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 www.regulations.gov 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.