Course Syllabus

Instructor: Cindy Jacobs, RN, JD

Primary guest/co-lecturer:  John Scott, MD (UW Medicine Telehealth Medical Director)

Other guest lecturers/panel participants TBD

Course Overview: This course will cover legal and related healthcare issues regarding emerging care delivery technologies that have developed in the healthcare arena over approximately the past decade. Topics covered will include telemedicine, healthcare robots and other innovative procedural devices, healthcare software/applications (including clinical decision support systems, mobile medical apps, and gene sequencing/ biotechnology/ nanotechnology).

Our goal is that this NOT be a "talking head" class.  "Background slides" will be posted a day or two before each class, along with one or more hypothetical case studies/examples representative of the class topic. We will use these slides in class, but as “agenda points” only.  Class time will primarily be spent discussing the class topic based on the class reading material, the background slides, and the hypothetical(s).

Course Materials: This rapidly-evolving area does not lend itself to a traditional law school casebook. The course text is Breuer, J. R. et al., AHLA Telehealth Law Handbook: A Practical Guide to Virtual Care (2018, AHLA), which will provide a good overview of telehealth-related course topics. This is available directly from the publisher (AHLA) in an e-book format at an academic discount.  Details on ordering are in the announcement on the course Canvas home page. Other course materials will consist of applicable statutes, regulations, administrative agency interpretive/policy guidelines, professional association guidelines and standards, professional journal articles (legal and healthcare), and case law where available.

Course Objectives: At the end of the course, students will be able to:

1. Identify and describe the regulatory scheme(s) governing telemedicine, health care robots and other software/technology-based medical devices, other healthcare-related software, and healthcare-related biotechnology.
2. Analyze legal issues related to the above healthcare technologies, including
   • Liability risk
   • Informed consent
   • Antitrust
   • Compliance and Regulatory

Reading/Assignments/Grading:

1. Reading/class preparation—Class readings (posted 1 week in advance), review of “background slides” (posted a day or two in advance), and preparing to discuss one or more hypothetical case studies/examples during each class (posted a day or two in advance). Readings, slides, and hypotheticals will be posted in the "detail" section of the calendar item for each class (see below), and a running list will also be on the Readings & Class Slides page.
2. Assignments/Grading
   • Small group project (approximately 4 students per group): Simulated presentation to a healthcare client (e.g., health system board) regarding a hypothetical set of questions pertaining to a specific healthcare technology of the group's choice (hypotheticals will be provided by the instructor in conjunction with relevant guest lecturers/subject matter experts). (35% of grade).
   • Individual final paper focused on the healthcare technology from the above small group, with an in-depth analysis of the issues from the presentation.  The paper should be in the format of a companion client memo to accompany the presentation. (55% of grade)
   • Class attendance/participation will be worth 10% of the grade.