A “quiet revolution” in medicine is underway that involves tailoring care to each patient’s unique genetic and health profile. To be successful, that revolution depends on patients’ access to their health information, which allows them to be partners in their own care. But data access may conflict with policies that support the very technologies that make personalized medicine possible. This conflict has come to a head in the latest challenge to the business model of Myriad Genetics.
A tale of two interests
In 2014, the Department of Health and Human Services (HHS) issued new rules that guarantee access to one’s own health information. The rules, which were adopted under the Health Insurance Portability and Accountability Act (HIPAA), give every person a right to a copy of any information related to their health held by their providers or insurers.
Yet, at the same time society is giving patients more access to and control over their health information, it’s also expanding protections for companies who wish to keep information secret. These protections involve trade secrets, a legal term that generally refers to a company’s information that is:
- Not known to the public;
- A source of economic benefit to the company; and
- Kept secret through reasonable effort.
Until recently, disputes over trade secrets were largely a matter for state judges to decide. But in May 2016, President Obama signed into law the Defend Trade Secrets Act, which allows companies to sue in federal court those who steal or disclose their trade secrets. For a number of reasons, trade secret holders prefer suing in federal court over state court, and so the law has been viewed as a big win for business interests.
The tension builds
In our recent Science magazine commentary, “Myriad Take Two,” my colleagues and I discuss the inherent tension between these two developments in the realm of genetic testing. As a case study, we focus on a test that identifies whether a woman carries a genetic mutation that increases her risk of developing breast or ovarian cancer. For many years, Myriad Genetics owned patents that enabled it to be the exclusive provider of this test.
When the U.S. Supreme Court invalidated some of those patents in 2013, competitors immediately began offering the test at a reduced price. But Myriad has maintained a competitive edge because of the vast amounts of patient data it accumulated when it had a monopoly on the testing market—data that it now keeps in secret. It uses these data to improve its test’s predictive power. Myriad’s results have long been more accurate than those of its competitors, although that gap has narrowed (and may even no longer exist).
But that’s only half the story. While Myriad may be able to legally protect its database and data algorithms as trade secrets, that right doesn’t extend to the underlying information. What’s more, thanks to the new HIPAA access right, patients can now demand access to that information if it concerns their personal health.
A year ago, four of Myriad’s customers asked the company to provide information related to their genetic tests held by Myriad. Although some information was provided, it was sent under cover of a letter that caused them to question how Myriad would respond to future requests. Seeking clarification, the customers filed a complaint with HHS, which has opened an investigation into the matter.
In our commentary, we predict that Myriad and other genetic test providers will be required to provide customers their requested health information. But to the extent that any trade secrets would be revealed in records that include the information, Myriad should be allowed to redact the trade secrets before disclosure, or if redaction is not possible, to withhold that material altogether.
This compromise will allow Myriad to continue to own the building and the blueprint. Yet it will also allow patients to access the bricks and share them with others. We believe the real challenge will be in figuring out how to use the bricks to build something better.