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Spring 2020
5397 Regulating Disruptive Innovation: Biomedicine & Beyond - EVANS- 28201

Professor(s): Barbara Evans (INACTIVE)

Credits: 3

Course Areas: Health Law 
Intellectual Property and Information Law

Time: 4:00p-5:30p  TTH  Location: 215  TUII

Course Outline: This course explores unresolved legal, societal, and ethical challenges with big data systems, AI/machine learning software, robotics, gene editing and other biotechnologies that already are disrupting healthcare and many other industries. It surveys the key legal frameworks for addressing those challenges (FDA, CDC, EPA, USDA, FTC, privacy, antitrust, healthcare reimbursement, welfare) and introduces crucial concepts in business-model and value-chain innovation.

This course is cross-listed with UH’s Electrical and Computer Engineering (ECE) Department as course ECE 6397-25251 Medical Devices: Law, Regulation, and Ethics and provides the opportunity for collaborative, multi-disciplinary learning and problem-solving. The course is accessible to students with various backgrounds. No special expertise of science, engineering, or law is required, and we will look for common ground and put our heads together to solve some of society’s most pressing problems.

Prof. Evans is an acclaimed law professor with credentials in engineering as well as law. She is a global authority on biotechnology and law.  See her bio below, and the short videos of her role in debates about DNA editing:

     http://www.law.uh.edu/faculty/main.asp?PID=4379 (UH bio page)

     Oxford Union Debating Society: Debate on the morality of human genome editing:

     https://www.youtube.cobm/watch?v=O4uyXpBAmXQ (DNA editing debate response)

     U.S. National Academies of Science, Engineering and Medicine, U.K.Royal Society, and Chinese Academy of Sciences, International Summit on Human Gene Editing:

     https://vimeo.com/showcase/3704161?page=2

Course Syllabus: Syllabus revised 1/14/2020

Syllabus revised 3/20/20

Course Notes:   Quota= 50.

CAREER DEVELOPMENT
This course is designed to enable students to think critically about some of the most important biomedical and industrial biotechnologies reshaping our world and our humanity.  Whether you are a law student and want to learn more about the technology, or a STEM student and want to know more about the law influencing these technologies, this course provides a gateway to both while building important analysis and writing skills to augment your career.

The course was developed in collaboration with leading professors and technologists from the BRAIN Center, a partnership in which UH plays a major role:
     http://brain.egr.uh.edu/

The course will examine the legal, societal, and ethical frameworks of technologies such as these:
     https://www.youtube.com/watch?v=eoJI19nlFAc

ENGINEERING COURSE NUMBER AND DESCRIPTION

6397 ECE Medical Devices: Law, Regulation, and Ethics Part II – EVANS- 25251

ASSESSMENT
There is no final exam. Students’ grades will be based on one 75-minute in-class examination (counting 50% of the grade, to take place after Spring Break); plus one take-home policy-oriented exam (counting 25% of the final grade, to take place two weeks before the end of classes). In addition, students (or collaborative teams of students) will elect to prepare either a written short paper (3,000 – 6,000 words) on a topic of students’ choosing or an in-class presentation on a chosen topic (counting 25%). The two tests will be scheduled in coordination with students to minimize scheduling conflicts, with make-ups available for students with bona fide conflicts on the chosen test dates. Short papers will be due during the finals period or the in-class presentations will occur on a schedule agreed with the professor.

Exam: one in-class exam (50%), one take-home policy exam during the semester (25%) and one short paper or in-class presentation (25%).

Law Center students are graded according to Law Center policies/curve, separately from students from other UH academic units.

MATERIALS
Assigned materials: Christenson, Grossman, and Hwang, The Innovator’s Prescription: A Disruptive Solution of Health Care (2017), available in paperback for $12.00, plus readings and supplements curated by Prof. Evans and supplied at no cost for electronic upload to your hard drive.

Prerequisites:  Note: No special legal or scientific background required. This course does not duplicate Biotech & Law, FDA Law, or US Biotech Regulatory Framework. Students who have registered for those courses can take this course. This course is suitable as an elective, or as part of an IPIL or Health Law concentration.

First Day Assignments: Read any 4 of the 8 short news items listed in the "Day 1 Assignment" file and come to class ready to summarize them and discuss them. URLs are provided in that file, except for Intro I and Intro 5 which are provided here as PDFs.

Day 1 Assignment

Intro 1 - Pham-et-al-2018-Robots and Jobs

Intro 5 - Washington Post - Gene therapies offer dramatic promise but shocking costs

Final Exam Schedule: Quiz/Paper      

This course will have:
Exam: No Final exam- Two Quizzes
Paper: Yes

Satisfies Skills Course Requirement: No
Satisfies Senior Upper Level Writing Requirement: No

Experiential Course Type: No

Bar Course: No

DistanceEd ABA 306:

Pass-Fail Student Election:

Course Materials (10/30/2019 4:21:02 PM)

Book(s) Required

The Innovator's Prescription: A Disruptive Solution for Health Care
Clayton M. Christenson, Jerome H. Grossman, and Jason Hwang
ISBN 13: 9781259860867
Paperback
Publisher: McGraw-Hill Education, 2016