Precision medicine won’t work without patients’ trust

The promise of precision medicine is bringing together patient data and accounting for factors like genetic variability, environment and lifestyle to tailor treatment to an individual. Fulfilling that potential, according to Acxiom and LiveRamp’s global chief data ethics officer Sheila Colclasure, MA, requires using the available data ethically and gaining the trust of patients.

In her presentation at HIMSS18 in Las Vegas, Colclasure said precision medicine is “the perfect storm of technology trends” which could transform healthcare. It’s also attracting major investments, like the $215 million the federal government put into the Precision Medicine Initiative in 2016 and private investments and donations from major companies like Microsoft, Google and Roche.

What could slow down this progress, Colclasure warned, is if precision medicine doesn’t address the lack of trust individuals have towards exchanging their data, which they believe will only benefit businesses who may not protect their personal information.

“When entities use data, even the government or the commercial sector, including our healthcare providers, do the benefits accrue to the individual or the entity? They accrue to the entity,” she said.

Patients will want to know what secondary uses of their data will be allowed, while lawmakers and regulators may question how precision medicine can be trusted with genomic data when breaches of existing protected health information have become so common. Colclasure said “getting your hands” on the data necessary to make precision medicine will be a challenge, considering the varying permissions and prohibitions and the existing data siloes in the healthcare industry.

To facilitate that data exchange easier and get patients to buy into precision medicine, Colclasure advised the industry not to make its data approach like a commercial endeavor, but rather “centered on the individual,” with “fairness at the targeted outcome” and data ethics—not just minimum legal requirements for protecting and using data—baked into every project from the start.

“You can’t bolt this on at the end. You’ve got to design all of that in,” she said. “Legal requirements are the minimum.”

These ethical standards, Colclasure said, should be built into every part of the precision medicine strategy, including data governance, system designs and how the data is used in context. The design should be based on individual benefit, rather than the potential commercial possibilities. As she put it: “You can’t just say ‘Innovators innovate.’ You have to have a way to ensure that we don’t abandon our human values, our cultural values and our social norms.”

One member of the audience asked why precision medicine can’t work with same kind of permissions people accept to use all kinds of mobile apps which collect data on everything from their email addresses to their location. Colclasure said that kind of consent, while meeting legal standards, can easily fall short of the standards of data ethics she’s advocating by putting on the responsibility of knowing how the data is truly being used on the patient—which isn’t going to gain their trust.