7220 SEM: E-Health Law - SCOTTR- 12703
Ronald Scott (RESEARCH PROFESSOR)
Course Areas: Health Law
Time: 5:30p-7:30p TLocation:
Course Outline: 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.
Course Syllabus: Syllabus
Course Notes: Quota= 12
First Day Assignments: Please read Section I of the Handout materials which will be available at the Copy Center in January 2014.
Final Exam Schedule:
This course will have:
Satisfies Skills Course Requirement: No
Satisfies Senior Writing Requirement: Yes