Yesterday, three agencies within the Department of Health and Human Services (“DHHS”) jointly issued the final rule to give patients (or persons designated by the patients) a means of direct access to the patients’ completed laboratory test reports.
This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) regulations to allow laboratories to give a patient, or a person designated by the patient, access to the patient’s completed test reports on the patient’s or patient’s personal representative’s request. At the same time, the final rule eliminates the exception under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule to an individual’s right to access his or her protected health information (“PHI”) when it is held by a CLIA-certified or CLIA-exempt laboratory. According to the press release, although patients can continue to get access to their laboratory test reports from their doctors, this final rule gives patients a new option to obtain their test reports directly from the laboratory while maintaining strong protections for patients’ privacy.
According to the DHHS press release regarding the new patient right to lab results final rule, the three DHHS agencies are the Centers for Medicare & Medicaid Services (“CMS”), which is generally responsible for laboratory regulation under CLIA, the Centers for Disease Control and Prevention (“CDC”), which provides scientific and technical advice to CMS related to CLIA, and the Office for Civil Rights (“OCR”), which is responsible for enforcing the HIPAA Privacy Rule.
One wonders whether giving patients and their personal representatives direct access to lab results out of context and without the benefit of explanation by the licensed clinicians who ordered the tests is a sound idea. Many examples of potential unpleasant outcomes immediately spring to mind.
On an entirely different topic, please note that I escaped Kansas City Monday before the big blizzard hit. I stopped in Glendale, California, to consult with a long-time HIPAA client and will be on my way shortly to present HIPAA seminars at the Elite Hearing Network 2014 Annual Business Summit in Hawaii February 5-9 and for Cross Country Education on February 10 in Honolulu. Yes, I know. It’s a rough life, but someone has to do it. If you can’t make it to Hawaii this time, I will also be presenting a live webinar on February 13 on the topic “How to Do a Risk Analysis” at noon CST through MentorHealth. My law partner, Richard Dvorak, will be presenting HIPAA seminars in Pittsburgh, Akron, and Cleveland this week. Please check out our upcoming HIPAA seminars schedule on our website and use the links provided there to sign up.
