A final ruling issued February 3 by the US Department of Health and Human Services (HHS) will give patients direct access to their laboratory results instead of having to get them through a doctor's office.
"The right to access personal health information is a cornerstone of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule," HHS Secretary Kathleen Sebelius said in a press release. "Information like lab results can empower patients to track their health progress, make decisions with their health care professionals, and adhere to important treatment plans."
Patients or someone a patient designates can still ask for the laboratory reports from their doctors, but this amendment to the Clinical Laboratory Improvement Amendments of 1988 adds the option of getting the information directly from the laboratory while promising to protect patients' privacy. The ruling will supersede laws in 13 states that prohibit such access.
However, adding this direct access can have consequences. When these changes were proposed in 2011, the American Academy of Family Physicians (AAFP) addressed some of them in a letter to the Centers for Medicare & Medicaid Services.
AAFP President Reid Blackwelder, MD, FAAFP, told Medscape Medical News that although AAFP supports the final ruling, the concerns still stand.
"Patients have a right to their records. We believe in transparency. Patients need to be a part of the process of taking care of themselves, so anything that helps patients be actively engaged is an appropriate and good thing," Dr. Blackwelder said.
"The concerns are that numbers in isolation aren't appropriate. We take care of patients and not numbers. The expectation and the best practice...is to be sure that there is communication between the physician and the practice and the patient about anything that we do."
Physicians' offices still have an obligation to get back to patients to discuss what the numbers mean, he said.
Because laboratory results compare patients' numbers with the "normal" range, numbers outside that range, without a doctor's explanation, may unnecessarily trigger patient fears, he said.
"If you take a normal person with no medical problems whatsoever and I do 100 tests on you, there's a 99-plus percent chance that you'll have at least one abnormal lab. That's why numbers without the context can be difficult."
Under the HIPAA Privacy Rule, patients or their designees or personal representatives can get a copy of their protected health information, including an electronic copy, with limited exceptions, but may have to put their request in writing and pay for the cost of copying, mailing, or electronic transfer, the release said. In most cases, copies must be given to the patient within 30 days of his or her request.
Dr. Blackwelder said he envisions access to laboratory results enhancing the patient portal experience with the transformation to medical homes and wider use of electronic records. For instance, a doctor could post laboratory results with notes on what they mean and recommendations for next steps, and a patient could access them in the portal.
"This is all about us working together. I want you as a patient to feel empowered and engaged," he said.
The rule would take effect 60 days after its official publication in the Federal Register, which is set for February 6. More information about the final rule is available on the Federal Register Web site.
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Cite this: New Ruling Means Patients Can Access Their Own Lab Results - Medscape - Feb 04, 2014.