The judge here is being incredibly silly. They are ordering the FDA to perform medical grade redaction on 55,000 pages a month.
These clinical trial documents are chock full of patient data and clinical notes.
These clinical trial documents are chock full of patient data and clinical notes.
If they are literally manually redacting patient data from pages and notes then that is a flaw in the study, I think.
I would expect patient data to be pretty limited in the trial data since they are purposefully double blind. Notes are a different story, but I’m sure there are techniques that can be purchased for entity resolution that can automate the scrubbing for PHI and PII.
Seems more like the FDA and Pfizer being silly than the judge.
You can't fully automate this because we require almost 100% accuracy. You need a manual review to ensure no data is leaked.
This is how medical providers share notes without manually reviewing them all.
[0] https://www.hhs.gov/hipaa/for-professionals/privacy/special-...
The FOIA request was for all of the documentation used to approve the vaccine.
> I’m sure there are techniques that can be purchased for entity resolution that can automate the scrubbing for PHI and PII.
Sounds like a good way to have "anonymized" data that isn't actually anonymized like most datasets ...
I think this is a big problem when it comes to stuff like data brokering and selling. Less so with issues like this because vaccine data researchers are less likely to cause harm to someone than others who buy anonymized data.
That's a feature, not a bug. Bureacracy is a game, and they are grandmasters.
The plaintiffs in this case are asking for the clinical medical history of everyone in the clinical trials, which is a bit trickier to provide.
I think they can hurry.
But my point on this being the subject of a vaccine mandate still holds.
That doing their job is hard isn't an excuse to not do it.
Personal medical information, especially as part of clinical trials, is some of the most legally protected data in the world. You can't just hand it out to people. And even with medical grade redaction (which is very expensive) there is always a risk of leaked information getting past the filters.
I just find it funny that HN, usually a place very concerned with privacy, is now suddenly demanding the release of some of the most private and personal information of tens if not hundreds of thousands of individuals.
Additionally, if Pfizer were to have been told to be prepared to redact PII, I'm sure authors could have easily marked PII during authoring for quick identification and removal. Someone had to write this stuff, it didn't just appear in the ether.
The data not available is personal medical information of patients that has to be collected for and during trials because some of it might become important if something bad happens during the trial. E.g, if some trial patients suffer serious adverse reactions you want to have all their medical information on hand to better understand what went wrong.
For a trial that goes well the vast majority of that information turns out to not have been looked at or used.
So 50 people on a normal (40 hour work week) could do this in a month. The FDA has 18 000 employees. I think the answer is clear.
The Judge told the FDA to take the FOIA law seriously and, so they remember to next time, ordered them to do so quickly.