Earlier this week, the United States Supreme Court ruled that a diagnostic testing company could not patent and exclusively control the use of a method for determining the right dosage level of a class of drugs; measuring metabolite levels and telling providers to make applicable adjustments, they said, is not a patentable invention.
The company at the heart of the case, Prometheus Laboratories, had patented a diagnostic testing kit which determined the dosage level of the drugs and issued a warning when the metabolite level was above or below a certain number. It sued the Mayo Clinic, which had purchased the kits, for patent infringement when the hospital refined the process and began using the newer one.
The Court said that the company couldn't restrict providers that way. "They tell a treating doctor to measure metabolite levels and to consider the resulting measurements in light of the statistical relationships they describe. In doing so, they tie up the doctor's subsequent treatment decision ... and threaten to inhibit the development of more refined treatment recommendations," Justice Stephen Breyer said, writing for the Court.
So what does all of this have to do with electronic health records? A lot, potentially, including beyond whether a lab can dictate treatment decisions by virtue of owning a patent.
Think of all those systems alerting clinicians about measurements that are too-high, for instance. Sure, providers often ignore such alerts. But now, will providers be able to change them without recourse if they want them at a different setting? Do providers now have more control over the clinical decision support tools in their EHR systems? Will vendors now be more likely to accept physician input in the design of their EHR systems, and maybe even make their EHR products more usable?
"Customizing depends on who owns the software," Marc Resnick, a professor of human factors and information design at Bentley University in Waltham, Mass. tells FierceEMR. Vendors, he says, often will allow their EHRs to be customized, but typically will do the work themselves, for fear of giving away trade secrets.
But while the software for products may be copyrightable, can the same be said for telling physicians what to do in a particular instance?
Patient safety and malpractice concerns also loom. Vendors typically set their alerts based on what they consider sound scientific evidence, according to Resnick. They may not want providers unilaterally changing an alert, however, because they don't want to be liable if any changes injure a patient.
On the other hand, some vendors may be willing to allow changes in the alerts because it could "absolve [them] from malpractice liability," Resnick says.
And what about the SMART program that will enable providers to buy EHR modules to add to their base EHR system, much as one adds an application to an iPhone? What if warning thresholds in those module applications differ from the ones in a base EHR system? Do providers get to choose which alerts to change?
Resnick sees an added EHR issue related to the Mayo case. When providers start to aggregate their data in health information exchanges and other networks, no one can patent or copyright the data. But if an entity invents an algorithm to mine and analyze the data, is that patentable? And if so, can that patent holder exclude others from accessing or mining the data?
"This will [all] be the subject of many cases. It's a gray area," Resnick says.
It is indeed. Legal issues tend to lag behind scientific advances. As the EHR industry matures, however, the law will do its best to catch up. Result: we'll be seeing many more lawsuits. - Marla