Diagnostic Image Storage: Regulations and Compliance

With more and more Picture Archiving and Communication System or PACS solutions being offered by different providers, it is essentially important for you to understand the regulations governing the use of PACS or diagnostic image storage solutions in medical practices. There are several regulations that need to be met, and we are going to look at them in this article.

Diagnostic image storage solutions are classified as medical devices, so you need to review the USFDA’s regulations regarding medical devices before completing your purchase. The Food and Drug Administration defines specific guidelines that all system providers must follow. Check if the system you are getting meets these regulations before completing the purchase.

Since the use of PACS is also related to patient’s privacy and sensitive patient details, you must also make sure that the system you are getting is properly secured. HIPAA compliance is a must, so check if the system you are getting is advertised as HIPAA compliant. If you don’t see proper description, don’t hesitate to ask questions regarding this particular compliance.

There are several other specific regulations that you need to understand before you can choose the most appropriate PACS solution to use. The Mammography Quality Standards Act, for example, must be met if PACS is used in conjunction with mammography diagnostic tools.