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Digital Health is a highly dynamic ecosystem of technological innovation with profound effects on all facets of health care. The key components of today's Digital Health are:
  • Electronic health records and other health information technology;
  • Big data and data analytics;
  • Telemedicine;
  • Mobile personal engagement tools.

This book explains how, taken together, these developments transform the provider-patient relationship, change the way research is conducted, trigger privacy and security concerns, alter relationships with health plans, and give rise to a new generation of innovation. Digital Health participants face an outdated and ambiguous legal and regulatory framework and enforcement by state and federal regulatory agencies, including:

  • State attorneys general;
  • State licensure and accreditation agencies;
  • Food and Drug Administration; Federal Trade Commission;
  • Federal Communications Commission;
  • Department of Health and Human Services’ Offices of Civil Rights, Human Research Protection, and Inspector General—among others.
This book provides both the fundamental understanding and tactical foresight you need to develop a comprehensive Digital Health strategy.

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Published March, 2018.

 

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Table of contents

CONTENTS

CHAPTER 1  INTRODUCTION
1.1 Introduction

CHAPTER 2  HEALTH INFORMATION TECHNOLOGY
2.1  Introduction to Health IT
2.2  Health IT Applications and Uses
2.3  Digital Health Value Proposition
2.4  Unique Legal and Regulatory Considerations Applicable to Health IT
2.5  Planning, Due Diligence, and Contracting Considerations

APPENDIX A  Overview of MACRA Quality Payment Program
APPENDIX B  Summary of Medicare EHR Incentive Program Stage 3 Meaningful Use Requirements for Eligible Hospitals and Critical Access Hospitals
APPENDIX C  Overview of 2015 Edition CEHRT Criteria for Medicare EHR Incentive Program Meaningful Use Program
APPENDIX D  Overview of HIPAA Security Assessment Requirements

CHAPTER 3  "BIG DATA" AND DATA ANALYTICS
3.1  Value Proposition
3.2  Applications and Use Cases
3.3  Unique Legal and Regulatory Considerations Applicable to Big Data
3.4  Compliance and Liability, and Contracting Considerations and Strategies
3.5  Key General Planning Considerations
3.6  Special Considerations in Data Governance

CHAPTER 4  TELEMEDICINE
4.1  Introduction
4.2   Applications and Uses
4.3  Value Proposition
4.4  Unique Legal and Regulatory Considerations Applicable to Telemedicine
4.5  Compliance and Liability Considerations
4.6  Considerations and Strategies for Health Care Providers Developing and Supporting Sustainable Telemedicine Programs

CHAPTER 5  PATIENT ENGAGEMENT AND CONSUMER WELLNESS TOOLS
5.1  Applications and Uses
5.2  Value Proposition
5.3  Unique Legal and Regulatory Considerations Applicable to Personal Health Tools
5.4  Compliance and Liability Considerations
5.5  Planning, Due Diligence, and Contracting Considerations and Strategies