New Rules Empower Patients to Access Data

Have you heard of the new rules requiring labs to provide test results directly to patients?

Here is a brief summary of the new rules: the order, issued by the U.S. Department of Health & Human Services (HHS), amends the Health Insurance Portability and Accountability Act (HIPAA) and the Clinical Laboratory Improvement Act (CLIA) to allow patients to contact clinical laboratories directly and request their test results. This is a change from the previous standard, in which a patient would make that request through the physician who ordered the test. Physician groups have expressed concern over patients mis-interpreting their own data, and suggested a disclaimer be attached to each test result, but no such errata was added.

New Amsterdam Genomics has developed a platform that makes a patient’s genomic data easily navigable for any type of doctor. The next step for us is to make sure it’s easy for patients, too. Our report highlights actionable information, which is defined medically as information that has a serious morbidity, or has a large risk to affect the patient’s quality of life. Defining “large risk” becomes tricky, though, because the spectrum of risk is often defined by a threshold. One gene that is linked to an increased susceptibility to diabetes, for example, increases the chances of that patient developing the disease by 25%-50%. Without a geneticists guidance, it’s difficult to understand the full implications. The patient may ask themselves, what does this mean? What do I do now? While our analysis may provide additional information that narrows that threshold, a doctor, or better yet, a certified genetic counselor, is best qualified to answer such questions.

Photo courtesy of stockimage via
Photo courtesy of stockimage via

Another element to consider: a genomics test stays with a patient for the rest of his/her life. Our report may reveal medical information that won’t have an impact for years. This can include the presence of a genetic disease that won’t show symptoms until the patient is much older, to hereditary factors for stroke or heart disease. Such sensitive information may cause a patient unnecessary worry and stress. Without the proper interpretation of such information, it is difficult for a patient to react and plan steps accordingly.

Healthcare consumers who take an active role in their care are essential for a healthier society, so making sure each patient who orders test results from us has the tools and resources to understand their report is essential. New Amsterdam Genomics is excited that patients will have the opportunity to take charge of their own health in such a powerful way, but we also have a special understanding of the sensitivity of genomic data. If you have access to a genetic test and would like to get your report sent directly to you, we recommend you take the time to sit down with your doctor in order to get the most well-rounded and informed interpretation of the report as possible.


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