IBM insists Watson should not be regulated as a medical device
IBM has been trying to persuade the US Food and Drug Administration (FDA) that its Watson supercomputer does not need the same regulatory oversight that medical devices are subject to. The FDA is set to release guidelines on which software products will be exempt from the forthcoming 21st Century Cures Act. The impending legislation prompted IBM to launch a $26m lobbying campaign seeking a "common-sense regulatory distinction between low-risk software and inherently higher risk technologies". Critics have said IBM's artificial intelligence algorithms are still not widely understood, blur decision-making between man and machine, and should be subject to regulation.

IBM to Congress: Watson will transform health care, so keep your hands off our supercomputer

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.

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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.