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.

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

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

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]

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

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

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

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

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

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]

1. Construction

2. Managing code and Revision Control Systems

3. Introduction to Software Testing

4. Integration Testing in realtime fMRI

5. Verification and Testing

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

1. Introduction to Validation

2. Introduction to Clinical Trials

3. Creating a Validation Plan

4. Deployment

5. Maintenance & Retirement

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]

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]

1. Therac-25 (A. Little)

2. Healthcare.gov (D. Roberts)

3. Iowa Caucus (A. Chen)

4. WannaCry (E. Gabriel)

These are also posted on YouTube.

See this page for more details.

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

The class was recorded at the Yale Broadcast Studio.