Coursera Class Information Page

Our goal in this class is to give students a broad overview of the field of Medical Software including the regulatory and business aspects, the impact of the clinical environment and the actual procedures for designing, implementing, and testing modern medical software. Released Oct 12, 2021.

About this class

This short video introduces the class. This class consists of over 13 hours of lecture videos and is supplemented by 8.5 hours of YouTube interviews with external experts.

The Instructors

This short video introduces the instructors for this class. For more detailed biographical information see this page.

The modules

The core of this class is made up of 12 modules (weeks) each consisting of a number of segments. Below, we list the segments for each module. Prof. Papademetris is the main lecturer. If somebody else was presenting, their name is listed after the segment title in square brackets. The URL for the class is

Module Introductions

This video clip consists of the introductions to the 12 modules of the Coursera class.

Week 1: Introduction to Medical Software & Digital Health

  1. Introduction to this class

  2. A guided tour of medical software

  3. A guided tour of medical software – 2

  4. Medical devices and the regulatory process

  5. U.S. healthcare landscape overview [G. Licholai]

  6. Why is healthcare so expensive? [G. Licholai]

  7. Promise of the digital transformation of healthcare [G. Licholai]

Week 2: Medical Software Regulation (FDA & IMDRF)

  1. The FDA: Mission and History

  2. The Quality System Regulation

  3. General Principles of Software Validation

  4. The IMDRF SaMD documents

  5. The Regulatory Process

  6. Emerging Issues: AI/ML

Week 3: The Healthcare Environment (Users, EHR, PACS, Data Privacy, Cybersecurity)

  1. Patients Doctors and ???

  2. Clinical Information Technology (IT)

  3. Clinical IT II – Medical Imaging

  4. Demo of PACS and EHR [M. Aboian]

  5. Data Privacy

  6. Cybersecurity

Week 4: Quality Management Systems & Risk Management

  1. Quality Management Systems

  2. The IMDRF QMS Guidance

  3. The IMDRF QMS Guidance – 2

  4. Introduction to Risk Management

  5. The Risk Management Process

  6. The Risk Management Process – 2

Week 5: Software Life Cycles

  1. Life Cycles and IEC 62304

  2. Life Cycles and IEC 62304 – 2

  3. The IGNS Example Project

  4. A Guided Tour of the Life Cycle Process

  5. Information Transmission

Week 6: User Needs & System Requirements

  1. Identifying User Needs

  2. Identifying User Needs – 2

  3. User Needs for our Image-Guided Neuro-Surgery (IGNS) Example Project

  4. Systems Requirement Specification (SRS)

  5. SRS Template

  6. SRS for our IGNS Project

Week 7: Software Architecture Design and Usability Engineering

  1. The Software Design Document

  2. A Template for the Software Design Document

  3. Example Software Design for our Image-Guided Neurosurgery (IGNS) project

  4. Usability Engineering

  5. Impact and Analysis of the Emerging Digital Behavioral Health Industry [G. Licholai]

Week 8: Construction & Testing

  1. Construction

  2. Managing code and Revision Control Systems

  3. Introduction to Software Testing

  4. Integration Testing in realtime fMRI

  5. Verification and Testing

Week 9: Probability and Statistics

  1. Introduction to Probability

  2. Multiple Events

  3. Introduction to Statistics

  4. Estimating Probability Density Functions

  5. Signal Detection

  6. Statistical Significance

  7. Statistical Significance – 2

  8. Importance of Randomization

Week 10: Software Validation, Deployment, Maintenance & Retirement

  1. Introduction to Validation

  2. Introduction to Clinical Trials

  3. Creating a Validation Plan

  4. Deployment

  5. Maintenance & Retirement

Week 11: Machine Learning

  1. Introduction to AI/ML

  2. Evaluation of ML Methods and Related Issues

  3. Introduction to Deep Learning [N. Dvornek]

  4. Regulatory Guidance

  5. The Singapore Guidance and AI/ML

  6. AI/ML and the Software Life Cycle [J. Onofrey]

Week 12: Business and Management Issues

  1. Value Drivers in Digital Medicine [G. Licholai]

  2. Changing Business Models in Healthcare [G. Licholai]

  3. Setting up a new Healthcare Venture [A. Quraishi]

  4. Finding your First Paying Customer [A. Quraishi]

  5. When and how to Raise Capital [A. Quraishi]

The class poster

This poster shows all the people that appear in the videos for this class.

Pictures from the recording

The class was recorded at the Yale Broadcast Studio.