 Theranos, a health care laboratory startup that was shut down amidst fraud, was the topic of the book Bad Blood by John Kerryru. Among the many mistakes Theranos made was not establishing an administrative barrier between their research and clinical data. According to the book, Theranos really did not have much in the way of policies and procedures, so it's not surprising that they did not think about building an administrative barrier between their research and clinical data. But boy did it ever slap them in the face later when they tried to get approval from the Food and Drug Administration for their new test. Data that are collected for clinical purposes have to follow certain rules. In the U.S., when data are collected for treatment, payment, and or health care operations, otherwise known as TPO, then our HIPAA law applies. And if data are being collected strictly for research, then we have a law called the Common Rule and that's what applies. The Common Rule is what sets up our research ethics boards in the U.S. called IRBs. Let's see how this works in real life. The Women's Health Initiative was a nationwide clinical trial in the United States studying different health conditions in women, including breast cancer. Everyone in the study needed a mammogram at baseline. If you consented to the research study and got a mammogram as part of the study, that fell under the Common Rule only. But if you just had a mammogram in clinical care right before you enrolled in the study, we couldn't just automatically take the clinical mammogram. Under HIPAA, the study participant had to authorize the transfer of the mammogram from clinical data to research data. Hey, if you're a health care startup and this video is making you a little worried, never fear. Just contact me, Monica Wahee, president of DeathWench Professional Services at DeathWench at gmail.com, or you can catch up with me on our webpage at www.deathwench.com. I'll be happy to give you a free consultation.