- Level Foundation
- Duration 8 hours
- Course by University of Florida
-
Offered by
About
This course seeks to create an informed public, aware of the technical, medical, legal, and ethical issues associated with implantable medical devices. The course features conversations with experts from a variety of relevant fields to discuss the present and future technological, ethical, legal, and social challenges associated with implantable medical devices. DISCLAIMER: This course is intended for educational purposes only. None of the information provided in this course constitutes medical or legal advice. If you have medical or legal questions, contact your physician or attorney.Modules
Introduction to Course Faculty
3
Videos
- Michael Bachmann Intro
- Adam Shniderman Intro
- Lauren Solberg Intro
Introduction to Experts on Medical, Technical, Legal, and Ethical Issues
8
Videos
- Jay Radcliffe 1
- Jay Radcliffe 2
- Andrew Woods 1
- Andrew Woods 2
- Julian Goldman
- Patricia Zettler 1
- Patricia Zettler 2
- Scott Erven
Introduction to Medical Devices
2
Videos
- Goldman
- Zettler
The Trend Toward Networked Computerized Medical Devices
3
Videos
- Radcliffe 1
- Radcliffe 2
- Goldman
1
Readings
- Infographic: An Overview of the Internet of Things
Why the Trend? Advantages of and Advances in Technology
1
Discussions
- Module 1 Discussion
4
Videos
- Radcliffe 1
- Radcliffe 2
- Erven
- Woods
1
Readings
- Advancing Safety in Medical Technology: Healthcare technology in a wireless world
Vulnerabilities of Medical Devices
8
Videos
- Radcliffe 1
- Radcliffe 2
- Woods
- Woods 2
- Woods 3
- Goldman 1
- Goldman 2
- Goldman 3
2
Readings
- Security and Privacy for Implantable Medical Devices
- MEDJACK: Hackers hijacking medical devices to create backdoors in hospital networks
Specific Problems of Embedded Devices and Older Technology
5
Videos
- Radcliffe 1
- Radcliffe 2
- Radcliffe 3
- Radcliffe 4
- Erven
New Technology Considerations
3
Videos
- Radcliffe 1
- Radcliffe 2
- Goldman 1
1
Readings
- LA Hospital Paid $17K to Hackers
Potential Attack Scenarios
9
Videos
- Radcliffe 1
- Radcliffe 2
- Radcliffe 3
- Erven 1
- Erven 2
- Erven 3
- Erven 4
- Erven 5
- Erven 6
2
Readings
- Terrorists could hack pacemakers like in Homeland, say security experts
- Keeping pacemakers safe from hackers
Security By Design: What Should Manufacturers Do About This?
8
Videos
- Radcliffe 1
- Erven 1
- Erven 2
- Erven 3
- Erven 4
- Erven 5
- Woods 1
- Woods 2
1
Readings
- Optimal Policy for Software Vulnerability Disclosure
What Can Hospitals/Health Providers Do?
1
Discussions
- Module 3 Discussion
2
Videos
- Erven 1
- Erven 2
Legal Issues with Medical Devices
1
Readings
- Riegel v Medtronic
Legal Considerations in the United States
5
Videos
- Woods 1
- Woods 2
- Goldman 1
- Goldman 2
- Zettler 1
Legal Considerations Outside of the United States
4
Videos
- Woods 1
- Woods 2
- Woods 3
- Woods 4
U.S. Regulation of Medical Devices
18
Videos
- Radcliffe 1
- Radcliffe 2
- Radcliffe 3
- Woods 1
- Woods 2
- Goldman 1
- Zettler 1
- Zettler 2
- Zettler 3
- Zettler 4
- Zettler 5
- Zettler 6
- Zettler 7
- Zettler 8
- Zettler 9
- Zettler 10
- Zettler 11
- Zettler 12
3
Readings
- FDA Overview
- FDA Overview of Device Regulation
- Medical device security: A call to action
U.S. Government Efforts to Address Medical Device Cybersecurity Issues
8
Videos
- Goldman 1
- Goldman 2
- Zettler 1
- Erven 1
- Erven 2
- Erven 3
- Erven 4
- Erven 5
1
Readings
- Draft Guidance for Industry and FDA Staff
Legal Recourse for Injured Patients
1
Discussions
- Module 4 Discussion
4
Videos
- Radcliffe 1`
- Zettler 1
- Zettler 2
- Erven 1
2
Readings
- Riegel v. Medtronic, SCOTUS
- Legal Disputes over Duties to Disclose Treatment Risks to Patients: A Review of Negligence Claims and Complaints in Australia
Patient Understanding of Risk
14
Videos
- Radcliffe 1
- Goldman 1
- Goldman 2
- Goldman 3
- Woods 1
- Woods 2
- Woods 3
- Woods 4
- Woods 5
- Zettler 1
- Zettler 2
- Zettler 3
- Erven 1
- Erven 2
1
Readings
- Patients' Interpretation of Qualitative Probability Statements
Patient Choice
4
Videos
- Zettler 1
- Zettler 2
- Erven 1
- Woods 1
1
Readings
- US Medical Devices, Choices and Consequences
Protection of Patients
5
Videos
- Radcliffe 1
- Radcliffe 2
- Radcliffe 3
- Radcliffe 4
- Zettler 1
2
Readings
- FDA Safety Communication
- MedWatch Consumer Reporting
Where Do We Go From Here?
1
Peer Review
- Final Peer Review Assignment
1
Discussions
- Module 5 Discussion
6
Videos
- Radcliffe 1
- Radcliffe 2
- Erven 1
- Erven 2
- Erven 3
- Woods 1
1
Readings
- The Proper Role of the FDA for the 21st Century
Auto Summary
TECH MeD is a foundational course focused on the technical, medical, legal, and ethical aspects of implantable medical devices, designed to create an informed public. Through expert discussions, it addresses current and future challenges. Offered by Coursera, the course spans 480 minutes and is available via a Starter subscription. Ideal for those interested in health and fitness domains.
Lauren Solberg
Michael Bachmann
Adam Shniderman
Molly Weinburgh
Brittany Bachmann