Patient Engagement, Policy, Startups

New lab result rule is real progress in the ‘Give me my d*^% data’ fight

I don’t usually get worked up about new HHS rules, but this announcement about access […]

I don’t usually get worked up about new HHS rules, but this announcement about access to test results is truly exciting. This is progress for patients and startups. Thirteen states have laws that prevent testing companies from releasing lab results directly to patients. Those outdated laws became obsolete yesterday when HHS issued this rule (emphasis mine):

This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that, upon the request of a patient (or the patient’s personal representative), laboratories subject to CLIA may provide the patient, the patient’s personal representative, or a person designated by the patient, as applicable, with copies of completed test reports that, using the laboratory’s authentication process, can be identified as belonging to that patient.

The rule also eliminates the HIPAA exception to an individual’s right to access his or her protected health information when it is held by a CLIA-certified or CLIA-exempt laboratory.

There was the also expected handwringing from a couple doctors’ groups: But what if patients can’t handle the data? Google already provides plenty of opportunities for patients to gorge themselves on data that they may or may not fully understand. Confusion is no reason to prevent people from getting direct access to their own data.

Plus there is already a perfect example of how test results should be formatted: WellnessFX. The design of their test results is enough to make a web designer swoon: just enough data beautifully presented with links to read more (see an example above). A person reading the results gets enough context to quickly understand what the different measurements mean and whether or not to worry.

If patients have to shoulder more financial and decision-making responsibilities for their own healthcare, they should have full control over all their health data. This was a smart and overdue move from the Obama administration. Now if we could get them to pass a national law standardizing reimbursement and other aspects of telemedicine, 2014 would be off to a strong start.

Veronica Combs

Veronica is an independent journalist and communications strategist. For more than 10 years, she has covered health and healthcare with a focus on innovation and patient engagement. Most recently she managed strategic partnerships and communications for AIR Louisville, a digital health project focused on asthma. The team recruited 7 employer partners, enrolled 1,100 participants and collected more than 250,000 data points about rescue inhaler use. Veronica has worked for startups for almost 20 years doing everything from launching blogs, newsletters and patient communities to recruiting speakers, moderating panel conversations and developing new products. You can reach her on Twitter @vmcombs.

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