STAT, October 4, 2017
Casey Ross and Ike Swetlitz

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To the public, IBM trumpets its Watson supercomputer as the next big thing in medicine, a new kind of machine that melds human expertise with digital speed to give patients personalized treatment advice.

Meanwhile, in the halls of Congress, company executives have been delivering a blunter message: We will revolutionize patient care, so please get out of the way.

Like any new technology, Watson poses unknown risks; for example, what if its advice is wrong and harms a patient? But IBM argues that its machine doesn’t need to be regulated because it’s different from other medical devices. It’s not like a pacemaker or a CT scanner, so the company shouldn’t have to prove to the government that it’s safe and effective.

Now, as federal regulators prepare to weigh in on that issue, a STAT examination shows the lengths to which IBM has gone to shield its prized machine from government scrutiny.

The company’s fingerprints are all over legislation passed last year that exempted several types of health software from FDA jurisdiction. A former IBM executive helped draft the blueprint for the law. In the months before its filing, IBM hosted an event with the eventual bill sponsor to introduce Watson to influential members of Congress. And the company then deployed a team of lobbyists to press its position that Watson should be legislatively walled off from regulation.

IBM got most of what it wanted, though not the ironclad protection it sought from FDA oversight. In coming months, the agency will issue new guidelines clarifying which software products will be exempt under the new law, known as the 21st Century Cures Act, and which will still require some level of review.

The implications are huge for IBM, and it’s not standing idly by: Eight of its employees were registered to lobby on this issue during the first half of this year. The company also is pressing its positions through a newly formed “AI Caucus,” a group of lawmakers whose stated goal is to ensure that innovations in artificial intelligence benefit Americans. [...]

biotechnology fda health information technology health law policy public health regulation