The majority of individuals on Luna want to accelerate research and ensure their data is used as they allow. We considered a recent article in Forbes, and we broke down two recent legal opinion articles on medical data privacy and rights when it comes to your data’s application in research (article links below).
As standard practice in US healthcare, laboratory results, doctor’s conclusions, and any other information collected during your virtual or in-person visit is digitally captured and stored for later reference by the healthcare provider. This information is protected under the Health Insurance Portability and Accountability Act, referred to as HIPAA, to protect your private information from disclosure to parties outside of your care team. There are provisions under HIPAA for the de-identification of health data (which is simply the removal of your name, address, and other information that would clearly link the data back to you) so it can be shared freely for health research purposes – so-called secondary use of health data. Some types of health data, such as DNA information that may be collected to make treatment decisions, are inherently challenging to de-identify, and some argue impossible, despite their significant utility for research.
The balance between research benefit (i.e., the advancement of knowledge to guide improvements in diagnosis and treatment of diseases) and the role that individuals play is evolving. Many of the contemporary data protection and privacy laws around the world such as Europe’s General Data Protection Regulation (GDPR) and California’s Privacy Rights Act (CPRA) are built upon HIPAA and Fair Information Practice Principles (FIPPs) from the 1970s to define a right for individuals to control the use of data that is collected from them. And while this right to have control over the use of one’s data is absolute, the intersection between secondary use of de-identified data and the control granted by privacy legislation needs to find common ground for health data from all peoples to be included for research to have representation from the widest range of backgrounds possible.
The debate on this intersection of approaches is couched in terms of data ownership and control of data use. Unlike many other tangible assets like real estate or a piece of furniture, data can be used simultaneously by many parties without degrading the value of each party’s use of the data. This difference has shifted thinking to consideration of the control of data use (i.e., rather than data ownership) to be of paramount importance. And moreover, the trend globally and increasingly at the State level in the US is that the control of data use should rest with the individual on whom the data was collected. This argument is most compelling when considering an individual’s DNA data that uniquely characterizes them. As it pertains to the secondary use of health data, a case can be made that shifting the control of data use from institutions to individuals provides a direct pathway to greater study participant engagement and more inclusive participation of individuals in future research studies.
Articles Reviewed for this Blog
“The Future Of Personally Identifiable Information And Health Data”
https://www.forbes.com/sites/forbestechcouncil/2023/07/18/the-future-of-personally-identifiable-information-and-health-data/?sh=694704622468
“Data Unlocked: Why Rights Mean More Than “Ownership” in B2B Data Sharing”
https://gowlingwlg.com/en/insights-resources/articles/2023/data-unlocked-rights-over-data/
“Ensuring Data Privacy in Genomic Medicine: Legal Challenges and Opportunities”
https://www.jdsupra.com/legalnews/ensuring-data-privacy-in-genomic-8975727/
About Luna
Luna’s suite of tools and services connects communities with researchers to accelerate health discoveries. With participation from more than 180 countries and communities advancing causes including disease-specific, public health, environmental, and emerging interests, Luna empowers these collectives to gather a wide range of data—health records, lived experience, disease history, genomics, and more—for research.
Luna gives academia and industry everything they need from engagement with study participants to data analysis across multiple modalities using a common data model. The platform is compliant with clinical regulatory requirements and international consumer data privacy laws.
By providing privacy-protected individuals a way to continually engage, Luna transforms the traditional patient-disconnected database into a dynamic, longitudinal discovery environment where researchers, industry, and community leaders can leverage a range of tools to surface insights and trends, study disease natural history and biomarkers, and enroll in clinical studies and trials.