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 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.
We will also 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?
Areas Covered in the Session :
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 Will Benefit:
This training applies to personnel / companies primarily in the Pharmaceutical, Medical Device, Biologics, Dietary Supplements, Combination products fields. The professionals who will benefit include:
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.