Yale University - Introduction to Medical Software 

Introduction to this class

A guided tour of medical software

A guided tour of medical software ? 2

Medical devices and the regulatory process

U.S. healthcare landscape overview

Why is healthcare so expensive?

Promise of the digital transformation of healthcare

Getting Started

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

National Health Expenditure Accounts

US Healthcare from a Global Perspective, 2019

Quiz 1

The FDA: Mission and History

The Quality System Regulation

General Principles of Software Validation

The IMDRF SaMD documents

The Regulatory Process

Emerging Issues: AI/ML

Promoting Safe and Effective Drugs for 100 Years

The Dalkon Shield Disaster

FDA Quality System Regulation

FDA General Principles of Software Validation

IMDRF SaMD Guidance Documents

FDA Draft Guidance on AI/ML

Quiz 2

Patients, Doctors and ???

Clinical Information Technology (IT)

Clinical IT II ? Medical Imaging

Demo of EHR & PACS (Prof. Mariam Aboian)

Data Privacy

Cybersecurity

Why Doctors Hate their Computers (Article)

Development of Electronic Health Record

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

Quiz 3

Quality Management Systems

The IMDRF QMS Guidance

The IMDRF QMS Guidance ? Continued

Introduction to Risk Management

The Risk Management Process

The Risk Management Process ? 2

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

IMDRF Guidance on Risk Categorization

Quiz 4

Life Cycles and IEC 62304

Life Cycles and IEC 62304 ? 2

The IGNS Example Project

A Guided Tour of the Life Cycle Process

Information Transmission

Software Life Cycles

Case Study of the use of Agile Techniques in Medical Software

Image Guided Surgery

From Medical Image Computing to Computer-Aided Intervention

Quiz 5

Identifying User Needs

Identifying User Needs Continued

User Needs For Example Project

Systems Requirement Specification (SRS)

SRS Template

SRS for our IGNS Project

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

Quiz 6

The Software Design Document

A Template for the Software Design Document

Example Software Design For Our IGNS project

Usability Engineering

Impact and Analysis Emerging Digital Behavioral Health Industry

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

Behavioral Health Landscape

Digital Behavioral Health Funding

Quiz 7

Construction

Managing code and Revision Control Systems

Introduction to Software Testing

Integration Testing in realtime fMRI

Verification and Testing

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

Quiz 8

Introduction to Probability

Multiple Events

Introduction to Statistics

Estimating Probability Density Functions

Signal Detection

Statistical Significance

Statistical Significance ? 2

Importance of Randomization

Receiver Operating Characteristic Curves

The Guinness Brewer Who Revolutionized Statistics

Quiz 9

Introduction to Validation

Introduction to Clinical Trials

Creating a Validation Plan

Deployment

Maintenance & Retirement

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

Quiz 10

Introduction to AI/ML

Evaluation of ML Methods and Related Issues

Introduction to Deep Learning (Prof. Nicha Dvornek)

Regulatory Guidance on AI/ML

The Singapore Guidance and AI/ML

AI/ML and the Software Life Cycle (Prof. John Onofrey)

Deep Learning Review Paper

A Guide to Deep Learning in Healthcare

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

Quiz 11

Value Drivers in Digital Medicine

Changing Business Models in Healthcare

Setting up a new Healthcare Venture

Finding your First Paying Customer

When and how to Raise Capital

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

Resources for Digital Health Venture Funding

Summary of Digital Health Ventures Financing

Therac-25 presented by AnMei Little

Healthcare.gov presented by Daisha Roberts

Iowa 2020 Caucus App presented by Alex Chen

WannaCry and the UK NHS presented by Ellie Gabriel

An Investigation of the Therac-25 Accidents

Fatal Dose - Radiation Deaths Linked to AECL Computer Errors

Link to the full segment from NBC News' Coverage of the Launch of HealthCare.gov (Oct. 24, 2013)

Health and Human Services Investigation

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

Link to the BBC News Segment used as part of the presentation

UK NHS Investigation Report

Descriptions and links to the complete videos on YouTube