Current Regulations under FDA and HIPAA

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:
Senior management
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.

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 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 and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

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