In February, the Department of Health and Human Services issued a ruling that’s worthy of notice: each of us now has the right to gain direct access to our medical lab reports. In some ways, the new rule isn’t all that new. There was considerable chatter about this prospect back in 2011, when Secretary Kathleen Sebelius first proposed it. Better late than never, I guess.
The final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow laboratories to give a patient, or a person designated by said patient, access to his or her own completed test reports upon request. Of course, patients can continue to get their laboratory reports in the usual way from their doctors, but they now have the option to obtain a copy of those same results themselves.
This change drew strong support from the Genetic Alliance (again, back in 2011). The advocacy organization’s policy statement on the matter argued that access to this information could help to inform patients about their condition and lead them to ask better questions. One of the strongest bits of evidence demonstrating the need for such a rule comes from a 2009 report in the Archives of Internal Medicine showing that 7 percent of primary care patients were never informed about abnormal test results. (When it comes to medical tests, I’ve generally assumed that no news is good news myself. Unfortunately, that’s not always the case.)
Of course, there is still plenty of information that the medical and research establishment continues to shield the rest of us from for a variety of logistical and philosophical reasons. In the realm of genomic and personalized medicine, patients may find themselves undergoing tests of various kinds in medical research (as opposed to standard medical care). Most of the time, those patient participants can’t expect access to either their own research results or raw data, although there are strong voices out there pushing for this kind of access too. There’s obviously plenty of regulatory angst about people gaining access to health-related information via direct-to-consumer companies such as 23andMe as well.
In other words, although the new rule and new access are a step in the right direction for personalized medicine and patient engagement, reluctance when it comes to handing patient data over directly remains high, especially when that data is unfiltered or its meaning uncertain.
“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,” Secretary Sebelius said in the HHS announcement of the new rule.
Let’s hope it does.