ABSTRACT

Luna is a member-owned genomic and medical research platform developed by the public benefit company LunaPBC. LunaPBC seeks to redefine the relationships between people, communities, industry, and researchers. LunaPBC envisions that people and leaders can come together as a problem-solving community-of-communities and use their data as a new way to address disease and improve quality of life. Luna is structured such that anyone in the world can join the platform, share their health data for research, and U.S. residents can take ownership shares in Luna. The leadership team was motivated to establish Luna to address the challenge that most patient data collected for research does not include the voices and lived experiences of individuals. It also becomes part of institutional data silos, rendering it largely inaccessible, and the individuals who contributed their data have virtually no way to guide how it is used beyond its original purpose. Founded in 2017, Luna is funded through biotechnology companies and venture capital organizations. Approximately 35 patient advocacy organizations and affinity groups host their communities on Luna as of October 2020. Luna has designed its platform and processes to better support connections between research participants and researchers and give participants direct control over how their data are used.

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Case Study at-a-Glance: Luna PBC and the Luna Platform.

BACKGROUND

Luna is a platform created by the public benefit company LunaPBC to support data sharing between individual consumers and researchers. LunaPBC serves as the management company for this platform. Ownership shares are available to Luna members based on the types and amount of health data that are shared for research; all shares in Luna are owned by members who have shared their data for research. As profits are generated from the research conducted in the platform, shareholders in Luna are entitled to dividends (cash distributions) in proportion to how many shares they own. The creators of Luna sought to encourage privacy-protected health data sharing by consumers, demonstrate a new model of consumer data transparency and oversight, make the process of contributing data straightforward for consumers, allow consumers to maintain control of their shared data, and make the data as accessible as possible to the research community.

The underlying philosophy is data democratization by giving participants control over how their research data will be used, which is further undergirded by stringent commitment to data privacy, security, and compliance laws—chiefly the European Union’s General Data Protection Regulations (GDPR) and the California Consumer Privacy Act (CCPA). In creating the Luna platform, the founders were motivated by what they saw as fundamental flaws in the research ecosystem, particularly that many studies do not attain a sufficiently diverse population, and that research dollars are effectively wasted if data are used for one study, when they could answer additional questions. The value proposition is similar for both people sharing their data and the research community, in that it allows everyone the opportunity to “put health information to work for good.” Offering a simple, secure way to contribute to health science and participate in communities of support is an additional way that Luna is seeking to create value.

DESCRIPTION

Luna as a platform is designed to ingest and manage numerous types and formats of data, enabled by application programming interfaces (APIs), which make it possible for different applications to talk to each other. The types of data that can be uploaded to the platform are dynamic and evolving. At this writing, the capabilities included DNA files from 23andMe, Ancestry.com, and other direct-to-consumer DNA companies, as well as patient-reported outcomes, such as Luna-generated health surveys and validated survey instruments. Information from electronic health records (EHRs) can also be supplied to the Luna platform via patient portal integrations for continuous data flow from the EHR to the platform. At a researcher’s or community’s request, Luna can bring in additional data types, such as whole genome and exome DNA files, RNA, microbiome, fitness/activity trackers, smart devices, and medical devices. Automated quality assurance protocols are built into the process of data ingestion and submission, based on the type of data (i.e., genomic data, survey data, registry data). For example, genomic data markers are well described and transparently reported in public databases. Thus, genotypic data uploaded by an individual may be compared against the expected type and structure of data from each direct-to-consumer DNA vendor.

Once health data are uploaded by a consumer and reviewed for quality and sufficiency, they are de-identified, encrypted, and aggregated by the Luna platform. From that point forward, the person is a member of the platform. Researchers from academic institutions and pharmaceutical companies are the typical “customers” for the data—they pay for services associated with and access to the platform and are only permitted to use the Luna platform for approved research studies. The Luna platform itself is Institutional Review Board (IRB) approved, and proof of approval for a given study by an IRB or comparable research oversight body is required as a prerequisite to data access. For instance, an academic researcher would gain approval from their home institution, including approval to use the platform, before the research study could proceed. All data analysis is performed within a secure computational “workbench” within the Luna platform to maintain a member’s control over their shared data. Comprehensive terms of use and an accompanying privacy policy function as a contract, and explain how data contributors and those who access data are expected to comply (LunaDNA, 2020a). The community is dynamic with respect to numbers of active studies and collaborators. At the time of this writing, Luna includes approximately 50 member communities active on the platform. Member communities range from 50 to more than 20,000 active participants.

Researchers initiate collaboration with Luna via direct outreach to LunaPBC or through an online inquiry link. Collaborations can advance pending internal review by LunaPBC staff, the researchers’ provision of IRB approval or exemption, and acceptance of the terms of use and associated policies. Review typically takes one-to-three business days, depending on the nature of the study. Not-for-profit research is made available at discounted rates in line with the LunaPBC corporate charter to advance improvements in human health and quality of life. Research in pursuit of commercial activities and the creation of intellectual property are priced accordingly.

Luna’s transparency and oversight architecture centers on recognizing individuals’ data as currency and compensating them for sharing personal genomic and health data for research. This is achieved by issuing shares based on the type and volume of data being shared within Luna. Per Luna’s SEC filing circular, 714,528,714 shares are available and are valued at $.07 each, for a total of $50 million (LunaDNA, 2020b). Approximately 285,000 shares had been issued as of November 2020. The ability to attract interest on the part of both consumers (data contributors) and the research community is an integral pillar and key dependency for this value proposition to succeed. The choice to establish LunaPBC as a public benefit corporation to operate the Luna platform was fundamental in the eyes of Luna’s founders, in that it creates a social contract with the shareholders.

For researchers to use the Luna platform, they must have IRB approval (or the equivalent outside of North America). Study design guidance is available through a partnership with Genetic Alliance, using the Alliance’s 30 years of experience advocating for and conducting research with disease and community-led patient groups. Luna’s ethos is “people-centered governance,” which is consistent with its adherence to and embrace of the European Union’s GDPR regulations: people have oversight and agency over their data and how they are used.

The Luna model addresses a key barrier noted in Health Data Sharing to Support Better Health Outcomes: Building a Foundation of Stakeholder Trust, namely that there is a lack of widespread understanding of the value of patient-generated data. Luna’s leaders cited a growing body of bioethical literature on personal agency and control over how one’s data is used, and the desire among consumers for reciprocity and transparency. They built the Luna platform using privacy-by-design in direct response. Development and launch of Luna followed a timeline similar to GDPR (passed in 2016, implemented in May 2018) and the 2018 CCPA; privacy-by-design was “very influential” in Luna leadership’s decision to create Luna as a public benefit corporation (PBC). Data from more than 180 countries are currently shared via the Luna platform. The founders note that their Securities and Exchange Commission (SEC) filing marks the first time that data are viewed as currency, as is the implementation of a research platform that treats personal data privacy as a fundamental right of an individual (Kain et al, 2019).

While discussing sociotechnical considerations of this model, the interviewees referenced the philosophical differences between surveillance and participation, and the positive connotations of providing data for participation in research—contrasted with companies owning data on an individual that the individual does not control. Luna uses a technology that creates pseudonymous records for each member that knit different data types together. Personal identifiers are separated from the shared research data while the platform maintains the ability to crosswalk different data sources as they are dynamically shared by each member. Two-factor identification is used to enhance data security to support data privacy control, recognizing that control of an individuals’ lived experience over time is paramount and will affect one’s inclination to participate in a given research study. Approval of one’s data use is granular to the level of study: the members themselves choose studies in which they will enroll. If a member is not enrolled in a study, the researcher cannot access their data for the purposes of executing that study. In short, trust is central to Luna’s social contract.

With respect to uptake of the platform, outreach for research participation occurs via email to registered participants. The majority of members have participated in more than one study. Contributing members can withdraw their data at any time. If a member joins a registry/community or study, the community leader and study PI can use a recontact agent embedded in the platform to contact the member while preserving the member’s anonymity. In this way, the member can be invited to new studies. The member also has the option to allow any researcher to contact them (and thus invite them to other studies) even if they did not join their community or study already. Inversely, members can restrict engagement to only a specific registry.

FUTURE DIRECTIONS

Luna is one of several companies developing a model of remunerating individuals for sharing access to their health data for research. As such, its leaders urged that the research community—both academia and technology companies—should keep evolving with consideration of “modern” data privacy gestalt. It is common to want to hold onto a historically entrenched perspective with respect to data ownership, but new models and innovations related to data control and data valuation are needed. They observed that data exchange platforms and partnerships on Amazon and other technology behemoths are proliferating, while universities are deliberating approaches to monetizing and licensing as it relates to health research data (Pew Charitable Trust, 2021). Luna’s leaders urged that academic systems leverage preexisting infrastructure rather than creating their own, and that decision-makers should “lean in” and learn from historic examples of health data being misused or used without consent. A 2021 survey of perceptions of sharing health data showed growing support for sharing of data with clinicians, portending that the terrain will change for research as well.

When asked about one thing that could be changed at will (e.g., with a “magic wand”), the Luna President noted, “We know digital, remote, longitudinal trials are the way to go, but we still have natural history studies in pediatrics where patients have to fly to a clinical site to be studied, which is extremely burdensome and, in some case, dangerous.” She noted that considering how to collect robust data while keeping people safe at home can be accomplished with the right infrastructure and participation platform, including deployment of in-home technology and assurance of proper oversight and participant protections. This type of platform, then, is of the essence, particularly as stakeholders in health and health care seek to accelerate patient-centered, real-world effectiveness research.