Introduction

With the rapid expansion of digital health technologies, electronic health records (EHRs), telemedicine, and artificial intelligence (AI) in healthcare, the legal landscape of Health Information Management (HIM) has become increasingly complex. Ensuring compliance with privacy laws, data security regulations, and ethical standards is critical for healthcare organizations, policymakers, and IT professionals.

This five-day intensive course provides a comprehensive understanding of the legal, regulatory, and ethical challenges in managing health information. Participants will gain practical insights into HIPAA compliance, data governance, cybersecurity, intellectual property, and AI ethics in HIM. Through real-world case studies, interactive discussions, and hands-on workshops, this course prepares healthcare professionals to effectively manage health information within legal and ethical boundaries.

Course Objectives

By the end of this course, participants will be able to:

• Understand the legal and regulatory frameworks governing health information management
• Navigate HIPAA, GDPR, HITECH, and other global privacy laws
• Ensure compliance in electronic health records (EHRs) and digital health platforms
• Address cybersecurity risks and legal challenges in health data protection
• Analyze legal risks in AI, big data, and blockchain applications in healthcare
• Examine patient rights, consent, and medical record confidentiality
• Understand intellectual property (IP) and ownership issues in health data management
• Develop institutional policies for legal compliance and ethical data governance

Who Should Attend?

This course is designed for professionals responsible for managing, securing, and regulating healthcare information, including:

• Health Information Management (HIM) professionals
• Compliance and privacy officers
• Healthcare IT specialists and data security professionals
• Healthcare administrators and policymakers
• Legal professionals specializing in healthcare law
• Cybersecurity experts in healthcare settings
• Medical and research professionals handling patient data
• Technology developers working on healthcare data solutions

Course Outline

Day 1: Legal Foundations of Health Information Management

Introduction to Health Information Management Law

• Overview of legal frameworks in healthcare data management
• Key US, EU, and international regulations on health data
• The role of government agencies and regulatory bodies (e.g., OCR, FDA, FTC, WHO)
• Case study: Legal implications of data breaches in healthcare

HIPAA, HITECH, and GDPR: Compliance in Health Information Management

• HIPAA Privacy Rule, Security Rule, and Breach Notification Rule
• HITECH Act and its impact on EHR security and patient data access
• GDPR compliance for global healthcare organizations
• Workshop: Developing a HIPAA-compliant data management plan

Day 2: Patient Rights, Privacy, and Consent

Confidentiality, Access, and Ownership of Health Records

• Who owns patient data? Legal and ethical considerations
• The balance between privacy and accessibility in healthcare data
• Medical record retention and destruction policies
• Case study: Patient lawsuits over denied access to health records

Informed Consent and Health Data Usage

• Legal and ethical principles of patient consent for data collection and sharing
• Special considerations in telemedicine and AI-driven diagnostics
• The legal landscape of opt-in vs. opt-out data policies
• Workshop: Drafting a legally sound patient consent form for digital health platforms

Day 3: Cybersecurity, Data Breaches, and Digital Health Compliance

Cybersecurity and Risk Management in Health Information Systems

• Common cybersecurity threats in healthcare (ransomware, phishing, insider threats)
• Legal implications of health data breaches and incident response plans
• The role of third-party vendors and cloud storage providers in legal compliance
• Case study: Legal consequences of major healthcare cyberattacks

Telemedicine and Digital Health: Regulatory Challenges

• Licensing and jurisdiction issues in cross-border telemedicine services
• Legal considerations for remote patient monitoring and wearable health devices
• Compliance risks in mHealth apps and virtual healthcare platforms
• Workshop: Developing a cybersecurity policy for a healthcare organization

Day 4: AI, Big Data, and Intellectual Property in Health Information

Legal and Ethical Considerations in AI and Big Data

• Liability concerns in AI-driven healthcare decision-making
• Legal issues in predictive analytics and machine learning
• Bias, fairness, and algorithmic transparency in AI healthcare applications
• Case study: Lawsuits related to biased AI models in healthcare

Intellectual Property (IP) and Health Data Commercialization

• Who owns medical research data and AI-generated insights?
• The role of patents, copyrights, and trade secrets in health IT
• Ethical considerations in selling anonymized patient data
• Workshop: Drafting a data-sharing agreement that balances innovation and patient privacy

Day 5: Future Trends and Global Perspectives on HIM Law

Health Information Governance and Compliance Strategies

• Best practices in policy development and risk mitigation
• The role of compliance audits and legal reviews in HIM
• Implementing enterprise-wide compliance training programs
• Case study: Building a legally compliant data governance framework

Global Trends in Health Data Regulation and Ethics

• Emerging regulations in AI-driven diagnostics, genomics, and blockchain in healthcare
• The role of international law in cross-border data sharing
• Preparing for the future: Regulatory challenges in precision medicine and smart hospitals
• Final Workshop: Developing a roadmap for legal compliance in a digital health system

Closing Remarks and Certification Ceremony