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FDA Crowdsourcing its Way to Precision Medicine. But What About Security?

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By Hallie Golden November 25, 2015

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When it comes to achieving President Barack Obama’s Precision Medicine Initiative -- an effort to laser-target medical care based on patients' genetic make-up -- collaboration among researchers is key.

So a team at the Food and Drug Administration is launching a crowdsourced platform to provide a digital environment for members of the genomics community to work together.  

PrecisionFDA is a cloud-based research and development portal designed to allow researchers to analyze genome data and run comparisons against reference material, such as sample data widely accepted. FDA launched the project in July, and a team of developers devoted to the project released a closed beta version of the site earlier this month. In just a few weeks, the site will transition into a beta format.

But with the onslaught of federal agency breaches, the question of securing a platform containing piles of genome data that anyone could potentially access by simply applying for an account is an important one.

“Privacy and security is not something you sprinkle on top at the end,” said Taha Kass-Hout, FDA’s chief health informatics officer, in an interview with Nextgov. “We worried a lot about meeting industry standards and federal standards as far as the infrastructure, as far as the platform and as far as the software that’s been added.”

Work on the platform began two years ago, he added.

All of the data and software included on the platform is encrypted, he said. The team also enabled "versioning" to keep track of all of the information shared on the site.

The site uses multifactor authentication and tests to make sure each user is a human and not a bot, Kass-Hout said.

Users can work in private and public spaces on the site, depending on whether they want to upload data and work with existing data in an environment open or closed to the whole PrecisionFDA community. When researchers use the private area, even the PrecisionFDA team can’t access their data, Kass-Hout said.

“This whole notion about private spaces and group shared areas, that was really necessary because a lot of folks say, 'Look you know, I just want to come to this environment to try things out right now; I'm not really ready to share stuff yet,’” he said.

The platform also asks users to submit only basic personal information, such as the names of organizations and people connected to each account and a phone number.

There are still some security questions the PrecisionFDA team is in the process of fleshing out. The team has not yet determined exactly how it plans to vet people who seek access to the platform.

The general consensus is that anyone should be able to access the public area, Kass-Hout said. The team plans to make a final decision based on the requests for access to the platform received over the next few weeks. 

(Image via venimo/Shutterstock.com)

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