Regulatory Open Forum

I think "believe" is the operative word here, because I can tell you from personal experience that patients do not have access to their own records. But I accept that Dr. Shuren believes this. He can probably speak from personal experience too, since it seems a virtual certainty that he can and does get access to his own records whenever he pleases.

The statement was in the context of NEST, which he described (not adamantly) as "a little bit unique because it's not an FDA system." He also also happily announced that they had already gotten access to nearly 500 million patient records, a revelation that did not inspire any happiness in me. Nor did the revelation that among those involved in this unique little venture include representation from the patient community, healthcare professionals, healthcare systems, payers, industry, and government.

With all these players potentially getting access to all those data, I started to wonder, if NEST isn't an FDA system, what does that imply about transparency and data access? And did Shuren just answer that question? Did "period" convey "…and that's that" or did it mean "…and that's all the data they can and should have access to"?

My spirits were lifted considerably when one of the Committee members took up the issue of data access, although not with respect to NEST:

…if the manufacturer is collecting any data, I think that data needs to be transparent, not just to the Agency but also to the broader community, and there are different ways that you could do that to make it safe.

 I know that there are competitor issues, but I don't think issues related to competitor advantages are sufficient to explain or excuse restricting access to data. That has been done, or they come up with other constructs for, you know, restricting access to certain datasets to patients versus physicians. And that, to me, is insane.

I think if the Agency is going to be able to use real-world evidence, we should be able to be able to access that structured data in a usable format, be able to pool that data as a patient population and do our own analysis, and be able to compare that with what the company is actually coming out with and what the Agency is acting on.

Of course I'm thinking how enthusiastic both industry and CDRH are likely to be about this plan, especially since she had just revealed that some of her patients are hackers who can help her do all kinds of great things. This left me wondering how many people would be lying awake that night, letting their imaginations run wild, lol.

Has anyone has been following NEST closely enough to know whether data access has been discussed?  If not, I expect that eventually we will all find out what that "period" really meant.

I think "believe" is the operative word here, because I can tell you from personal experience that patients do not have access to their own records. But I accept that Dr. Shuren believes this. He can probably speak from personal experience too, since it seems a virtual certainty that he can and does get access to his own records whenever he pleases.

The statement was in the context of NEST, which he described (not adamantly) as "a little bit unique because it's not an FDA system." He also also happily announced that they had already gotten access to nearly 500 million patient records, a revelation that did not inspire any happiness in me. Nor did the revelation that among those involved in this unique little venture include representation from the patient community, healthcare professionals, healthcare systems, payers, industry, and government.

With all these players potentially getting access to all those data, I started to wonder, if NEST isn't an FDA system, what does that imply about transparency and data access? And did Shuren just answer that question? Did "period" convey "…and that's that" or did it mean "…and that's all the data they can and should have access to"?

My spirits were lifted considerably when one of the Committee members took up the issue of data access, although not with respect to NEST:

…if the manufacturer is collecting any data, I think that data needs to be transparent, not just to the Agency but also to the broader community, and there are different ways that you could do that to make it safe.

 I know that there are competitor issues, but I don't think issues related to competitor advantages are sufficient to explain or excuse restricting access to data. That has been done, or they come up with other constructs for, you know, restricting access to certain datasets to patients versus physicians. And that, to me, is insane.

I think if the Agency is going to be able to use real-world evidence, we should be able to be able to access that structured data in a usable format, be able to pool that data as a patient population and do our own analysis, and be able to compare that with what the company is actually coming out with and what the Agency is acting on.

Of course I'm thinking how enthusiastic both industry and CDRH are likely to be about this plan, especially since she had just revealed that some of her patients are hackers who can help her do all kinds of great things. This left me wondering how many people would be lying awake that night, letting their imaginations run wild, lol.

Has anyone has been following NEST closely enough to know whether data access has been discussed?  If not, I expect that eventually we will all find out what that "period" really meant.