“In health research, there is a notion that being included is a human right because otherwise you may not be awarded the benefits.”
Limor Shmerling Magazanik, managing director of the Israel Tech Policy Institute, shared this insight during her guest lecture in Professor David Hoffman’s Cybersecurity and Health Data Policy class. The more patients who agree to allow use of their health data for research, the better informed medical professionals will become, creating the opportunity for more personalized care.
During her lecture, Magazanik focused on the secondary use of health data. Secondary use is the practice of repurposing information originally collected for clinical trials or for the provision of healthcare and then using this information for new, unrelated research. It raises questions of both privacy and cybersecurity. Different countries have different methods of collecting, organizing and protecting health data for secondary use.
Magazanik’s discussion of several of these methods made clear that the United States has much to learn from its global peers. However, she also acknowledged that our country’s unique political structure will likely pose a challenge to implementing strategies from abroad.
One such strategy is the creation of central data hubs in Finland and France, which store the health information of residents in secure, government-controlled environments. Researchers can apply to use data from these hubs. An ethical board then reviews the researchers’ project proposals to ensure that they are designed to respect the integrity of data subjects and promote wide-spread healthcare improvement. Central data hubs thus streamline the process of obtaining health data for secondary use by creating a system under which the data is both well-protected and easily accessible.
Implementing a similar system in the U.S. has the potential to improve patient outcomes and decrease the high costs of healthcare. However, tensions between the federal and state governments may limit this system’s effectiveness.
Based on Magazanik’s insights, I believe a possible way forward for the U.S. is to create central hubs at the state level, allowing for each state to have its own health data repository. This would require additional regulations governing data transfer between states. Such regulations must ensure that health information remains secure, while also setting out requirements for institutional review board (IRB) evaluation – specifically, whether the evaluation should take place in the state where the data originates or, alternatively, in the location where the research project will ultimately occur. However, if researchers fail to share data across state lines, it may create issues related to skewed demographics. For example, people of color are unlikely to benefit from the results of a study that uses data exclusively from a state with a disproportionate number of white residents.
An alternative model is to have each state keep its own repository and then regularly transfer its data to a national hub under the federal government’s jurisdiction. Similar to the Finnish and French models, researchers can then apply to the national hub for diverse data sets. I believe that this model is preferable to the former because it gives researchers access to a larger data pool, allowing them to conduct more informative studies.
Gaining public support for a central data hub requires that we cultivate greater trust in the ethical review process. All U.S. residents – especially those who have historically faced discrimination at the hands of the healthcare system – must feel that they can trust IRBs to ensure that researchers are using data to improve health outcomes.
The first step to generating this trust is to amend IRB membership requirements so that boards are composed of individuals with diverse backgrounds, experiences, and perspectives, who can help confirm that data sets accurately reflect population demographics. Data subjects must then be made aware of this change. From here, it may be possible, in the words of Magazanik, to shift the narrative from a “right to opt out” to a “right to be included.” If individuals understand how including their data in secondary research can improve their health outcomes, they will likely be more willing to allow it.
We should all have a right to privacy, especially when it comes to sensitive health data. However, we should also all have access to personalized, effective care. Increasing the amount of data available for secondary use is the most direct route to achieving this. Once the public is able to recognize that the inclusion of data in medical research is a human right, rather than just a potential privacy violation, we will all begin to reap the benefits of more advanced medical insights.
Samantha Littenberg is a rising senior at Duke majoring in Public Policy with a minor in History and a certificate in Markets & Management. She plans to pursue Environmental, Social and Governance (ESG) work in the financial sector after graduation, integrating her study of environmental and social policy with her interest in business.