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Tuesday, April 14, 2020
Verily’s Baseline Platform: Investing in Security and Privacy
The Public Health Crisis
We are in the midst of the most significant health crisis in over a century. COVID-19 has been declared a global pandemic, and we have yet to understand how it will affect us today and in the future. The more we know, the better and sooner we can respond. At Verily, we are doing everything we can to assist in developing
smarter COVID-19 testing
to inform public health. In March, we launched the Baseline COVID-19 Program to expand availability of COVID-19 screening and testing, beginning in California.
Verily’s Baseline
Verily’s
Baseline platform
has been in development for almost five years and was envisioned as a new approach to bridge clinical research and clinical care. The platform is designed to benefit from the profound improvement in computing and the new digital environment, often referred to as the
Fourth Industrial Revolution
. A much more interactive approach to discovery is now achievable. Furthermore, a modern health data and clinical research platform can deal with the vast amount of data that must be stored and analyzed to develop new treatments and to understand which medicines, devices, digital tools, and care delivery are best for which people.
Privacy and Data Minimization
A primary goal of Baseline is to make it easier for people to engage in research so that we can ensure better representation in clinical studies, more comprehensive data collection, and faster evaluation and time-to-market for innovative tools and therapeutics. We understand that privacy and confidentiality of people’s data is critical to building the trust of the community we serve.
Verily has done extensive work over the past few years to develop private and secure platforms, and has published
Verily’s privacy commitments
. The Baseline platform has been employed in clinical research for years and hardened to protect data and users. Our privacy practices specific to Baseline are informed by the following frameworks:
FDA: The Baseline platform is
Part 11 compliant
, a key component of privacy and security in dealing with sensitive research data regulated by the Food and Drug Administration.
ISO 27001: The Baseline platform is
ISO 27001 certified
to ensure compliance with leading security standards.
CCPA: The Baseline platform supports compliance with the
California Consumer Privacy Act (CCPA)
, which enhances privacy rights and consumer protections. Verily is applying the protections of CCPA across our operation of the
Baseline COVID-19 Program
.
HIPAA: The Baseline platform supports HIPAA compliance, depending on partner needs. With regard to the Baseline COVID-19 Program, Verily is not acting as a covered entity or business associate within the context of HIPAA. Verily employs security controls that map to the HIPAA Security Rule (for more, please see the
HIPAA Security Rule Crosswalk to NIST Cybersecurity Framework
). Verily strives to go above and beyond the requirements of individual regulatory frameworks to appropriately safeguard user information and to help in this public health emergency.
For the Baseline COVID-19 Program, we have committed to minimizing the data we collect for the purpose of enabling this testing and only collecting what is necessary to enable people to get tested. We are committed to deleting this data once the public health emergency is over, except where individuals provide their explicit consent for additional uses of their data, such as clinical studies. To provide context, current expert projections are that this public health emergency will last at least 18 months; because COVID-19 is a new disease, we expect to retain the data throughout this time period to assist public health.
Authentication with Google Accounts
As we build products that are used for clinical research or healthcare delivery many people have asked why we require that a person have a Google account. As part of the sign-up flow for all Baseline clinical studies, including the Baseline COVID-19 Program, our platform requires individuals to link to an existing Google Account or to create a new Google Account (which can be done with any email address) for authentication purposes. This is important for two reasons:
Data Security:
We need world class authentication to protect people’s information. We are protecting health information, ordering tests, and returning health results. Without a strong authentication procedure, unknown people could send or receive information with serious consequences for health or well-being, and bots or fraudulent attacks could be made on the platform.
Proven Solution:
Verily uses Google for cloud services, including data storage, computing infrastructure and authentication services, as do many other organizations. Google provides best-in-class authentication and has a world-class team of security and privacy experts dedicated to building, maintaining and evolving defense for the Google ecosystem. Features such as
two-factor authentication
, account recovery,
fraud/bot detection
, and
phishing protection
are important. This authentication system enables clinicians, researchers and healthcare systems to securely and privately contact individuals and transfer information during the screening, testing and research process. Google’s access to data is strictly limited to the purpose of providing such services. All the data provided by Baseline COVID-19 Program users for screening is stored separately and not linked to a user’s Google Account, which is used for authentication purposes. Data will never be used for advertising purposes.
The Future
We are dealing with a crisis in the midst of a pandemic. This will take considerable work in a shorter period of time than “business as usual,” and there are many priorities vital to the public health. Given that the Baseline COVID-19 Program was built on Verily’s pre-existing Baseline platform to secure health information, it enabled us to quickly develop a reliable, secure and authenticated site. We feel fortunate that the Baseline platform was ready to go and fit for this public health purpose.
We appreciate the opportunity to help people, patients, health departments, clinicians, and researchers deal with this pandemic. We take our responsibility to protect data seriously and will continue to explicitly inform people as we take this journey together.
Wednesday, April 8, 2020
Developing smarter COVID-19 testing to inform public health
As we’ve rolled out a
community-based COVID-19 testing program
in conjunction with the State of California, we’ve received many questions about how we collect data during the screening process, why it matters, and who is eligible for testing through our program. In short, the process is designed to quickly, securely and accurately screen and test individuals with concerns about COVID-19 while also giving state public health officials high-quality information to respond to this crisis. As former Commissioner of the FDA during the Zika virus crisis, I have a healthy respect for the value of taking action to deal with an infectious epidemic. I also developed a deep appreciation for the importance of reliable data to support the best decisions about policy and healthcare.
The goal of our work with the California community-based testing program is to rapidly screen and test high-risk people who do not need immediate medical attention, such as those exposed to COVID-19 or frontline healthcare workers and first responders. It is also critical for health officials to have timely and accurate public health data to help determine where the novel coronavirus is likely to spread and where the most vulnerable communities are. While many public health departments have systems for tracking positive tests, more comprehensive information across counties and systems is
currently lacking
. Data from individual testing sites and aggregate data could inform decisions the local and state authorities will make about social distancing measures and provide a basis to adjust screening criteria to ensure that people with the greatest need for testing receive it.
Over the past few weeks, we and our partners have established four community-based COVID-19 drive-through testing sites in San Mateo, Santa Clara, Sacramento and Riverside Counties. We’ve quickly and responsibly scaled each site and intend to launch with three new sites in California this week.
As COVID-19 spreads exponentially, we must move fast to stand up more community-based testing centers. On March 31, there were more than 186,000 confirmed cases in the U.S. up from roughly 30 on March 1, according to the
Centers for Disease Control and Prevention
(CDC). As the pandemic continues to spread, hospitals will need to focus on people with significant illness and healthcare workers. During this acute phase, screening less symptomatic people away from a healthcare setting can help avoid spread of infection and consumption of stressed hospital resources.
Additionally, a secure and connected system that enables a person to register, get an appointment, complete the test quickly and receive a secure test result can help communities efficiently establish a systematic testing approach. Our
Community Based Testing Guide
provides publicly available information about what we have learned that will be useful to others setting up testing sites.
Why We Need Data for Public Health
Because COVID-19 represents a public health emergency, federal, state and county public health agencies are required to track the results of the tests and analyze data about people who are infected to inform decisions about how to manage the epidemic. Typically, there is a significant lag between the return of a test result and the collection of more detailed information, and little is known about what is different about people whose tests are positive versus those whose tests are negative. The Baseline COVID-19 Program’s technology platform is designed to collect this information, which by law is handled confidentially by public health authorities.
Anonymous screeners are readily available on the CDC.gov website and elsewhere, and some allow people to input information and find a potential testing site without identifying themselves. These screeners also have an important role in stemming the epidemic, but they do not enable receiving an appointment for the test, nor do they enable followup of a person linked to their test result. Accordingly, we support the use of available screeners, but the Baseline COVID-19 Program has a specific use in the testing and public health ecosystem.
Since our launch on March 15, more than 60,000* individuals have completed the public health screener through the online tool. The screener is dynamic and the criteria may change over time based on public health data and directives by the California Department of Public Health (CDPH) on
populations of greatest concern
. As we scale testing at these facilities and begin opening new ones, the triage algorithm will be adjusted in response to CDPH objectives. As a result, it’s possible that individuals who are not currently eligible for testing through this program may become eligible in the future, as public health guidance involving testing shifts.
In-depth data on COVID-19 spread and its impact on specific at-risk populations such as the elderly or people with multiple illnesses can help health authorities make more informed decisions and tailor containment efforts at the local, county, and state level. Data can also help determine which underlying health conditions pose the greatest risk to people infected with COVID-19. In the U.S., preliminary data show that those with diabetes mellitus, chronic lung disease and cardiovascular disease appear to be at higher risk for severe COVID-19-associated disease,
according to a March 31 report
by the CDC. Further data will help validate those findings.
Along with increasing visibility into positive results across counties, collecting public health data through smarter screening and testing can also help public health officials see how initial findings map to key risk factors.
We will continue to develop the Baseline COVID-19 Program and to share updates on our progress as the pandemic runs its course. We will provide individuals and public health authorities with information needed to improve decisions about individual health and to reduce the impact of the epidemic as much as possible. As the pandemic continues to evolve we will adapt our approach based on data and the guidance of public health officials who have
served California well
in order to help individuals who need to be tested for COVID-19 while also providing information for the critical role of evidence-driven policy that is so critical to successful management of health crises.
- Robert M. Califf, MD, MACC, Head of Clinical Policy and Strategy for Verily and Google Health
*Based on data collected as of 4/06/20.
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