Get updates on Eligibility, Admission, Placements Fees Structure
Quick Facts
| Medium Of Instructions | Mode Of Learning | Mode Of Delivery |
|---|---|---|
| English | Self Study | Video and Text Based |
Course Overview
This Introduction to Medical Software certification course starts by talking about the regulatory frameworks for medical devices, data protection, cybersecurity laws, and important enabling technologies like quality control and risk management. The life cycle of medical software is then examined in depth, beginning with the identification of user demands, their mapping to system requirements, and finally the stages of software design, coding, testing, and validation.
This course is offered by Yale University in partnership with Coursera and as the Introduction to Medical Software training moves forward, it considers legal and software engineering concerns relating to the usage of machine learning methods in medical applications. The consideration of the business and management concerns in this field concludes with a focus on the effects of digital health on contemporary healthcare and the problems associated with launching new businesses.
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The Highlights
- Flexible deadlines
- Shareable certificate
- Online mode
- 37 hours of learning
- Intermediate level
Programme Offerings
- Yale University Certificate
- Self-paced learning
- course videos and readings
- practice quizzes
- Graded Assignments with peer feedback
- graded Quizzes with feedback
Courses and Certificate Fees
| Fees Informations | Certificate Availability | Certificate Providing Authority |
|---|---|---|
| INR 2435 | yes | Coursera |
The students have two alternatives when it comes to paying the fees. First, if the student wants to receive a certificate of completion at the conclusion of the course, they must pay Rs. 2435 as the Introduction to Medical Software certification fees. The second is an unpaid course in which participants won't receive a certificate of completion or graded assignments.
Introduction to Medical Software Fee Structure
Course | Fees |
Introduction to Medical Software (with certificate) | Rs. 2435 |
Introduction to Medical Software | Free |
Eligibility Criteria
Work Experience
Participants with preferably some exposure to basic medical terms and some programming experience would be ideal.
Certification Qualifying Details
You may receive Introduction to Medical Software certification by Coursera after completing the necessary curriculum.
What you will learn
After completing the Introduction to Medical Software certification syllabus students will learn:
- How different countries control software and medical equipment.
- How medical software is conceived, designed, and used in practice.
Who it is for
People interested in learning about and using software programmes created expressly for medical and healthcare reasons should take the Introduction to Medical Software course. This course is appropriate for healthcare professionals who want to improve their knowledge and abilities in using medical software for a variety of jobs, such as:
Admission Details
Learners can start with the Introduction to Medical Software classes by following the given steps:
Step 1: Browse the official URL
https://www.coursera.org/learn/introduction-to-medical-software
Step 2: Click the Enrolment button on the website.
Step 3: Make the payment if the paid course is selected.
Step 4: After receiving a confirmation mail on the registered email id, students can start their course.
Application Details
Visit the official website and click on the enrolment option, make the payment if the paid course is selected to enrol in the Introduction to Medical Software online course.
The Syllabus
Videos
- 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
Readings
- Getting Started
- Pre-Course Survey
- 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
- Quiz 1
Videos
- 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
Readings
- 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
- Quiz 2
Videos
- Patients, Doctors and ???
- Clinical Information Technology (IT)
- Clinical IT II – Medical Imaging
- Demo of EHR & PACS (Prof. Mariam Aboian)
- Data Privacy
- Cybersecurity
Readings
- 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
- Quiz 3
Videos
- 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
Readings
- Software as a Medical Device (SaMD): Application of Quality Management System
- IMDRF Guidance on Risk Categorization
Quiz
- Quiz 4
Videos
- 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
Readings
- 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
- Quiz 5
Videos
- Identifying User Needs
- Identifying User Needs Continued
- User Needs For Example Project
- Systems Requirement Specification (SRS)
- SRS Template
- SRS for our IGNS Project
Readings
- Don't Fire the Architect! Where Were the Requirements?
Quiz
- Quiz 6
Videos
- 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
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
- Behavioral Health Landscape
- Digital Behavioral Health Funding
Quiz
- Quiz 7
Videos
- Construction
- Managing code and Revision Control Systems
- Introduction to Software Testing
- Integration Testing in realtime fMRI
- Verification and Testing
Readings
- A Graphics Processing Unit Accelerated Motion Correction Algorithm and Modular System for Real-time fMRI
Quiz
- Quiz 8
Videos
- Introduction to Probability
- Multiple Events
- Introduction to Statistics
- Estimating Probability Density Functions
- Signal Detection
- Statistical Significance
- Statistical Significance – 2
- Importance of Randomization
Readings
- Receiver Operating Characteristic Curves
- The Guinness Brewer Who Revolutionized Statistics
Quiz
- Quiz 9
Videos
- Introduction to Validation
- Introduction to Clinical Trials
- Creating a Validation Plan
- Deployment
- Maintenance & Retirement
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
Quiz
- Quiz 10
Videos
- 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)
Readings
- 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
- Quiz 11
Videos
- 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
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
- Resources for Digital Health Venture Funding
- Summary of Digital Health Ventures Financing
Videos
- 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
Readings
- 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
Readings
- Descriptions and links to the complete videos on YouTube
- Post Course Survey
Instructors
Yale University, New Haven Frequently Asked Questions (FAQ's)
There are fourteen modules in this course that will be covered online.
This training offered by Yale University is most beneficial for participants who have prior knowledge or experience in programming and basic medical terminology.
It will take learners approximately 37 hours to complete the course, which they can also cover at their own pace.
Yes, financial support is available for students unable to afford the fees.
Students have unlimited access to the study material, which they can access anywhere and anytime.