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irst, some context. My first computer was an Apple IIe. It had a 1.023MHz CPU, 64KB of RAM and booted off of floppy disks with a whopping 360KB capacity. For its time it was amazing; however, there was no such thing as “big data” thirty-four years ago. That computer, which I loved so much, would’ve failed miserably if given the task of crunching “big data” numbers. Fast forward to today. My iPhone has 128GB and my computer has a terabyte of storage. That terabyte is 8000GB, or to put that into context: more than 8000 times the storage capacity of that Apple IIe. In short, “big data”—and the machines required to process it—are now a reality.

Clinical Research and Data: HIPAA, the Common Rule, the General Data Protection Regulation, and Data Repositories