RAS-641: Health Policy and the Medical Technology Industry

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Regulatory Affairs and Services
RAS-641: Health Policy and the Medical
Technology Industry
Course Description: : This course covers the effect of health policy
on the medical device industry and the development and diffusion of
medical technology. The historical development of health policy
affecting medical device regulation, reimbursement and research
funding are presented. A model is presented for analyzing how
policy issues promote or inhibit the development and diffusion of
medical technology. Current and proposed health policies are
analyzed and critiqued for their impact on medical technology.
Learning Objectives: The student will be generally knowledgeable and
know how to access details on the following.
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A framework for the stages of medical technology innovation.
The roles and responsibilities of key agencies affecting policy
development including Food and Drug Administration,
Centers for Medicare and Medicaid Services, National
Institutes of Health and the Agency for Healthcare Research
and Quality
A framework for classifying the types of policies that affect
medical technology innovation and diffusion.
The history of selected public policies affecting medical
technology development.
The role of government affairs in medical device policy
formation.
Prerequisites:
None
Who Would Benefit:
Regulatory, clinical and
reimbursement personnel
Credits/Cost:
3 credits, $2250
When Offered:
Summer semester
www.stcloudstate.edu/ras/schedule.asp