Based on advances in biotechnology and neuroscience, neuromodulation devices are poised to gain clinical importance in the coming years and to be of increasing interest to patients, health care providers and payers, and industry. Emerging evidence suggests that the potential therapeutic and non-therapeutic uses of non-invasive neuromodulation devices for the central nervous system are broad and will continue to expand. Along with the growing number of opportunities, there are challenges and open questions associated with the use of these devices. Currently, there is a need for greater understanding of the potential benefits and risks; in particular, of the short- and long-term impact of using these devices. From a regulatory standpoint, there are scientific and clinical questions that are important for regulatory approval and usability for consumers. A third area of consideration is the existing, and appropriate, levels of evidence for reimbursement. Several issues raise ethical questions, including the potential for off-label, over-the-counter, or “do it yourself” uses or for enhancement. Given the growing interest in non-invasive neuromodulation devices for the central nervous system, the goal of this workshop is to explore opportunities, challenges, and ethical questions surrounding the development, regulation and reimbursement of such devices.
Highlight potential benefits and risks of non-invasive neuromodulation based on known short and long-term central nervous system mechanisms of action
Explore the scientific landscape of non-invasive neuromodulation device development for both therapeutic and non-therapeutic uses
Consider issues concerning vulnerable populations
Consider the regulatory landscape for non-invasive neuromodulation devices
Discuss potential outcome measures for therapeutic uses in regulatory processes
Explore pathways for regulatory approval of therapies utilizing a combination of non-invasive neuromodulation devices and pharmaceuticals
Discuss differences in regulatory pathways among countries
Explore current and potential use reimbursement practices for therapeutic use of non-invasive neuromodulation devices
Explore the evidence base and acceptable therapeutic outcome measures utilized in reimbursement decisions
Consider economic outcome measures used to determine payer practices
Examine ethical questions around the use of non-invasive neuromodulation devices
Consider ethical issues of off-label and over-the counter use on regulation, reimbursement and patient safety
Discuss the use of these devices for enhancement in individuals without an impaired baseline
Consider the implications of involuntary or coercive use (e.g., children, court ordered treatment)
If you are interested in attending this workshop, please click here for more information and to register.
**NOTE: THE SEMINAR WILL BE HELD ON THE GEORGE WASHINGTON UNIVERSITY CAMPUS IN WASHINGTON, DC.