This week, a New York Metropolis-based startup determined to wage its personal David vs. Goliath-style battle within the healthcare expertise world.
Following a months-long dispute, information platform Particle Well being sued EHR behemoth Epic. The startup filed an antitrust lawsuit towards Epic within the Southern District of New York on Monday, alleging that the EHR vendor is utilizing its dominance out there to stop competitors within the payer platform area.
The payer platform area refers back to the rising marketplace for digital platforms that enable payers to entry and analyze affected person information at scale for quite a lot of functions, together with bettering care coordination, designing inhabitants well being applications or streamlining claims processing. Particle’s criticism alleges that Epic is stopping the startup from competing on this area by reducing off Particle clients from accessing Epic’s EHR information.
Particle believes the lawsuit is an “unprecedented problem” to Epic’s market energy. Epic thinks the startup’s claims are with out benefit.
The payer platform market
Particle, based in 2018, seeks to assist its clients, together with suppliers and well being plans, entry and perceive affected person information held by Epic and different EHR techniques.
Primarily, Particle acts as a intermediary, utilizing an API to allow well being information entry between Epic and its personal clients. The startup participates in a number of nationwide well being information exchanges, resembling Carequality, CommonWell, and eHealth Alternate.
Particle put itself on “a meteoric progress path” when it started providing its companies to payers final 12 months, the criticism learn.
The startup made its transfer into the payer market as a result of it observed that an rising variety of payers had been changing into “payviders,” that means they supply healthcare companies to their members. As an illustration, UnitedHealth Group, the nation’s largest healthcare insurer, is the biggest employer of physicians within the nation by means of its Optum subsidiary, and Humana, additionally a payer, has a senior care unit referred to as CenterWell Major Care.
“Particle was the primary to comprehend that payers providing these companies legitimately wanted data to help physicians with offering remedy, and will subsequently, underneath sure circumstances, make the most of the centralized alternate networks to acquire medical data by means of probably the most environment friendly means at present out there,” the criticism learn.
Below the foundations of HIPAA and well being info networks, those self same payers are allowed to make use of the data for “secondary” functions, resembling inhabitants well being analytics or processing claims, the criticism said.
By giving payers entry to this info, Particle entered into competitors with Epic, mentioned Adam Wolfson, one of many attorneys representing Particle.
Epic launched its payer platform in 2021, permitting insurers to request, obtain, retailer and analyze well being data at scale. When Particle determined to compete in 2023, Epic had agency management of the rising market, together with contracts with the seven largest well being plans within the nation, based on the criticism.
“Within the payer platform market, [Epic] was the one sport on the town for a number of years,” Wolfson remarked.
Whereas Epic could also be dominant within the area, different firms like Zus Well being, Make clear Well being and Well being Gorilla additionally goal to fulfill payers’ appetites for affected person information. Zus Well being and Well being Gorilla, like Particle Well being and Epic, are additionally a part of Carequality’s alternate community.
When did the dispute start?
In March, Epic filed a proper criticism with Carequality, a well being info alternate that helps the alternate of 400 million scientific data monthly. The criticism alleged that Particle was sharing affected person information with payers that weren’t utilizing the info for remedy — and subsequently violating HIPAA.
Epic additionally despatched its clients a discover informing them that the corporate was reducing off information entry for Particle Well being.
“This poses potential safety and privateness dangers, together with the potential for HIPAA Privateness Rule violations within the occasion disclosures of protected well being info had been made underneath the Remedy Permitted Function when the requesting entities didn’t have remedy relationships with the sufferers to whom the data associated,” Epic mentioned in a discover to its clients, which was obtained by CNBC.
Particle launched a weblog submit on April 12 stating that Epic had stopped responding to information requests from a “subset” of Particle’s payer clients “with out a clearly said purpose or clarification.” Particle additionally mentioned that it “started addressing this subject instantly” and wished to work with Epic to revive entry for these clients.
Moreover, Troy Bannister, Particle’s founder, launched a assertion refuting Epic’s declare that the startup’s clients had been requesting affected person information for functions aside from remedy.
“To our information, the entire affected companions immediately help remedy. They pull information for suppliers on the level of care and subsequently share information again with the Carequality community. These companions had been all reviewed by Carequality previous to onboarding and they’re entitled to truthful and clear remedy by the community and different implementers,” Bannister’s assertion learn.
The disagreement underscored the necessity for better transparency in well being information alternate networks, famous Brendan Keeler — who has held management positions at healthcare information firms like Zus Well being and Redox — in an article he wrote on the time of the preliminary dispute.
In his view, the dialog shouldn’t middle on whether or not or not Particle’s clients are utilizing information solely for remedy functions — as a result of there are numerous different official causes for which healthcare organizations would search information.
As an illustration, well being navigators and insurance coverage brokers require information to assist sufferers choose the very best suppliers and plans, and pharma firms want information to maximise the success of their scientific trials, Keeler identified.
At current, EHR firms like Epic get to arbitrate which requests are acceptable and which requests must be denied. However Keeler thinks well being info exchanges and regulators want to come back collectively and construct a extra clear system that permits stakeholders to see the precise use circumstances for which payers are requesting information.
“The very best motion is to behave with rising unfettered transparency — publish your clients’ use circumstances, make their listing entries granular and clear, and talk the supposed functions of use,” Keeler argued.
What does the lawsuit allege?
Particle’s antitrust lawsuit alleges that Epic “is engaged in a scheme to stamp out competitors in an vital new market by misusing energy that it has attributable to its management over digital well being data,” said Wolfson, certainly one of Particle’s attorneys.
The criticism claims that Epic has been blocking Particle clients from information — and subsequently stifling Particle’s entry into the payer platform market — for the previous six months which have continued following the preliminary dispute within the spring.
“Between 80-94% of individuals within the nation have at the least one Epic digital well being document of their file. So if Epic is refusing to offer these data for remedy requests, then you definately’re not getting somebody’s full medical well being historical past. We allege that provides Epic a ton of energy over those that have to get these full medical histories,” Wolfson defined.
Particle CEO Jason Prestinario launched an announcement and video testimonial on LinkedIn this week declaring that the lawsuit is not only a enterprise dispute, however moderately additionally a transfer to guard sufferers’ rights to their well being information.
Within the six months following Particle’s preliminary dispute with Epic, the EHR vendor “induced actual affected person hurt” and broken Particle’s popularity with its “false allegations” of HIPAA violations, he mentioned within the video.
“We’re involved about what’s to cease them from doing that to extra sufferers, to us, or to every other competitor that emerges,” Prestinario remarked.
By submitting the lawsuit, Particle seeks financial damages, injunctive aid and to place an finish to Epic’s alleged info blocking practices. The startup additionally filed a proper info blocking criticism with the ONC, which has now been referred to HHS’ Workplace of the Inspector Common, Prestinario famous.
The lawsuit additionally goals to create extra room for competitors within the payer information platform market, he added.
“We have to guarantee a degree taking part in area the place firms like Particle — however not simply Particle — can proceed to innovate, the place suppliers and payers have decisions, and the place sufferers in the end profit from higher, extra environment friendly care,” Prestinario declared.
An Epic spokesperson referred to as the lawsuit’s claims “baseless” in an announcement despatched to MedCity Information.
“This lawsuit makes an attempt to divert consideration from the true subject: Particle’s illegal actions on the Carequality well being info alternate community violated HIPAA privateness laws. Particle’s criticism mischaracterizes Carequality’s resolution, which in reality proposes banning Particle clients that had been accessing affected person information for impermissible functions,” the assertion learn.
Carequality advised MedCity Information that it “wouldn’t be acceptable” to touch upon the continuing litigation between Particle and Epic as a result of it’s not a named occasion within the lawsuit.
“What we will say is that Carequality is dedicated to the integrity and transparency of our interoperability framework. We really feel assured in our impartial and non-biased dispute decision course of, which considers all the knowledge in meticulous element to succeed in an end result that preserves belief, improves our community, and reaches the very best end result for our neighborhood. That course of resulted in a decision that’s nonetheless being thought-about by the events and subsequently we won’t touch upon the specifics,” the emailed assertion learn.
What does this imply for the longer term?
Within the feedback part of Prestinario’s LinkedIn submit, Lisa Bari — CEO of Civitas Networks for Well being, a nationwide group representing regional well being info exchanges — echoed Keeler’s feedback from earlier this 12 months concerning the want for better transparency.
“Simply studying the criticism, it looks like there’s a little bit of a misunderstanding (to say the least) concerning the remedy use case underneath Carequality because it pertains to payers and plans (and TEFCA, though this isn’t, at current, immediately about TEFCA). From my perspective, I’m trying ahead to discovery, to deliver extra of those complaints into the general public area. Transparency is essential to belief,” she wrote.
The Trusted Alternate Framework and Widespread Settlement (TEFCA) is a federal initiative designed to create a standardized, nationwide framework for the alternate of healthcare information between varied techniques and organizations.
The lawsuit additionally attracts consideration to the truth that sufferers usually bear the brunt of the hurt in relation to the trade’s messy information alternate practices.
Unrestricted entry to healthcare information is essential for bettering the standard of affected person care, identified Mitesh Rao, CEO of OMNY Well being, a nationwide information ecosystem that facilitates biotech and medical analysis.
“Healthcare is more and more a data-driven trade. Entry to the wealth of insights buried within the troves of information we generate will help quickly enhance each high quality and security in scientific care. Information also can function a basis for suppliers to collaborate in bettering affected person outcomes,” he remarked.
The free circulate of information helps physicians higher establish and tackle sufferers’ well being complexities, ship acceptable medicines and care plans, and form the way forward for medical analysis, Rao added.
It’s unsure whether or not Particle’s lawsuit will make it to trial. Whether or not or not the underdog triumphs or fails, this authorized battle underscores a bigger battle for affected person information entry, in addition to the fitting to compete in an EHR market dominated by giants.
Photograph: AndreyPopov, Getty Pictures
Editor’s observe: This story was up to date to incorporate commentary from Carequality.
