Clinical Operations-Design to Execution

BayBiotech.NET Health Insurance Portability and Accountability Act of 1996 (HIPAA, Title II) required the Department of Health and Human Services (HHS) to establish national standards for the security of electronic health care information. Department of Health and Human Services prepared certain guidelines that specify a series of administrative, technical, and physical security procedures for covered entities to use to assure the confidentiality of electronic protected health information (EPHI). This is particularly relevant for organizations that allow remote access to EPHI through portable devices or on external systems or hardware not owned or managed by the covered entity. Guidelines address mainly the privacy of health information issues that may arise by using laptops; home-based personal computers; PDAs and Smart Phones; hotel, library or other public workstations and Wireless Access Points (WAPs); USB Flash Drives and Memory Cards; floppy disks; CDs; DVDs; backup media; E...

BayBiotech.NET The European Commission’s Directive on Data Protection w.e.f.October of 1998 prohibits the transfer of personal data to non-European Union nations that do not meet the European “adequacy” standard for privacy protection of the personal data. For purposes of the policy, "personal information" means information that:  is transferred from the European Union to the United States;  is recorded in any form;  is about, or pertains to, a specific individual or can be linked to that individual. While both the United States and the European Union share the goal of enhancing privacy protection for their citizens, the United States takes a different approach to privacy from that taken by the European Union. With a goal to bridge the different privacy approaches between the United States and European Union and provide a streamlined means for U.S. organizations to comply with the Directive, the U.S. Department of Commerce in consultation with the European Commissi...