E-Health, Privacy, and Security Law, Third Edition, with 2017 Supplement

DESCRIPTION

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

The new Third Edition includes updated chapters on the e-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 2017 Supplement discusses:

• Telemedicine, with a brand new overview chapter covering issues such as modalities, reimbursement, and mobile applications
• Multiple HIPAA enforcement resolution agreements arising from public OCR investigations of alleged security rule infractions
• 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 Privacy rules
• Legal ethics issues, including attorneys as whistleblowers, use of biometric data, and artificial intelligence
• 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 secondary research
• The 21st Century Cures Act safe harbors from device regulation for certain categories of medical software