Procurement, Privacy, and Regulatory Affairs
Privacy: Students 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. Students 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 though 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: Students 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.
At the end of this module students should be able to: (1) Define privacy and demonstrate how it affects health information; (2) Define procurement and describe who it works in hospital contexts; and (3) And communicate the purpose and significance of regulatory standards in healthcare.
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