In 1999 Caresoft developed a consumer web portal called the Daily Apple. The Daily Apple wasn’t all that unique or different than other health portals, until in May of 2000 they began helping consumers download their lab test results from Quest Diagnostics. Now THAT was different! A portal aggregating real clinical data on behalf of consumers, with the potential to drive personalized health information, recommendations, and alerts to the individual. “Looks like your exercise and your diet are keeping your blood sugar under good control. Great Job!” and “Your liver enzymes are elevated, which might be due to your Lipitor. You should talk with your doctor.” Now that’s information a person can use! But sometimes even the best ideas suffer from poor market timing. It was only 19 months later, in December, 2001, that the service was discontinued. Many of us on the outside wondered why such a seemingly unique and valuable service would be disabled. But whether it was the lawyers, the doctors, or the business model, timing wasn’t right.
Only a couple years later, in 2003, the Office of Civil Rights at HHS wrote the HIPAA Privacy Rule regulations, allowing consumers to access a copy of their own protected health information. But they carved out lab data as a special case. Lab data (or data governed under the Clinical Laboratory Improvement Amendments, or CLIA), was to be governed under CMS regulations that stated that lab test results could only be delivered to “Authorized Persons”, defined as “an individual authorized under state law to order tests or receive test results, or both.”
Only a few states have passed laws stating that the individual subject of the test is considered authorized to receive test results, so in almost all states consumers are not able to do so. They can only legally get test results from their ordering provider. And yet who would have anticipated in 2003 (Caresoft and other savants aside) that just six years later we would have major health systems like Kaiser Permanente routinely delivering lab results online to their members within just a couple days, dozens of health applications and health platforms that help consumers download and manage their lab results, and even iPhone applications that download lab results?
But lab data access by consumers isn’t for the sole purpose of driving next-generation applications and services. Consumer lab data access fills a critical gap. Today, approximately 7% of clinically significant results never get reported to the patients, i.e. they’re “lost to the ether.” And approximately 14% of labs are duplicates, performed because prior results couldn’t be located. So data access by consumers can help remedy these problems and potentially lower costs as a result. If all doctors had an EMR that allowed ubiquitous access to test results when and where they’re needed, then things might be different. But they don’t. Most doctors don’t have any way to easily convey test results electronically to their patients or other providers. It’s for all these reasons that giving consumers access to their own data is so important.
Consider the case of Jim Renfro, a triple-decorated Vietnam war veteran who was diagnosed in 2004 with Multiple Myeloma, and then that diagnosis was changed to non-Hodgkin’s Lymphoma. In Jim’s own words:
“I went through three rounds of treatment in Atlanta, GA and then was sent to UMAS in Little Rock, AK for tests to see if I was a candidate for a stem cell transplant. After four days of testing in meeting with my assigned doctor he asked me why was I being treated for Multiple Myeloma, since my tests results clearly showed that I had Non-Hodgkin’s Lymphoma. Had I had full access to my tests results maybe I would not have gone through three months of treatments for the wrong cancer.”
An open letter has been posted at HealthDataRights.org for all those who wish to support two common sense changes to federal regulations that would allow consumers the same access to test results as they have to their other protected health information. People interested in signing the letter, to be delivered Tuesday October 20th, can email firstname.lastname@example.org with their name and, if they choose, their organization.
Making these changes is just a first step. It doesn’t address the many state laws that further restrict access, but at least the federal barrier to access would be removed. And there’s tremendous interest across the board, from consumers to providers to labs to health plans. We can, and we must, make these changes.
Phil Marshall is VP, Product Management at WebMD and on Tuesday is presenting testimony to the Health IT Policy Committee at ONC which is holding a hearing regarding CLIA laws.