Clinical Trials in the Cloud (Part II)

The other day I posted an overview of the new OpenClinica Optimized Hosting offering. Since then we have received requests for more detail on how we secure the data in a customer’s OpenClinica instance against unauthorized access. This is obviously a very important topic!

The particular questions were asked in the context of HIPAA–particularly the HIPAA Security Rule–and the answer below is framed in this context. But even if HIPAA is not relevant to you (because you have no PHI in your OpenClinica instance, you’re not part of a covered entity, or you’re outside the U.S.), the safeguards described below are generally applicable best practices and can be applied in the context of most security compliance/regulatory regimes.

In general the requirements of the HIPAA Security Rule can be summed up as...