Johns Hopkins' Kulynych: Privacy issues a threat to the future of precision medicine

Detailed data that advance precision medicine may not be as anonymous as researchers suggest they are.

Precision medicine is poised to change the face of healthcare, but privacy issues could present a significant challenge.

The rapid growth in the collection and analysis of huge amounts of healthcare data rests upon the idea that medical researchers can identify useful patterns. In an op-ed for OUPblog, Jennifer Kulynych, J.D., Ph.D., senior counsel for The Johns Hopkins Hospital and Health System argued that the industry has oversold its ability to effectively anonymize the medical information necessary for precision medicine.

Researchers have traditionally been allowed to use “de-identified” data, but Kulyniych noted that term doesn’t have a consistent definition. That leaves open the possibility that such “anonymized” data could actually be linked back up to its source—a process known as “re-identification.”

“While your fingerprint, long known to be useful for re-identification, was protected under the 2003 federal HIPAA Privacy and Security rules as a ‘biometric identifier,’ your genome was not—and today, 14 years and millions of genotypes later, still is not,” wrote Kulynych.

That’s a problem in an era of high-profile security breaches, which have raised alarms among privacy advocates and government agencies. With more and more interconnected electronic health record systems and the likelihood that genomic data seem increasingly likely to be included in the typical healthcare data collected on patients, Kulynych sees a growing need to “demand better security oversight of the privacy risks” such practices would create.

Furthermore, she noted, most patients never know that their medical records have been shared for research purposes, and therefore might not even be aware their privacy is at risk in the first place. That has meant little pressure on researchers to pursue better security technologies and practices.

The window of opportunity for any costly development may also be narrowing, given the cuts to the National Institutes of Health in President Donald Trump’s proposed budget, which have raised concerns around funding for initiatives supporting precision medicine as well as the Cancer Moonshot.