LMP 2345: Procurement, Privacy, and Regulatory Affairs
Credit: 0.25 FCE
Privacy
You will be introduced to the privacy legislation applicable in Ontario and Canada, including the Personal Information Protection and Electronic Documents Act (PIPEDA), the Ontario Personal Health Information Protection Act (PHIPA), and the Digital Privacy Act (DPA) to understand the requirements of these pieces of legislation.
Procurement
Unlike in a direct-to-consumer business model where a company’s customer is also the purchaser and likely end-user of a product, engaging with a healthcare system is vastly different.
You will be introduced to the concept of supply chain management, (i.e. the processes that manage the flow of goods and services, information and dollars between companies/suppliers, their customers, and end-users), will have an opportunity to explore the challenges of iterating a product through proof of concept, piloting, and early adoption, and will emerge with a deeper understanding of the importance of clearly identifying the customer, payer, and end-user for a product or service.
Regulatory Affairs
You will be introduced to the regulatory lifecycles of medical devices through sessions led by domain experts and will address how a variety of standardized practice guidelines, including good laboratory practices (GLPs), good clinical practices (GCPs), good manufacturing practices (GMPs), and quality systems regulations (QSPs), dictate the types of data required for quality review and approval of regulatory submissions.
Learning outcomes
At the end of this module you will be able to:
- Define privacy and demonstrate how it affects health information.
- Define procurement and describe how it works in hospital contexts.
- Communicate the purpose and significance of regulatory standards in healthcare.
Enrollment
- Students are required to complete eight modules (0.25 FCE each) spread out within 2 years of study.
- Students may enroll in modular courses using ACORN.
- The modular schedule will be emailed to students prior to the start of each semester.
- Modules offered outside of the program are also permitted such as ones offered by the Institute of Medical Science (IMS).