The Irony of COVID-19 Delaying the Interoperability Rule

One year after being proposed, federal rules to advance interoperability in healthcare and create easier access for patients to obtain and control their medical data were finalized. In early March of this year, the Health and Human Services (HHS) Office of the National Coordinator for Health IT (ONC) along with the Centers for Medicare and Medicaid Services (CMS) announced unprecedented rules that would finally lead healthcare IT into the 21st century. Unfortunately, just days later, the impact of COVID-19 on the U.S. healthcare system was being recognized, forcing a delicate balance between two intertwined but conflicting exigencies in healthcare. The health system nationwide was immediately stressed, and everyone pivoted their focus to pandemic response. 

The paradox is that COVID-19 has manifested the critical need for exactly what the rules require: advancement of interoperability and digital online access to clinical data and imaging, at scale, for care coordination and infection control. Yet healthcare is primarily still stuck in the dark ages of faxes, CDs and data silos trapped in proprietary systems.

Federal Recognition of Imaging Data’s Clinical Value

ONC’s rules provide a baseline for transparency of clinical data, incorporating key data elements that have traditionally been locked in silos that interrupt effective care coordination and delivery. For decades, accessible healthcare data has been limited to structured data typically found in claims systems and, more recently, electronic health records (EHR). While this information identifies procedure type and cost, it has very limited clinical value. 

The ONC rules define eight standard data elements, U.S. Core Data for Interoperability (USCDI), that are now required for nationwide interoperability of health information. Data elements include pathology reports, diagnostic imaging and the corresponding narrative, and lab report narratives, among other data now required as part of new application program interface (API) certification criteria to make data more accessible. Never mandated before, this significant development will advance the availability of common data and expand to include other clinical data over time. Unlike structured data in claims and EHRs, these more complex elements provide serious clinical value which, when exposed, has the opportunity of reducing misdiagnoses, medical errors and suboptimal outcomes. 

Now, more than ever, it is imperative that healthcare workers have as much relevant clinical data in advance as possible. COVID-19 is a respiratory illness with corresponding impacts to organs such as the liver, heart and kidneys. Current research demonstrates that diagnostic imaging will play a crucial role in diagnosis, treatment, recovery care, and ongoing monitoring. Patient data needs to be digitally accessible and analyzed by geographically dispersed care teams. 

Digital Exchange of Imaging’s Role in Managing COVID-19

Prior to the public health crisis, the industry resisted interoperability for a variety of reasons — from “I’m too busy to change how I do things even if it is better in the long run” to “this is bad for our business.” COVID-19 has significantly amplified the clinical, operational and business risks that result from a lack of seamless digital data sharing at scale. 

From a basic safety level, the lack of digital connections between primary care doctors with urgent care centers and acute care hospitals has a detrimental impact on ability to control infection spread and protect frontline healthcare workers and patients. 

Imaging Interoperability With Patients is Virtually Non-existent

Based on data from Life Image’s internal research, as much as 75 percent of all medical images are still exchanged between providers via CDs even though the technology exists to exchange digitally on the patient’s behalf. 

Another policy goal of the ONC interoperability rules is to provide patients greater control over their health data, which is near impossible under the current system. Life Image recently conducted a patient survey and found that nearly 40 percent of patients are still required to go to a healthcare facility and physically pick up CDs if they want ownership of their medical records and related imaging. 

Under the conditions of a public health crisis, the last thing a clinician wants is a patient — either symptomatic or asymptomatic — to present with medical information on a CD that has passed through many hands and will pass through many more hands, introducing a potential infection risk.  

While the industry has made some gains in imaging interoperability between large, tertiary hospitals and their primary referral sites, patient sharing of digital images online is virtually nonexistent. 

The Ironic Necessity of Delaying Rule Implementation

Upon rule finalization in early March, there was a six to 24-month timeline for implementation of most of the rule’s parameters. Now that timeline seems near impossible given the dedication of limited resources and time to a pandemic. Making matters worse, many hospitals have furloughed non-essential, administrative staff and have limited resources to urgent clinical care. 

A delay in implementation would allow proper focus on COVID-19-related priorities and then a later proper focus on rule implementation when the crisis is under control. The irony, of course, is that the pandemic has heightened realization of the importance of interoperability for more effective care coordination and infection control. 

Technology Solutions Do Exist to Help Manage Imaging Interoperability

While many of the larger, more urban health systems have digital connections in place with their main referral sites, no site is fully digital and many smaller institutions, and especially those in more rural communities, are not yet connected for digital transfer. It is imperative to establish these digital connections, which can be done quickly and cost effectively without a lot of demand on hospital IT staff. Apply technology that currently exists first, even if used in other settings, before creating or implementing newer or untested technologies.  

How many physicians, for example, went immediately to connecting with their patients using online video from a wide variety of existing technology vendors, rather than attempting to lead with truly untested solutions promising more comprehensive integration? With no time to waste, the healthcare and imaging industry should rely on proven scale capabilities, even if they are not perfect, and build upon them systematically. As an industry, we need to innovate, but we also need to be measured in our choices and not be fooled or distracted by promises of the next disruptive technology that may never be delivered. In our time of crisis, it is better to get the job actually done now and enhance it later rather than wait for the promise of tomorrow’s technology.

In relation to medical imaging and the efforts to digitize it for both the quality of patient care and the safety of those providing the care, work with established companies; avoid betting on next generation solutions to minimize your immediate workflow risks; and do not lose track of advancing interoperability so you can respond more quickly in the future.

Advancing Interoperability for the Future

Virtualizing and digitizing care has proven effective. Healthcare currently has mature technology solutions to advance interoperability today using common standards at scale. ONC’s rules break down barriers that lie within institutional practices. Refusal to change approaches at a practice level inhibit the inclusion of imaging and other complex clinical data with the rest of a patient’s history. The coronavirus demonstrated why the rules were needed long ago. Paradoxically, the coronavirus is helping to fast-track interoperability even as the federal interoperability rules face implementation delay.

Matthew A. Michela is president and CEO of Life Image. He has been a healthcare industry executive for 30 years, serving in leadership positions in both the payer and care management sectors. Michela joined Life Image in 2015 with the mission of democratizing data to create an interoperable healthcare ecosystem that creates a connected view of a patient’s journey. By evolving and transforming the Life Image network into an innovative digital platform for the sharing of any and all clinical information including medical images, healthcare professionals can see data in a comprehensive way. This enables them to better learn from the data, make better informed clinical decisions, improve the patient care experience, and ultimately make new discoveries.