With this important guide from AHLA, those who represent healthcare entities will gain insight into the growing interrelationship between health law and life sciences, as well as the growing risks and compliance issues facing clients involved in this complex area.
The Second Edition of the popular Practice Guide is extensively enhanced and updated with coverage of:
Changes to HIPAA that affect research and IRBs
New Food and Drug Administration guidance and finalization of draft guidance
Changes to patent law due to the America Invents Act
HITECH and enhanced coverage of the Security Rule
New requirements for group health plans and health insurers to cover routine patient costs in an approved clinical trial
Covers the Full Spectrum of Related Legal Issues
Clinical trials play an essential role in the advancement of healthcare in the U.S. and abroad. They are designed to evaluate the safety and efficacy of new drugs, devices, treatments, or preventative measures using human subjects. Comprehensive coverage is both analytical and practical, with thorough treatment of:
The development of human subject protections and the important function played by both institutional review boards (IRBs) and federal regulatory agencies
The federal approval process for pharmaceuticals, medical devices, and biologics
The responsibility for regulatory oversight and investigations, with a discussion of which agency in the U.S. Department of Health and Human Services has responsibility for ensuring compliance
Intellectual property considerations, including an extensive discussion of the basics of intellectual property rights in the U.S.
Information management, including the sources for human subject protection: the Federal Common Rule, FDA Guidance, and HIPAA
Insurance payments for clinical trial services, whether through private insurance or federal reimbursement and the top ten steps to ensure that the application for billing is appropriate
The eBook versions of this title feature links to Lexis Advance for further legal research options.