What You Need to Know Regarding Sharing Clinical Trial Data

With the onslaught of discussions relating to personalized medicine and patient centric approaches to drug development and our recent blog on scanning EHRs for clinical trial patient recruitment, we wanted to take a closer look at the rules and regulations involved in ownership of patient data in clinical trials.  

Traditionally, patients enrolled in clinical trials never obtain follow-up results from their lab tests, medical imaging or the results of the trial overall.  With technological advances such as eConsentmHealth, we wondered how patient clinical data ownership is considered now and how it may be considered in the future.  Additionally, what are the laws concerning this patient data according to The Health Insurance Portability and Accountability Act (HIPAA). 


Here’s a breakdown out what we found...

Patient data, even when decoded, cannot be shared without patient approval

This is the case in general, but of course, with every rule there is always an exception.  If an entity is interested in obtaining your information, they could potential position the data to fall under a TPO (treatment, payment or operations) exception and circumvent the need for patient approval.  The process for this goes far beyond this blog, so for more information on this, we’ll refer you to the HIPAA website page that discusses this in more detail.

Patients always have the right to collect their clinical data results

This may seem obvious, but some patients who would like access to their data do not always ask for it.  Although, realistically, the results from the data may not make sense to a lay person, it’s important that people know they do have access to all their tests and results and are always free to ask for copies.  These documents in turn, for instance, can be sent to another provider for interpretation help.


If an entity is making money off of patient data, the patient must be notified – no exceptions

Unfortunately, if an entity is making money off of your clinical data, you are not subject to receive payment for its use.  Yet, you must always be notified of such endeavors.  We’d like to note, we do see a sea change in this area though, with start-up companies like, LunaDNA, that will offer people a form of currency for sharing personal clinical data.