Many companies in the healthcare and bioscience industries utilize Protected Health Information (PHI) or Personally Identifiable Information (PII) to develop and test products such as medical devices and mobile applications, or to perform other services, including data analysis, on their customer’s healthcare related data. This course examines the important data privacy and security issues that govern these industries.

You will develop a complete understanding of the regulations and requirements relevant to your industry and learn how to develop a plan of action for compliance with those standards.

Learning Outcomes

At the conclusion of the course, you should be able to

• Identify the data security and privacy issues associated with the industries using health data, such as those in healthcare, drug development, device development, and health research.
• Determine when companies are subject to state, federal and international data security and privacy regulations, and understand how to comply with those regulations.
• Develop a compliance plan for appropriate privacy and security regulations.

Topics Include

• Relevant state, national and international data privacy and security regulations, including public and private sector laws and rules
• Inappropriate disclosure of PII
• Guiding principles for information privacy
• Medical device security and privacy
• Mobile health (mHealth) security and privacy
• PII and PHI
• HIPAA and HITECH Act requirements and implementation guidelines
• Audit criteria, with particular focus on ONC audits
• FTC requirements
• HIPAA training and risk analysis requirements
• Breach notification requirements and procedures
• Upcoming data privacy and security issues and regulations

Working knowledge of:

• Communication and collaboration tools such as Google Workspace, Microsoft Office, or LibreOffice
• Learning Management Systems (LMS) such as Canvas including navigation links, modules, etc.

Additional Information

Please review section notes to view the full schedule.

The skills presented in this course are valuable to any company that deals with healthcare or patient data. It is intended for regulatory, clinical or IT professionals working in healthcare, the biopharmaceutical, mobile health (mHealth), biotechnology, medical device and healthcare startup sectors, and anyone interested in regulatory issues faced by these industries. This is a great opportunity to learn how to develop a plan to make these companies compliant with privacy and security regulations.

Professional Credit

CA BRN/LVN Credit--Provider #CEP13114