RECORDED SEMINARS

Recorded Seminar

International Seminar on Protecting Patient Information - It's the Law

timelapse 5 hours with 10-15 mins of Q and A

Note:

Recorded Seminar can be played unlimited times
Along with recorded seminar, copy of presentation slides will be shared

Speaker/Presenter

J. Lawrence Stevens, RAC

FDA Regulatory Expert

Consultant, One Way Consultants, LLC

Short Abstract

This seminar is a must for any company who is involved with clinical studies and who has access to data with patient identity included.

It is imperative that any company that performs clinical trials be aware of the laws and regulations that govern the protection of patient related data gathered as part of the clinical trial. Medical institutions are well aware of the privacy laws, and in you work with them in the course of performing a clinical trial, you should be able to confirm to the institution that you are well aware of the privacy laws, and have adequate training and procedures regarding protection of patient data. In addition, if you have employees in your company who have access to patient data, they must be trained.

Two major laws apply to your situation

  • The Health Insurance Portability and Accountability Act of 1996 – HIPAA
  • Health Information Technology for Economic and Clinical Health Act - HITECH

The objectives of this seminar are:

If you have access to any patient identified data or information as part of your job responsibilities, you must attend this seminar. If your employees have access to any patient identified data or information as part of their job responsibilities, you must send them to this seminar. Noncompliance with HPPAA or HITECH can cause major problems for your company.


Get this seminar

Program Agenda

9:30 AM – 10:00 AM Breakfast + Introduction
10:00 AM - 12:00 PM
  • Introduction of seminar objectives
  • Patient Protection Laws
    • HIPAA
    • HTECH
    • Protected Health Information
  • Your company and HIPAA
12:00 PM - 01:00 PM Lunch
01:00 PM - 02:45 PM
  • Clinical Environments
    • a. Purpose of Access
    • Policy on Access
    • Rules during Access
    • In House Clinical Support
    • Downloading Images
    • Thumb Drives
  • Foreign Law on patient data
  • Non Compliance Consequences
  • Practice Scenarios – How to handle
02:45 PM - 03:00 PM Conclusions and Open Discussion


Who should attend this seminar? All employees who may have contact with patient information, including clinical affairs managers, clinical monitors, directors of clinical departments, regulatory affairs personnel, internal auditors, and marketing personnel who are regulatory in clinical environments.

Registration Information

  • Registration Fee : USD $299
  • For assistance on registration, please send an email to marketing@biopractice.com or
    Please call: Ph - 1-646-216-8860
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