Support Your Right to Access Your Clinical Lab Results

Giving people access to their genetic information is what we are about at 23andMe. We believe that it is not just a fundamental right, but, as with access to all of your health records, it is vital to making informed decisions about your wellbeing.

That is why 23andMe is so encouraged by statements coming from Kathleen Sebelius, Secretary of the U.S. Department of Health and Human Service. In September, Secretary Sebelius proposed a regulation to give patients direct access to their clinical laboratory results. This is in addition to current rules that give patients the right to obtain those records from their health care providers. “When it comes to healthcare, information is power,” Sebelius said back in September. “When patients have their lab results, they are more likely to ask the right questions, make better decisions and receive better care.” We could not have said it better. But just because Secretary Sebelius is supporting the change does not mean it will happen. Your comments may help make a difference between whether you get the right to easily access your laboratory records or not. We want to encourage you to make your voice heard. Many people may not know that they currently have the right to access their medical records under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The proposed regulation would expand the rights of patients to access their health information directly — and likely more quickly — by removing regulatory barriers to the electronic exchange of clinical laboratory data. For a company like 23andMe, which was founded on a philosophy that individuals have the right to access directly their genetic information, clearing away these kinds of barriers more widely is extremely important. “As a company committed to advancing personalized medicine, 23andMe could not agree more with the sentiments expressed by Secretary Sebelius,” said Ashley C. Gould, Vice President of Corporate Development & Chief Legal Officer.   “We believe the proposed changes will facilitate personalized medicine by empowering individuals to take an active role in understanding their own health and healthcare. 23andMe was founded, in part, to provide people with direct access to their health information and foster this empowerment.” 23andMe now has years of experience giving individuals access to their genetic information and we have received strong, positive feedback from our customers.   We have found that the concerns raised by critics of this open approach have not materialized. In addition, while we send each individual’s genetic data directly to them, we encourage our customers to discuss their data with their physicians or other healthcare providers. We have found that genetic information often serves as a catalyst for useful conversations between our customers and their healthcare providers. We believe that giving people access to their clinical laboratory tests will trigger more engagement by patients and better dialogue between patients and their healthcare providers.
SAMPLE COMMENT LETTER Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-2319-P PO Box 8010 Baltimore, MD 21244-8010 RE: Access to Clinical Laboratory Test Reports To Whom it May Concern, I am writing in support of the proposed rule to expand the rights of individuals to obtain their health information by giving them direct access to their clinical laboratory test results (Proposed Rule CMS-2319-P.) [Please share your thoughts as to why this might be an important step for individuals and how it might help you and others, even though it might impose additional costs on clinical laboratories.   You might wish to address the issue of access to health records or how the move toward patient centered care requires that patients have access to their own health information.] Sincerely, [Your name]
The proposed regulation simply amends the current quality standards that are part of the  Clinical Laboratory Improvement Amendments of 1988 – known as CLIA. The change specifies that, upon a patient’s request, the laboratory must provide access to completed test reports. The laboratory would use its existing authentication process to ensure the results belong to the patient before they were sent. This proposed regulation would also amend the Privacy Rule that’s part of HIPAA. Currently, the Privacy Rule exempts CLIA laboratories from the obligation to provide an individual with access to his or her own health information. Public comments are still being taken on the proposed regulatory changes.   23andMe is submitting comments in favor of the proposed regulation and we encourage you to show your support by taking the time to comment as well. Your input does make a difference — the more comments people submit, the more likely it will be that these rules become reality. Send your comments no later than 5 pm Eastern Standard Time on November 14th, 2011. To let your voice be heard go here. You can type or paste in comments on the form or upload comments to the site. You can also access both the proposed regulation and the comments page by going to and searching using the regulation number, CMS–2319–P. You may also submit your comment using regular mail by sending a letter to: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: Proposed Rule CMS-2319-P, P.O. Box 8010,   Baltimore, MD 21244-8010.  
  • Linda Bique (Ellis)

    Thank you for this effort…letter sent!

  • Margaret O’Brien

    Thanks for your efforts in this area. I totally agree and have sent my comments just minutes ago.

  • mark

    Ah, if only this had happened back when Google Health existed. It seemingly failed because it couldn’t get enough partners among labs and pharmacies, etc., to really make it possible for people to access all their health data in one place, at least not without a lot of manual entry. Hopefully Microsoft’s HealthVault will pick up the slack…

  • Laurence W Smiser

    Really, the Secretary HHS is proposing a regulation to control our access to ourselves. Do you really believe that the Government has the right to control such personal information access to your very essence? What is being proposed is complete control over all citizens by an uncontrollable, unaccountable bureaucracy.

    Beware, what the government assumes it to “grant”, IT CAN TAKE AWAY. If we allow the government to determine what we can know about ourselves what limit is their on its power to control every facet of our existence? The constitution was never meant to grant such power to political leaders. It was designed to do exactly the opposite…limit the powers of the government toward the citizens. This intent has been turned on its head by the present politics.

    The simple act of agreeing to such an invasive proposal is to AGREE that the government has such control of your very life. You can rest assured that if the government can control it the governing politicians will exploit for the power to control you. “Knowledge is power” has never been better illustrated.

  • Rachel

    Even though this is a proposed rule change by an agency and not legislation, I recommend CC’ing your legislators–both senators and your congressman–in addition to mailing the original to Medicare/Medicaid. While they may not be able to vote on this rule, they can always influence these decisions or propose legislation.

    Don’t bother writing to the President. Not because he won’t do anything, just because in my experience while working in government, he gets so many letters that the issue will be over and done with before anyone at the WH reads your letter. If you want to comment to him go to his website or call.

  • Kate

    Thank you for bringing this to our attention. I wrote a comment in strong support of this regulation. My late husband’s oncologist lied not only to us, but also our family doctor, about the type of lymphoma he had. We were told that with an aggressive chemo his odds of survival were 50 to 60 percent.

    It was only after nine grueling months of hospitalizations for aggressive chemo and the subsequent infections, that we learned the truth. When it was clear that the chemo wasn’t working, he was given the option of a stem cell transplant. Rather the transmitting his records directly to the facility that did the transplants, the oncologist’s receptionist gave them to us. I scanned through them the day before our appointment and was shocked to see the biopsy results, true diagnosis, and prognosis (very poor). A quick google search showed that no one had ever survived this type of lymphoma. I was infuriated.

    My husband was given false hope and endured nine months of unnecessary suffering you cannot begin to imagine. Had we, or our family doctor, known the truth we would have undoubtedly just called in hospice and my husband would have been much better prepared for and suffered much less at his death. The final tab for his ‘treatment’ was $700,000 of which we paid $20,000.

    I will never again trust a doctor and will always ask to see ALL test results, but this regulation would make it much easier.

  • Erica

    I just missed the deadline for this – how do you recommend we show our support for this from this point forward?

    P.S. Any chance of adding Google Health features to 23&me?

    • Hi Erica,

      You can try submitting a comment even though it’s after the deadline — they sometimes still accept comments submitted late. Best of luck and thank you so much for the support!

      Google has discontinued Google Health, so there will be no product integration between their services and 23andMe.

  • margaret ann bledsoe

    I support being allowed to access all my genetic information. As an adoptee in Pennsylvania, which does not allow adult adoptees born in the same period as me access to any original birth records, this is the only way I can discover any familial disease tendencies or if I am a carrier. Although Pennsylvania has had a medical info registry for birth parents I was recently told that since its inception only a handful of birth parents have provided medical information. Without the genetic information provided by 23andMe I would still be clueless.