drugs, cosmetics, and medical devices. The course focuses primarily on substantive and procedural requirements of the Food, Drug, and Cosmetic Act.

Health and Human Rights Clinic (3 cr.) D/N 808 In this clinic, students in the Health and Human Rights Clinic engage in domestic human rights advocacy and litigation addressing the social determinants of health. Students directly represent, under faculty supervision, low-income clients from the community, especially workers who have been wrongfully denied their earned wages or are appealing a challenge to their access to unemployment benefits. On issues including workers' rights, students engage in advocacy in the form of appellate briefs, investigations and reports, and public education. These cases and these projects, and companion international projects pursued in partnership with global justice advocates, also provide a platform for the review of issues in international human rights law and comparative law. Students must submit an application to be considered for this clinic.

Health Care Fraud and Abuse Regulation (2 or 3 cr.) D/N 600 This course examines legal issues relevant to healthcare providers that involve health care fraud and abuse regulation. Health care fraud is an intentional attempt to collect money for medical services wrongly and abuse pertains to actions which are inconsistent with acceptable business and medical practices. The course will focus on fraud and abuse in the Medicare and Medicaid programs and the four major statutes containing federal fraud and abuse prohibitions. Specific statutes studied include the Anti-Kickback Statute, the Stark law and regulations, the False Claims Act and the Civil Monetary Penalty Act.

Health Care Quality and Safety (2 or 3 cr.) D/N 791 This is an advanced health law course that explores the legal issues that arise between and among patients, health care providers and regulators with regard to the quality and safety of health care. Quality is one of the major themes in the study of health care law and policy, in particular as it is frequently in tension with cost and access considerations. This course focuses on both private and public law responses to quality and safety issues, examines the impact of common law liability models on changing provider behavior, federal and state regulatory agencies and their quality and safety research, and process and technology- driven reforms. While not a prerequisite, it is assumed that most students will have taken the health law survey course, Introduction to Health Care Law and Policy.

Health Care Reimbursement (2 or 3 cr.) D/N 771 This course examines the Medicare and Medicaid systems and the regulation of health care providers participating in those programs. The course describes how health care providers set charges and relate to public and private health insurers. The course will provide an overview of the Medicare, Medicaid, and State ChildrenÂ’s Health Insurance Program as well as the administrative law framework for governmental decisions. Additionally, each major provider type will be examined (e.g., hospitals, long term care facilities, home health care providers, hospices, and physicians) including the regulations specific to each. In all cases, both the reimbursement structure and legal requirements for participation in the program will be discussed. The course will also focus on recent developments and trends in the law and policies that affect public payers. Students will apply these statutes (and related regulations) and other regulatory materials to hypothetical healthcare business arrangements and will address the health care sectorÂ’s complex regulatory environment.

Health Information Technology and Privacy (2 cr.) D/N ___ explores the legal issues that arise between and among patients, health care providers and regulators with regard to the use of various information technologies (including telemedicine, electronic medical records decision support systems, personal health records and wellness or diagnostic applications running on smartphones). Implementation of these technologies frequently is in response to health law or policy initiatives. In such cases the existence or interpretation of legal structures can provide incentives or disincentives to implementation or efficient use of technologies. Equally health information technologies that are not the products of formal initiatives can challenge or disrupt existing legal relationships or standards. Two of the areas most implicated are privacy and security. As a result approximately one-third of the course will deal specifically with this topic, examining state common law and statutory provisions in addition to the federal HIPAA rules and Breach Notification regulation. P: While not a prerequisite it is assumed that most students will have taken the health law survey course (Introduction to Health Care Law & Policy) and one or more advanced health law courses.

Health, Housing, and the Law (3 cr.) D/N ___ explores the connections between between health and housing with a particular focus on identifying ways in which law and lawyers can effectively improve unit, building, and neighborhood conditions that have deleterious health consequences. The course will review the inadequacy of code enforcement and individual litigation as remedies for bad conditions; it will consider structural remedies for the racial, ethnic, and economic segregation and severe rent burdens that impose severe health consequences. Specific consideration will be given to asthma, tuberculosis, and lead poisoning. Federal housing programs will be surveyed, and the use of fair housing and disability rights legislation will be considered. While the focus of the course is on how law can be used to improve health, the course is intended for other professionals as well, certainly including those concerned with political effectiveness of community efforts to improve housing conditions.

Hospital Legal Department Externship (2 or 3 cr.) D802 Externs work in legal and/or ethical departments of a hospital or with the Marion County Health Corporation on issues concerning health care, public health, guardianships, and the development of hospital policies required by federal and state laws, including ethical considerations in the treatment of patients. (Application(s): Spring 2015)

Intellectual Property of Pharmaceutical Products and Medical Devices (2 or 3 cr.) D/N 698 This seminar/course will offer a detailed and high-level analysis of intellectual property law as it applies to medical devices and medical therapeutics, including pharmaceuticals, genetics, proteomics, etc. Topics to be covered are patent law, copyright law and trademark law, as well as some discussion of their potential anticompetitive effects in the biomedical industry. Coursework or related experience in intellectual property, patent law or copyright law is required to enroll. No background in pharmaceuticals or medical technology will be necessary, but some knowledge of any of the life sciences or of chemistry will be helpful. Students will be expected to write and present a research paper of adequate length to satisfy the advanced writing requirement when the course is taught as a seminar. This course may be taught either as a seminar or as a regular course.

Introduction to Health Care Law and Policy (3 cr.) D/N 785 This introductory health law course is designed to introduce students to the legal issues that arise between and among patients and health care providers and surveys current federal and state regulatory schemes of health care law and policy, quality, access and cost containment. Topics surveyed will include accreditation and licensure, individual and institutional liability, the legal and ethical properties of the hospital/medical staff relationships, the regulation of health insurers, funding mechanisms such as Medicare/Medicaid, federal self-referral and "anti-kickback" prohibitions, and other topics.

Issues in Death and Dying (2 cr.) D/N 694 examines the ethical, legal and medical issues concerning the refusal, removal and/or withdrawal of life-sustaining medical procedures, and assisted suicide. The course will consider whether there is a morally relevant distinction that should be reflected in our legal norms between passive measures, such as the refusal or removal of life support, and more active measures that bring about death. The course will survey legal issues such as treatment of the unconscious or non-competent patient, including infants, a discussion of living wills and durable powers of attorney, and recent constitutional developments relevant to the patient's right to refuse medical treatment.

Law and Public Health (2 cr.) D/N 761 covers the law governing the practice of public health by state, local, and federal agencies, as well as health care professionals and institutions. Topics addressed include legal mandates on public health agencies, physicians, and other health practitioners regarding testing, reporting, and contact tracing with respect to specific diseases, as well as laws for the imposition of quarantine, civil commitment, and mandatory treatment. Also covered are public health aspects of the regulation of health care institutions, legal issues associated with risk assessment and cost benefit analysis, along with the environment.

Law of Medical Malpractice (2 or 3 cr.) D/N 824 covers law relating to the practice of medicine and allied fields in contexts of organizing and regulating professions, theories of liability and defenses pertinent to claims of patients for injurious professional conduct, along with practice and procedure in professional malpractice claims.

Life Sciences Compliance Law (2 or 3 cr.) D/N 693 The course examines law and regulation pertaining to the initiation of research projects involving human and animal subjects by both universities and manufacturers. It examines the pertinent government regulations, guidance documents and enforcement initiatives forming the framework for the conduct of clinical trials and focuses upon the practical aspects of clinical trial contracting, application of regulatory guidelines, quality system compliance and corresponding documentation requirements. The course will provide experience in drafting and negotiating clinical trial contract provisions, addressing publication rights, intellectual property ownership, indemnification and confidentiality.

Marion County Public Health Externship (2 or 3 cr.) D802 Student externs will assist health department attorneys in enforcement of the Marion County Public Health Code in environmental court and drafting of health department regulations and contracts. (Application(s): Spring 2015)

Neuroscience and the Law (2 cr.) D/N 686 focuses on aspects of neuroscience relevant to legal decision-making. Subjects addressed will include an overview of brain structure, relevance of brain to behavior, an exploration of medical and scientific tools used to better understand the brain, and applications of this knowledge to areas such as the adolescent brain, addictions, and psychopathy. Advances in neuroscience may well challenge traditional understandings of concepts such as culpability, propensity, andresponsibility.

Program on Law and State Government Externship Course (3 cr.) D802 Allows students the opportunity to learn about the practice of law within the state government setting with a combination of traditional classroom learning and an externship placement at one of a wide variety of law offices and agencies within the executive and legislative branches of Indiana's state government. The class meetings explore topics such as ethical considerations for the public lawyer, rulemaking and the administrative process, federalism and state sovereignty, state supported speech, and state budgeting issues. (Two of the course credits will be graded S/F, based upon satisfaction of externship requirements, with the remaining credit carrying a course grade based upon performance in the classroom component of the course.) (Application: Spring 2015 | More info: PLSG web site)

Psychiatry and the Law (2 cr.) D/N 874 introduces the psychiatric discipline as it relates to the law and covers its use as a forensic art in court.

Seminar in Law and Medicine (2 cr.) D/N 841 This seminar covers selected issues in law and medicine.

Social Regulation of the Body and Its Processes (2 cr.) D/N 691 examines problems related to the social allocation of the body and its products such as the extent to which individuals have an ethically and legally protectable interest in their bodies and body processes. Topics for consideration will include the legal status of human ova and sperm, frozen embryos, and the products of medical research developed from materials taken from the bodies of interested subjects. The course will also consider the ethics and the legal regulation of organ allocation.

Topics in Health Law (2 or 3 cr.) D/N 763 examines specialized topics in health law not addressed in depth by other courses. Possible topics include health care fraud and abuse law, the regulation of long term care, the law of payment of health care providers, biotechnology and the law, genetics and the law, reproductive rights, end-of-life decision making, and privacy issues in health law. Prerequisites will vary according to the subject of the course as announced.