The increased sharing of patient data as hospitals and health systems research COVID-19 and seek new revenue streams as businesses seek "mining rights" to that data has raised patient privacy concerns.
In a May 28 article published in the New England Journal of Medicine, a team of Ann Arbor-based Michigan Medicine clinicians and researchers highlighted its health system's approach to "big data" agreements with industry partners. The principles have been applied to thousands of UM patients and research study volunteers since 2018.
Before the COVID-19 pandemic began, major health systems had already started selling the "mining rights" to their health data, which current law allows as long as the data is deidentified, according to Kara Gavin, a research and policy media relations manager at the UM Institute for Healthcare Policy and Innovation. Last year, St. Louis-based Ascension made headlines for its Project Nightingale initiative, which raised concerns about the access the health system gave to Google to collect and analyze the personal health information of millions of Ascension patients.
The core of University of Michigan's patient data-sharing system relies on an easily understandable consent document given to research participants when joining one of the organization's research projects. The consent focuses on sharing patient information and any samples the patient provides outside the university. The patient must discuss the outside-sharing consent form with research staff, who are required to assess the patient's understanding of what the additional consent means.
More than half of research volunteers have given consent for their data to be shared, and if their samples are sought for a project with a specific company, the patient is informed of the specific project and company. Patients are allowed to revoke their consent in the future. If a patient does not consent to sharing their data or samples, UM teams may still use their information for academic research under a broader consent document and approval from the ethics board, according to the report.
The other component of Michigan Medicine's data-sharing approach is a committee that meets weekly to review, approve and track any projects that involve patient data- or sample-sharing with companies. The committee is responsible for overseeing all proposals that include sharing data and specimens with nonacademic entities.
"The temptation has never been greater to take shortcuts around health data protections to vie for huge federal grants or to develop and monetize intellectual property,” said Marschall Runge, MD, PhD, executive vice president for medical affairs and dean of University of Michigan medical school. "That is why we have adopted our approach, and we hope it will serve as an example for others"