Personal health information (PHI) carries indisputable value to individuals — both clinically and financially. Yet, as it stands, patients have little or no say on how their own health data are shared. Some ethicists argue nonfungible tokens (NFTs) can be used to create a more ethical and transparent system.
“Given the sensitivity and granularity of a lot of digital health data, we saw an ethical concern that needed to be addressed,” says Kristin Kostick-Quenet, PhD, lead author of a recent paper on this topic.1
Kostick-Quenet was joined by legal scholars, health information exchange experts, and bioethicists. “Despite our differences of perspective, we all agreed on one thing: Data protections, in the current health information exchange marketplace, fall short,” says Kostick-Quenet, PhD, an assistant professor at the Baylor College of Medicine Center for Medical Ethics and Health Policy.
Concurrently, there is growing capacity to access de-identified PHI and trace it back to individuals. Patient privacy regulations dictate patient data stored in localized, centralized servers or in electronic health record systems must be de-identified before sharing. Yet Kostick-Quenet warns “a burgeoning industry has emerged, with the aim of re-identifying that information and tracing it back to individuals.”
Although patients face clear risks from someone de-identifying and sharing their data, they do not have any control over who can access their data and for what purposes. During the current buzz about NFTs, “we noticed that the underlying technology offers potential to address the data protection gaps,” Kostick-Quenet says.
The goal is to return some measure of control to patients. By linking health data to a “smart contract” (the technology underlying NFTs), people could control who can access the information. “This has direct ethical implications for patient autonomy and agency over personal and sensitive health information,” Kostick-Quenet cautions.
However, there are obstacles if the data are stored in an insecure system, or if hospitals already are sharing data based on agreements outside the patient’s control. If so, Kostick-Quenet says NFTs will not be of much value.
She stresses that if “smart contracts” are to protect data appropriately, they must be protected under the umbrella of a broader system of technologies — and patients must actually care about protecting their privacy.
When someone agrees to donate biosamples to research, that person probably believes researchers will put those samples to good use. Many researchers are making good faith efforts to turn donated biosamples into scientific discoveries or medically actionable information. In reality, the samples likely are to be stored in a freezer for years and eventually discarded, although data about them likely remain in a database indefinitely.
“What we in the bioethics world call the learning health system has a critical design flaw,” argues Marielle S. Gross, MD, MBE, assistant professor of OB/GYN and bioethics at the University of Pittsburgh. Gross co-authored a paper arguing NFTs can promote efficiency, effectiveness, and justice in learning health systems.2
Current research practices force patients to sacrifice their right to know what happens to their own samples, or to have access to benefits if samples are clinically relevant. Researchers are prohibited from identifying those individuals or contacting their physicians. This is ethically problematic, since many participants donate samples with the specific intent of wanting to help others. “They have a right to know that the system they donated to made good on that offer,” Gross says.
Gross says there is a “massive disconnect” between the intentions of patients and health systems to capture biosamples as resources for research, and the reality that biosamples are not widely available to people who would want to use them. “That essentially prevents that work from manifesting its potential,” Gross argues.
Ethically, patients have a right to benefit from research using their own samples. That issue has become more pressing because of recent advancements in precision medicine. Biosamples are far more likely to be clinically relevant to individual patients. “Even in the past five years, what we’ve learned in genomics is totally frame-shifting. Ten years ago, if the sample wasn’t clinically relevant, they didn’t have a reason to update you,” Gross observes.
Now, that biosample sitting in a freezer could be informing the patient’s (or a family member’s) treatment. “It’s sitting there, and it doesn’t belong to you — and other people are monetizing it in the meantime,” Gross adds.
There is ongoing controversy over who owns the biosample. Is it the principal investigator on the research protocol, the hospital, the university, the funding organization that sponsored the biobank or study, or the patient? “There’s just no good reason why somebody shouldn’t be considered the owner of their own literal body part,” Gross offers. “We’ve identified the biggest bioethical problem in the learning health system, and we’ve done absolutely nothing to solve it.”
Research labs take biosamples from patients and might identify pathogenic mutations in those samples, but then have no way to let the patients know about the findings. This is even the case if the patients are undergoing treatment within the researcher’s health system. “The researcher is now burdened by knowing this information is relevant to this person, but has no way to return the results,” Gross notes.
Gross sees a parallel with controversial research on stem cells derived from embryonic tissue. Technology enabled researchers to induce stem cells from induced pluripotent stem calls. “People still use embryonic stem cells. But the reliance of the entire field on it was eliminated, along with the surrounding tensions. It allowed science to move forward with a technological fix to that ethical problem,” Gross says.
Likewise, NFTs offer a technological solution to the ethical problem involving patients’ biosamples. “NFTs can be utilized, in a privacy-preserving way, to tether individuals to their samples,” Gross explains. “It can empower people to assert their ownership of biosamples. It’s an ethical problem that’s solvable with a technological solution.”
Meanwhile, biobanks are discarding samples that are only becoming more valuable in terms of potential benefit to individuals as precision medicine continues to advance. If patients were actively involved in ownership of their biosamples, Gross says it is unlikely the biosamples would just sit in freezers for years, unused, and ultimately discarded. Instead, those patients likely would seek out researchers to use their biosamples. In turn, researchers would be permitted to share the data with patients.
“It’s going to take a combination of enabling technology, possibly an act of Congress, to move the health systems into alignment with what the right thing to do is here,” Gross predicts. “But it’s unquestionably necessary to do that.”
REFERENCES
- Kostick-Quenet K, Mandl KD, Minssen T, et al. How NFTs could transform health information exchange. Science 2022;375:500-502.
- Gross M, Hood A, Miller Jr R. Nonfungible tokens as a blockchain solution to ethical challenges for the secondary use of biospecimens: Viewpoint. JMIR Bioinform Biotech 2021;2:e29905.
Personal health information carries indisputable value to individuals — both clinically and financially. Yet, as it stands, patients have little or no say on how their own health data are shared. Some ethicists argue nonfungible tokens (NFTs) can be used to create a more ethical and transparent system.
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