AHLA The Law of Digital Health (AHLA Members)
The Law of Digital Health provides both the fundamental understanding and tactical foresight you need to develop a comprehensive Digital Health strategy.
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Subscribers receive the product(s) listed on the Order Form and any Updates made available during the annual subscription period. Shipping and handling fees are not included in the annual price.
Subscribers are advised of the number of Updates that were made to the particular publication the prior year. The number of Updates may vary due to developments in the law and other publishing issues, but subscribers may use this as a rough estimate of future shipments. Subscribers may call Customer Support at 800-833-9844 for additional information.
Subscribers may cancel this subscription by: calling Customer Support at 800-833-9844; emailing customer.support@lexisnexis.com; or returning the invoice marked 'CANCEL'.
If subscribers cancel within 30 days after the product is ordered or received and return the product at their expense, then they will receive a full credit of the price for the annual subscription.
If subscribers cancel between 31 and 60 days after the invoice date and return the product at their expense, then they will receive a 5/6th credit of the price for the annual subscription. No credit will be given for cancellations more than 60 days after the invoice date. To receive any credit, subscriber must return all product(s) shipped during the year at their expense within the applicable cancellation period listed above.
Product description
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- 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 Digital Health participants face an outdated and ambiguous legal and regulatory framework and enforcement by state and federal regulatory agencies, including: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.
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Published March, 2018.
Featured Authors
Bernadette M. Broccolo
Bernadette M. Broccolo (Editor), is a partner in the Chicago office of McDermott Will & Emery LLP and has been counseling health industry organizations for more than 38 years on complex health industry innovation strategies, most recently including provider networks and big data strategies for transitioning to value-based care, development and deployment of digital health solutions, formation of electronic health information networks and exchanges to support improvements health care quality and accountability, and collaborations for streamlining and accelerating innovations in digital health, translational research and precision medicine. Her specialties include the full scope of legal and regulatory compliance in the areas of federal taxation of exempt organizations and not-for-profit corporate governance, privacy, human subject protection, and technology contracting. Bernadette is a frequent speaker and author on topics in her areas of practice.
She is co-author of Tax-Exempt Status of Health Care Organizations, which is part of BNA’s Health Law & Business Series. She has served in numerous leadership positions for organizations serving the health industry and the legal profession, including the Board of Directors of the American Health Lawyers Association (AHLA) and she is an AHLA Fellow. She has been selected by her peers to be included in The Best Lawyers in America for her expertise in health care law and was named Best Lawyers’ Chicago Health Care Lawyer of the Year for 2010. Bernadette is listed as a leading individual in health care in Chambers USA: America’s Leading Lawyers for Business, US Healthcare Expert Guide (EuroMoney Legal Media Group), Illinois Super Lawyer, and Leading Lawyers Network.
Lisa Schmitz Mazur
Lisa Schmitz Mazur (Editor), a partner in the law firm of McDermott Will & Emery LLP, advises health care providers, payers, investors, associations, and technology companies on the legal, regulatory, and compliance matters touching digital health, including telehealth, telemedicine, mobile health, and consumer wellness tools, and develops practical, forward-thinking solutions and strategies that meet the complex and still-evolving digital health regulatory landscape. She has helped numerous clients to build and implement revenue and reimbursement strategies that comply with laws and regulations and contemplate the shift to value-based reimbursement and future policy changes. Lisa is a co-leader of the McDermott Digital Health Practice, the editor of the Of Digital Interest blog, a proud board member of and mentor to cutting-edge health care organizations, and a prolific speaker and author in the area of digital health
Shelby Buettner
Shelby, an associate in the law firm of McDermott Will & Emery LLP, advises pharmaceutical, medical device manufacturers, health care technology companies, and health care providers on health care and U.S. Food and Drug Administration (FDA) legal, regulatory, and compliance matters. She regularly counsels clients on related considerations associated with mobile medical technology, telehealth, telemedicine, digital health, and clinical research. Shelby also has experience providing guidance concerning the Open Payments provisions of the Patient Protection and Affordable Care Act and state “sunshine” laws.
Vanessa K. Burrows
Vanessa, an associate in the law firm of McDermott Will & Emery LLP, counsels health care entities, FDA-regulated entities, and their contractors on health care transactions, regulatory compliance, and reimbursement issues in connection with product development, marketing, data sharing, licensing, enforcement, and public health matters. Her broad-expertise includes compliance with FDA laws, regulations, executive orders, and guidance, and, as a former HIPAA privacy officer, compliance with HIPAA/HITECH’s privacy, security, and data breach response requirements and standards.
Jiayan Chen
Jiayan, a partner in the law firm of McDermott Will & Emery LLP, counsels a wide range of clients on complex regulatory and strategic issues arising in biomedical innovation and data sharing initiatives. In her regulatory and transactional practice, Jiayan advises health systems, professional associations, and digital health and life sciences companies in connection with the development of innovative research collaborations, data sharing initiatives, quality improvement endeavors, and biospecimen and data repositories. Jiayan has particular expertise advising on such issues in the context of precision medicine and secondary use.
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
