К содержимому
learnspaceYOUR NEXT CHAPTER
ПРОСТРАНСТВО ОБУЧЕНИЯ
ГлавнаяКаталог курсовМоё обучениеCoursera

Знания без границ

Учитесь у лучших университетов и компаний мира.

Открыть Coursera
Интеграция
Пространство университета
Моё пространствоСтраница курса
↵
ЯЛичный кабинетСтудент
© 2026 LearnSpaceКаждый день — возможность узнать больше.Помощь
Introduction to Medical Software · LearnSpace
Назад в каталог
courseraПрограммирование

Introduction to Medical Software

Курс от Yale University
Средний≈ 38.1 чАнглийский
О курсеНавыкиПрограммаПреподаватели

О курсе

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.

Навыки, которые вы освоите

Risk ManagementVerification And ValidationClinical TrialsSoftware TestingUsabilitySoftware Development Life CycleRegulatory ComplianceMedical PrivacySoftware DevelopmentSoftware Quality AssuranceHuman FactorsSoftware Quality (SQA/SQC)Health TechnologyMedical DevicesBiomedical EngineeringEntrepreneurshipSoftware DesignUser ResearchUser Interface (UI)Machine Learning

Программа курса

14 модулей · 142 учебных материалов

01Introduction to Medical Software and Digital Health12 материалов

Overview

Getting StartedЧтениеIntroduction to this classВидеоA guided tour of medical softwareВидеоA guided tour of medical software – 2Видео

The Regulatory Landscape

Учитесь у экспертов

Xenophon Papademetris

Professor

Introduction to Medical Software
В каталоге вашей программы

Инвестируйте в себя

Новые знания — в удобное для вас время.

Начать на Coursera

Обучение откроется на Coursera
в новой вкладке

Обучение на Coursera

≈ 38.1 ч

14 модулей

Язык: Английский

Субтитры: Арабский, Французский, Украинский, Китайский (Китай), Греческий, Итальянский, Бразильский португальский, Нидерландский, Корейский, Немецкий, Русский, Тайский, Индонезийский, Шведский, Турецкий, Испанский, Хинди, Японский, Казахский, Польский

Часть программы вашего университета
Medical devices and the regulatory processВидео
U.S. Food and Drug Administration (FDA). General Wellness: Policy for Low Risk DevicesЧтение

The Digital Transformation of Healthcare (Dr. Gregory Licholai)

U.S. healthcare landscape overviewВидеоWhy is healthcare so expensive?ВидеоPromise of the digital transformation of healthcareВидеоNational Health Expenditure AccountsЧтениеUS Healthcare from a Global Perspective, 2019Чтение

Week 1 Quiz

Quiz 1Задание
02Medical Software Regulation (FDA and IMDRF)13 материалов

FDA History and Original Regulations

The FDA: Mission and HistoryВидеоPromoting Safe and Effective Drugs for 100 Years ЧтениеThe Dalkon Shield DisasterЧтениеThe Quality System RegulationВидеоFDA Quality System RegulationЧтениеGeneral Principles of Software ValidationВидеоFDA General Principles of Software ValidationЧтение

Contemporary Guidance and Regulatory Processes

The IMDRF SaMD documentsВидеоIMDRF SaMD Guidance DocumentsЧтениеThe Regulatory ProcessВидеоEmerging Issues: AI/MLВидеоFDA Draft Guidance on AI/MLЧтение

Week 2 Quiz

Quiz 2Задание
03The Healthcare Environment (EHR, PACS, Data Privacy, and Cybersecurity)12 материалов

The Clinical Environment

Patients, Doctors and ???ВидеоClinical Information Technology (IT)ВидеоWhy Doctors Hate their Computers (Article)ЧтениеDevelopment of Electronic Health RecordЧтениеClinical IT II – Medical ImagingВидеоDemo of EHR & PACS (Prof. Mariam Aboian)Видео

Cybersecurity and Data Privacy

Data PrivacyВидеоDHSS: Office of Civil Rights. Guidance Regarding Methods for De-identification of Protected health InformationЧтениеCybersecurityВидеоFramework for Improving Critical Infrastructure CybersecurityЧтениеPrinciples and Practices for Medical Device CybersecurityЧтение

Week 3 Quiz

Quiz 3Задание
04Quality and Risk Management9 материалов

Quality Management Systems

Quality Management SystemsВидеоThe IMDRF QMS GuidanceВидеоThe IMDRF QMS Guidance – ContinuedВидеоSoftware as a Medical Device (SaMD): Application of Quality Management SystemЧтение

Introduction to Risk Management

Introduction to Risk ManagementВидеоThe Risk Management ProcessВидеоThe Risk Management Process – 2ВидеоIMDRF Guidance on Risk CategorizationЧтение

Week 4 Quiz

Quiz 4Задание
05Software Development Life Cycle10 материалов

Life Cycles and the IEC 62304 Standard

Life Cycles and IEC 62304ВидеоLife Cycles and IEC 62304 – 2ВидеоSoftware Life CyclesЧтениеCase Study of the use of Agile Techniques in Medical SoftwareЧтение

The Example Project and a Guided Tour of the Process

The IGNS Example ProjectВидеоImage Guided SurgeryЧтениеFrom Medical Image Computing to Computer-Aided InterventionЧтениеA Guided Tour of the Life Cycle ProcessВидеоInformation TransmissionВидео

Week 5 Quiz

Quiz 5Задание
06User Needs & System Requirements8 материалов

Identifying User Needs

Identifying User NeedsВидеоIdentifying User Needs ContinuedВидеоUser Needs For Example ProjectВидео

Systems Requirement Specification

Systems Requirement Specification (SRS)ВидеоSRS TemplateВидеоSRS for our IGNS ProjectВидеоDon't Fire the Architect! Where Were the Requirements?Чтение

Week 6 Quiz

Quiz 6Задание
07Software Architecture Design and Usability Engineering10 материалов

Software Design

The Software Design DocumentВидеоA Template for the Software Design DocumentВидеоExample Software Design For Our IGNS projectВидео

Usability Engineering

Usability EngineeringВидеоApplying Human Factors and Usability Engineering to Medical Devices; Guidance for Industry and Food and Drug Administration StaffЧтениеHuman Factors and Usability Engineering -- Guidance for Medical Devices Including Drug-device Combination ProductsЧтение

Digital Behavioral Health (Dr. Gregory Licholai)

Impact and Analysis Emerging Digital Behavioral Health IndustryВидеоBehavioral Health LandscapeЧтениеDigital Behavioral Health FundingЧтение

Week 7 Quiz

Quiz 7Задание
08Construction and Testing7 материалов

Software Construction (or Coding)

ConstructionВидеоManaging code and Revision Control SystemsВидео

Software Testing

Introduction to Software TestingВидеоIntegration Testing in realtime fMRIВидеоVerification and TestingВидеоA Graphics Processing Unit Accelerated Motion Correction Algorithm and Modular System for Real-time fMRIЧтение

Week 8 Quiz

Quiz 8Задание
09Probability and Statistics11 материалов

Probability Overview

Introduction to ProbabilityВидеоMultiple EventsВидео

Statistics Overview

Introduction to StatisticsВидеоEstimating Probability Density FunctionsВидео

Signal Detection

Signal DetectionВидеоReceiver Operating Characteristic CurvesЧтение

Tools for Clinical Trials

Statistical SignificanceВидеоStatistical Significance – 2ВидеоImportance of RandomizationВидеоThe Guinness Brewer Who Revolutionized StatisticsЧтение

Week 9 Quiz

Quiz 9Задание
10Software Validation, Deployment, Maintenance and Retirement9 материалов

Software Validation

Introduction to ValidationВидеоSoftware as Medical Device (SAMD): Clinical Evaluation. Guidance for Industry and Food and Drug Administration StaffЧтениеIntroduction to Clinical TrialsВидеоDeclaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, 1964--2013ЧтениеPractical tips for surgical research: Research questions, hypotheses and objectivesЧтениеCreating a Validation PlanВидео

Deployment, Maintenance, and Retirement

DeploymentВидеоMaintenance & RetirementВидео

Week 10 Quiz

Quiz 10Задание
11Machine Learning14 материалов

Artificial Intelligence, Machine Learning, and Deep Learning

Introduction to AI/MLВидеоEvaluation of ML Methods and Related IssuesВидеоIntroduction to Deep Learning (Prof. Nicha Dvornek)ВидеоDeep Learning Review PaperЧтениеA Guide to Deep Learning in HealthcareЧтение

Regulatory Issues in using AI/ML for Medical Applications

Regulatory Guidance on AI/MLВидеоA Survey on Explainable Artificial Intelligence (XAI): Towards Medical XAIЧтениеPerspectives and Good Practices for AI and Continuously Learning Systems in HealthcareЧтениеThe Singapore Guidance and AI/MLВидеоSingapore Guidance on Medical SoftwareЧтениеAI/ML and the Software Life Cycle (Prof. John Onofrey)ВидеоIntriguing properties of neural networksЧтениеGeneralizable Multi-Site Training and Testing of Deep Neural Networks Using Image NormalizationЧтение

Week 11 Quiz

Quiz 11Задание
12Business and Management Issues12 материалов

Digital Medicine and Business (Dr. Gregory Licholai)

Value Drivers in Digital MedicineВидеоChanging Business Models in HealthcareВидеоFunding for Digital Health Skyrockets (article)ЧтениеDrivers of Digital Health GrowthЧтениеFuture of Digital Health DriversЧтениеFDA: What is Digital HealthЧтениеFDA Guidance Documents that relate to Digital HealthЧтение

Launching a Healthcare Venture (Dr. Ayesha Quraishi)

Setting up a new Healthcare VentureВидеоFinding your First Paying CustomerВидеоWhen and how to Raise CapitalВидеоResources for Digital Health Venture FundingЧтениеSummary of Digital Health Ventures FinancingЧтение
13Optional Supplement: Case Studies 14 материалов

Therac-25

Therac-25 presented by AnMei LittleВидеоAn Investigation of the Therac-25 AccidentsЧтениеFatal Dose - Radiation Deaths Linked to AECL Computer ErrorsЧтение

Healthcare.gov

Healthcare.gov presented by Daisha RobertsВидеоLink to the full segment from NBC News' Coverage of the Launch of HealthCare.gov (Oct. 24, 2013)ЧтениеHealth and Human Services InvestigationЧтение

Iowa Caucus

Iowa 2020 Caucus App presented by Alex ChenВидеоLink to the full segment from MSNBC's Coverage of the Iowa Democratic Party Caucus ЧтениеIowa's Tally-by-App Experiment FailsЧтениеHere's the Shadow Inc. App that Failed in Iowa Last NightЧтение

WannaCry

WannaCry and the UK NHS presented by Ellie GabrielВидеоLink to the BBC News Segment used as part of the presentationЧтениеUK NHS Investigation ReportЧтениеWhat's Next?Чтение
14Optional Supplement: Expert Interviews1 материалов

Interviews

Descriptions and links to the complete videos on YouTubeЧтение