Matthew A. Michela, President and CEO, Life Image

President Biden took office on Jan. 20 with an aggressive 100-day to-do list. Healthcare, and more specifically coronavirus control, are top priorities, but the role of interoperability and the secure access and exchange of health information remain underlying critical components that will contribute to or foil the success of these initiatives. 

In a statement from Biden’s administration, a common theme to measure progress is to “harness the full power of science and technology on behalf of the American people.” And, we have learned, we cannot have effective healthcare on either an individual or a national basis without interoperability technology.

The Office of the National Coordinator for Health IT (ONC) announced new rules in March 2020 to prevent information blocking and to help patients more easily access their data in order to fuel new digital innovations. Interoperability has proven to be an important innovation in healthcare that has gained acceptance across party lines.

Time’s Up: Interoperability and patient data access requirements are here

It was during President Biden’s time as Vice President in 2016 that the bipartisan 21st Century Cures Act was signed into law to, among other things, advance interoperability and adopt electronic health records to collect data for research and care. There has been significant effort and attention on this since 2016, and this is expected to continue.

President Biden also plans to expand the Affordable Care Act (ACA), promote additional enrollment, and increased value-based care payments to “give Americans more choice, reduce healthcare costs and make our healthcare system less complex to navigate.”With the reinforcement of ACA, we may expect to see continued expansion of digital health apps to manage care, lower costs while improving quality, and empower patients to own and utilize their data to support care management.

New Leadership Offers Promising Indications

President Biden has not yet explicitly addressed the direction of health IT, but his selection of leaders in the new administration cast a strong indication. His most recent selections for the Department of Health and Human Services (HHS) are known to be strong advocates for interoperability, including Dr. Rachel Levine as HHS Assistant Secretary and Micky Tripathi appointed as the National Coordinator for Health IT.

The Reading Room: Data Interoperability's Role in the Pandemic

Dr. Levine is a strong proponent of interoperability with a keen understanding of the value it offers in supporting public health initiatives. During her tenure as Pennsylvania Health Secretary, and prior to that as the state’s physicians general, she was instrumental in 

 interoperability of health systems in the state to be an example to the rest of the country.

ONC, a department under HHS, does not appear to be pausing interoperability efforts. Tripathi has self-proclaimed as “bullish” on driving interoperability and advancing the national health information technology framework, and his demonstrated 

 in health IT and participation in interoperability advocacy groups, such as 

In the spirit of carrying on business-as-usual, in January 2021, ONC released a draft of Version Two of U.S. Core Data for Interoperability (USCDI) to expand the core data classes and elements required for nationwide interoperable health information exchange. The update to USCDI includes a class designation for diagnostic imaging and required elements of diagnostic imaging narrative, orders, and reports among several other new data classes, such as care team and encounter information. While there have been compliance delays in recognition of the need to focus all resources on managing the pandemic, ONC is carefully expanding requirements so as not to stall efforts completely to increase access to critical clinical data.

While the future of interoperability and digital health under the Biden administration remains to be wholly seen, so far, key indicators demonstrate that health data interoperability continues to gain momentum.

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Biden’s Era of Interoperability 

As of November 2020, mandatory compliance with the new federal policies aimed at preventing information blocking of health data goes into effect, backed by what should be significant penalties. The Office of the National Coordinator for Health Information Technology (ONC) promulgated the new interoperability rules in March 2020. This rule seeks to increase health information sharing between patients, providers, and other participants while maintaining privacy and security.

The goal is to create electronic health information (EHI) data that moves with and is possessed by the patient, rather than being scattered, siloed, captive, and largely inaccessible in a variety of locations and formats. This access will be supported by an infrastructure based on standardized application programming interfaces (APIs). With any change of provider or treatment, even for complex cases, information should be easily exportable and accessible.

With this important milestone, data management and accessibility issues will need to be at the top of everyone’s agenda.

Information blocking is any practice that makes it harder to get access to, exchange, or use EHI. Information can be blocked in a variety of ways, some overt and some more subtle, including the use of proprietary software and message standards, siloed databases, onerous procedures, and costs for fulfilling data requests. It is a regrettably common practice.

COVID-19 Both Shifts Focus Away From and Highlights Need for Interoperability

The rule does allow for eight situations where requests for access, exchange, or use of EHI can be denied or limited without violating the information blocking provisions. This is no place to detail them, but every provider has to pay close attention to the limits of these exceptions.

The exceptions help make clear what is information blocking and what isn’t, providing the confidence necessary to invest in freeing all healthcare data that does not fall under one of the exceptions.

While nationwide healthcare data interoperability is recognized to be of immense benefit to the entire healthcare system, and was actually required by HIPAA, movement toward it has been slowed by poor incentives and enforcement, the absence of real market drivers, and the resistance of incumbents who have a business interest in the status quo. The ONC rule is intended to drive behavior change by providers and technology companies to ensure that EHI can routinely be exchanged and used without special efforts and that patients can get their own EHI in a form they can understand and use.

So, while the rule really sets only a minimal standard, everyone in the healthcare system needs to be aware that this as only the first step in a long-term interoperability effort and they should find suitable partners and develop an interoperability road map. Meeting only the currently required data standard will inevitably result in significantly more work in the future, as these requirements evolve.

While there are certainly influential organizations with business models that rely on controlling significant amounts of data, a large part of the problem stems from the simple lack of time, money, skill, and staff needed to move toward interoperability.

And, finally, it never pays to underestimate the force of habit and inertia. Many healthcare business practices have routinely involved information blocking: contract terms include restrictions on data exchange, pricing models discourage it, and incompatible systems are not integrated.

But the ONC rule recognizes that, though the process of interoperability is difficult, it is also essential. The healthcare system’s various interoperability deficiencies have been exposed by the response to the COVID-19 epidemic, including a lack of access to useful health history information as infected patients presented at emergency rooms.

The technology is available, and the potential is great—even greater than most people realize, because interoperability benefits don’t apply only to EHRs. The issue of diagnostic imaging has long been neglected, partly because making it fully interoperable seemed so difficult. But, this is no longer true. A number of organizations have been working on technical and procedural solutions to the problem of integrating EHR data with medical imaging data and presenting all of it via a simple, clear interface usable by patients and clinicians.

In order to succeed in this new world, everyone in the healthcare system will need to make interoperability part of their long-term business planning. And, “long term” means exactly that: information silos will not vanish in a year or two. Additionally, new data types and sources are continually becoming available. As with any incremental process, data integration will be achieved through small, individual changes, which will add up as time goes by. A decade from now, the system will be completely transformed.

Of the three categories of what the ONC rule calls “actors”—healthcare providers, health information networks (HINs), and health IT developers—providers, for the moment, do not face the same specific penalties faced by HINs and HIT developers for information blocking, which can go as high as $1,000,000 per violation.

Providers should not rest easy, however. Section 4004 of the Cures Act provides for the Secretary of Health and Human Services (HHS) to develop disincentives through notice and comment rulemaking, and these penalties will become codified over time. No one will improve their situation by delaying compliance.

It is better to think of information blocking as a business problem. Before the ONC rule, there could be some value in hoarding healthcare data—though probably nowhere near as much value as some organizations tried to tell themselves. Now, the cost of information blocking is part of the competitive landscape, and a real cost of doing business. And, that cost will continue to rise, as the demand for interoperability grows.

The rule will inevitably shake things up in a salutary way. Various new technological solutions will enter the market. Telemedicine, which has been inhibited by the difficulty in guaranteeing access to the necessary data, will gain the necessary foundation to continue the growth it has seen during the COVID-19 pandemic. Diagnostic imaging will become fully integrated into patient health records, workflow, and longitudinal research.

The best way to respond to this change is to embrace it—with the appropriate planning and technical support.

For more coverage based on industry expert insights and research, subscribe to the Diagnostic Imaging e-newsletter

Delaying compliance with Office of the National Coordinator for Health Information Technology interoperability rules can lead to fines.