Clinical Informatics Study Guide: Text and Review

Foreword
Preface
How to Use This Book
Structure of the Book
Structure of Each Chapter
Statement from the Editors
Acknowledgements
Contents
Contributors
Part I: Fundamentals
1: The Discipline of Clinical Informatics: Maturation of a New Profession
Introduction
History and Development of Clinical Informatics as a Medical Subspecialty
Defining the Characteristics of the Profession
Seeking Approval for the Clinical Subspecialty
The Clinical Informatics Subspecialty in the Context of ABMS Evolution
Creating and Offering the Board Examination
Initial Development of Fellowship Programs
Updating the CIS Core Content
Career Options for Clinical Informaticians
Current Challenges for Clinical Informatics
Complementary Developments
New Professional Recognition Opportunities
Health Informatics Certification
Looking to the Future
Questions for Discussion
References
2: Fundamentals of Computer Science
Introduction
Programming and Computational Thinking
Computer Primer
The Von Neumann Model
Programming Terms
Computer Language
Binary
Machine Code
Assembly Language
Compiled Language
Interpretive Language
Control Structures
Sequential
Conditional (If/Else, Switch)
Iterative (While, for)
Recursion
Computational Thinking
Specification
Decomposition
Abstraction
Pattern Recognition
Parallel Processing
Algorithm Design
Coding Best Practice
Operating System
Application
Beyond the Application
Preparing the Code for Use
Specifications
Unit Testing
Reading Other People’s Code
Reading Other People’s Code for Errors
Recommended Resources/Tools
Emerging Trends
Summary
Questions for Discussion
References
3: Clinical Informatics Policy and Regulations
Introduction
Fundamentals of Policy and Historical Regulations
Organization of the Federal Government and Agencies with Oversight for Health Care and Health Information Technology
The Congressional Branch
The Executive Branch
The Role of the Private Sector Including Standards Development Organizations (SDO) and Healthcare Industry Trade Associations and Lobbying Groups
What Every Clinical Informaticist Needs to Know About Health IT Policy: The Basics
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
American Recovery and Reinvestment Act and the Health Information Technology for Economic and Clinical Health Act of 2009 (ARRA and HITECH Act)
HITECH Changes to HIPAA
An Evolving Meaningful Use Program
Patient Protection and Affordable Care Act (ACA) of 2010
Food and Drug Administration Safety and Innovation Act (FDASIA) (2012)
Medicare and CHIP (Children’s Health Insurance Program) Reauthorization Act of 2015 (MACRA)
More Recent Legislation and Regulations
TEFCA
Fraud, Stark and Anti-Kickback Laws
Veterans Access, Choice, and Accountability Act of 2014
State Health Care Oversight
Advocacy
Summary
Questions for Discussion
References
4: The U.S. Health System
Introduction
Health or Wellness Versus Sick Care
Individual Versus Population Health
Complexity
The United States Health System
Health Care Delivery
Health Care Delivery: Providers
Health Care Delivery: Payers
Health Care Delivery: Suppliers
Health Care Delivery: Regulators
Forces Shaping Health Care Delivery
A Culture Change
Public Health Systems
Clinical Research
Personal Health
The Flow of Data, Information, and Knowledge Within the Health System
Understanding the Flow of Data
Clinical Informatics: Unifying the Health System
Emerging Trends in Clinical Informatics: An Effort to Improve Quality
Learning Health System and Electronic Health Records
Chapter Summary
Application Exercise/Questions for Discussion
References
Part II: Clinical Decision Making and Care Process Improvement
5: Evidence-Based Health Care
Introduction
Evidence-Based Health Care
Types of Research Studies
Experimental Study Designs
Observational Study Designs
Systematic Reviews and Meta-analysis
Other Study Designs
Grading the Quality of Evidence
Grading the Quality of Evidence and Strength of Recommendation
Clinical Guidelines
Quality Measurement
Evidence Sources
Primary Medical Literature
Summarized Evidence
Electronic Health Records
Emerging Trends
Summary
Questions for Discussion
References
6: Clinical Decision-Making
Introduction
Cognitive Aspects of Decision-Making
Probability: The Heart of Rational Decision Making
Classical Probability Theory
Frequentist Probability Theory
Subjectivist Probability Theory
Biases in Estimating Probability
Combining Probabilities: Bayes Theorem
Decision Science
Decision Trees
Sensitivity Analysis
Expected Utility Theory
The Standard Gamble
Time Trade-Off
Quality Adjusted Life Years
Cost-Effectiveness and Cost-Utility Analysis
Calculating Costs
Advanced Decision Modeling
Markov Models
Influence Diagrams
Shared Decision Making
Decision Support Prioritization
The Role of Decision Sciences in Clinical Informatics
Future Directions
Chapter Summary
Questions for Discussion
References
7: Clinical Decision Support: It’s More than Just Alerts
Introduction
Defining Clinical Decision Support and Clinical Decision Support Systems
Architecture of CDS Systems
History of CDS
CDS Evolution
CDS Components
CDS Standards for Rules and Knowledge Representation
Types of Clinical Decision Support
Active (Push) Versus Passive (Pull) CDS
Active Decision Support: Actionable Versus Non-actionable
Hybrid Decision Support
CDS Delivery Mechanism: Internal Versus External
Traditionally Delivered CDS
Externally Delivered CDS
Delivering External CDS
AHRQ
Open CDS
CDS Hooks
SMART on FHIR
Protecting Access to Medicare Act and Imaging (PAMA)
The Reality
Knowledge Maintenance
What Is Knowledge Maintenance?
What Evidence Is the ‘Right’ Evidence?
Efficiency and Usability
What Is Efficiency?
Usability
Governance
Successful Implementation of CDS
Beyond the Five Rights
Legal, Regulatory and Ethics
The Role of the FDA in Regulatory Oversight of CDS
Legal Model for CDS
Vendors and CDS Content
Impact of the 21st Century Cures Act
Ethical Challenges of Adaptive CDS
Emerging Trends
Summary
Questions for Discussion
References
8: Clinical Workflow Analysis, Process Redesign, and Quality Improvement
Introduction
What Is Workflow?
Pervasive and Specific Levels of Workflow
Workflow as the Collection of Individuals’ Routines
Patient-Oriented Workflow
Organizational Routines
Methods to Develop a Better Understanding of Workflow
Qualitative Approaches
Quantitative and Statistical Approaches
Markov Chains
Pattern Mining
Discrete Event Simulation (DES)
Visualizing Workflow
Process Map/Flow (Process) Charts
Data Flow Diagrams
Spaghetti Diagrams
Swimlane Diagrams
Selecting Appropriate Methods
Process Redesign
Quality Improvement in Health Care
Important Quality Improvement Frameworks
Plan-Do-Check-Act
Lean Methods
Six Sigma
Important Components of Quality Improvement
Emerging Trends
Workflow in the Era of Data Science and Artificial Intelligence
Workflow for Patients
Summary
Application Exercise/Questions for Discussion
References
9: Human Factors Engineering and Human-Computer Interaction: Supporting User Performance and Experience
Introduction
Putting HFE and HCI in Context
HFE and HCI Models
HFE and HCI Practices
HFE and HCI Principles for Design
HFE and HCI Challenges Specific to Clinical Information Systems and EHRS
Additional HFE and HCI Resources
Emerging Trends
Summary
Questions for Discussion
References
Part III: Health Information Systems
10: Information Technology Systems
Introduction
Data and Databases
Getting Data
Data Sources
Interoperability: Mapping and ETL
Data Representation
Storing Data (Databases)
Relational Databases
Database Schema Design
Cloud Database Providers
Database Integrity and Performance
Non-relational Databases (NoSQL)
Using Data
Health Information Systems
Data Warehouses
Health Information Exchange
Knowledge Discovery and Data Mining (KDDM)
Data Quality
Networks and Network Architecture
Networks
Network Topology
Seven-Layer Network Model
Network Speed
Network Architecture
Architectural Diagrams
Application Architecture
Non-functional Requirements
Integration and Interfaces
Software, Computer Languages, and Programming
Data Types
Programming
Database Programming
Software Development
Object-Oriented vs. Procedural Programming
Control Structures
Compiled and Interpreted Languages
Software Design Considerations
Code Modularity, Reuse, and Performance
Methodology and Quality Assurance
Other Considerations
Security
The Health Insurance Portability and Accountability Act
The Common Rule
Malicious Attacks
The Federal Information Security Management Act (FISMA)
De-identified Data
Emerging Trends
Summary
Query Tools and Techniques: Resources
Questions for Discussion
References
11: Clinical Information Systems and Applications
Introduction
Enterprise Clinical Information System Settings
Functionalities of Clinical Information Systems
Electronic Medical Records/Electronic Health Records
Core Functions of the EHR
Institute of Medicine
ONCs Certification Criteria
Beyond the EHR
Hospital Information Systems
HIMSS Adoption Model
The Traditional Ancillary Systems: “Lab/Rad/Pharm”
Laboratory Information Systems
Radiology Information Systems
Pharmacy Information Systems
Beyond the Hospital Information System
Telehealth
Telehealth Models and Modalities
Telehealth Hardware and Software
Telehealth Workflow and Integration
Clinical Communication Channels and Best Practices
Regulatory Factors
Security
Channels for Communication
Communication in Acute Care or Hospital Settings
Communication in Ambulatory Settings
Communication Between the Clinical Teams Across Healthcare Venues
Clinical Registries
Uses and Value
Mechanism of Data Entry and Interfaces with EHR and Other Sources
Regulated Medical Devices
Medical Device Integration
Medical Device Management Systems
Medical Device Standards Organizations
Regulation of Medical Devices
Emerging Trends
Pediatric Functionalities
Documentation
Use of Artificial Intelligence
Innovation in Portal Use
Laboratory Information Systems
Pharmacy Information Systems
Supply Chain Systems
Blood Bank Systems
Summary
Questions for Discussion
References
12: System Development Life Cycle
Introduction
What Is SDLC?
Brief History of SDLC and Its Relevance Today
Phases of SDLC
The Initiation Phase
The Development and Acquisition Phase
The Implementation Phase
The Operations/Maintenance Phase
The Disposal Phase
Discussion of SDLC in Use: A Common Clinical Informatics Software-Related Project Scenario
Discussion of SDLC in Use: A Common Clinical Informatics Hardware-Related Project Scenario
Conclusion
Questions for Discussion
References
13: Healthcare Data and Exchange Standards
Introduction
Standards and Interoperability: Basic Concepts
Standards Development
Standards Development Organizations
Identifier Standards
Patient Identifiers
Other Identifiers
Transaction Standards
Message Exchange Standards
HL7
Imaging Standards
Prescribing Standards
Patient Summaries
Terminology Standards
International Classification of Diseases (ICD), Version 9
International Classification of Diseases (ICD), Version 10
Diagnosis Related Groups (DRGs)
Drug Terminology
Logical Observation Identifiers Names and Codes (LOINC)
Current Procedural Terminology (CPT-4)
Systematized Nomenclature of Medicine (SNOMED)
Nursing Terminologies
Unified Medical Language System (UMLS)
Other Terminologies and Activities
SMART on FHIR
Emerging Trends
Summary
Questions for Discussion
References
14: Health Information Exchange and Interoperability
Introduction
Interoperability and Health Information Exchange
Interoperability and HIE in Medicine
Interoperability and HIE for Population Health
Health Information Exchange Networks
A Brief History of HIE Networks
HIE Networks Today
Private HIE
State Government-Facilitated HIE
Community-Based HIE
Vendor-Facilitated HIE
National Networks/Frameworks
Which Type of HIE Network Is Best for My Hospital?
Adoption of Health Information Exchange in the United States
Health Information Exchange Adoption Through the Years
Drivers of Adoption
Barriers to Health Information Exchange Adoption
Technical and Implementation Barriers
Workflow
Usability/Usefulness of Data
Financial and Incentive Barriers
Direct Costs
Incentives
Present Problems and Future Solutions
Patient Matching
Reconciling Patient Identifiers
Deterministic Matching
Probabilistic Matching
Emerging Trends
Incorporating Behavioral Health Data into HIE Networks
Leveraging HIE Networks to Address the Social Determinants of Health
Expanding the Use of API-Based Information Exchange
Summary
Questions for Discussion
References
15: Data Information and Governance
Introduction
Laws, Organizations, and Best Practices for Accessing and Disclosing Data
Laws and Regulations
State Laws
Organizations
Data Access and Data Sharing Agreements
Content
After the Agreement Is Executed
Best Practices Related to Data Use, Privacy, Security, and Portability (Data Stewardship)
Data Stewardship Concepts
Institutional Governance
The Business Case
Organization
Policies and Procedures
Data Access and Data Usage Policies
Emerging Trends
Federal Privacy Law
Increasing Use of Secure Data Enclaves
Summary
Questions for Discussion
References
16: Analytics
Introduction
Data to Wisdom
Key Terms in Analytics
Descriptive and Inferential Statistics
Data Sources
Data Pre-Processing: What Pre-Processing Steps Are Necessary to Convert a Data Set into a Format Suitable for Analytics?
Introduction to NLP
Machine Learning Approaches
Supervised Learning Approaches
Unsupervised Learning Approaches
Neural Networks
Applications of Analytics in Clinical Informatics
Common Pitfalls and Challenges
Model Training, Evaluation, and Validation
Model Training Approaches
Performance Metrics
Feature Selection Techniques
Model Validation
Risk Stratification and Adjustment
Data Visualization
Emerging Trends
Democratizing Access to Datasets for Effective Analytical Efforts
Awareness of Biases Present in Analytical Models
Summary
Questions for Discussion
References
17: Cybersecurity in Healthcare
Introduction
Laws Impacting Healthcare Information Privacy and Cybersecurity
Federal Trade Commission Act
Computer Fraud and Abuse Act
Cybersecurity Act of 2015
HIPAA
Gramm-Leach-Bliley
HITECH Act
GDPR
Anti-Kickback Statute and Stark Law
DEA Electronic Prescription of Controlled Substances
California SB-327
Methods of Cyber-Attack
Types of Cyber-Attacks
Malicious Software “Malware”
Mitigation Techniques for Healthcare Cybersecurity & NIST Cybersecurity Framework
NIST CSF [59]
Emerging Trends
Internet of Medical Things
Blockchain and its Application in Healthcare
Artificial Intelligence and Cybersecurity
Twenty-First Century Cures Act
Questions for Discussion
References
18: Telehealth
Introduction
Telehealth and the Coronavirus Pandemic
Practical Considerations with Telehealth
Emerging Trends
Summary
Questions for Discussion
References
Part IV: Leading and Managing Change
19: Leadership Models, Processes, and Practices
Introduction
Definitions of Leadership/Leadership vs. Management/Leadership Models
Leadership vs. Management
Leadership Models
Leadership/Managerial Grid
Situational Leadership
Servant Leadership
Action-Centered Leadership
Functional Results-Oriented Healthcare Leadership Model
Healthcare Quality Professional Leadership Development Model
National Center for Healthcare Leadership Competency Model
Healthcare Leadership Alliance model
Center for Creative Leadership Six-Part Model
Dimensions of Effective Leadership
Communication and Leadership
Strategic/Tactical/Analytical/Innovative Thinking
Analytical/Critical Thinking
Decision Making and Accountability
Understanding, Surviving, and Changing Organizational Culture
Negotiation Strategies, Methods, and Techniques
Collaboration
Conflict Management Strategies, Methods, and Techniques
Conflict Management
Methods to Assess the Effectiveness of Training and Competency Development
Motivational Strategies, Methods, and Techniques
Emerging Trends in Leadership
Chapter Summary
Questions for Discussion
References
20: Effective Interdisciplinary Teams
Introduction
Human Resources Organization Planning and Development
The Human Resources Process
Human Resources Planning
Jobs
Developing Job Descriptions
Staffing
Internal Recruiting Sources
External Recruiting Sources
Networking
Diversity
Employment Branding
Recruitment Effectiveness
Selection Process
Development
Hiring and New Employee Training Process
Evaluation, Compensation, and Maintaining the Workforce
Annual Evaluations
Compensation
Departure of Staff
Legal Framework
Retention
Forming and Maintaining High-Performing Teams
Forming a Team
Initiating a Team
Relationships
Team Structure
Task Structure
Group Management Processes
Coordination
Task Realignment
Team Commitments
Resource Changes
External to Internal Communication
Conflict
Constructive Conflict
Destructive Conflict
A Successful Team
Managing Meetings
Using Meetings for the Right Purpose
Leading Meetings
Using Meetings for Maximum Effect
Out-of-the-Box Ideas for Making Meetings Successful
Conclusion
References
21: Strategic and Financial Planning
Introduction
Mission & Vision
Environmental Scan
Organizational Benchmarking
Key Performance Indicators
IT Planning Approach
Planning
Design
Implementation
Support and Evaluation
Financial Planning
Capital Expenses (Capex) vs Operating Expenses (Opex)
Enterprise Resource Planning Systems
Business Plans and Business Cases
Revenue Cycle
Role of Clinical Information Systems in the Revenue Cycle
Emerging Trends
Summary
Questions for Discussion
References
22: Effective Implementation of a Clinical Information System
Introduction
Case Vignette
chemoSABE: Designing for Success
Lag Time between Reported Lab Values and Actions
Parenteral Nutrition
Overview
Toward Adoption: The Product/System
Culture of the Organization
The Organization’s Culture
General Assessment
Organizational Climate Assessment
Assess the Workflow
Current and Emerging Political Trends
Power Assessment
Prepare Organizations for Change
Strong Organizational Commitment
Leadership & Champions
Prepare People for Adoption
Build Ownership
Senior Leaders
System Users
Incentives
Training
Process of Implementation
Good Communication
Implementation Planning
Local Change Agents
Implementation Support
Addressing Problems in a Rapid Cycle approach
Technology: The Interplay of Usability, Context, and Implementation
Other Key Vendor Considerations: Culture and Service
Summary
Questions for Discussion
References
23: Project Management
Introduction
Definitions
What Is a Project?
What Is Project Management?
Why Does a Project Need Management?
The Swing Cartoon
Project Constraints
Why Does a Clinical Informaticist Need to know about Project Management?
History of Project Management
Five Phases of a Project
Phase One: Initiating
Phase Two: Planning
Phase Three: Execution
Phase Four: Monitor and Controlling
Phase Five: Closing
Tools of Project Management
Tools: Charts and Graphs
Business Case
Project Charter
Stakeholder Analysis
Work Breakdown Structure (WBS)
The Project Management Office
Communication Plan
Risk Management
Resource Allocation
Human Resources
Non-human Resources
Financial Resources
Informatics Project Challenges
Unclear Requirements
Resource Allocation
Organizational Attributes
External Challenges
Scope Creep
Managing Expectations
Balancing Competing Priorities
Emerging Trends
Project Management Skills
Summary
Questions for Discussion
References
Part V: Beyond Clinical Informatics
24: Consumer Health Informatics: Engaging and Empowering Patients and Families
Introduction
A Sociotechnical Perspective of Consumer Health Informatics
Patient-Focused Informatics Solutions
Seeking and Managing Personal Health Information
Self-Management
Changing Health Behavior
Communicating with Others
Coordinating Care
Technologies: A Rapidly Changing Landscape
Personal Health Records (PHRs)
Patient Portals and Shared Access to Electronic Health Records
Secure Electronic Communication between Patients and Healthcare Providers
Sharing and Integration of Patient-Generated Data
Internet or Web-Based Interventions
Major Drivers and Trends in Consumer Health Informatics
Increased Availability and Use of Technology
Consumer Information Needs and Desire for Engagement
Financial Incentives
Impact of Major Drivers
Major Factors Influencing Adoption and Use
Access and Usability
Awareness, Motivation, and Usefulness
Clinician Endorsement
Implementation of Consumer Health Informatics
User-Centered Design
Integration with Existing Practices and Workflows
Engaging Stakeholders, Leadership, and Clinical Informaticists
Providing Education and Incentives
Assessing the Impact of Consumer Health Informatics
Methodological Approaches to Consumer Health Informatics Research
Patient Portals
Mobile Health (mHealth) Technology
Unintended Consequences and Emerging Trends
Future Research
Emerging Trends
Mobile Health-Devices, Monitors, Sensors and Wearables
Complimentary Models of In-Person and Virtual Care
Remote Patient Monitoring
Summary
References
25: Public Health Informatics
Introduction
The Scope of Public Health Informatics
Informatics Capacity in Public Health Agencies
Public Health Informatics Education and Training
Major Players in Public Health Informatics
Examples of Public Health Information Systems
Electronic Laboratory Reporting
Electronic Case Reporting
Syndromic Surveillance
Population Health Disease Registries
Chronic Disease Registries
Immunization Registries
Cancer Registries
Community Health Assessment
Contact Tracing Applications
Toward Public Health Decision Support
Illustration
Public Health EHR Alerting
Case Reporting Reminders
Infrastructure to Support Bidirectional Exchange
Emerging Trends
Post-Pandemic Recovery and Health System Evolution
Policy Landscape
Improvements in Technology
Improving Health Equity and Creating a Culture of Health
Summary
Questions for Discussion
References
26: Precision Health
Introduction
Precision Health
“Imprecision” Healthcare
PH Is an Informatics Opportunity
Precision Health Examples
Oncology
Immunology
Infectious Diseases
Pharmacogenomics
Antecedents to Precision Health
Biomedical Knowledge and Scientific Discovery
Digital and Information Technology
Social and Environmental Determinants of Health Data
Changing Regulatory Efforts
Components of Precision Health
Clinical Care
Genetics and Biology
Behavioral Factors
Environmental and Social factors
Informatics Infrastructure and Considerations for Precision Health
Supporting Discovery Activities
Supporting Hypothesis Generating Activities
Support for Hypothesis Testing Activities
Informatics Tools for Treatment and Maintaining Precision Health
Clinical Decision Support Systems
Health Information Exchanges
Care Coordination Toolsets
Telehealth
Bench to Bedside Research Informatics Tools
Health Services Research
Learning Health System Informatics Infrastructure
Healthcare Information Technology (HIT) Considerations for Precision Health
Electronic Health Records
Patient Portals
Internet of Things
Laboratory Systems
Genetic Analysis Instruments
Devices and Interfaces
Data Standards
Barriers to Precision Health Adoption
Provider Awareness
Cost and Financing
Reimbursement
Patient
EHR Integration Barriers
Emerging Informatics Trends for Precision Health
Platform for Artificial Intelligence
Synthetic Healthcare Data
Learning Health System
Summary
Questions for Discussion
References
Index