Americans Want to Share Their Medical Data. So Why Can't They?
Americans are willing to share personal data — even sensitive medical data — to advance the common good. A recent Stanford University study found that 93 percent of medical trial participants in the United States are willing to share their medical data with university scientists and 82 percent are willing to share with scientists at for-profit companies. In contrast, less than a third are concerned that their data might be stolen or used for marketing purposes.
However, the majority of regulations surrounding medical data focus on individuals’ ability to restrict the use of their medical data, with scant attention paid to supporting the ability to share personal data for the common good. Policymakers can begin to right this balance by establishing a national medical data donor registry that lets individuals contribute their medical data to support research after their deaths. Doing so would help medical researchers pursue cures and improve health care outcomes for all Americans.
Increased medical data sharing facilitates advances in medical science in three key ways. First, de-identified participant-level data can be used to understand the results of trials, enabling researchers to better explicate the relationship between treatments and outcomes. Second, researchers can use shared data to verify studies and identify cases of data fraud and research misconduct in the medical community. For example, one researcher recently discovered a prolific Japanese anesthesiologist had falsified data for almost two decades. Third, shared data can be combined and supplemented to support new studies and discoveries.
Despite these benefits, researchers, research funders, and regulators have struggled to establish a norm for sharing clinical research data. In some cases, regulatory obstacles are to blame. HIPAA — the federal law regulating medical data — blocks some sharing on grounds of patient privacy, while federal and state regulations governing data sharing are inconsistent. Researchers themselves have a proprietary interest in data they produce, while academic researchers seeking to maximize publications may guard data jealously.
Though funding bodies are aware of this tension, they are unable to resolve it on their own. The National Institutes of Health, for example, requires a data sharing plan for big-ticket funding but recognizes that proprietary interests may make sharing impossible.
The best way to fix this problem is to go straight to the willing sources: individuals who want to donate their data to science. At present, there is no simple way for patients to donate their personal data for broad use in medical research. Individuals can consent to specific uses of specific portions of their medical data while they are alive — consenting, for example, to sharing records associated with participation in a particular clinical trial. However, this consent does not extend to the entirety of an individual’s medical data or enable future researchers to access that data. If individuals have not affirmatively provided consent, HIPAA restricts the use of their personally identifiable health information for 50 years after death. As a result, a massive amount of valuable medical data is locked up and inaccessible to researchers.
To address this problem, policymakers should establish a national medical data donor registry to enable individuals to donate their medical data to science after death as easily as they can check “organ donor” on their driver’s license application. Congress facilitated organ donation by passing the National Organ Transplant Act in 1984. It should now pass legislation authorizing the creation of a data donor registry. This registry could be operated by a non-profit organization under the oversight of the Department of Health and Human Services (HHS). Allowing individuals to donate their medical records would create a rich trove of shared data for medical and scientific research. Individuals’ records of consent for data sharing could be linked to a range of invaluable medical data sources, from electronic health records and mobile medical app data to government vital records, such as the Social Security Administration’s Death Master File. A national medical data donor registry would save lives.
For its part, HHS could establish and enforce policies to maximize the beneficial use of data, protect donors’ interests, and restrict data access to legitimate researchers and research projects. It would ensure compliance with U.S. law regarding genomic data, and other laws related to individuals’ health data. It could also establish processes for enrolling patients in the registry, which might occur at any qualified health provider’s office, and allowing individuals to give informed consent for donation. The result — a single set of national policies for donating data —would make it easy for people to understand and trust data donation and expedite the registry’s expansion.
There is broad agreement about the benefits of medical data sharing. Moreover, it is clear that many patients want to share their medical data to better medical science. Policymakers should make it easy for Americans to donate their medical data to science by establishing a national medical data donor registry. A registry is a key step toward breaking the gridlock around data sharing in medical research, and breaking that gridlock is a key step toward saving lives.
Eleni Manis is the 2018 Google Public Policy Fellow at the Center for Data Innovation and an MPA candidate at New York University's Robert F. Wagner Graduate School of Public Service.