General Health Law Certificate Course Descriptions
The 17-credit General Health Law Certificate curriculum begins with the four required core courses. These core courses give students a firm foundation in health law - how health care is paid for and regulated; what legal tools are available to adjust the accessibility, cost, and quality of health care; and how the core norms of biomedical ethics interact with the law.
The remainder of the certificate curriculum is designed by the student, with the guidance of a certificate advisor. This flexibility allows students to focus and individualize the health law curriculum according to their desired practice area. Students should refer to the Course Planning Tool to aid in their selection of elective courses. Students choose their 6 credits of elective courses from a wide-range of heath law electives that include the Health Law Clinic, the Health Law Practicum, regularly offered health law courses, and a rotating range of special topics courses focusing on timely and emerging issues in the field.
This list reflects suggested and commonly-offered electives, but additional special topic and seminar courses may count as elective credit for the certificate. Please note that specific offerings may be different, so students should consult their certificate advisor for guidance on elective courses each term.
Core Course Descriptions
Health Law: Quality of Care and Liability
This is an introductory course examining how the regulatory and legal systems approach quality of care. The focus is 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 focuses on confidentiality obligations (including HIPAA), informed consent, and hospital and managed care liability. The course reviews the role of ERISA in both managed care liability and health plan regulation. Finally, the course provides 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.
Heath Law Organization and Finance
This course addresses the regulation, structure, and financing of the American health care system. It focuses on the cost and access issues which permeate health care. The class examines how health care is funded through both private and public insurance, including Medicare and Medicaid. The obligations of hospitals and professionals to treat the uninsured are reviewed, as well as the policy questions about addressing access to the large uninsured population. The course also reviews the forms and structure of health care enterprises, with a focus on the creation and regulation of tax-exempt organizations. The fraud and abuse laws, including the False Claims Act, the Anti-Kickback law and STARK, are reviewed both from the perspective of the compliance department and of the lawyer who must structure health care entities with these laws in mind. Finally, the course reviews how the antitrust laws impact the structure and conduct of health care providers.
State and federal agencies govern many aspects of public policy, business and economic regulations, social values, politics and regulatory compliance. Issues relating to banking, environmental protection, food and drug regulations and health care matters are especially important in Administrative Law. The course examines the rights, power and procedures of administrative agencies in investigation, rulemaking, adjudication, and informal actions. The course raises student awareness regarding the legislative, executive and judicial branches of government in the creation, implementation, and review of public policy and agency action.
Law and Bioethics
This course covers constitutional and statutory rights of patients, as well as ethical and policy concerns in the area of medical treatment, including confidentiality, informed consent, right to treatment, and bioethical concerns involving matters such as emerging reproductive, transplant, and life support technologies.
Developments in biotechnology and the life sciences have thrown into question existing legal approaches and instruments dealing with such critical issues as discrimination, intellectual property, reproduction, health, drug development, informed consent, and privacy. These developments are reconstituting concepts of legal rights and obligations of people in relation to their governing institutions. Focusing in particular on new genetic technologies, this course seeks to identify and explore important ethical, legal, and policy issues associated with these developments.
Elective Course Descriptions
Complementary and Alternative Medicine and the Law
This course examines the legal, ethical, and policy issues raised by the delivery of complementary and alternative medicine (CAM). Special attention is given to the definitions, theories, and practice of major CAM therapies, including chiropractic, acupuncture, homeopathy, naturopathy, massage therapy, dietary supplementation, herbal medicine, and various cancer therapies; the role of evidence-based medicine in evaluating CAM therapies; the licensure, regulation, and certification (or lack thereof) of CAM providers; the historical bias of allopathic physicians and health insurance companies against CAM providers; legal issues relating to collaboration with CAM providers, including credentialing, medical staff membership, clinical privileges, ordering, and referrals; informed consent to CAM therapies and CAM research; CAM malpractice; other civil and criminal law issues cases involving CAM providers; truth-in-advertising by CAM providers; and public and commercial insurance coverage of CAM.
This course examines the legal issues raised by our nation's growing elder population. Special attention is given to the housing and health care needs of the elderly; liability and advocacy issues; financing of elder care; life and estate planning; guardianship; conservatorship, advance directives and end-of-life decisions; and elder abuse and neglect.
Food and Drug Law
This course focuses on the regulation of food, drugs and medical devices by the U.S. Food and Drug Administration (FDA). Students learn about the statutory framework involved with particular emphasis on the Federal Food, Drug and Cosmetic Act. Students also learn the FDA's interpretation and enforcement of its status and regulations and gain insight into the FDA's decision-making processes and policies.
Governance and Ethics in Health Care Compliance
Our health care system is plagued with high costs and inconsistent outcomes. This class focuses on the role of Boards of Directors in meeting these and other health care challenges. In addition to outlining governance structure and responsibilities, the course reviews current state and federal laws that apply to our health care system, as well as tax policy with respect to tax exemptions for charitable entities and detail how the 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.
Health Care Compliance Summer Institute
This is an intensive two week, three credit course taught by compliance industry leaders designed to deliver the tools necessary for working professionals and students to enhance job performance and become more competitive in the compliance job market. During the course students gain a more sophisticated understanding of the laws and regulations encountered by compliance professionals in daily practice, develop the skills to conduct audits and investigation, and learn how to manage employee and vendor issues including enforcement and reporting requirements.
Health Care Fraud and Abuse
This course examines federal and state laws and regulations that impose criminal and civil penalties on health care providers for fraudulent and wasteful activities. Special attention is given to federal False Claims and Anti-kickback statutes, physician self-referral (Stark) laws, civil monetary penalty and exclusion laws, and the application of traditional federal white collar criminal laws to health care. The course also examines how these laws drive the structure of health care enterprises. This course is particularly important for students interested in health care regulation compliance or transactional work.
Health Care Mergers & Acquisitions
This course looks at the legal, tax, business, and practical aspects of health care mergers, acquisitions and affiliations, involving both tax-exempt and taxable organizations, with an emphasis on provider side transactions. Taught by experienced health care transaction attorneys, the course looks at transaction structure, valuation, drafting and negotiating issues from the perspective of both inside and outside legal counsel.
This course examines the health information confidentiality regulations that promulgate one portion of the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act (HIPAA ), signed into law by President Clinton on August 21, 1996, as amended by the American Recovery and Reinvestment Act (ARRA), signed into law by President Obama on February 17, 2009, as recently amended and/or implemented on August 24, 2009 (by the Breach Notification Interim Final Rule), October 7, 2009 (by the GINA/HIPAA Proposed Rule), October 30, 2009 (by the HIPAA Enforcement Interim Final Rule), July 14, 2010 (by the Proposed Modifications to the HIPAA Privacy and Enforcement Rules), and any additional proposed or final rules that may be issued prior to the commencement of this course.
Medical Malpractice: Theory and Practice
This course introduces the law of medical malpractice, combining review of substantive law with simulation exercises from discovery to the trial of a malpractice case. Subject areas include tort and contract theories of liability, informed consent and right to treatment, procedural and evidentiary aspects of malpractice claims including expert testimony and scientific evidence, and defenses including indemnity and contribution and comparative fault.
Mental Health Law
This course examines the legal and ethical duties that apply to mental health care providers, as well as the rights of individuals with mental illness, intellectual disabilities, neurodegenerative diseases, alcohol and drug dependency, and brain injuries. Special attention is given to the licensing, certification, and accreditation of mental health care providers; informed consent to mental health treatment and behavioral research; the confidentiality of mental health records under Minnesota and federal law; the requirements for using physical and chemical restraints, seclusion, and electroconvulsive therapy; the question of whether patients have a right to mental health care; the prerequisites for involuntary mental health commitment; mental health parity legislation; and the burgeoning field of neuroethics.
This course examines the legal and ethical sources of patients' rights as well as the duties of patient advocates, ombudspersons, ethics committees, and risk management departments as they relate to patients' rights. Examples of issues that are examined during class include, but certainly are not limited to, whether patients have the right to refuse to be examined and treated by medical and nursing students and residents; whether patients have a right to know their prognosis; whether patients have the right to know the HIV-status of their physicians; whether hospitals can prevent patients from leaving; whether patients have the right to videotape childbirth or other activities, treatments, or procedures in which they are involved; whether health care facilities such as nursing homes can videotape their residents' activities; whether patients in all health care facilities have the right to receive visitors and to associate with other patients; whether pregnant women have the right to be informed of the option of genetic counseling and screening; whether pregnant women can refuse to be tested for illegal drugs; whether pregnant women can elect to give birth at home; and whether patients can refuse to consent to autopsy prior to death. Many other issues relating to patients' rights are also introduced.
Public Health Law
This course addresses governmental powers, duties, and limits in regards to the health of the American population. It emphasizes the relationship between law and policy issues concerning state intervention in health affairs, which can implicate constitutional issues of federal power and individual rights. The course will include topics such as the regulation of public health research, governmental promotion of health practices, control of infectious diseases, the use of humans as research subjects, and governmental response to natural disasters, quarantine, forced inoculation, and bioterrorism.
Visit Hamline University's Health Law Institute for more information.