Much information exists about HIPAA–a multifaceted legislation covering the insurance portability and fraud enforcement (accountability) acts.  However, the guidance for privacy and security laws are vague, particularly regarding:

• Clinical study conduct and searching for patients that have prematurely dropped out and are lost to follow-up
• How HIPAA affects long-term follow-up (pharmacovigilance) programs encourage by the FDA for subjects in clinical trials

OmniTrace Corp. has expended considerable effort to clarify the above issues.  We have communicated with sponsers, sites, ethics committees, Institutional Review Boards and legal departments of major pharmaceutical companies. 

Expanding on the above issues, we have tried to answer the following questions to the best extent possible: 

• What is HIPAA’s position for searching for patients lost to follow-up (LTFU) and for long-term follow-up programs?
• When may subjects in a clinical trial be contacted and for what purpose?
• What services can a third party contracted by the Sponsor company offer and how?
• Do existing HIPAA mandates cover these issues or are additional authorizations required?

We’ll share the information we have developed in future posts.  We bet the suspense is killing you though!  

You can contact David Betz at 888-965-6696, and he will answer any immediate questions you have and provide you information about our lost to follow-up patient search services.  You can also email David at:  dave@omnitrace.com.

THE CONTENT ON OUR OMNITRACE OWNED WEBSITES IS MERELY GENERAL INFORMATION OBTAINED BY ORDINARY PEOPLE AND NOT LEGAL ADVICE.  ONLY A QUALIFIED LAWYER CAN GIVE LEGAL ADVICE.  WE ARE NOT LAWYERS.