Healthcare Interoperability in the United States (Interoperability, Part 1 of 2)

The healthcare industry in the United States is valued at over $2 trillion, making up roughly 19% of the country's GDP (CMS.gov, 2022 ). Despite its significant contribution to the economy, the industry faces various challenges, including increasing costs and concerns about the quality of care. The push for universal coverage will likely drive-up care expenses further. The nation's economy risks collapsing due to rising healthcare costs.

Why is Interoperability so Urgent?

The US healthcare system has three significant challenges: access, quality, and affordability. These challenges are interlinked and have no easy solutions. Meanwhile, preventable medical errors cause harm and death to many patients, and many lack health insurance. A national eHealth system could be a vital tool in addressing some of these challenges but faces several obstacles as it requires a coordinated national effort (Hill, Powell, 2009). In order for a national eHealth system to succeed, it is crucial to exchange Electronic Medical Records (EMR) and Electronic Health Records (EHR) seamlessly.

Numerous studies have indicated insufficient information exchange is a significant reason for soaring healthcare expenses. This frequently results in delayed care, unplanned hospital readmissions, and unnecessary tests, ultimately hurting patients' health. Efforts are underway by the US Government to promote better communication and collaboration among critical parties, intending to build trust to facilitate smooth information exchange. Implementing mandated EMR/EHR interoperability is a crucial stride towards realizing a nationwide eHealth system. The unhindered exchange of data or information among healthcare institutions via interoperability can create significant value for the whole healthcare system (Wang et al., 2007).

State of Interoperability in the United States

Interoperability—the seamless flow of healthcare information between providers, patients, and payers—has been a long-term goal of the healthcare industry and policymakers in the United States. The mandate to facilitate the smooth exchange of health data among multiple healthcare IT systems for coordinating care across different healthcare settings throughout the country began with the implementation of the Hitech Act (HITECH, 2009 ).

Despite notable advancements toward achieving interoperability objectives, considerable obstacles still must be overcome. The ONC Data Brief evaluated hospitals' capacity to perform four essential domains of interoperability: finding, sending, receiving, and integrating electronic health information (EHI) from sources outside their health systems. The results have been a mixed bag, with some hospitals showing progress while others needed to catch up. The 2018 Brief below for non-federal acute care hospitals in 15 major cities across the United States reveals that Cleveland, Miami, and Detroit have more than 70% of hospitals that exchange interoperable data. However, the percentage is substantially lower in other cities.

Barriers to Interoperability in the United States

Over the years, various healthcare interoperability initiatives, health data exchange frameworks, and health IT standards have significantly facilitated efficient information exchange. However, we still must overcome various challenges to achieve true interoperability.

These barriers are as follows:

• inconsistent approach for identifying patients across health systems
• insufficient interoperability standards across hospitals, care settings, and providers
• lack of standard KPIs for measuring and reporting industry-wide interoperability progress
• ineffective coordination among multiple parties within the healthcare industry
• unclear rules for resolving obstacles in sharing data
• lack of adequate punitive measures for information blocking

Promoting a new Interoperability Framework in the United States

American interoperability is based on the foundation of the "may share" and "minimum data share" paradigms of HIPPA. Under this, the parties negotiate the minimum patient data sharing between partners based on the context. American "May share" paradigm is starkly different from the "must share" paradigm of European interoperability. The policy shift from "may share" to "must share" can boost interoperability in healthcare across the United States.

In an upcoming article (part 2), I plan to delve into the EU's healthcare interoperability approach. For now, I would like to stay focused on the state of interoperability in the US, including the barriers and progress made so far.

In the context of Interop in the United States, we must deal with the tension between the Government's ability to legislate a policy framework and the industry consensus on policy issues. Legislating industry standards is feasible when they align with the consensus of the industry. However, if there is a disparity, healthcare lobbying efforts tend to hinder reforms. Public-private negotiations involving multiple stakeholders are necessary to apply a single digital market construct of European interoperability to American circumstances. These negotiations must still adhere to the prevailing self-governing paradigm of the US healthcare industry. While preserving the market mechanism is important in America, it is necessary for the government to intervene and prevent harmful practices like information blocking by hospitals. Both federal and state governments need to collaborate in a non-partisan manner to accomplish full industry-wide interoperability.?

Encouraging Interoperability through standardized EMR/EHR

A formal methodology is needed to assess and design electric health systems with interoperability as a core feature (Gaynor, Andrus, et al., 2014). According to the Health Information and Management Systems Society (HIMSS ), there are four levels of interoperability.

• Level 1: Foundational, it defines the necessary connectivity specifications to enable secure communication between systems or applications for data transmission and retrieval.
• Level 2:?Structural, it pertains to format, syntax, and organization of data exchange, even down to the individual data fields for easy understanding. It promotes data exchange in a standardized format that any other system or device can interpret.?
• Level 3:?Semantic, it ensures data modeling and coding consistency by utilizing standardized definitions from publicly available value sets and coding vocabularies. This promotes a shared understanding and meaning for all users.
• Level 4: Organizational, it includes governance, policy, social, legal, and organizational considerations.

The government and private sector both have a crucial role in establishing standards that encourage the growth of interoperable EMR/EHR systems.

The US government is encouraging interoperability through the meaningful use of EMR and EHR and incentivizing their adoption. The Office of the National Coordinator for Health Information Technology (ONC ) oversees interoperability efforts nationwide. They facilitate interoperability at all four levels through technical projects, such as developing standards, certifying health IT systems, and partnering with healthcare industry leaders to implement policy and programmatic initiatives.

The HL7 messaging standard, created by the non-profit international organization Health Level Seven International (HL7) , provides a set of global guidelines that facilitate the transfer and sharing of data between different healthcare providers. By providing structural and semantic interoperability, HL7 integration standards allow for EMR/EHR exchange in standardized formats that are easily understandable by any receiving system.

Role of Government and Policies in Enabling Interoperability

Interoperability requires common data formats, communication protocols, and a semantic understanding of the exchanged information. Government organizations play a crucial role in promoting the adoption of common standards and work practices for interoperable systems, which helps to share and integrate information effectively (Gottschalk, 2009). Governments worldwide have used legislative power to enact regulations advancing interoperability goals. In addition to legislation, the Government has been encouraging public-private partnerships to make the regulatory mandates more business-friendly.?

In the United States, the HIPPA Act of 1996 allowed healthcare providers to share patient information face-to-face, over the phone, or in writing with other entities, public or private (hhs.gov ).

Health data exchange was conceptualized in the subsequent Hitech Act (HITECH, 2009). The 21st Century Cures Act of 2015 in the United States mandated the CMS and ONC to create a policy charter for "information blocking" and standards to promote interoperability.

In 2020, the CMS and ONC released separate final rules with specific guidance on policies, standards, timelines, and further information blocking, a practice that hospitals use to impede patients from changing care providers by creating purposeful barriers to information sharing.?

Currently, several legal mandates and private initiatives are in place in the United States?to promote interoperability goals. ?

1. Federal Health IT Strategic Plan 2020-2025. The Plan aims to improve access, exchange, and use of electronic health information.
2. Trusted Exchange Framework and Common Agreement (TEFCA), a federal interoperability framework developed by the Office of the National Coordinator for Health Information Technology (ONC).
3. Centers for Medicare & Medicaid Services (CMS) mandated Payer-to-Patient and Provider-to-Patient Application Provider Interface (API) requirements. The provider and payer organizations must use EHRs certified per the 2015 Edition Cures Update Criteria to comply with the CMS mandate for promoting interoperability.

In addition to the federal mandates above, the following private, nonpartisan, multi-stakeholder, and multi-sector alliances are operative to advance interoperability goals in the United States:

1. Health Level Seven (HL7?) Da Vinci Project to promote real-time care data exchange by championing the adoption of FHIR standards across the healthcare sector, and
2. CARIN Alliance to remove barriers to patients' right to access their data via consumer-directed exchange.

These five initiatives, which result from government mandates as well as public-private partnerships, have a common goal of promoting interoperability throughout the United States. However, these bodies often act independently of each other, leading to a need for coordination in their efforts.

Conclusion

In essence, Interoperability is essential for ensuring services are delivered on a harmonized and compatible platform. Just as interoperability is critical to successfully establishing a single digital market in the European Union, linking interoperability to strategic healthcare objectives such as improving patient care, promoting better health outcomes, and reducing costs are essential for the US Healthcare sector. In my upcoming article, I will discuss the plan for a federally mandated American Interoperable Framework. This framework can be extended to all states, with the option for states to customize it according to their local policies and regulations.

This piece of writing has been adopted from the author's academic work at The London School of Economics and Political Science .