The Struggle to Build a Massive 'Biobank' of Patient Data (nytimes.com) 48
An anonymous reader shares a report: This spring, the National Institutes of Health will start recruiting participants for one of the most ambitious medical projects ever envisioned. The goal is to find one million people in the United States, from all walks of life and all racial and ethnic groups, who are willing to have their genomes sequenced, and to provide their medical records and regular blood samples. They may choose to wear devices that continuously monitor physical activity, perhaps even devices not yet developed that will track heart rate and blood pressure. They will fill out surveys about what they eat and how much. If all goes well, experts say, the result will be a trove of health information like nothing the world has seen. The project, called the All of Us Research Program, should provide new insights into who gets sick and why, and how to prevent and treat chronic diseases.
The All of Us program joins a wave of similar efforts to construct gigantic "biobanks" by, among others, the Department of Veterans Affairs, a British collaboration and private companies like Geisinger Health Systems and Kaiser Permanente. But All of Us is the only one that attempts to capture a huge sample that is representative of the United States population. "It will be transformative," said Dr. Francis Collins, director of the National Institutes of Health. It will also be expensive. In 2017 alone, the budget for All of Us was $230 million, of which $40 million came from the 21st Century Cures Act. Congress has authorized an astounding $1.455 billion over 10 years for the project.
While supporters say the results will be well worth the money and effort, others have begun to question whether All of Us is just too ambitious, too loaded with cumbersome bureaucracy -- and too duplicative of smaller programs that are moving much more quickly. In the three years since the All of Us program was announced, not a single person's DNA has been sequenced. Instead, project leaders have signed up more than 17,000 volunteers as "beta testers" in a pilot phase of the program. They supplied blood and urine samples, had measurements taken, and filled out surveys.
The All of Us program joins a wave of similar efforts to construct gigantic "biobanks" by, among others, the Department of Veterans Affairs, a British collaboration and private companies like Geisinger Health Systems and Kaiser Permanente. But All of Us is the only one that attempts to capture a huge sample that is representative of the United States population. "It will be transformative," said Dr. Francis Collins, director of the National Institutes of Health. It will also be expensive. In 2017 alone, the budget for All of Us was $230 million, of which $40 million came from the 21st Century Cures Act. Congress has authorized an astounding $1.455 billion over 10 years for the project.
While supporters say the results will be well worth the money and effort, others have begun to question whether All of Us is just too ambitious, too loaded with cumbersome bureaucracy -- and too duplicative of smaller programs that are moving much more quickly. In the three years since the All of Us program was announced, not a single person's DNA has been sequenced. Instead, project leaders have signed up more than 17,000 volunteers as "beta testers" in a pilot phase of the program. They supplied blood and urine samples, had measurements taken, and filled out surveys.
Big hipaa issues (Score:2)
Big hipaa issues
No HIPAA issues (Score:4)
They're following all the HIPAA security rules for protecting PHI.
Within a couple of years DNA testing will be commonplace, your choices will be submit to it or self-treat with herbs (and good luck with that).
Re:No HIPAA issues (Score:4, Insightful)
PHI gets hacked every day. Someone leaves their patient DB in a public S3 bucket, a database runs as SYSDBA because the developer has to make deliverables, and consequences for a breach will not filter to him/her, backups are done without any regard for encryption key management, AD doesn't have lockouts, nor someone giving a shit enough to actually read logs, especially if someone is trying to brute-force the DA/EA account (which is likely not even renamed.)
Do we want more stuff which eventually will become public domain? With the pathetic way a lot of companies protect PHI/PII, the best thing is that the data never exists in the first place, or is destroyed as soon as possible.
Re: (Score:1)
Very true. The grandparant is a dunce. Being HIPAA compliant means that your stuff is 100% secure, completely hackproof from those physically on site, spear phishing, or from remote attacks. Just saying one is HIPAA compliant means that you don't have to worry about any data ever leaking, just like I click the "turn on encryption" checkbox, and all my data on my laptop is completely hackproof.
I 100% trust companies to store my healthcare and gene records with the utmost confidence, just like I do my cred
Microbiomes (Score:4, Interesting)
This is really behind the times. Sequencing your DNA doesn't tell you your state of health.
The big problem we have with things right now is we don't have a lot of samples of unhealthy people and more specifically pre-symtomatic or people in the process of healing. Static snapshots of DNA are not useful. Your actual state of health is contained in your DNA transcription profile and your microbiome DNA (the relative ratios and types of bugs in your gut)
Amazingly, In the very near future the cost of having your microbiome sequenced is going to drop under $100. At that point every doctors office visit will also include a microbiome sequence. Every person in the ICU getting drip antibiotics will get sequenced every day. At that price it would be stupid not to do it given all that it potentially reveals about your state of health. These sequencing will also sequence the hosts transcription profile as well. That is, what your DNA is doing today rather than just what it contains.
There's a few companies out there now that are doing this on a boutique basis, catering mainly to the current lucrative market of selling supplements and diet advice. (e.g. Viome) But THe infrastructure they are building will get switched on to public health when it's ready. That will mean literally millions of sequencing events every day (world wide) when it's up to full speed.
At that point we'll reach where data analysis can do actual prediction of the health state and be used to guide a patient in an unhealthy state to a healthy one.
Re: (Score:2)
Sequencing your DNA doesn't tell you your state of health.
Sheesh, at least read the summary. This isn't a one-time DNA sample; the study is to track the volunteers' medical records for several years.
Re: (Score:3)
So far as the ACA being repealed: they can and are chipping away at it. De-funding it is all it'll take, or an EO to the IRS to not enforce the Individual Mandate, and it all falls apart.
Just need to integrate with Apple Health (Score:2)
I track my food and exercise, plus the Apple Watch stores my heart rate. All of this data is in Apple Health, and I am sure I'm not the only person. The NIH, others should work with Apple's efforts to bring medial records to iOS 11.3. Save the gov some money, use Apple's infrastructure.
Beta tester here (Score:5, Informative)
Re:Beta tester here (Score:5, Interesting)
Re: (Score:1)
At least, you can bear arms when they are collecting your data. You are safe.
weak troll (Score:2)
data collected by some program like this has no such protections
All medical data (PHI - Protected Health Information) falls under HIPAA, doesn't matter who collects it.
Re: (Score:2)
Re: (Score:2)
Obvious reasons (Score:3, Insightful)
SO, don't work in tech (Score:1)
When I left the tech profession, I was able to sleep well, eat well because I had time to make good food and time for exercise.
you conveniently omitted (Score:2)
one of the favorite subject of 15-year old libertarians: Ganja.
Million genomes or 5 days of war in Iraq (Score:2, Interesting)
Congress has authorized an astounding $1.455 billion over 10 years for the project.
The Iraq war lasted about 10 years and cost a billion dollars every three days. So this million genomes project costs about as much as 5 days of war in Iraq.
Re: (Score:1)
Sure, but the war in Iraq ensuring your freedom so you can't really put a price tag on that can you?
Pay me and we'll talk... (Score:4, Insightful)
I can see this going the same way as all of my other "personal information," in the information age. Namely, all of the data about me will belong to entities that are not me. And from that ownership of my data, they will generate huge streams of income in perpetuity. I propose that this is a fucked up and ridiculous way to continue, especially with detailed medical data on an unprecedented level.
Without a change in this policy I would be lucky to receive nothing from this arrangement. This is highly unlikely though. If it goes like the other arrangements we have seen so far, my information will be covertly used in an attempt to manipulate and control me and others like me. My information will not be available to me. The effects of my information, how it is used, and to what purposes, is also kept from me.
In this case, my data could help cure cancer, prevent genetic diseases, extend life, eradicate obesity. The companies who used this data would become wealthy beyond current imagining. In return for providing the data used to create a new era in the practice of medicine, donors of their data would get to pay for the cures their data created. This is the fucked up part.
You want my data to fundamentally transform the medical field for all time? Cool. Put in writing that I and my descendants will receive full control over how my information is used. I don't want it sold to another country to create mind control drugs or new nerve agents. Second, any advancements that my data helps create are available to me and my descendants free of charge. Lastly, I want royalties payable to me and my descendants, in perpetuity, for any and every use of my data, and for any new treatments that come from my data.
Oh, you wanted all of this information for free, without strings attached? Go fuck yourself.
HIPAA issues, no (Score:3)
Where do I start? Well, how about that the raw data, with the PII and HIPAA information, will probably be on the NIH campus, in their datacenter (also home to the currently 66th most powerful supercomputer in the world, and the most powerful dedicated solely to bioscientific and biomedical research).
Data released will be anonymized - that's std. procedure.
And it's a good step up from the Framingham Heart Survey database, which is three generations into a multigenerational study from 5,000 residents of Framingham, MA (US), which one can assume is a limited view of the population, and still results in very important results. (Yes, I personally know someone working with that data, and the kind of results he's getting have already resulted in at least one published paper by him.)
And I'd CERTAINLY trust the NIH before I'd trust some scumbag private company... like the ones that wanted to patent individuals' own genes.