03/31/2014

Dear Colleague,

I would like to introduce you to Barnett's newest publication, HIPAA and U.S. Clinical Trials: A Question & Answer Reference Guide 2014 that I authored.

http://www.barnettinternational.com/EducationalServices_Publication.aspx?p=12580&id=136321

This guide can support clinical trial stakeholders, including sponsors, contract research organizations (CROs), investigators or delegates, institutional review boards (IRBs), and research subjects. This Guide includes the regulatory changes and updates from 2003 to present.

Some of the key items covered include:

Common misunderstandings of the requirements of the HIPAA Privacy Rule regarding clinical trials Monitoring electronic health records (EHRs) under HIPAA
Defining covered entities and hybrid entities
Authorizations and Clinical Trial Agreements mapping to ensure access to pertinent data
The use of Review Preparatory to Research to support subject enrollment
Changes to the requirements of Business Associates
Compound and Future HIPAA Authorizations
The 2014 HIPAA and U.S. Clinical Trials: Question & Answer Reference Guide will be ready to ship mid April.

For questions or to order your copy today call: 1-800-856-2556 or email: customer.service@barnettinternational.com.