The Role of Patient Data in Specialty Labs and Precision Medicine

Personalized healthcare is driven by advances in testing but also requires a more complete view of the patient, something only an interoperability platform can provide.

The United States spent an estimated $4.3 trillion on healthcare in 2021, but only about 2.5 cents per dollar spent goes toward clinical laboratory services. Yet lab values inform up to 70 percent of decisions made by providers when treating patients. 

Since the COVID-19 pandemic, public health and clinical diagnostics have been moved to the forefront and the work being done by Clinical Lab 2.0 (CL2.0), a project of the Project Santa Fe Foundation, has been amplified. In the publication Future Role of the Clinical Lab in Population Health, clinical laboratories are touted as being positioned to improve public health across the board. “The clinical laboratory can support community health in this model by providing risk stratification, closing gaps in care, and facilitating clinical interventions, thus leading to improved outcomes and cost avoidance,” the authors said.

The advent of digitized medical records has greatly improved the ability of healthcare providers to deliver more impactful care – driving decision-making that is more accurate, effective, precise, and proactive. Still, there are some diseases that have so far eluded cures or even adequate treatment plans. Neurodegenerative diseases and rarified genetic conditions are blights on individuals, families, and population health as a whole.

Cancer, in particular, which has a huge footprint with an estimated 1.9 million new cases to be diagnosed in 2022, is ripe for the kind of personalized medicine that has become more available with sophisticated EMRs, genetic testing, and big data analytics all tracking inherited predispositions to certain diseases. And as the risk of dying from cancer continues to drop at an accelerated pace, about 2 percent each year between 2015 and 2019 compared to 1 percent in the 1990s, much of this can be attributed to prevention and early detection through screening. Treatment has also improved, with more personalized plans informed by better data.

The conventional one-size-fits-all healthcare model is being replaced by medical decisions, treatments, practices, or medications tailored to a specific patient. And with the rise of digital health applications, which treat everything from diabetes to mental illness, innovators in this space are looking for more information about their patients than what has traditionally been available to them.

Lab results paired with clinical data provide immense value – but only if you can get to them. Like everything else in healthcare, laboratories suffer from disparate and disconnected information and data silos. But they are essential to health information exchange, and not just for diagnostic purposes. They can also screen for diseases so physicians can catch them sooner; monitor the effectiveness of a particular treatment plan, including medicines and lifestyle changes; and enable research to increase our collective knowledge and improve population health.

According to the IQVIA Institute for Human Data Science, more than 90,000 digital health apps were released in 2021 bringing the grand total to around 350,000 applications. And while many are geared towards general wellness, including diet and fitness, there has been a notable increase in condition-specific apps. In fact, chronic health conditions or specific diseases comprised 47 percent of apps in 2021, compared to just 28 percent in 2015. 

“We are finding evidence of a growing maturity of digital health tools in mainstream medicine,” Murray Aitken, IQVIA senior vice president and executive director of the IQVIA Institute for Human Data Science, said in a statement. “While there has been a significant growth in apps and digital health tools since 2013, we are beginning to detect improved quality of the digital health tools in the management of health conditions. These quality improvements result in robust evidence of their impact on patient outcomes and subsequent inclusion in clinical practice.”

This kind of medical care is often driven by laboratory results, but precision medicine that offers personalized treatment pathways requires a more holistic view of the patient. In the case of cancer screening, a complete family history is of paramount importance. When managing diabetes, it’s critical to see historical data about the patient. Specialized laboratories are in many cases becoming care providers, offering up a custom plan for treatment or management with the patient’s primary care physician as proxy. To do this, they need a complete medical record.  

Other use cases for laboratories needing access to a full patient record include genetic testing, cancer screening, and mobile phlebotomy. The precision medicine market has benefited enormously from advances in life sciences, as well as artificial intelligence and data analytics.

CLIA Treatment Purposes

Established in 1988 to establish, maintain, and oversee safe laboratory testing standards, the Clinical Laboratory Improvement Amendments (CLIA) regulate labs testing human specimens and ensures they provide accurate, reliable, and timely patient test results no matter where the test is done. Across the country, an estimated 260,000 CLIA-certified labs are the cornerstone of testing required for diagnosis and treatment of disease. 

Laboratory medicine is used increasingly by the digital health sector to support direct patient care and extend its reach in clinical and direct-to-consumer applications. Recognizing this, CLIA certifications are being acknowledged as evidence of a permitted treatment purpose for health information networks (HINs) including Health Gorilla, CommonWell Health Alliance, and Carequality.

With access to an actionable view of their patient’s clinical history, labs with a CLIA certification can:

  • Participate in bidirectional data exchanges.
  • Inform genetic testing.
  • Share test results nationwide.
  • Identify future testing needs.
  • Avoid unnecessary and expensive tests.
  • Ensure results are interpreted correctly.
  • Create the most optimal treatment plan for patients.

About Health Gorilla

Founded in 2014 as a software solution for healthcare providers to order tests and receive results from all the major labs, Health Gorilla is a longtime partner of LabCorp, Quest Diagnostics, BioReference, and more than 100 others, making lab interoperability possible through a FHIR-based API that digital health developers can embed into their own products.

Our Lab Network product streamlines workflows and automates outcomes tracking for leading healthcare organizations including virtual care providers, electronic medical records (EMR) vendors, and Federally Qualified Health Centers (FQHCs).

We believe that lab access to a patient's complete information holds a tremendous amount of value for the healthcare ecosystem. As an industry-leading Health Interoperability Platform (HIP), we offer Patient360, a patient-querying engine that yields aggregated, actionable data in an accessible format.

With connections to most major EMRs, including Epic and Cerner, and memberships in CommonWell Health Alliance, Carequality, and eHealth Exchange, Health Gorilla has access to more than 220 million patients nationwide. We are working to make it easier for the entire healthcare ecosystem to seamlessly share clinical data and aggregate each patient's complete clinical history in one place. We provide bi-directional interfaces with most major labs and serve as the intermediary that labs can leverage to distribute test results with a national network of providers and become compliant with new interoperability rules – without having to build their own direct connections.

In May 2020, Health Gorilla was recognized by the Margolis Center for Health Policy at Duke University as the only clinical exchange portal that met functional and security requirements for public health departments to support COVID-19 containment. The report stated that Health Gorilla “provides query access to all acute care sites on both networks and maintains its own set of services (MPI and RLS) and capabilities (event notifications) that could increase utility for public health.”

To learn more about how Health Gorilla and Patient360 can help your lab enterprise succeed in the new age of precision medicine powered by next generation testing and diagnostics, contact an expert today.