Book

E-Health, Privacy, and Security Law, Third Edition, with Cumulative 2018 Supplement

This treatise provides health law practitioners and digital health professionals with a full exploration of the legal, regulatory, transactional, and ethical issues at the nexus of health and information technology, including digital health, privacy, security, social media, HIPAA, HITECH, and more. It also includes guidance on maximizing technology to cut costs and improve marketing, all while staying compliant and avoiding penalties.

 


Description

CLEAR INFORMATION on the full range of today’s digital health business and transactional law issues 

The new Third Edition includes updated chapters on the digital health industry and health information technology, as well as discussion of:

  • recent security breach settlements with HHS’s Office for Civil Rights (OCR) and the implications, as well as a new chapter on other cybersecurity developments in healthcare
  • how health information technologies will play a key role in the shift from fee-for-service medicine to payment for quality and cost-effectiveness;
  • the European Data Privacy Regime, including the Data Protection Directive, and key changes the General Data Protection Regulation (GDPR) will bring, such as mandatory breach reporting and significant fines.
  • OCR's Phase 2 HIPAA compliance audit program, evaluating compliance with privacy, security, and breach notification rules
  • the impact of patient-generated health data, including that originating with mobile and wearable devices;
  • the increasing use of telemedicine, both in the U.S. and globally, and the barriers to it;
  • HHS’s imposition of civil monetary penalties (CMP) under HIPAA, as well as new actions brought by state attorneys general under the HITECH Act; and
  • FDA warning letters related to social media promotion of pharmaceutical and dietary supplement products, and FDA final guidance detailing the regulatory scheme for mobile medical apps.
  • the Part 2 Regulations Proposed Rule from the Substance Abuse and Mental Health Services Administration (SAMHSA) of HHS on the exchange of substance use disorder information
  • the Stage 3 Final Rule under the American Recovery and Reinvestment Act (ARRA) specifying the requirements that eligible professionals and hospitals must meet to qualify for Medicare and Medicaid EHR incentive payments;
  • the FTC’s Health Breach Notification Rule (“HBNR”) and its applicability to PHR vendors, PHR-related entities, and third-party service providers

Supplement Information    

The 2018 Cumulative Supplement includes:

  • Extensive updates on the General Data Protection Regulation (GDPR)
  • Internet pharmacies, with a brand new chapter on laws governing them, and federal, international, and private sector enforcement activities
  • Important cybersecurity laws, regulations, and guidance changes, including the issuance of SEC guidance
  • Recent breach reports, as well as information on an HHS fact sheet offering guidance on specific HIPAA compliance requirements on ransomware attacks
  • An updated analysis of the legal and market trends related to digital health
  • The Bipartisan Budget Act of 2018 with impacts on telemedicine, MACRA’s Merit-Based Incentive Payment System (MIPS), and more
  • Mobile devices and patient-generated health data (PGHD), which may not yield data in forms commonly recognized by or transmittable among EHRs
  • The Substance Abuse and Mental Health Services Administration  (SAMHSA) issuance of an additional final rule on the confidentiality of substance use disorder records

 

 


 

Summary of Contents

 

Chapter 1. The Digital Health Explosion—An Analysis of Legal and Market Trends

 

Chapter 2. E-Health Industry Overview

 

Chapter 3. Health Information Technology

 

Chapter 4. Privacy, PHRs, and Social Media

 

Chapter 5. Privacy Issues in U.S. Health Care

 

Chapter 6. The European Data Privacy Regime

 

Chapter 7. Information Security and Breach Notification Under HIPAA and HITECH

 

Chapter 8. Enforcement of the Health Insurance Portability and Accountability Act of 1996

 

Chapter 9. E-Health Liability

 

Chapter 10. FDA Regulation of E-Health Technology and Services

 

Chapter 11. Obligations in Response to a Health Care Data Security Breach

 

Chapter 12. Due Diligence in E-Health Transactions

 

Chapter 13. Contracts in the Digital Age: Adapting to Changing Times

 

Chapter 14. Evaluating Antitrust Concerns in the Electronic Marketplace

 

Chapter 15. The Intersection of Health Law and Intellectual Property Law

 

Chapter 16. Allocation and Mitigation of Liability

 

Chapter 17. Recent Cybersecurity Developments in Health Care

 

Chapter 18. Legal Ethics and E-Health

 

Chapter 19. Telemedicine

 

Chapter 20. Internet Pharmacies

 

Appendices • Table of Cases • Index

 

 

 

Authors

think and code authors and editors are practicing professionals with insider perspectives and real-life experience. Learn more about this book’s authors and editors.
 of Gantt Law, LLC, focuses his practice on health care and life sciences regulatory counseling, complex transactions, and strategic business advice.

Contents

View full tables of contents and read the book’s preface or introduction.
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