The US Privacy Data Shield: Is Your GDPR Compliance Plan Ruined?

Narrator: This is the DarshanTalks Podcast. Before this week's podcast, US privacy data shield is your GDPR compliance plan ruined, Darshan will introduce this episode with a recap for the week of Friday, July 31st, 2020. Darshan: This week has been a little bit of a clinical trial heavy week. We've seen notices from the FDA where they've put out a guidance on how they want companies to deal with cannabis and CBD products, and they put our guidance on specifically how the clinical research should be done. They had some interesting ideas about where do you actually procure the hemp, if you will. This has been interesting in light of the actual farm bill. This is going to be interesting, because that speaks not only to the clinical research that's being done, but the enforcement efforts the FDA will expect as well in the context of promotion. So if you are manufacturing a product that does not meet FDA standards, or if you're making a product that does not meet FDA standards, but you're making claims that are drug-like claims, the FDA might start prosecuting based on that. So that should be an interesting thing to look out for. Additionally, there is some news out there about how pharma is starting to work more with telehealth. So keep an eye out for that. You'll see that in the newsletter if you subscribe to it. I also am going to do a separate podcast on a CBD and the FDA's position on that. So keep an eye out for that as well. However, talking about telehealth and pharma, we've done several interviews on this so we know that this is an area that is of particular interest to companies right now, so obviously in the area of clinical research, there are companies that are now switching over to doing full blown remote studies. You combine that with telehealth, that's the Holton combination that companies are looking out for. In fact, there was a article that came out saying that clinical trials are rebounding after the COVID-19 crash. Darshan: The question is, are patients going to continue coming in and participating in these studies, when it's evident that there is still a continuing fear about infection because of COVID. The last piece of information that I thought was kind of interesting is this article that I've seen pop up every so often, but the idea that drug companies are influencing academic conferences. We did an interview with Kelly Willenberg where we talked about how important the conferences are for a lot of the companies that are selling to drug companies or to sites. But the question of do drug companies actually use these conferences to influence physicians is really important. On one hand, obviously associations and groups like ASCO and conferences, like ASCO are really important to spread information, but if the information has been contaminated, that's not good. However, when is something contaminated? Is it when there's just no study done and the pharma happens to actually sponsor the conference, or is it in the actual writing of the study itself? Stay tuned. We'll probably keep exploring this as new news keeps coming out. Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com. Darshan: So the recent holding, talking about the US/EU privacy data shield, and I want to talk about that in the context of what's been happening. So let's start from what is GDPR. GDPR is the General Data Protection Regulation. Comes out of the European Union. It covers an individual's rights to basic identity information, such as name, address, ID numbers, web data, such as location, IP address, cookie data, RFID tags, health and genetic data, biometric data, racial or ethnic data,