Course Syllabus

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Instructor: Cindy Jacobs, RN, JD

Guests/co-lecturers:  

  • Primary guest instructor: John Scott, MD, UW Medicine Digital Health Medical Director.
  • Other regular guest class participants:
    • Terri Butler, PhD, Director of Research Partnerships at ITHS, primary contact for the ITHS Drug and Device Advisory Committee, Assistant Director of the Hollomon Health Innovation Challenge at the Buerk Center for Entrepreneurship in the Foster School of Business.
    • Ali Ansary, MD, School of Medicine, Department of Medicine
  • Other one-time guest lecturers/panel participants: TBD/as noted in syllabus.

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, generally 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).  Hypothetical case studies/example discussions will continue/develop outside of class in Canvas discussion boards.

Course Materials: This rapidly-evolving area does not lend itself to a traditional law school casebook. The only course textbook is Breuer, J. R. et al., AHLA Telehealth Law Handbook: A Practical Guide to Virtual Care (2018, AHLA), which provides a good overview of the 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 this announcement.

Other course materials, including all materials for the non-telehealth portions of the course, 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--the healthcare technology arena is very light on case law).

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, including privacy/security and FDA regulation

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 (most posted a day or two in advance). Readings will be posted as assignments; hypotheticals will be posted on Canvas discussion boards (see below). Readings and hypotheticals, along with the background slides, also will be posted on a running list at the Readings & Class Slides page.
  2. Assignments/Grading
    • Small group project (approximately 2-3 students per group): 35% of grade. Details TBD, but the concept is to have each group represent the legal/regulatory expertise for an advice-seeking session by an actual UW group working on a healthcare tech project, offer preliminary advice during session (the UW group seeking advice will provide advance information), and then prepare a written summary of its advice. This project will be coordinated with Terri Butler. The UW groups seeking advice are typically made up of students and faculty from various parts of campus, including, e.g., the School of Medicine, School of Pharmacy, and Computer Science and Engineering. Some are in early start-up company mode, and others are looking to license technology via UW. The sessions will take place during the 2nd and 3rd weeks of November. Written summaries will be due on the last day of the quarter.
    • Individual final paper focused on a specific issue hypothetical: 45% of grade. There will be two hypotheticals to choose from. The paper should be in the form of a client memo and will be due on the last day of the quarter.
    • Class participation--20% of grade. Class participation includes the following:
      • Class attendance 
      • Participation in class discussions
      • Participation in Canvas discussion boards
        • Most in-class hypotheticals will also be posted on the discussion board; participation = posting a comment or question.
        • Comments that simply say “I agree,”  “I disagree,” "Great comment," etc., will not count as participation.
        • You also may participate by beginning a discussion thread yourself and/or participating in a student-posted discussion thread.

Religious Accommodation:

Washington state law requires that UW develop a policy for accommodation of student absences or significant hardship due to reasons of faith or conscience, or for organized religious activities. The UW’s policy, including more information about how to request an accommodation, is available at Religious Accommodations Policy (https://registrar.washington.edu/staffandfaculty/religious-accommodations-policy/). Accommodations must be requested within the first two weeks of this course using the Religious Accommodations Request form (https://registrar.washington.edu/students/religious-accommodations-request/).

Course Summary:

Date Details Due