In the fight against COVID, the feds may have done something right

August 29, 2020  |  Greg Stein  | 


Everything from op-eds to angry tweets are being written about the US Government’s apparent missteps in addressing the Coronavirus (COVID-19) pandemic.  Buried in the back pages, however, are new regulations implementing the 21st Century CURES Act (Cures Act) that may have a powerful impact on combating the disease).

The Cures Act was enacted to accelerate medical product development and deliver innovative healthcare advances to patients who need them faster and more efficiently. Signed into law in December 2016, these regulations provide protections for technology companies enabling them to improve patient care through innovation, integration, and information transparency.

The new regulations encourage technologies designed to help patient data flow more efficiently across the healthcare ecosystem, while still maintaining patient privacy and security. It also prevents technology incumbents from blocking a clinician or patient’s access to the electronic health information stored on their systems.

So how does this enhance the fight against Coronavirus? Part and parcel to ubiquitous access to Coronavirus testing, is ensuring that information flows quickly and efficiently to the right place. To stem the tide of the virus, we need to know who has been exposed, how they are reacting, and whether to quarantine in place or hospitalize.  All these data points can be answered by diagnostic laboratory testing – and laboratories are responding.

Diagnostic laboratory companies like Principal Health Systems (PHS) have developed tests to address these concerns. PHS is specifically focused on nursing home care, where the risk of dying from COVID-19 can be as high as 15%. Early testing can clearly save lives, especially for those who are at high risk.  However, the availability of testing is merely half the battle, the other half is getting those tests into the hands of doctors as quickly as possible.

Today, if a clinician wants to order one of these lab tests, that lab must be “integrated” into that clinician’s electronic health record (EHR) software.  But what if they aren’t?  In that case, the clinician must write an order on a piece of paper and – we aren’t kidding here – FAX it to the lab.  In some cases, the lab may have an online ordering portal, but even then, the clinician must now perform data entry which is both time-consuming and a high potential for error.

If the lab wants to integrate with that clinician’s EHR, they must be willing to invest thousands of dollars per location, commit internal IT staff, and if everything goes smoothly, get the integration up and running in a few months.  In the crisis environment in which we are operating today, this is simply unacceptable.  We don’t have a few months to make tests available everywhere.  Even a single days’ delay can result in exponential expansion of infections.

The CURES Act now allows labs and doctors to “instantly integrate.” This means the innovative lab paired with the innovative software technology can offer tests to clinicians within minutes of a request.  Technology companies such as Shadowbox are specialized in the lab and healthcare integration space to accelerate the integration of systems to allow doctors to electronically order a test from an otherwise non-integrated lab that day.  These orders and their results are securely, compliantly, and securely exchanged between systems in seconds.

We believe that every person desiring to be tested for COVID-19 should have access to, and payer support for, immediate and periodic testing; for peace of mind, for informed behavior changes, and for the sake of protecting our loved ones and community. While there is still much to do to ensure the widespread availability of diagnostic tests, The CURES Act rules now make it easier and far faster to access those tests and receive results.

Greg brings diverse experience, a vast network, and over 30 years of leadership to his role at Shadowbox. Most recently, Greg was Vice President of Strategic and Community Affairs and an original investor with Millennium Health, where he helped grow the company to more than 1,500 employees and $1.8BN in enterprise value. Prior to Millennium, Greg served in numerous leadership roles such as CFO of a start-up in the defense and action sports space; EVP of a political economics start-up division in the macroeconomic firm founded by Dr. Arthur Laffer, the world-renowned economist; VP of a start-up in a sell-side investment bank; and CEO of a start-up consortium of defense contractors delivering software to the US Air Force and Navy.

Additional articles by Greg Stein