This is a great question and one that can be answered the same way for any self-developed data collection tool like Clinical Studio.The nature of this type of software actually prevents it from being organically HIPAA certifiable, given that customers use the software to design their own databases and collect the type of data they need in a study. When customers build their studies, Crucial Data Solutions does not directly certify studies to ensure they are not collecting combinations of personal identifying information which would violate HIPAA guidelines. Study validation must include direct certification by the sponsor or study manager if it is required.
The question naturally becomes, "Is my study HIPAA compliant?" The Sponsor or Study Manager would be able to answer that question. Certification is an option the sponsor would also have with an external certifying entity.