IBM Works To Avoid FDA Oversight For Its Watson Software

Posted on October 25, 2017 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

I live in DC, where the fog of politics permeates the air. Maybe that’s given me more of a taste for political inside baseball than most. But lest the following story seems to fall into that category, put that aside – it actually involves some moves that could affect all of us.

According to Stat News, IBM has been lobbying hard to have its “cognitive computing” (read: AI) superbrain Watson exempt from FDA oversight. Earlier this year, eight of its employees were registered to lobby Congress on this subject, the site reports.

Through its Watson Health subsidiary, IBM has joined the crowded clinical decision support arena, a software category which could face FDA regulation soon.

Historically, the agency has dragged its heels on issuing CDS review guidelines. In fact, as of late last year, one-third of CDS developers were abandoning product development due to their uncertainty about the outcome of the FDA’s deliberations, according to a survey by the Clinical Decision Support Alliance.

Now, the agency is poised to issue new guidelines clarifying which software types will be reviewed and which will be exempt under the provisions of the 21st Century Cures Act. Naturally, IBM wants Watson to fall into the latter category.

According to Stat News, IBM spent $26.4 million lobbying Congress between 2013 and June 2017. While IBM didn’t disclose how much of that spent on the CDS regulation issue, it did tell the site that it was “one of many organizations, including patient and physician groups, that supported a common sense regulatory distinction between low-risk software and inherently higher-risk technologies.”

IBM also backed a bill known as the Software Act, which was opposed by the FDA office in charge of device regulation but backed enthusiastically by many software makers. The bill, which was first introduced in 2013, specified that health software would be exempted from FDA regulation unless it provided patient-specific recommendations and posed a significant risk to patient safety. It didn’t pass.

Now, executives with the computing giant will soon learn what fruit their lobbying efforts bore. The FDA said it intends to issue guidance documents explaining how it will implement the exemptions in the 21st Century Cures Act during the first quarter of next year.

No matter what direction it takes, the new FDA guidance is likely to be controversial, as key regulatory language in the 21st Century Cures Act remains open to interpretation. The law includes exemptions for advisory systems, but only if it’s they allow “health care professional to independently review the basis for such recommendations.”  Lawyers representing software makers told Stat News that no one’s sure what the phrase “independently review the basis” means, and that’s a big deal.

Regardless, it’s the FDA’s job to figure out what key provisions in the new law mean. In the meantime, waiting will be a bit stressful even for giants like IBM. Big Blue has made a huge bet on Watson Health, and if the FDA doesn’t rule in is favor, it might need a new strategy.