Robert (Bob) R. Hearn, Member of the Firm in the Health Care & Life Sciences and Litigation & Business Disputes practices, in the firm’s St. Petersburg office, was quoted in Healthcare IT Today, in “Surveying Laboratory Tests from a Health IT Perspective,” by Andy Oram.

Following is an excerpt:

We read that “70% of today’s medical decisions depend on laboratory test results,” according to the CDC. This three-part series looks at modern tests from a health IT perspective. How can we make them more accurate and delivery faster results? Which ones can we move into the home? How do we eliminate wasteful, unnecessary tests? This first article offer an overview of tests and their context. …

The Regulatory Landscape

Attorney Robert Hearn of Epstein Becker Green says that labs and tests fall under a “patchwork” of regulations. To ensure accuracy, Congress passed the Clinical Laboratory Improvement Amendments (CLIA) 25 years ago. All states except New York and Washington states require adherence to the CLIA. The FDA has separate regulations for in vitro diagnostic (IVD) products, which run tests on blood or tissue.

Furthermore, state laws dictate who can order certain types of tests: For instance, to avoid the abuses created by direct-to-consumer marketing, you can’t order most clinical tests for yourself.
Not all states require licenses from labs, and those that do so enjoy the revenue they get from issuing licenses. Many states are dismantling their lab regulations because they just duplicate the CLIA or add little value.

Finally, payers have requirements, as we’ll see in the next article. Hearn would like more homogeneous regulation.

Wellness tests and tests for ancestry, such as 23andMe, are not regulated, but they can’t be used for diagnosis or to provide medical information. Hearn says that the health care industry is moving to make more tests accessible to patients directly.

New tests are usually developed in academia or by start-up companies associated with academic institutions. The big commercial labs tend to take the “bench science” and create tests around it. Getting a test approved by payers requires a big investment.

Barriers to Data Sharing

Hearn predicts that the genetic and biomarker information being collected on patients can help researchers develop new tests faster. Sharing information on patients can also improve testing in other ways that we’ll see in the next article.

Hearn worries that the integration of information from many sources will lead to problems with privacy protection and data ownership. Labs have to figure out how to seamlessly share data while preserving their proprietary interests.

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