7397 WRS: E-Health Law - SCOTTR-
Ronald Scott (RESEARCH PROFESSOR)
Course Areas: Health Law
Time: 2:30p-3:45p MWLocation:
Course Outline: This seminar will examine regulatory approaches to new technology, including health information technology (HIT), by state legislatures, boards of medicine and pharmacy, and federal agencies including the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA).
Some of the topics we will address include healthcare privacy (the Health Insurance Portability and Accountability Act (HIPAA), regulation of physicians practicing medicine via the Internet, Internet pharmacies and e-prescribing, electronic health records, personal health records maintained online, and regulation of iPhone apps as “medical devices.” We will also discuss use of social media such as Facebook and Twitter by healthcare providers and the legal and ethical considerations arising from such use.
The Internet is largely unregulated, and reaches across state and international borders. Physicians, pharmacies, pharmacists, and other health care providers have historically been regulated by the states. Perceived abuses by virtual pharmacies and physicians prescribing drugs based on on-line consultations have resulted in state and federal regulatory responses, together with attempts at self-regulation.
Consumers are concerned about the privacy of health information they provide to e-health Web sites for the purpose of getting answers to medical questions, learning about new therapies, or accessing other health-related information. Physicians’ and patients’ use of social networking sites such as Facebook has raised new privacy concerns. Cybermedicine (on-line consultations) also presents newly emerging liability exposures for physicians.
Mobile health devices such as the iPhone have also triggered regulatory responses from the FDA. Physicians are using the iPhone to access patients’ medical records, to electronically prescribe drugs, and order needed medical tests such as lab work. More than 1400 health care apps are available for the iPhone including apps that check medication dosing and allow obstetricians to monitor a baby’s heartbeat remotely. Powerful apps converting iPhones and smartphones into electrocardiographs, electronic stethoscopes and glucose monitors have prompted the FDA to regulate some of the apps as “medical devices” under federal Food, Drug and Cosmetic Act.
Physicians, hospitals, insurers and other stakeholders in health care are already asking e-health questions. Should a physician communicate via e-mail with her patients? The Patient Protection and Affordable Care Act of 2010 (federal health reform law) includes provisions that encourage physicians and hospitals to deploy electronic health records (EHR) over the next four years. How can a hospital comply with federal law when it moves to electronic health records? Join us to learn the answer to these and other cutting-edge legal issues.
This seminar will have three short papers rather than one long paper, in accordance with the alternative revised Upper Level Writing Requirement for a “Writing Course.”
The requirements state in part: “Students in a Writing Course must complete several kinds of practical writing assignments. Assignments must be no more than 2,500 words each, when feasible. Instructors have discretion over the kind and number of assignments students complete; however, students must complete at least 5,000 words of writing over the course of the semester.”
In this course, students will complete three assignments. The first assignment will be a client letter reviewing and analyzing a proposed or recently enacted statute or a proposed or enacted regulation. For example, in 2013, new regulations and guidance addressed prescription refill reminders under the Health Insurance Portability and Accountability Act (HIPAA), i.e., when such reminders constitute “marketing” and require an “authorization” from the patient. . Students could be asked to explain the regulations to clients.
The second assignment is also a client letter, but will require students to answer a specific legal question or questions posed by the professor related to the class.
The final assignment is mini-thesis on a subject chosen by the student (related to the course). It should be similar to a bar journal type article. The final assignment will be due during finals, after the course is finished, but a draft will be due earlier, during the course.
For each of the assignments, students must submit a draft, although the draft must not necessarily be as long as the final version. I will provide detailed comments on the drafts which I will expect you to incorporate into the final versions of the papers. Each of these assignments should be about 2000 words each including footnotes (3 pages single spaced or 6 pages double spaced). The total of all assignments must total 5000 words to meet the Upper Level Writing Requirement.
Course Notes: Quota= 12
First Day Assignments:
Final Exam Schedule:
This course will have:
Paper: See Above
Satisfies Skills Course Requirement: No
Satisfies Senior Upper Level Writing Requirement: Yes