IBM lobbies Congress to ease FDA regulations on Watson

IBM is eager to deploy supercomputer Watson into the healthcare industry, but still faces regulatory barriers.

Now, IBM is lobbying Congress to reduce the federal regulations on the supercomputer to lessen the time until Watson and other decision support technologies can be utilized, according to a Bloomberg report.

Watson, IBM argues, is not a medical device, so it does not require clinical trials to demonstrate its safety and efficacy, according to the report.

Rep. Fred Upton's (R-Mich.) "21st Century Cures" initiative aims to quicken the pace of introducing cures and treatments into the market. "Health research is moving quickly, but the federal drug and device approval apparatus is in many ways the relic of another era," according to the initiative's website.

Rep. Upton introduced a bill that would allow the U.S. Food and Drug Administration to develop a verification process for "medical software," which would not need to undergo the strict approval process that medical devices like heart stents are required to undergo. Watson would fall under another category of "health software," along with other clinical decision support tools, which would be exempt from all regulation, according to the Bloomberg report.

In a previous address to the House Energy and Commerce subcommittee on health in 2013, Zachary Lemnios, vice president of research strategy at IBM, said current regulations are outdated. "It is important to recognize that the current FDA regulatory framework was largely developed during the decades before the rise of today's sophisticated IT technologies," he said, according to the report.

Rep. Upton wants Congress to pass a bill by the end of the year, according to the report.

More articles on Watson:

VA signs $16M contract with Watson to study PTSD
IBM Watson-powered app to deliver personalized health info
IBM, Cleveland Clinic to use Watson for cancer genomics pilot

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