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

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

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.

What is information blocking?

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.

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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.

Why is the ONC doing this?

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.

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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.

The road to interoperability

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.

Compliance and opportunity

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.

Innovation and growth

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.

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