Lina Khan, chair of the Federal Trade Commission (FTC), would not rule out the possibility of the agency filing an amicus brief to weigh in on Particle Health's antitrust lawsuit against Epic, she told a Wisconsin reporter Thursday.
During a visit to southern Wisconsin yesterday, Khan appeared at a press conference with a local lawmaker to highlight corporate consolidation of grocery stores, Madison Wisconsin media outlet WKOW 27 News reported.
A reporter from 27 News asked Khan if the FTC should involve itself in enforcing antitrust laws against Epic.
“We're not involved in that litigation, which is brought by a private company, but it's actually something I had heard concerns about, especially among entrepreneurs and startups that were trying to enter the healthcare space,” Khan said, the media outlet reported.
When a court considers a case between private companies whose outcome may affect consumers or competition, the FTC may file a “friend of the court” brief to provide information that can help the court make its decision. These briefs offer the court the agency’s interpretation of the law.
When asked if the FTC would file a brief in the Particle lawsuit, Khan responded, “It's too early for us to say,” 27 News reported.
Khan also noted that companies controlling large amounts of information can present risks outside of restricting competition.
“Another concern we've seen is that when you consolidate control over data that can actually leave systems much more vulnerable to certain types of cyber attacks or other hacks that lead to systems really crashing,” Khan said, as 27 News reported.
Health data startup Particle Health filed an antitrust lawsuit against Epic on September 23 alleging that the electronic health records (EHR) giant is trying to muscle out competition.
The 81-page lawsuit (PDF) argues Epic engaged in monopolistic, anti-competitive practices, using its "power over EHRs to expand its dominance into the fledgling market for payer platforms," according to the lawsuit, which was reviewed by Fierce Healthcare.
The lawsuit, in part, stems from developments last spring and growing tensions between the two companies over access and use of patients' clinical data.
"Epic has used its position of dominance to worm its way to the core of the U.S. healthcare system and stamp out competition in a wide variety of interrelated markets, thereby generating billions of dollars for itself," Particle claimed in the complaint.
The startup claims in its lawsuit that Epic is using its massive influence over the EHR market to freeze Particle out of the fledgling payer platform market.
And, Particle Health argues in its federal complaint that Epic has not only engaged in anticompetitive behavior but has purposefully blocked the exchange of patient information.
The suit seeks an adjudication that Epic has violated the Sherman Act as well as monetary damages and injunctive relief compelling Epic to cease its anticompetitive conduct.
An Epic spokesperson called Particle’s claims "baseless" and said the lawsuit attempts to "divert attention from the real issue" as Epic, in turn, alleges that the startup's health data exchange practices violated HIPAA [Health Insurance Portability and Accountability Act] privacy regulations.
The health data feud between Epic and Particle Health
In parallel to the lawsuit, there also is a dispute resolution process involving Epic and Particle Health that is being mitigated by Carequality, a nonprofit organization that operates an interoperability framework.
Carequality is not a party in Particle Health's antitrust lawsuit. But, the data dispute between the two health tech companies formed the basis for Particle Health's beef with Epic.
Particle Health, founded in 2018, is a data platform that aggregates health information for digital health companies through APIs, providing access to more than 300 million patients’ medical records. Particle’s platform provides both a record retrieval service, which allows users to interface with EHR companies like Epic to smoothly request medical records at scale, and an analytics service, which allows users to efficiently store and monitor trends in the medical records they request.
Starting last year, Particle expanded its services to payers to assist so-called "pay-viders" with accessing patients records for “secondary” purposes more typically associated with health insurance, like population health analytics or processing claim, which is allowed under HIPAA and the rules of health information networks, the company said in the lawsuit.
Both Epic and Particle Health are connected to Carequality, which operates a nationwide health data exchange service used by more than 600,000 care providers, 50,000 clinics and 4,200 hospitals to access patients’ medical records. Carequality says it supports the exchange of 1 billion clinical documents each month.
It's made up of dozens of implementer organizations that in turn onboard their participant organizations to the framework. Epic connects its provider customers to Carequality as an extension of its Care Everywhere network.
Organizations that connect to Carequality agree to an “interoperability framework,” which is a collection of legal, governance and technical documents used to operationalize trusted exchange of health information nationwide, according to the organization.
Epic filed a formal dispute with Carequality on March 21, claiming that Particle was sharing patient data with some companies who were then using the data for reasons unrelated to treatment. "This poses potential security and privacy risks, including the potential for HIPAA Privacy Rule violations in the event disclosures of protected health information were made under the Treatment Permitted Purpose when the requesting entities did not have treatment relationships with the patients to whom the records related,” Epic said in the notice to its customers.
Epic then cut off data requests from some Particle Health customers, citing concerns about potentially inappropriate disclosures of protected health information and privacy risks to patients’ medical data, according to a notice sent to Epic customers April 10.
In a statement, Epic said it filed the dispute against Particle Health at the direction of its customer governing council "because some Particle customers used the network to take people’s medical records under false pretenses."
"For example, a business, Integritort, claimed to be treating patients when in fact it was gathering medical records for personal injury law firms to review for potential class action lawsuits," Epic said in its statement.
Particle Health, Epic not appealing dispute resolution
In the ensuing months, there has been a closed-door resolution process involving Carequality’s Steering Committee, which issued a resolution.
That process has been confidential, but Particle Health publicly disclosed some details about that closed-door discussion in its lawsuit against Epic. Particle said the steering committee fully agreed with Particle’s arguments, "expressly finding that Particle did absolutely nothing wrong and that Particle acted within the law and Carequality rules."
The Steering Committee, however, imposed a 'corrective action plan' on Particle that "gave Epic much of what it wanted while expressly disclaiming any finding of wrongdoing by Particle," the company wrote in the lawsuit.
Epic shot back, saying Particle "publicly mischaracterized the resolution," in a statement to Fierce Healthcare.
The EHR giant is calling for Carequality to make the dispute resolution available to the public for full transparency.
Last week, Alan Swenson, Carequality's executive director, said the dispute resolution was a confidential process and would not be publicly disclosed as it was still subject to appeal.
"We will disclose more information once the process has come to a conclusion," Swenson said in a statement to Fierce Healthcare.
There was a deadline this week for the parties to file an appeal, according to Epic. The company notified Carequality that it will not appeal the dispute resolution. "It has been more than six months since the dispute was filed. An appeal could push the resolution well into next year," an Epic spokesperson said in a statement on Monday.
Particle Health also is not appealing Carequality's resolution, according to sources close to the matter.
As of press time, Carequality did not confirm when the corrective action plan would go into effect or when it would publicly disclose more information on the dispute.
"To protect patient privacy and restore trust in interoperability, the Carequality Steering Committee’s corrective action plan should go into effect immediately," an Epic spokesperson said in a statement.
And, Epic is calling for Carequality to release the Steering Committee Resolution "in full."
"A summary is not sufficient. Trust cannot be restored without transparency," the Epic spokesperson said.