Administrative Law (3130) Clean water, safe food and drugs, stable banks, sensible land use, an open and accessible internet-these and many more aspects of modern American life depend largely on decisions made by unelected officials staffing administrative agencies at the local, state, and federal levels. This course examines the authority and procedures that these administrative agencies use to make law, investigate violations of the law, and adjudicate the application of the law to individuals and businesses. The course raises student awareness regarding the operation of the administrative state and important separation of powers and due process questions raised by ubiquitous administrative governance. Grading: Exam Credits: 3 Offered: Fall/Spring Subject Areas: Administrative and Legislative Process, Child and Family Law, Government Practice, Health Law, Public Interest Law, Business and Commercial, Criminal Law, Employment Law, Environmental Law Antitrust (3190) Surveys the antitrust field and legal restraints on economic activity. Focuses on trade practices prohibited by the Sherman, Clayton and FTC Acts, including monopolization, price-fixing, distribution restrictions, boycotts, and tying. Brief review of price discrimination and mergers. Some knowledge of basic economics is desirable but not necessary. Grading: Letter graded Credits: 3 Offered: Every Other Spring Subject Areas: Health Law, Business and Commercial Clinic: COVID-Response (4033) Students in this clinic will work under the direct supervision of members of the clinic faculty on cases referred from legal services organizations to address the legal needs of indigent clients created by the public health, social, and economic effects of the coronavirus pandemic. Areas of legal need are anticipated to include access to unemployment, social security, and other COVID-related benefits, employee rights, advance planning for eviction defense and other housing remedies, and petitions for medical release from confinement. In addition to learning basic poverty law, students in this clinic will develop skills for using technology to remote representation. A classroom component will meet synchronously but remotely once a week to address common issues of substantive law, procedure, and client representation. Students will have additional remote meetings with the faculty members supervising their cases. Grading: Letter Credits: 2 or 3 Offered: Irregularly Categories: Experiential Subject Areas: Administrative and Legislative Process, Health Law, Public Interest Law Clinic: Health Law (3062) This clinic offers students the opportunity to represent individuals whose health is being affected by a legal concern. Because there are many social determinants of health, the clinic handles a wide range of case types. Students will gain experience in interviewing, counseling, and litigating client matters and interacting with health providers at a community health center. Grading: Letter graded Credits: Variable Offered: Fall/Spring Categories: Experiential Subject Areas: Health Law Drug and Device Law (3006) This course examines the role of the Food and Drug Administration in the regulation of prescription drugs and medical devices, the tort liability of drug and device manufacturers, the novel legal issues that arise from the acknowledged risks and side-effects associated with the use of such products, the role of physicians in prescribing them, and the policy-based legislative limits on the liability of those who develop and manufacture them. The course may also include a discussion of the economics of new products innovation. Grading: Letter-graded. Credits: 2 Offered: Subject Areas: Health Law, Personal Injury, Torts Elder Law (3836) This course examines legal, ethical, and social issues raised by our nation's growing elder population. Focus is on the practical application of concepts in Elder Law. Special attention is given to: (1) ethical issues in elder representation; (2) family issues, such as grandparent rights and marriage; (3) retirement; (4) property management, including joint ownership and financial accounts, trusts, and estate planning; (5) alternative decision-making, including health care directives, powers of attorney, and guardianship and conservatorship; (6) managing and paying for health care, including Medicaid, Medicare, and long-term care insurance; (7) health care options and licensing and regulation of health care and housing providers; (8) elder abuse, neglect, and financial exploitation; (9) remedies, such as criminal, administrative, and civil remedies, including medical malpractice; (10) elder mediation; and (11) end-of-life issues, including POLST and physician aid in dying. Grading: Letter-graded. Credits: 2 Offered: Subject Areas: Child and Family Law, Health Law Externship: Health Law (3036) This course focuses on Externships in health law, healthcare compliance, and health policy. Contact the professor to explore Externships in hospitals, insurance companies, device makers, state agencies, federal agencies, and professional associations. In addition to the Field Placement work (45 hours per credit), students must attend a multually- and periodically-scheduled seminar to discuss their externship experiences as well as legal, ethical, and professional issues raised by the professor. In between class sessions, students must complete written exercises assigned by the professor. Grading: Pass/Fail Credits: Variable Offered: Fall/Spring Categories: Experiential Subject Areas: Health Law Food Law (1957) This course will explore some of the many legal issues related to food, from farm to fork and beyond. It will review basic regulatory issues - the roles of FDA, USDA, and other agencies in regulating food production and safety, FDA approval of ingredients and oversight of labeling and marketing, and local menu labeling standards, for example. Seminar participants will also consider agricultural law topics such as organic standards, regulation of genetically engineered crops and animals, pesticide use, and national farm policy, and may explore issues of personal responsibility and tort claims arising from food consumption (such as recent litigation about obesity and E. coli outbreaks.) Grading: Letter graded. Credits: 2 Offered: Fall Subject Areas: Health Law Health Care Compliance Governance and Ethics (3023) This course focuses on the role of Boards of Directors in meeting health care challenges and the ethical dilemmas commonly faced by compliance officers. In addition to outlining governance structure and responsibilities, the course will review tax policy with respect to tax exemptions for charitable entities and detail how that tax exemption is conferred. Special attention is given to not-for-profit, as well as for-profit entities and the unique ethical and governance issues presented by various organizational structures. Prerequisites: Health Care Compliance Institute Grading: Letter graded Credits: 2 Offered: Fall/Spring Subject Areas: Health Law Health Care Compliance Institute (3021) This course introduces students to the most important legal and practical concepts in the health care compliance field. Specifically, students will develop an understanding of the laws and regulations encountered by compliance professionals in daily practice with specific attention paid to the federal regulatory infrastructure. Students will also explore key operational concepts including audits, investigations, enforcement and reporting requirements, billing and coding basics, along with employee and vendor issues. Students will test legal and operational concepts through simulation-based projects and small group exercises, including drafting assignments and mock interviews. Grading: Letter graded Credits: 3 Offered: Subject Areas: Health Law Health Care Compliance Skills (3022) This course is designed to expose students to key legal and operational concepts in the health care compliance field. Students use knowledge gained in prior mandatory coursework and participate in simulation-based projects that require them to perform audits, investigations, and reporting activities to ensure compliance with applicable federal and state laws. The course also includes a mentoring component that builds on the theory of experiential learning whereby students are paired with industry professionals effectively linking Mitchell Hamline’s strong academic/classroom environment with the real world of health care compliance. Prerequisites: Health Care Compliance Institute Grading: Letter graded Credits: 3 Offered: Categories: Experiential Subject Areas: Health Law Health Care Law & Opioids: How the "Man-Made Plague" Is Transforming the Pharmaceutical Industry (4064) The current opioid epidemic has been branded as “the worst drug crisis in America’s history” and a “man-made plague.” According to the Centers for Disease Control and Prevention (“CDC”), the current public health crisis has claimed more than 351,000 lives to opioid overdoses since 1999 with no end in sight. Its origins are a convoluted mixture of history, medicine, public policy, and regulation. The current opioid crisis also has generated an enormous amount of federal, state, and local litigation, much of which is ongoing. However, it is clear, even though the litigation is far from over, that the aftermath of the opioid cases will transform the pharmaceutical industry in much the same way that the big tobacco cases did. With the amount of information that is publicly available (e.g., media coverage, case evidence, pleadings, settlements and verdicts), the opioid crisis and its attendant litigation present students with a unique opportunity to explore the intersection between public health, regulations, compliance, and the law. Grading: Letter Credits: 2 Offered: Irregularly Subject Areas: Health Law Health Law Quality and Liability (3035) This is an introductory course examining how the regulatory and legal systems approach quality of care. The focus will be on mechanisms for assuring quality of care including self regulation, credentialing, the doctor-patient relationship, professional licensure, government regulation, and the tort system. Examination of the tort system will focus on confidentiality obligations (including HIPAA), informed consent, and hospital and managed care liability. The course will review the role of ERISA in both managed care liability and health plan regulation. Finally, the course will provide an overview of how the public health system operates to protect both our health care and our civil rights. At the end of the course, students will have examined both the law and policy issues such as the problems arising from medical errors and the struggle to balance the need for quality against rising costs and lack of health care access. The curriculum focuses on cases applying administrative and common law, as well as a variety of statutory schemes. Grading: Letter graded Credits: 3 Offered: Spring Subject Areas: Health Law Health Law: Organization and Finance (3026) In this course, we will explore the regulation, structure, and financing of the United States health care system. We will examine structure and regulation of private health insurance coverage at the state and federal levels, as well as Medicare and Medicaid, our two major public coverage programs. We will consider policy questions regarding the appropriate division of responsibility between the public and private spheres in both funding and regulating coverage, as well as in ensuring that those who need health care can afford to access it. We will consider the organization of health care entities such as hospitals, with an emphasis issues concerning not-for-profit organizations. We will learn how the federal and state governments seek to prevent fraud and abuse in Medicare and Medicaid. Finally, we will examine antitrust concerns in the health care industry and efforts to prevent unlawful consolidation of market power. Grading: Letter graded Credits: 3 Offered: Fall Subject Areas: Health Law HIPAA Privacy (4154) The focus of this course are the privacy and security provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the foundation for federal protections of health care information, including updates in the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH). The course will also discuss additional international, federal and state health privacy laws, and the application and enforcement of those laws as they relate to privacy and security in the health care setting. The objectives of this course include learning how to: (i) identify situations that implicate HIPAA and how to appropriately navigate the Department of Health and Humans Services' resources; (ii) understand which provisions of the privacy and security law and rules apply to given situations and how to apply those provisions; and (iii) understand the significance of sound security measures in an era of increasing electronic crimes. Given the breadth of the subject matter and the short time allotted, students will not be expected to understand the full depth and complexity of applicable laws and rules; they will, however, be expected to understand key definitions and basic concepts under HIPAA and be proficient in navigating the healthcare privacy landscape. Grading: Credits: Offered: Subject Areas: Health Law Medical Malpractice (4830) Examines medical and legal aspects of litigation against physicians, hospitals, and other allied health professionals with consideration given to dilemmas of medical ethics not adequately addressed by the tort system. Grading: Exam Credits: 2 Offered: Fall Subject Areas: Health Law, Personal Injury, Torts Mental Health Law Seminar (4840) Covers the nature of mental illness, intellectual disabilities, and other mental disabilities; the provision of treatment and services for mental disabilities: financing, regulation, and administration; involuntary hospitalization and treatment; the right to treatment and services; incompetence and substitute decision-making mechanisms; informed consent; confidentiality, privacy, privilege and the duty to warn; mental disability and the criminal justice system; lawyering and mental disabilities; ethical and practical issues; sexually violent predator civil commitment laws; international human rights norms. This course will be co-taught by a forensic psychiatrist. Grading: Letter graded Credits: Variable Offered: Irregularly Subject Areas: Health Law, Public Interest Law Public Health Law (4345) Introduces students to the fundamentals of public health law, including those constitutional, administrative, and statutory provisions that empower or mandate government to act for the health of the community and those that curtail the state's power to do so. By analyzing the legal dimensions of critical current issues, such as bioterrorism, the control of HIV/AIDS, the obesity epidemic, smoking regulation, food safety, and pandemic flu, students will gain concrete experience applying constitutional and legal principles important to all attorneys, regardless of their areas of practice. Grading: Letter-graded. Credits: 2 or 3 Offered: Irregularly Subject Areas: Health Law Residency - Health Law Field Placement (3037) Only offered in the spring, the Health Law Residency Program gives students in their final year of law school an opportunity for intensive practical training in the field. The 2-credit weekly seminar focuses on development of professional judgment as well as doctrine and skills related to the Residency. In addition to the 2-credit seminar, students receive between 8 and 13 credits for work at the Residency Placement. Students must apply and be accepted into the program before being matched with a Residency Placement. Due to the intensity of the workload, applicants should be in their final year of law school and have a demonstrated interest and prior course work in the substantive area of health law. Grading: Pass/Fail Credits: Variable Offered: Spring Categories: Experiential Subject Areas: Health Law Seminar: Health Law (3125) In this course, you will choose a health law topic on which to focus your attention for the semester, research intensively, and write about in a paper that will, if you desire, fulfill your Advanced Research and Writing Requirement. In the process, we will address how to choose an interesting and appropriate topic on which to write an extended paper; research topics in health law, policy, and medicine; use and cite research correctly; avoid plagiarism; write a useful paper outline; prepare a first paper draft; edit one’s own and others’ work; and write a polished final draft. Grading: Letter graded Credits: Variable Offered: Irregularly Subject Areas: Health Law Seminar: Race, Health Equity & the Law (4028) The Institute of Medicine defines public health as "what we, as a society do collectively to assure the conditions for people to be healthy." Unlike health care, which focuses on medical interventions to improve the health of individual patients, public health takes a broader look at the wide-ranging determinants of population health. Although various interventions have been devised to protect health at the population level, disparities in health outcomes persist, with marginalized communities--racial and ethnic minorities, sexual minorities, low socioeconomic status people--bearing a disproportionate amount of negative health outcomes. These inequitable health outcomes are largely products of structural and institutional factors that are grounded in the law. This course will adopt a critical approach to law--along the axes of race, ethnicity, gender, and sexual identity, and class--to examine how the law creates, sustains, and legitimizes inequitable health outcomes. This critical approach will be used to analyze the legal dimensions of current public health issues, such as the COVID-19 pandemic, the obesity epidemic, tobacco control, healthcare access, natural disasters & climate change, and socio-political determinants of health to challenge students think beyond the traditional paradigms of legal reasoning. Grading: Letter Credits: Variable Offered: Irregularly Categories: Long Paper Subject Areas: Health Law, Public Interest Law, Constitutional Law and Civil Rights, Environmental Law Telemedicine (3126) Using the seven elements of the Department of Health and Human Services (HHS) Office of Inspector General (OIG) Effective Compliance Program, as outlined in the Federal Sentencing Guidelines, this telemedicine law course will evaluate common telemedicine legal and regulatory considerations as well as integration of legal and compliance best practices within the telemedicine implementation process and clinical practice. The development of sustainable and scalable telemedicine services can be decelerated by a multitude of rapidly changing legal and regulatory requirements on both state and federal levels. Often, the laws and guidance are confusing and outdated because they were drafted at a time when telemedicine did not exist, making them difficult to interpret and apply to today’s new health care modalities. An embedded practice-oriented compliance program helps to operationalize the regulatory requirements while managing an organization’s risk. This course provides an overview of common telemedicine legal and regulatory considerations. In particular, students will examine guiding principles and tools that can be utilized in integrating legal and compliance into a virtual care network. And they will consider the operational value in compliance by design. In addition, the course will bring the principles to life by featuring relevant clinical use case examples highlighting the integration of legal and compliance best practices within the telemedicine implementation process. Grading: Letter graded Credits: 2 Offered: Irregularly Subject Areas: Health Law Workers' Compensation (5570) Surveys no-fault compensation laws covering personal injuries in employment, including substance, procedure, and benefits under workers' compensation law. Grading: Letter graded. Credits: 3 Offered: Spring Subject Areas: Health Law, Personal Injury, Torts, Employment Law
