E-Health, Privacy, and Security Law, Third Edition, with 2017 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.
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
The 2017 Supplement discusses:
Telemedicine, with a brand new
overview chapter covering issues such as modalities, reimbursement, and
Multiple HIPAA enforcement
resolution agreements arising from public OCR investigations of alleged security
The new draft E-Privacy
Regulation and other developments in the European data privacy regime
Ransomware, including OCR’s
informal guidance on such attacks under the Breach Notification Rule
Updates on OCR’s Phase 2 HIPAA
Audit Program, as well as active enforcement of the HIPAA Security and
Legal ethics issues, including
attorneys as whistleblowers, use of biometric data, and artificial
The Part 2 Final Rule issued by
HHS’s SAMHSA, updating regulations on substance abuse
The Federal Policy for the
Protection of Human Subjects Final Rule and the new exemption for
The 21st Century Cures Act safe
harbors from device regulation for certain categories of medical software
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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.
is a partner at Venable LLP, Baltimore, MD, and Co-Chair of Venable's healthcare practice.
View full tables of contents and read the book’s preface or introduction.
Main Volume Information
2016/1,020 pp. Hardcover/ISBN 978-1-68267-009-5/Order #P3218
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