consumer expectations around the treatment of personal data, said Steve Weber, faculty director of the Center for Long-Term Cybersecurity at the University of California, Berkeley. “That’s one of the key stories to tell about this incredibly ambitious initiative.” The involvement of Google, which makes money from mining people’s data, “could make people nervous,” Weber said.
When asked about these concerns, Wang provided this statement: “We do not share personal health information with Google unless we are collaborating with Google on a Verily project or using Google’s infrastructure or services, and then only as permitted by law, our contracts, and patient consent. Verily does not permit the use of the personal health information it collects for marketing or similar purposes.”
As for the recruitment portal that Vanderbilt and Verily were working on in their pilot project, that job—as well as building mobile apps and wearable sensors—is now in the hands of a group that includes Topol and Wilbanks. That piece of the PMI is dubbed the Participant Technologies Center. In addition to Scripps and Sage, mobile health-app builder Vibrent is the third major contractor.
The goal there is to recruit 350,000 Americans, said Topol. (Those recruits would, in effect, walk in off the street. The PMI also aims to bring in hundreds of thousands more people through health plans, such as those affiliated with the University of Pittsburgh and Columbia University in New York, and through community health centers.)
November is three months away. The last time the Obama administration rushed a healthcare-related portal—the launch of the Affordable Care Act sign-up site Healthcare.gov—it was a disaster.
Topol said the only parallel in this case is the government oversight. “We have exquisite plans for this to run smoothly” at launch, he said. From the get-go, infrastructure should be in place for all volunteers to get a baseline physical exam, a blood draw, and to fill out a survey. But genome sequencing and other high-tech tools, like wearable sensors, wouldn’t be available immediately for everyone. “It won’t be launched at scale,” said Topol. Stitching in people’s electronic health records could also take some time, especially if they join the PMI on their own instead of through their health plan.
As details of Google/Verily’s involvement in the PMI continue to emerge, it’s also worth noting what the company is not contributing to the PMI. Verily scientists are working on an array of medical devices for their own projects, but for the PMI, wearables and sensors fall under the Participant Technologies Center. And despite months of work on the recruitment pilot, Vanderbilt and Verily aren’t handing over technology to the Scripps-led team. “It was more foundational [thinking] about how to start this program,” said Denny. (Topol characterized the pilot project as “warm-up things.”)
A critical part of the PMI will be the consent form that lets volunteers know clearly what they’re signing up for. That piece of the recruitment puzzle goes to Wilbanks’s Sage Bionetworks. Sage did similar work for the Apple ResearchKit software, which lets citizens share health data through their iPhones with scientists.
Vanderbilt and Verily did “background work” on consent as part of their pilot, said Wilbanks. Notably, the consent form from Verily’s own long-term health study called Baseline came under scrutiny just after the pilot project with Vanderbilt was announced. In April, a STAT report questioned whether the consent form in an early version of Baseline, conducted at a health spa owned by Verily’s CEO, was transparent about the potential use of volunteers’ health data for profit—licensing their data, for example, to drug companies eager for new insights into health and disease.
When asked if the Baseline consent form has changed, Mega said, “We have a responsibility to have consents that inform patients. It always has been and will be our intent to lean into these areas that are regulated and to provide full transparency to patients.”
There has been talk that long-term studies such as Baseline or the Murdock study at Duke University might eventually contribute data to the PMI, helping it reach its goal of one million people.
Mega said there are no plans to funnel data into the PMI from Baseline, which has not begun recruitment beyond the controversial test run. When asked why, Mega implied that the data sets wouldn’t line up. Baseline will try to capture “a more comprehensive view of an individual,” she said, with “clinical assessments that will require people coming into a facility, undergoing imaging tests or studies beyond genomics. I don’t think one million people are going to contribute in that way.”
Even if PMI volunteers commit varying levels of information, proponents hope the sheer scale will drive new discoveries. “This gives us the opportunity to identify root causes of many diseases, the same way that the Framingham Heart Study”—a intergenerational study in Massachusetts that began in 1948—“identified the root causes of heart attacks,” said Broad’s Kathiresan. “With Framingham, data came to the researcher. That’s no longer feasible. We’re moving to a world where the researcher goes to the data.”
