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The MS in Health Informatics with concentration in FDA and Regulations:

  • FDA and Regulations: The U.S. Food and Drug Administration (FDA) has an essential role in structuring how innovations are evaluated, approved, monitored and integrated into the whole cycle of health care. This concentration provides students with knowledge and skills to understand the regulatory frameworks that impact health informatics practice, research and industry.

 Each degree program requires a minimum of 36 credit hours for a total of 12 courses.

Students interested in the FDA and Regulations concentration within the MS in Health Informatics should note that these are available face-to-face only.

For those seeking greater flexibility, the general MS in Health Informatics (without a concentration) is available in a fully online format.

Students will take:

  • 4 required courses that provide a foundation for health informatics, health data analytics, and health information systems
  • 4 concentration courses on the area of focus:  FDA and Regulations
  • 4 guided electives of the student's choice to explore areas of interest

Students must complete 18 credit hours (6 courses) of HINF courses.

Required Courses, 12 credit hours 

  • HINF 5365: Information Systems in Healthcare
  • HINF 5637: Introduction to Health Informatics 
  • HINF 5770: Introduction to Health Data Analytics
  • HINF 5955: Health Informatics Capstone Project

FDA and Regulations Concentration Courses, 12 credit hours

  • BMEN 5100: Standards and FDA Regulations
  • BMEN 5150: Medical Device Marketing and New Product Integration
  • BMEN 5175: Medical Device Clinical Requirements
  • BMEN 5800: Topics in Biomedical Engineering: Project and Product Management Frameworks

Guided Electives, 12 credit hours

Students select 4 courses from the following list.  Students may take courses other than the ones listed below with advisor approval. 

  • DSCI 5360 - Data Visualization for Analytics
  • DTSC 5525 - Generative AI and Large Language Models for Data Science
  • HINF 5025 - Legal and Ethical Issues in Health Informatics
  • HINF 5204 - Health Information Terminology and Standards
  • HINF 5506 - Artificial Intelligence in Healthcare
  • HINF 5631 - Evidence based Practice in Health
  • HINF 5638 - Consumer Health Informatics
  • HINF 5639 - Population Health Informatics
  • HINF 5771 - Applications of Health Data Analytics
  • INFO 5080 - Research Methods and Analysis
  • INFO 5306 - Project Management for Information Systems
  • INFO 5709 - Data Visualization and Communication

Students have the option of completing a Graduate Academic Certificate in Health Data Science and/or a Graduate Academic Certificate in Health Information concurrently with the MS in Health Informatics with concentration in FDA and Regulations.  Note: This may require additional courses.  

For questions regarding the MS in Health Informatics with concentration in FDA and Regulations,  please email ci-advising@unt.edu. 

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