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Introduction to Medical Software
  • Level Professional
  • Duration 38 hours
  • Course by Yale University
  • Offered by

About

In this class, we present a broad overview of the field of medical software. You will learn from Yale professors and a series of industry experts who connect the course concepts to their real world applications. We begin by discussing medical device regulatory structures, data privacy and cybersecurity regulations, and key support technologies such quality management systems and risk management. We then take a detailed look at the medical software life cycle, starting with identifying user needs, mapping these to system requirements and then the process of software design, coding, testing and validation. We continue by exploring issues related to the use of machine learning techniques in medical applications from both a software engineering and a regulatory perspective. We conclude with a discussion of the business and management issues in this area focusing on the impact on digital health on modern healthcare and issues related to starting new ventures. This is a class aimed at either third- or fourth-year undergraduates in computer science, biomedical engineering, and related fields, and to junior software engineers currently either working in, or interested in moving to, the medical device industry.

Modules

Overview

    • 3 Videos
    • 1 Readings
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3 Videos

  • Introduction to this class
  • A guided tour of medical software
  • A guided tour of medical software – 2

1 Readings

  • Getting Started

The Regulatory Landscape

    • 1 Videos
    • 1 Readings
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1 Videos

  • Medical devices and the regulatory process

1 Readings

  • U.S. Food and Drug Administration (FDA). General Wellness: Policy for Low Risk Devices

The Digital Transformation of Healthcare (Dr. Gregory Licholai)

    • 3 Videos
    • 2 Readings
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3 Videos

  • U.S. healthcare landscape overview
  • Why is healthcare so expensive?
  • Promise of the digital transformation of healthcare

2 Readings

  • National Health Expenditure Accounts
  • US Healthcare from a Global Perspective, 2019

Week 1 Quiz

    • 1 Assignment
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1 Assignment

  • Quiz 1

FDA History and Original Regulations

    • 3 Videos
    • 4 Readings
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3 Videos

  • The FDA: Mission and History
  • The Quality System Regulation
  • General Principles of Software Validation

4 Readings

  • Promoting Safe and Effective Drugs for 100 Years
  • The Dalkon Shield Disaster
  • FDA Quality System Regulation
  • FDA General Principles of Software Validation

Contemporary Guidance and Regulatory Processes

    • 3 Videos
    • 2 Readings
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3 Videos

  • The IMDRF SaMD documents
  • The Regulatory Process
  • Emerging Issues: AI/ML

2 Readings

  • IMDRF SaMD Guidance Documents
  • FDA Draft Guidance on AI/ML

Week 2 Quiz

    • 1 Assignment
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1 Assignment

  • Quiz 2

The Clinical Environment

    • 4 Videos
    • 2 Readings
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4 Videos

  • Patients, Doctors and ???
  • Clinical Information Technology (IT)
  • Clinical IT II – Medical Imaging
  • Demo of EHR & PACS (Prof. Mariam Aboian)

2 Readings

  • Why Doctors Hate their Computers (Article)
  • Development of Electronic Health Record

Cybersecurity and Data Privacy

    • 2 Videos
    • 3 Readings
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2 Videos

  • Data Privacy
  • Cybersecurity

3 Readings

  • DHSS: Office of Civil Rights. Guidance Regarding Methods for De-identification of Protected health Information
  • Framework for Improving Critical Infrastructure Cybersecurity
  • Principles and Practices for Medical Device Cybersecurity

Week 3 Quiz

    • 1 Assignment
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1 Assignment

  • Quiz 3

Quality Management Systems

    • 3 Videos
    • 1 Readings
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3 Videos

  • Quality Management Systems
  • The IMDRF QMS Guidance
  • The IMDRF QMS Guidance – Continued

1 Readings

  • Software as a Medical Device (SaMD): Application of Quality Management System

Introduction to Risk Management

    • 3 Videos
    • 1 Readings
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3 Videos

  • Introduction to Risk Management
  • The Risk Management Process
  • The Risk Management Process – 2

1 Readings

  • IMDRF Guidance on Risk Categorization

Week 4 Quiz

    • 1 Assignment
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1 Assignment

  • Quiz 4

Life Cycles and the IEC 62304 Standard

    • 2 Videos
    • 2 Readings
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2 Videos

  • Life Cycles and IEC 62304
  • Life Cycles and IEC 62304 – 2

2 Readings

  • Software Life Cycles
  • Case Study of the use of Agile Techniques in Medical Software

The Example Project and a Guided Tour of the Process

    • 3 Videos
    • 2 Readings
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3 Videos

  • The IGNS Example Project
  • A Guided Tour of the Life Cycle Process
  • Information Transmission

2 Readings

  • Image Guided Surgery
  • From Medical Image Computing to Computer-Aided Intervention

Week 5 Quiz

    • 1 Assignment
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1 Assignment

  • Quiz 5

Identifying User Needs

    • 3 Videos
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3 Videos

  • Identifying User Needs
  • Identifying User Needs Continued
  • User Needs For Example Project

Systems Requirement Specification

    • 3 Videos
    • 1 Readings
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3 Videos

  • Systems Requirement Specification (SRS)
  • SRS Template
  • SRS for our IGNS Project

1 Readings

  • Don't Fire the Architect! Where Were the Requirements?

Week 6 Quiz

    • 1 Assignment
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1 Assignment

  • Quiz 6

Software Design

    • 3 Videos
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3 Videos

  • The Software Design Document
  • A Template for the Software Design Document
  • Example Software Design For Our IGNS project

Usability Engineering

    • 1 Videos
    • 2 Readings
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1 Videos

  • Usability Engineering

2 Readings

  • Applying Human Factors and Usability Engineering to Medical Devices; Guidance for Industry and Food and Drug Administration Staff
  • Human Factors and Usability Engineering -- Guidance for Medical Devices Including Drug-device Combination Products

Digital Behavioral Health (Dr. Gregory Licholai)

    • 1 Videos
    • 2 Readings
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1 Videos

  • Impact and Analysis Emerging Digital Behavioral Health Industry

2 Readings

  • Behavioral Health Landscape
  • Digital Behavioral Health Funding

Week 7 Quiz

    • 1 Assignment
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1 Assignment

  • Quiz 7

Software Construction (or Coding)

    • 2 Videos
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2 Videos

  • Construction
  • Managing code and Revision Control Systems

Software Testing

    • 3 Videos
    • 1 Readings
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3 Videos

  • Introduction to Software Testing
  • Integration Testing in realtime fMRI
  • Verification and Testing

1 Readings

  • A Graphics Processing Unit Accelerated Motion Correction Algorithm and Modular System for Real-time fMRI

Week 8 Quiz

    • 1 Assignment
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1 Assignment

  • Quiz 8

Probability Overview

    • 2 Videos
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2 Videos

  • Introduction to Probability
  • Multiple Events

Statistics Overview

    • 2 Videos
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2 Videos

  • Introduction to Statistics
  • Estimating Probability Density Functions

Signal Detection

    • 1 Videos
    • 1 Readings
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1 Videos

  • Signal Detection

1 Readings

  • Receiver Operating Characteristic Curves

Tools for Clinical Trials

    • 3 Videos
    • 1 Readings
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3 Videos

  • Statistical Significance
  • Statistical Significance – 2
  • Importance of Randomization

1 Readings

  • The Guinness Brewer Who Revolutionized Statistics

Week 9 Quiz

    • 1 Assignment
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1 Assignment

  • Quiz 9

Software Validation

    • 3 Videos
    • 3 Readings
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3 Videos

  • Introduction to Validation
  • Introduction to Clinical Trials
  • Creating a Validation Plan

3 Readings

  • Software as Medical Device (SAMD): Clinical Evaluation. Guidance for Industry and Food and Drug Administration Staff
  • Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, 1964--2013
  • Practical tips for surgical research: Research questions, hypotheses and objectives

Deployment, Maintenance, and Retirement

    • 2 Videos
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2 Videos

  • Deployment
  • Maintenance & Retirement

Week 10 Quiz

    • 1 Assignment
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1 Assignment

  • Quiz 10

Artificial Intelligence, Machine Learning, and Deep Learning

    • 3 Videos
    • 2 Readings
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3 Videos

  • Introduction to AI/ML
  • Evaluation of ML Methods and Related Issues
  • Introduction to Deep Learning (Prof. Nicha Dvornek)

2 Readings

  • Deep Learning Review Paper
  • A Guide to Deep Learning in Healthcare

Regulatory Issues in using AI/ML for Medical Applications

    • 3 Videos
    • 5 Readings
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3 Videos

  • Regulatory Guidance on AI/ML
  • The Singapore Guidance and AI/ML
  • AI/ML and the Software Life Cycle (Prof. John Onofrey)

5 Readings

  • A Survey on Explainable Artificial Intelligence (XAI): Towards Medical XAI
  • Perspectives and Good Practices for AI and Continuously Learning Systems in Healthcare
  • Singapore Guidance on Medical Software
  • Intriguing properties of neural networks
  • Generalizable Multi-Site Training and Testing of Deep Neural Networks Using Image Normalization

Week 11 Quiz

    • 1 Assignment
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1 Assignment

  • Quiz 11

Digital Medicine and Business (Dr. Gregory Licholai)

    • 2 Videos
    • 5 Readings
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2 Videos

  • Value Drivers in Digital Medicine
  • Changing Business Models in Healthcare

5 Readings

  • Funding for Digital Health Skyrockets (article)
  • Drivers of Digital Health Growth
  • Future of Digital Health Drivers
  • FDA: What is Digital Health
  • FDA Guidance Documents that relate to Digital Health

Launching a Healthcare Venture (Dr. Ayesha Quraishi)

    • 3 Videos
    • 2 Readings
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3 Videos

  • Setting up a new Healthcare Venture
  • Finding your First Paying Customer
  • When and how to Raise Capital

2 Readings

  • Resources for Digital Health Venture Funding
  • Summary of Digital Health Ventures Financing

Therac-25

    • 1 Videos
    • 2 Readings
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1 Videos

  • Therac-25 presented by AnMei Little

2 Readings

  • An Investigation of the Therac-25 Accidents
  • Fatal Dose - Radiation Deaths Linked to AECL Computer Errors

Healthcare.gov

    • 1 Videos
    • 2 Readings
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1 Videos

  • Healthcare.gov presented by Daisha Roberts

2 Readings

  • Link to the full segment from NBC News' Coverage of the Launch of HealthCare.gov (Oct. 24, 2013)
  • Health and Human Services Investigation

Iowa Caucus

    • 1 Videos
    • 3 Readings
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1 Videos

  • Iowa 2020 Caucus App presented by Alex Chen

3 Readings

  • Link to the full segment from MSNBC's Coverage of the Iowa Democratic Party Caucus
  • Iowa's Tally-by-App Experiment Fails
  • Here's the Shadow Inc. App that Failed in Iowa Last Night

WannaCry

    • 1 Videos
    • 2 Readings
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1 Videos

  • WannaCry and the UK NHS presented by Ellie Gabriel

2 Readings

  • Link to the BBC News Segment used as part of the presentation
  • UK NHS Investigation Report

Interviews

    • 1 Readings
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1 Readings

  • Descriptions and links to the complete videos on YouTube

Auto Summary

Explore the dynamic field of medical software with Yale professors and industry experts in this engaging course. Covering regulatory structures, data privacy, cybersecurity, and the medical software life cycle, this class is perfect for advanced undergraduates and junior software engineers. Topics include machine learning in medical applications, digital health's impact, and business issues in healthcare. Offered by Coursera, it provides a comprehensive 2280-minute learning experience for those looking to advance in the medical device industry.

Xenophon Papademetris
Instructor

Xenophon Papademetris