Balancing Hipaa Regulations with Gathering Critical Customer Information

MessageThis Webinar is over
Date Feb 17, 2015
Time 01:00 PM EDT
Cost $139.00
Overview: In addition to the FDA's 21 CFR Part 11 and 21 CFR 820 requirements, medical device companies also face strict regulatory statutes from the Department of HHS and its HIPAA patient privacy regulations. As HIPAA laws continue to strengthen, it becomes increasingly difficult for complaint specialists to gather pertinent information needed to accurately recognize and report a complaint. One of the main hurdles when gathering personal patient information is advis-ing healthcare personnel when disclosure of protected health information is warranted. While HHS emphasizes individual privacy interests should be care-fully balanced with the general interest in public health and safety, having clear guidelines on HIPAA regulations and communicating these regulations to accu-rately gather customer complaint information is critical to reporting complaints and increasing quality functions for a device. 

Why should you attend: Ensuring the privacy of patient data is a critical compliance requirement for all medical device and pharmaceutical companies. 

Areas Covered in the Session:
  • FDA Privacy Guidance
  • European Union Data Protection Requirements

Who Will Benefit:
  • General Counsel
  • Compliance Officers/Compliance Office Personnel
  • Privacy Officers
  • Complaint Handlers
  • Internal Auditors

Drew Barnholtz serves as an outside general counsel and compliance officer for skilled nursing facilities, hospice providers, home health providers, physician practice groups, durable medical equipment companies, pharmaceutical and start-up businesses. Drew has served as a general counsel and compliance officer for numerous health care organizations, and has firsthand experience assisting organizations in responding to government investigations (including serving as the Deputy General Counsel of Invacare Corporation, and the Assistant General Counsel for University Hospitals Health System). Drew also advises clients on commercial transactions, acquisitions & divestitures, compliance, licensure, bond financing, and a variety of agreements.

Roger Steven
contact no: 8003851607
fax no: 302-288-6884
Event Link:


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