November 17, 2016
By Brian Castelli, Luminate Health
President Obama launched the Precision Medicine Initiative last year, with the following mission statement: “To enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care.”
One of the critical success factors of the Precision Medicine Initiative is patients getting better, more efficient access to their health data, which includes lab results. Lab results make up as much as 80% of a patient’s medical record and about 70% of clinical decisions are based on this critical medical information.1 In 2014, in a rule amending both HIPAA and CLIA, the federal government gave patients the right to access their lab results directly from labs2, and since that time Luminate Health has been partnering with labs to empower patients with this information and with the tools to become active participants in their own health.
The Luminate Health team was in Washington D.C. last month coordinating and participating in a panel discussion at the G2 Lab Institute conference. The panel included senior representatives from the U.S. Department of Health and Human Services Office for Civil Rights (OCR) and the White House Office of Science and Technology Policy (OSTP), as well as Sidd Sinha, our Co-founder and CEO. We appreciated the opportunity to join senior policy makers in an open discussion around the Precision Medicine Initiative as it relates to providing patients with access to their healthcare information.
Industry representatives present were largely in favor of providing access to patients, but some voiced concerns around how they felt that the results needed to be coupled with educational content to make the information approachable. At Luminate Health, we are strong advocates of patients’ need for context around their lab results, which is why we curate and provide educational materials within our application. During the panel, we also shared the perspective of how lab work has become commoditized, which has created a race to the bottom on pricing, and how laboratories who shift their paradigm from being testing companies to being health information companies will succeed well into the future. The representative from OCR stressed the portion of the rule that requires labs to provide patients with access to their results in electronic format. They further clarified that if a patient requests their results in electronic format, and the results are readily producible in this way, then the lab must comply with this request. Given the fact that nearly all labs now store their results electronically, labs are therefore required to provide patient results electronically, upon request. In an effort to demonstrate how serious HHS is about enforcing individual rights, the OCR representative also cited an example of how OCR fined a healthcare organization $4.3M for violating the HIPAA Privacy Rule by denying patients access to their medical records.3
At Luminate Health we are proud of the contribution that we are making to the Precision Medicine Initiative. We work hard every day for our laboratory customers to turn regulatory compliance into a competitive advantage, by improving patient care and transforming lab data into meaningful analytics for a lab’s patients, clients, and partners. In doing this, we are helping labs make the transition from a commodity to a value-added partner in the healthcare ecosystem.
We were honored to contribute to the important dialogue around empowering patients with access to their healthcare information, and we look forward to keeping the conversation going. In the meantime, we will continue with our goal of helping labs differentiate their services by providing patients with great access and understanding around their lab results.
1. “Electronic Release of Clinical Laboratory Results: A Review of State and Federal Policy”. California Healthcare Foundation. http://www.nashp.org/sites/default/files/ElectronicLabResultsExchangePolicy.pdf
2. “CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports”. Federal Register. https://www.federalregister.gov/documents/2014/02/06/2014-02280/clia-program-and-hipaa-privacy-rule-patients-access-to-test-reports
3. “Civil Money Penalty: Cignet Health Fined a $4.3M Civil Money Penalty for HIPAA Privacy Rule Violations”. HHS.gov. http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/examples/cignet-health/