H2O opens a way for future data sharing

Public private consortium, led by Takeda, collects and incorporates patient outcomes into healthcare decision making, while ensuring patients have control of their data.

Meni Styliadou, VP, Global Program Leader, Health Data Partnerships and Founder & Co-Lead of the Health Outcomes Observatory or H2O, explained the scope and project details to the Clinical Data Disclosure Transparency and Plain Language Summaries Europe, audience.

Under the framework that real-world evidence data in all its forms is necessary to provide for better patient care, Styliadou told the audience: "We think that real world evidence can be a treasure trove, and what creates the biggest opportunity going forward is the fact that now, with digital technologies, we could actually have better quality real world evidence than we had in the past."

Meni Styliadou, VP, Global Program Leader, Health Data Partnerships and Founder & Co-Lead of the Health Outcomes Observatory

H2O includes 20 partners from 12 different countries, and includes academic institutions, research organizations, non-profits and European Federation of Pharmaceutical Industries and Associations (EFPIA) companies. The H2O project is led by Takeda and coordinated by the Medical University of Vienna (MedUni Vienna).

Clearly, one of the most significant challenges in this process is striking the right balance between data sharing and protection. Especially in the European health data space under the auspices of the GDPR. To address this at H2O, it gives patients ultimate control of their health data and ensures that only they exercise this control.

The H2O project does this through the concept of "data trusts" or "outcomes observatories," which operate under independent boards comprising clinicians, patients, government representatives, and health technology assessment (HTA) bodies. This structure ensures that data is managed ethically and effectively on behalf of patients.

Styliadou described the independent data trust as, “It's outside of any organization, and it's a bit like a library, if you will, a real world evidence library with an independent board, with clinicians, patients, the government, HTAs being on the board of this independent entity.”

The next step is the use of that data. Since the data is held within an independent trust, the thought was they woudn’t need to ask patients for consent for the secondary use of data, explained Styliadou. However, the patient organizations that were consulted by H2O in the development were adamant that patients have an opt-out provision in the use of their secondary data. What the final solution allowed was a built-in technology opt-out that patients would get a notice of a query on their data set, and they can opt-out there, in a simple way.

“The patients were saying that we will probably never exercise the opt out, but we just want to know that we have it,” said Styliadou. “The patients really appreciate [the process]. We have only 1,000 patients right now, but no one has exercised [the opt-out].”

The implications of this project extend beyond immediate patient care. The improved quality and accessibility of real world data, as well as the growing capabilities of digital technologies, could transform other aspects of healthcare, from drug development to regulatory decision-making and health technology assessments.

Styliadou envisions a future where this data "can start being really complementary to what we have from the clinical trials and open completely new ways for us for doing research, post-marketing surveillance, evidence generation for HTAs and improve patient outcomes at the same time."

Learn more about clinical data sharing at our upcoming conference.

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