Research Project (35%) – Case Study, Presentation and Written Analysis:
For the final project, each student should select a recent FDA approved or cleared medical device and conduct a case study on the following aspects that have been covered in this class: security design, risk assessment, data privacy/security review, and an evaluation and recommendation. Each student will develop a case presentation and written analysis of his or her selected device. Students will make oral presentations of the case analyses in class explaining the above aspects and, in particular, the privacy and security rules and regulations implicated by the enforcement actions. A separate handout will be available on Canvas that describes the requirements for this project. Besides a written research report, students also need to present the project in class. The final project will be graded for content and presentation quality according to a rubric provided. The completed project must be submitted to Canvas before the due date listed in the syllabus. In addition to the oral presentation, each student should provide a written analysis, no shorter than 10 pages, of at least the following aspects of the selected case: a summary of the facts of the case, a narrative to identify and briefly discuss the legal issues raised in the case, a description of any ethical issues raised in the case (i.e. what seemed wrong or right about the enforcement action), and discuss whether or not you agree with the enforcement analysis and outcome. 10-15 literature/resources need to be included as references. Each student will be assigned to provide a written critique of no more than one page of another classmate’s oral presentation.
Topic Proposal
What medical device do you want to research? write
- 2 pages on the topic you have selected
- A description of the function of the device
- A description of the medical or fitness use of the device
- A summary of the elements you will discuss in your report
- 5 potential sources of information