Monday's announcement that the proposed rules will grant patients or their personal representatives the ability to access lab results over the Internet came at the kick-off of the first-ever HHS Consumer Health IT Summit, held at the Department of Health and Human Services in Washington, D.C. The summit brought consumers, providers, and the public and private sectors together to discuss measures that can best empower consumers through health IT to be partners in monitoring and making decisions about their care.
"Today we are releasing a proposed rule that gives every American the right to get their own laboratory test results directly from the lab. That's a big deal!" HHS Secretary Kathleen Sebelius enthusiastically told the audience. "In the past you often had to wait days or weeks to get the results from your doctor, and as many as 20% of the lab results never even made it out of the lab."
The notice of proposed rulemaking (NPRM), jointly drafted by the Centers for Medicare & Medicaid Services, the HHS Office for Civil Rights (OCR), and the Centers for Disease Control and Prevention, proposes to amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and HIPAA privacy regulations, HHS said in a statement.
However, while HHS officials heralded the new proposed rules, J. Fred Ralston, MD, former president of the American College of Physicians (ACP), and a practicing internist at Fayetteville Medical Associates (Tenn,), shared his personal concerns.
"Lab results often contain a lot of information. A patient downloading many raw lab results over the Internet may be overwhelmed by lots of tiny insignificant abnormalities that could each demand an individual explanation--and cause significant worry until those concerns are dealt with. We also need to understand that no table or explanation can fully describe different ranges of normal. In some cases what a patient might think is a normal reading for them may not be the case," Ralston told InformationWeek Healthcare. "I am always concerned about somebody with heart disease, for example, seeing what they consider to be normal cholesterol reading on their lab report and they don't discuss that with the doctor. That reading may actually be much too high for them in their individual circumstances."
Yul Ejnes, MD, chair of the ACP Board of Regents, echoed Ralston's concerns. "I think the proposed rule is well intentioned but misguided because ... it leaves out a very important part of the process of lab testing, which is the physician and his or her interpretation of the results," Ejnes said in an interview with InformationWeek Healthcare.
On the other hand, executives at Quest Diagnostics, a leading provider of diagnostic testing said it welcomes HHS' proposal to expand patient data rights that will change the status quo in many states where laboratory test results can only be provided to "authorized individuals," typically a physician or healthcare provider.
The proposed rules would ensure that labs covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) provide such information, upon request, directly to patients or their personal representatives by mail, fax, email, or other electronic means.
Quest officials said they look forward to providing a direct link to share patient results through programs such as its Gazelle application that gives patients a portable record of their lab results to share with doctors via smartphone.
"Patient engagement in healthcare decision making is vital to promoting better health outcomes and reduced costs in our healthcare system," Surya Mohapatra, chairman and chief executive officer of Quest Diagnostics, said in a statement. "HHS's proposed rule will help to empower patients to understand their health condition and discuss their healthcare options more constructively with their physicians."
Find out how health IT leaders are dealing with the industry's pain points, from allowing unfettered patient data access to sharing electronic records. Also in the new, all-digital issue of InformationWeek Healthcare: There needs to be better e-communication between technologists and clinicians. Download the issue now. (Free registration required.)