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.
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.
Watson and similar “clinical decision support” technologies help guide physicians in their diagnosis and treatment of diseases. This new generation of machines promises to harness the power of big data to improve the care of patients, but it also blurs medicine’s traditional line between doctor and machine, posing new potential risks to patients.
Some doctors and consumer groups have argued that artificial intelligence systems such as Watson are exactly the kind of technology the FDA should be examining more carefully.
“Until we understand the basis for the AI and how the algorithms work, there really needs to be that third-party check and transparency,” said Dr. Reshma Ramachandran, cochair of the FDA task force at the National Physicians Alliance. “We want to make sure there’s no harm done at the end of the road.”
The alliance was one of a handful of groups that raised concerns about the software exemptions included in the 21st Century Cures Act. Its lobbying was dwarfed by the efforts of IBM and other deep-pocketed companies and interest groups that spent large sums to sway lawmakers.
Between 2013 and June 2017, IBM spent $26.4 million lobbying Congress, the White House, and federal agencies, according to the company’s disclosure forms. It is unclear how much of that money was spent pushing for proposals to reduce regulatory barriers facing health software. IBM said in a statement that its advocacy on these topics “represented a fraction of one percent of our lobbying spending from 2013 to 2017.”
But the company declined to say exactly how much it spent or answer questions about whom it lobbied during that time period.
IBM had one of the largest teams of lobbyists working the issue over the past four years, with 14 of its own employees registered to lobby on the software proposals, along with three outside firms. Their advocacy coincided with a massive marketing campaign featuring celebrities such as Bob Dylan and Serena Williams, in which the company repeatedly dangled promises that Watson would transform health care.
‘Until we understand the basis for the AI and how the algorithms work, there really needs to be that third-party check and transparency.’
A recent STAT investigation found that one of Watson’s flagship products, Watson for Oncology, is falling far short of that goal. The system claims to recommend the best treatments for individual patients, but Watson is struggling to master the various forms of cancer and has only been adopted by a few dozen hospitals worldwide.
IBM is also selling products that help match patients to clinical trials and provide cancer treatment recommendations based on genomic data, through a partnership with Quest Diagnostics.
Whether the Food and Drug Administration will regulate these products should become clear shortly. The agency has said it intends to issue guidance documents spelling out how it will implement the exemptions in the 21st Century Cures Act in the first quarter of 2018.
Watson poses unique challenges for the FDA, which until now has used a clear dividing line to exercise its powers: It does not regulate the judgment of doctors, only the safety and effectiveness of medical devices and drugs they prescribe.
But systems that rely on artificial intelligence, by their nature, are meant to combine man and machine, presenting questions that test the relevance of the FDA’s framework. Dr. Meghan Dierks, a professor at Harvard Medical School and director of clinical systems analysis at Beth Israel Deaconess Medical Center in Boston, said the implications of this new union must be considered carefully.
For example, IBM executives say Watson for Oncology is designed to “democratize” medical knowledge and help guide doctors with less specialized expertise in treating cancer patients. But in advising those doctors, Watson cannot fully explain the rationale for its decisions.
So in those situations, where the dependency on the machine is higher, and the underlying rationale for the decision less clear, more oversight of the system might be warranted, she said.
“If how Watson got from input to output is not obvious to the end user, it’s a harder case to be made that the practitioner is independently making the choice and simply using this as an information tool,” Dierks said.
She served on a federal panel that advised the FDA on how it should regulate medical software and mobile health applications. The panel, known as the FDASIA work group, called for a flexible approach to these technologies.
IBM, which also served on the panel, disagreed with that position. The company supported the work group’s approach of assigning risk levels to various categories of software, and exempting low-risk decision support tools from review.
“We believe that Congress should update the statutory framework to provide clarity that ‘health management’ or clinical decision support software should not be regulated as a medical device,” Tim Sheehy, an IBM lobbyist, wrote to the FDA in July 2014.
By then, the company was already pushing a bill known as the Software Act.
The bill, filed by Representative Marsha Blackburn, a Tennessee Republican, was modeled on a legislative framework created by a nonprofit Washington think tank, the Bipartisan Policy Center, which has received funding from IBM and an array of other technology and health companies, including Intel Corp., McKesson Corp., and Johnson & Johnson.
The drafting of the blueprint was led by Janet Marchibroda, a former chief health care officer at IBM. Marchibroda, who worked for the company in 2009, said IBM was an active player in the effort to develop the framework, but so were many other companies and stakeholders. She added that the group did not directly address questions posed by Watson and other systems that use artificial intelligence.
“At the time — no one was really working in that area to be honest,” Marchibroda said. “I mean Watson was beginning, but ... I think our principles still stand.”
The FDA office in charge of device regulation opposed the Software Act, saying it could limit its discretion to balance patient safety against the potential benefits of new software. But IBM was among the earliest and most ardent backers of the bill.
Zachary Lemnios, vice president of research strategy at the company, told the House Energy and Commerce Committee in November 2013 that Watson could “impact patient treatment and save lives” and that such software is “low risk” and need not be regulated. He said the Software Act would “ensure that US consumers have access to the most innovative health care IT without being burdened by regulatory requirements that will not improve the safety of the products.”