Current Regulations under FDA and HIPAA

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Tue, Sep 29, 2015
Length
90 minutes
Product Description

FDA and HIPAA Requirements and Guidelines to Help You Ensure Compliance and Avoid Lawsuits

There are potential pitfalls to the flow of medical information and a patient’s privacy rights under HIPAA. What was done years ago is no longer acceptable.

This session by our expert speaker John Lincoln will help you understand the basic requirements of HIPAA and FDA. It will help you review key U.S. FDA publications that address HIPAA in a regulated medical environment. You will get to know about HIPAA and clinical trials issues. This session will also would review current and trending issues regarding electronic records and their transmission and how is industry meeting/not meeting HIPAA requirements/trends.

John, a regulatory compliance consultant, will present and discuss published requirements and guidelines to assist your company and legal staff to get and remain in compliance.

Get answers to some important questions in layman terms:

  • How can a company acquire necessary medical information or disseminate such information to regulatory agencies as required under Adverse Events reporting without breaking the law and being open to lawsuits?
  • What do the many published guidelines and policy statements tell industry?
  • What vital information can be gathered from such sources?
  • How can these be implemented in a medical products company without violating HIPAA?

Session Topics:

  • HIPAA and the U.S. FDA
  • HIPAA and MedWatch
  • HIPAA and IRB’s
  • HIPAA and Mammography Quality Standards Act (MQSA) and similar:  Inspections, Outcomes Audits and Reporting
  • HIPAA and Electronic Records / Submissions 
  • HIPAA and the new UDI / GUDID

Who should attend?

  • Senior management in Biologics, Drugs, Dietary Supplements, Devices, Combination products
  • QA/RA
  • CROs and Clinicals personnel
  • Medical personnel and other healthcare professionals, staff and office personnel
  • Consultants and others who are tasked with product, process, validations and CGMP responsibilities
  • Useful for members of AQC, RAPS, AAMI, etc.

 Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

Order Below or Call 1-866-458-2965 Today

You can also order through:
Phone

1-866-458-2965

Fax

1-919-287-2643

About Our Speaker

John E. Lincoln


John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company; with over 35 years of experience in U.S. FDA-regulated industries, 21 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation...   More Info
More Events By The Speaker

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