The quest to unlock healthcare data in the United States has evolved from a technical challenge into a high-stakes legal and philosophical battle. While government mandates like the 21st Century Cures Act have successfully built the "pipes" for digital data exchange, the industry remains locked in a struggle over who controls the flow, who profits from it, and whether patients can truly exercise their right to their own medical records.
To unpack the current state of healthcare interoperability, MedCity News spoke with Jason Prestinario, CEO of Particle Health. The discussion, featured on the latest episode of the Pivot podcast, highlights a sobering reality: while the infrastructure is improving, the ecosystem is currently mired in litigation and systemic gatekeeping that continues to hinder the transition to true value-based care.
The Current State of Interoperability: A Letter Grade Assessment
If one were to grade the U.S. healthcare system on its ability to share data, the results would be split. Prestinario suggests a bifurcated reality: the technical infrastructure earns a respectable "B+," but the governance of that data—who accesses it and why—struggles to reach a "C."
"When it comes to the actual pipes, we’ve come pretty far," Prestinario explains. "We are seeing transmissions and interactions going back and forth at a high velocity. But where things get complicated is who gets to use the pipes, when, and for what purpose."
The progress is undeniable. From the launch of the Trusted Exchange Framework and Common Agreement (TEFCA) to various CMS interoperability frameworks, the federal government has been aggressive in pushing for transparency. However, as Prestinario notes, the goal is not merely to move data from point A to point B. The true objective is to synthesize that data into actionable clinical insights that improve patient outcomes.
Chronology: From Policy Mandates to Legal Stand-offs
The modern era of interoperability is defined by a series of legislative and judicial markers that have shaped the current landscape:
- 2016: The 21st Century Cures Act is signed into law, serving as the foundational mandate to stop information blocking and force the industry to make medical records programmatically available.
- 2020-2023: Regulatory agencies, including the ONC and CMS, ramp up enforcement, introducing penalties for information blocking and establishing the TEFCA framework to standardize national data exchange.
- 2024: Particle Health files a major antitrust lawsuit against Epic Systems, alleging that the EHR giant is leveraging its market dominance to stifle competition in the payer platform space by blocking access to data.
- September 2024: A federal judge rules that Particle Health’s core antitrust claims against Epic can proceed, marking a significant, precedent-setting moment in healthcare litigation.
- 2025: The landscape remains volatile, with additional lawsuits from various actors, including the state of Texas, challenging Epic’s data-sharing policies.
The Value-Based Care Imperative
Interoperability is often treated as a technical "nice-to-have," but in the context of value-based care (VBC), it is a "need-to-have." In a fee-for-service model, providers are incentivized to perform procedures. In a VBC model, they are incentivized to keep patients healthy.
"If you cannot get data from different sectors, how do you measure success?" asks host Arundhati Parmar.
Prestinario agrees, noting that value-based care requires a holistic view of the patient—especially for care occurring outside the four walls of a single hospital. "In a value-based care construct, access to data is a requirement. It is the difference between a nice-to-have and a necessity. If we want to move toward a system where we care about the end result—how healthy a patient is—we must have the data to track that progress."
The Epic Litigation: A Battle for the Soul of Data
The lawsuit between Particle Health and Epic Systems is the most prominent signal of the current tension. Epic has defended its actions by claiming that companies like Particle Health were facilitating the sale of patient data to third parties, such as law firms, for non-treatment purposes.
Prestinario frames the lawsuit as a David vs. Goliath struggle for patient empowerment. "This lawsuit is about making data work for patients," he says. "We believe Epic is using its monopolistic position to stop the flow of data. That’s bad for patients, bad for professionals, and it runs counter to the laws put in place to ensure patient choice."
The "Treatment" Purpose Controversy
The core of the legal dispute hinges on the definition of "treatment." Epic alleges that some entities are using "treatment" as a cover to pull data that is actually intended for litigation support or other commercial purposes.
Prestinario emphasizes that there is a vast, fundamental difference between a patient requesting their own data for their health and a third party scraping data without explicit, informed authorization. "If it’s not a treatment purpose, you shouldn’t request it under a treatment purpose. But we have to distinguish between bad actors and the systemic need for data to flow."
Implications: The Patient’s Lost Agency
Perhaps the most startling revelation in the discussion is the state of individual access. Despite the rhetoric that "data belongs to the patient," the technical reality is often vastly different.
"The facility to easily access my own data doesn’t really work today," admits Prestinario. "Even if I want to see my records, I often need to create a portal account for every single provider I’ve visited, remember passwords, and go through onerous authentication processes. That’s not programmatic access; that’s a barrier."
Prestinario points out that many of the existing "interoperability" networks, while large, still rely on legacy systems that do not provide the seamless, patient-centered experience promised by the Cures Act. Until the government enforces information blocking penalties with real-world consequences, these barriers will likely persist.
Looking Ahead: What Needs to Change?
For the nation to move toward a more robust interoperability framework, the focus must shift from building new networks to enforcing existing laws.
- Adjudication and Enforcement: The "rules of the road" are in place, but they lack a consistent referee. The industry needs to see clear, decisive actions from the Office of the National Coordinator (ONC) and the Office for Civil Rights (OCR) regarding information blocking and HIPAA violations.
- Standardization of API Access: True interoperability requires a shift away from password-protected, portal-based data access toward standardized, programmatic API access that empowers patients to port their own data without needing a separate login for every health system.
- Reframing the "Speed Bumps": As the industry grows, legal and technical disputes—the "speed bumps"—are inevitable. However, these disputes must not be used as an excuse to shut down the entire ecosystem of data exchange.
As the legal battles continue to play out in courtrooms, the broader industry must grapple with a simple question: Is healthcare data a public utility meant to drive patient health, or is it a proprietary asset used to build moats around health systems?
"I would love to stop talking about interoperability," concludes Prestinario. "I would love to talk about how we’re using this data to solve clinical problems, improve quality, and lower costs. But until we fix the accessibility, we’re stuck on the starting line."
For now, the industry remains in a state of flux—advancing in its technical capabilities while fighting over the regulatory and ethical guardrails that will define the future of American healthcare.
