Mayo Leaders Call For New Health Records Standards

They say benefits from sequencing genomes can’t be widely applied without changes.

Mayo Leaders Call For New Health Records Standards
The promise of tailoring medical treatments to patients’ individual genomes is huge, but can’t be widely applied until medical records are standardized to cope with the massive amounts of data generated by genome sequencing. That’s according to leaders of the Mayo Clinic’s precision medicine efforts.
Work now being done by Mayo and others has brought us to the brink of having genetic information about patients available to caregivers at the bedside, where they can use it to tailor day-to-day decisions about what kinds of drugs would best benefit them against cancer and many other ailments.
But because there are few standards for representing those complex datasets on electronic health records (EHRs), the goal of applying precision medicine on a large scale will be hard to reach unless major changes are made in how those health records are kept.
That’s the take presented by the Mayo Clinic authors of an article published late last month in the medical records industry trade journal For the Record. They included Dr. Richard Weinshilboum, director of the pharmacogenomics program at Mayo’s Center for Individualized Medicine; Dr. Liewei Wang, a Mayo medical school pharmacology professor; and Robert Freimuth, an assistant professor of biomedical informatics at Mayo.
In the piece, the trio lamented that none of the health record systems currently used by Mayo as part of a major new effort to sequence the genomes of 10,000 archived biobank samples were designed to handle the massive amounts of data generated.
And early results of the “RIGHT 10K” project have shown just how important it may be to make that information readily conveyable: Indications are genetic data could be clinically useful on a very broad scale indeed. A pilot study found that 99 percent of the bio-samples yielded “clinically actionable” DNA sequence variations, even just when looking at a small number of genes. It likely means that genetic data could be useful for nearly everyone in determining which drugs are best and which should be avoided.
The RIGHT Study is aimed at figuring how to use this data to alert pharmacists and physicians about possible drug-gene interactions. But the researchers found that conveying it via traditional medical records was cumbersome and time-consuming. As a result, they said, “significant investments” and ad hoc fixes were needed to upgrade Mayo’s EHR infrastructure – something that would not be cost-effective on an industry-wide scale.
So they’re suggesting that new medical record standards will be needed to incorporate patient’s genetic information.
“The lessons learned from this effort identified many opportunities to enhance the organization's EHR infrastructure to more fully support pharmacogenomics and, more broadly, genomic-based precision medicine,” they wrote. “In particular, there are clear needs for advances in EHR design and standards for the representation of genomic data and knowledge.”
Most importantly, they wrote, “robust standards are needed for expressing the results of clinical genomic tests, including both raw results and interpretations, which are unambiguous and computable. Standards are also needed for expressing genomic knowledge, which is used to translate raw results into interpretations.”
The ultimate goal in precision medicine is to move past the current “one-gene-at-a-time” model of implementing care and expanding the scope to look to the entire human genome. But that won’t be possible, the Mayo team concluded, until the info can be reflected in medical records available for doctors, nurses and pharmacists at the bedside. 
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