Google sister company Verily Life Sciences LLC has been under an unprecedented amount of scrutiny since it was promoted over the weekend by President Donald Trump as responsible for a nationwide information and testing program for the emerging novel coronavirus. But, in fact, the existing version is a pilot program in two California Bay Area counties that reportedly only processed 20 tests on March 16, its first day of operation.

The South San Francisco-based company is incorporating the coronavirus testing as part of its existing Project Baseline, a longitudinal study that was designed to monitor 10,000 people to assess various health data to better understand when health tips into disease. Started in 2017, the four-year study officially is no longer enrolling and is slated to report data in December 2023.

But Verily allows an unlimited number of participants in a Project Baseline registry, from which the actual study participants are selected. It is using the pilot COVID-19 program, which is being created in cooperation with California public health authorities, to further expand upon Project Baseline by offering to enroll those tested for the novel coronavirus into the study.

Altering Baseline

“After your testing is completed, you will be asked if you wish to participate in the Baseline Community,” Carolyn Wang, Head of Communications at Verily, told BioWorld of its COVID-19 pilot program. “This will enable you to participate in creating new knowledge that is critically important to the health of all of us in the face of the COVID-19 pandemic.”

“You will also receive information and have a chance to participate in an online community to share insights and knowledge,” she continued. “Participation in the Baseline Community is entirely voluntary, so you will be completely free to decline, in which case your data will not be used for research other than by the California public health authorities for this public health emergency. Under no circumstance will your data be joined with data from Google projects without your specific consent.”

Verily declined to comment on the extent to which it is already seeing COVID-19 symptoms or related complaints or concerns amidst its existing registry or in Project Baseline itself, which includes only U.S. residents who are 18 or older. But it did suggest that updates on this front could be forthcoming.

The Baseline COVID-19 Program is a public health philanthropic effort that is being funded and supported by various entities, Wang said, including Verily, Google and undisclosed health care industry partners.

Privacy concerns

The pilot program consists of three drive-through collection sites, one in San Mateo County and two in Santa Clara County. These two counties encompass the heart of Silicon Valley; Verily itself is based in San Mateo County while its sister company Google is headquartered in Santa Clara County. The Bay Area also has a relatively high concentration of coronavirus cases as compared to the rest of the U.S., but an expansion of the program is planned although it remains unclear when that could roll-out.

“We’re collaborating with the California Governor’s office and federal and local public health authorities early on to expand risk assessment and testing in areas with high volumes of known cases, like the Bay Area,” said Wang. “As testing capabilities expand, we will work with various health authorities to scale our efforts. We are still in the early stages, and based on learnings from the initial pilot, we hope to be able to scale this effort.”

A blog update on Verily’s efforts posted on Wednesday that clearly aimed to quell privacy concerns that have been fueled in the media by its ties to Google. Verily aimed to underscore its adherence to existing health care privacy regulations and its existence as a distinct corporate entity from Google, but the waters were muddied, particularly by a requirement that people tested via their sites are required to have or create a Google email address for authentication, updates and communication.

“Verily is a separate company from Google, and we use Google’s infrastructure to ensure safe encryption and protection of health information,” the blog post noted. It later added, “We are compliant with the California Consumer Privacy Act and comply with all applicable data privacy and security regulations. We are committed to maintaining high privacy standards and keeping your data safe. Project Baseline by Verily follows federal and state regulations governing the collection and use of an individual’s data.”

But some health care privacy regulations already are falling by the wayside in the effort to rapidly meet the patient needs presented by this largely unprecedented crisis. On Tuesday, the U.S. Department of Health and Human Services (HHS) authorized the use of non-HIPAA compliant modes of communication, such as unsecured video chat applications, to enable remote health care services.

How it works

The primary aim of the Verily COVID-19 program is to triage people who are at high risk of exposure and high morbidity. Various chronic diseases have been found to be associated with more severe cases of COVID-19. But even obesity itself is suspected to aggravate the disease progression, which could mean that altogether when considering the elderly, obese and chronic disease patient population there are an enormous number of people who could have an elevated risk for severe cases of COVID-19 that could require hospitalization and even lead to death.

The Verily testing is currently available to people who are 18 or older who live in one of the two counties. Participants are required to sign a public health authorization form, as well as to have or create a Google account.

The website takes potential test subjects through screening questions to determine if they are eligible for testing. However, people with severe symptoms, many of whom still are reportedly struggling to get tested, are excluded from the program and referred to the Centers for Disease Control and Prevention (CDC) site for next steps.

People who meet the eligibility and requirements are then referred to the mobile testing sites, or wait-listed for them, where they will complete a nasal swab test. Similar drive-through testing efforts have gained traction recently, but one of the remaining issues is how to adequately protect the person swabbing for the sample, as well as the best protocol to ensure there is no potential transmission between tested individuals that is tied to the provider’s own protective equipment.

Wang said the company is using “a variety of testing facilities” to process the tests and that results will be returned via email within “several days.” It remains unclear, however, how useful coronavirus testing will be now that community spread is wide enough that many locations in the U.S. are abandoning or failing to implement standard epidemiological contact tracing practices.

Concluded Wang, “We are still in the early stages, and based on learnings from the initial pilot, we hope to be able to scale this effort.”