The Epic-Health Gorilla case just got juicier

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The Epic-Health Gorilla Case Just Got Juicier

The skinny
Epic's high-profile lawsuit over the alleged misuse of patient data just scored its first major concession. Last Friday, GuardDog Telehealth — one of the defendants accused of exploiting interoperability networks to obtain people's health information — admitted in a legal filing that it falsely represented itself as providing treatment in order to access medical records.

The case at hand
Epic filed its complaint on January 13, alleging that Health Gorilla allowed other companies to improperly access and monetize nearly 300,000 patient records — a claim Health Gorilla denies. The plaintiffs include Epic, Trinity Health, UMass Memorial Health, Reid Health and OCHIN.

According to the complaint, Health Gorilla and affiliated companies created fake healthcare providers, shell websites, and provider IDs to make data requests appear legitimate, while diverting records for non-treatment purposes such as marketing to lawyers. GuardDog is the first defendant to admit in court that it misrepresented itself as a treating provider in order to gain access to patient records.

The agreement
"GuardDog admits that, since it began operating as a company in 2024, its goal was to provide chronic care management and remote patient monitoring for patients, but that did not happen. For the duration of its existence, its business instead focused on requesting, reviewing, and summarizing medical records, and providing those medical records to law firms," the company said in a court filing.

As part of its agreement with Epic and the other plaintiffs, the company agreed to stop accessing records through major interoperability frameworks, as well as to delete any patient data it gathered through those systems.

Health Gorilla's response
Health Gorilla maintains that GuardDog's consent judgement changes nothing for the company.

"If you read carefully, GuardDog does not state it ever informed Health Gorilla of any non-treatment use of patient information, and we are prepared to demonstrate it did not. In addition, when Health Gorilla sought to investigate GuardDog along with the interoperability networks and several major health providers, GuardDog failed to respond and refused to cooperate," the company said in a statement sent to MedCity News.

— By Katie Adams

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'Injectable-Like Efficacy' for an Oral Obesity Drug

The news
Structure Therapeutics is preparing for Phase 3 testing of its oral GLP-1 obesity drug, aleniglipron, after the once-daily pill posted Phase 2 results showing an average 16% weight loss measured at 44 weeks. There was no plateau for the weight loss, suggesting patients would keep losing weight if they kept taking the drug. Also important, the results showed low rates of the gastrointestinal problems that are a class-wide effect for GLP-1 drugs and lead many patients to stop taking them.

The drug
The first GLP-1 obesity drugs, Wegovy from Novo Nordisk and Zepbound from Eli Lilly, are engineered peptides designed to bind to and activate their targets (Zepbound targets the GIP receptor as well as the GLP-1 receptor). Peptide drugs typically must be administered as injections, though Novo recently launched a pill version of Wegovy that makes oral administration of its peptide ingredient possible. Structure's aleniglipron is small molecule designed to target GLP-1. It's formulated as a once-daily pill.

Why it matters
Injectable GLP-1 drugs are effective, but they are also expensive. Besides the fact that manufacturing peptides drugs costs more than making oral small molecules, self-injection pens add to the overall cost of a product. A daily pill offers patient convenience and lower manufacturing costs, which in turn supports a lower price point. If Structure's drug succeeds in Phase 3, it will compete against Wegovy pill and potentially against Lilly's orforglipron, an oral GLP-1 obesity drug currently under FDA review.

Soundbite
"The consistent weight loss observed across multiple studies to date reaffirms aleniglipron's potential to be a best-in-class oral GLP-1, with injectable-like efficacy that could become a backbone oral small molecule therapy for obesity," Structure CEO Raymond Stevens said.

—By Frank Vinluan

The Last Human at the FDA: AI on a Skeleton Crew

A snazzy SXSW panel title
The link above was actually the session title of a panel at SXSW on Monday featuring a former FDA official and an attorney. Organized by Real Chemistry, a marketing and communications firm, the panel featured a candid discussion about the level of stability across divisions at the agency, while AI hopes to pick up the slack of lost personnel.

Around 20% of positions were cut by DOGE last year leading to a lot of lost policy and legal expertise, said Alan Minsk, an attorney with Arnall Golden Gregory LLP and Tala Fakhouri a former FDA official now with clinical research organization Parexel. Real Chemistry's Leslie Isenegger explained that into this gap AI tools are being implemented – 70% of the agency has access to Elsa, the agency's gen AI tool.

Will the gamble succeed?
No panelist directly addressed the question, but there were plenty of caveats. Transparency is key exhorted Fakhouri and Minsk – not just in terms of how industry is using AI and communicating that to the FDA but also how the agency is using AI to do reviews and other tasks.

Soundbite
"There's no magical large language model at the FDA. The magical thing at the FDA is the knowledge base, whether it's data that the agency has, or the staff that the agency has. That's where the magic happens," Fakhouri said. "So when you lose a large proportion of your experienced staff, and then you're supposed to build AI tools to help fill this gap, what you end up with is AI applications that can optimize certain parts of the process. It's kind of wild to say that regulatory decisions could be done with AI. I think we'll all know when the FDA is doing that because we'll be doing it within our organizations, and it's not there yet."

Employer Groups Applaud Healthcare Competition Bill

The news
In a letter to lawmakers Monday, employer advocacy groups applauded the Healthy Competition for Better Care Act, a bill aimed at increasing competition in healthcare.

The bill
The bill was introduced in the Senate last week by Jon Husted (R-Ohio). Reps. Jodey Arrington (R-Texas), Rick Allen (R-Georgia), Donald Davis (D-North Carolina) and Chuck Edwards (R-North Carolina) previously introduced a companion bill in the House.

The Healthy Competition for Better Care Act aims to boost competition by banning several types of anticompetitive contracts between insurers and healthcare providers. The legislation would prohibit all-or-nothing clauses that force insurers to include every provider in a network, anti-steering and anti-tiering clauses that limit employers' ability to direct patients to lower-cost or higher-quality providers, most-favored-nation clauses that can drive up prices and gag clauses that restrict the sharing of cost information.

What employer groups are saying
The letter was signed by the American Benefits Council, the ERISA Industry Committee, the National Alliance of Healthcare Purchaser Coalitions, the Purchaser Business Group on Health, the Silicon Valley Employers Forum and the Small Business Majority.

"Across the country, provider systems are using their dominant positions to impose restrictive and often unfair contractual terms that limit network flexibility, reduce access to high-value providers, and drive up costs without improving quality," the organizations stated in the letter. "These trends undermine employers' ability to design benefit plans that prioritize value, support innovation, and deliver high-quality care. … Your bill meaningfully addresses these issues."

— By Marissa Plescia

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The Epic-Health Gorilla case just got juicier