Alexander: Give patients access to health records

A top Senate Republican is calling on the Obama administration to give consumers direct access to their personal health information.

In a letter to Health and Human Services (HHS) Secretary Kathleen Sebelius, Sen. Lamar Alexander (R-Tenn.) blamed the agency for a "resistance" to make medical test results directly available to patients.

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"This is the information age," Alexander, the top Republican on the Senate Health Committee, wrote in the letter sent Thursday. "Individuals should have direct access to personal health information, and federal policies should clearly support that goal."

Alexander pointed out what he said were contradicting policies from the HHS that will "slow down" the process of giving patients access to their own health information through direct-to-consumer technologies such as novel diagnostics and targeted therapies.

He also accused the agency of "not trusting" patients with their own health information.

"Consumers who want to take control of their health should have the right to their personal information to help in making personal healthcare decisions," he wrote.

This comes after the Food and Drug Administration (FDA) in November forced genetic test maker 23andMe to stop selling personal test kits that use saliva samples to diagnose health conditions that people risk developing and negative reactions they might have to certain medications. 

The FDA said it had not approved the test kits for sale, and voiced concerns that the tests could issue false negatives and false positives that could lead consumers to misdiagnose themselves. The agency indicated it didn't want to encourage consumers to replace their doctors with these devices.

Alexander was referring to an FDA warning that "risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed" with these direct-to-consumer devices, and said this move impeded efforts to give consumers direct access to their personal health information.

But he also acknowledged more recent comments from Sebelius stating the need for consumers to have access to this information. On Feb. 4, she said, "Information like lab results can empower patients to track their health progress, make decisions with their healthcare professionals, and adhere to important treatment plans."

In the letter, Alexander asked Sebelius to clarify the agency's policies, as to whether or not they support giving consumers access to their personal health information, and also to describe the criteria it uses to evaluate direct-to-consumer medical tests such as the product 23andMe was marketing.