Thomas Komaromi

My colleague Larry Bucshon, M.D. helped author this thoughtful article regarding the challenges of fragmented state regulation of AI in healthcare and advocates for a pragmatic path forward. ⬇️

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“Governor Glenn Youngkin today issued an executive order launching a first-of-its-kind agentic artificial intelligence (AI) regulatory reduction pilot to ensure that the Commonwealth captures the benefits of the latest artificial intelligence technology in reducing regulatory burdens and keeping regulations and guidance documents streamlined and up to date.” https://lnkd.in/eKRENYWi

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Recommend that you review this new blog post from my Reed Smith LLP colleagues, Nancy Bonifant Halstead, Nicole Aiken-Shaban, Caitlin Chambers and Alexa Chronister. They describe a negative opinion given to a request of the HHS Office of Inspector General from a device manufacturer regarding a proposed arrangement with the company's customers. Under the proposed arrangement, some customers would request or require, as a condition of doing business, that the manufacturer pay for third-party screening and monitoring of the manufacturer for exclusion from Federal health care programs and to ensure compliance with certain other legal requirements.The OIG said it was unwilling to sign off on the provision of such free items or services by individuals and entities, like the dlevice manufacturer, to referral sources (e.g., manufacturer's customers) that could lead to the ordering and provision of an item or service payable by Federal health care programs. In taking this view, the OIG reaffirms its long-held view of financial arrangements between referral dependent entities and referral sources that are not grounded in fair market value. Similarly, the OIG has concern with business relationships between hospitals and physicians in this regard. For example, on January 31, 1991, the OIG issued a Fraud Alert entitled "Office of Inspector General Management Advisory Report No. OEI-09-89-00330, Financial Arrangements Between Hospitals and Hospital-Based Physicians" ("MAR"). Here is a link to this document on the HHS-OIG Web site. https://lnkd.in/eA-yunia The MAR notes that hospitals are referral sources of Medicare patients receiving services from diagnostic radiologists who contract with hospitals to provide professional services. Radiologists receive referrals from hospitals, because hospitals controls access to their plant, equipment and other resources necessary to provide services to hospital patients. The anti-kickback law is violated when a hospital or other entity knowingly solicits or receives remuneration from a group of referral-dependent physicians, such as radiologists, in return for the right to practice at the facility and have access to the flow of Medicare and other patients. In its Compliance Program Guidance for Hospitals, published in the February 23, 1998 Federal Register, the OIG noted its concern with hospital financial arrangements with hospital-based physicians that compensate physicians for less than the fair market value of services they provide to hospitals or require physicians to pay more than market value for services provided by the hospital. The new advisory opinion highlights the importance of maintaining vigilance to fair market value in transactions between referral dependent entities and those who make referrals to them that are paid via Federal health care programs.

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But in 2025 and beyond, Unified Law Group, PB LLC attorneys are experts in providing outsourced law department services for individuals and organizations who are serious about privacy matters. These experts include Krista O'Donnell , our founder Amy Natasha Osteen and others. Efficient. Cost-effective. Responsive. Pragmatic. Multi-national. Unified Law Group, PB LLC. We want to work with and for you. #privacy #GDPR #CCPA #fractionallegal

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Foley represented Sorcero in its strategic acquisition of Axiom Health, a medtech DaaS company. This marks a pivotal expansion for Sorcero into the medical device market and expands the company’s product suite to include market and product intelligence.

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It’s not every day a company sues U.S. Customs and Border Protection in a patent infringement matter. Masimo just did in its fight with Apple over the Apple Watch. I was excited to provide perspective in this article for WIPR - World IP Review on what makes this case so unusual and how it could provide a blueprint for companies seeking to avoid an ITC exclusion order.

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The education vs promotion line keeps getting thinner, especially in medical affairs. At DIA MASC, we’ll discuss where companies are getting this wrong and why enforcement is watching. https://lnkd.in/epyr2PrC #klf #kulkarnilawfirm #MedicalCompliance #FDA

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SEC settlement with former public company CEO includes Reg. FD charges for comments allegedly made to institutional investors at invitation-only event; a reminder to use care in semi-public communications and to provide training for executives and IR personnel on the line between permissible and impermissible comms about corporate developments. https://lnkd.in/gJxDn9UG

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Incredibly fortunate to be working with the team of Brendan McMurrer Ava Guo Timothy H. Lee Kate Marcom to launch our new Center of Expertise: AT&T LegalEdge. We are focused on building an expert in-house team of attorney and professionals who will channel AI-driven capabilities to deliver faster, higher‑quality, and more cost‑effective legal work at a time when the legal industry is ripe for disruption. We think that those who join AT&T LegalEdge will become experts in how law will be practiced in an AI-enabled future and we couldn’t be more excited.

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Old Laws, New Tech, Same Consumer Protection: A Timeless Principle We often think of technology as outpacing regulation, but some foundational consumer protection principles remain incredibly potent, even decades later. My recent experience highlights this perfectly. Consider the Federal Trade Commission's (FTC) "Notice of Penalty Offenses Concerning Automobile Rental Practices" – a document originally created in 1978. You might think, "What could that possibly have to say about today's online bookings or electric vehicles?" A lot, actually. This document outlines deceptive practices like misrepresenting vehicle availability/type and failing to disclose material terms. It also includes a crucial point: it's an unfair practice to "furnish to others the means or instrumentalities with which to engage in the unfair or deceptive practices." Our family recently faced this head-on: + United Airlines' car rental portal listed a "standard SUV" for our Rome rental, with NO DISCLOSURE it was electric. This misleading information directly set us up for problems. + Upon arrival, Budget (an Avis Budget Group brand) at Rome Fiumicino then engaged in high-pressure tactics, adding numerous undisclosed and unwanted extras, leading to a charge more than double our original quote. + When we contacted United's customer service, they deflected responsibility, stating they "don't have the tools" to address issues stemming from their own portal's inaccuracies. These are modern scenarios, yet they directly fall under the deceptive practices identified by the FTC decades ago. United's portal, by providing inaccurate information, arguably furnished the means for Budget's subsequent deceptive practices. It's a powerful reminder that while innovation sprints ahead, the core principles of transparency, fairness, and accountability in business are timeless. Consumer protection isn't just about new regulations for new tech; it's about applying enduring ethical and legal standards to every new frontier. What are your thoughts on how classic consumer laws adapt to the digital age? Have you experienced similar situations where old rules still apply? #ConsumerRights #FTC #DigitalEthics #ConsumerProtection #BusinessTransparency #LegalTech #Innovation #AvisBudgetGroup #UnitedAirlines #CarRental

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The Senate IP Subcommittee, led by Sens. Tillis and Coons, will hold tomorrow (Oct. 8) a hearing on the #Patent #Eligibility Restoration Act (S.1546)—a bipartisan effort to rewrite § 101 and clarify patent eligibility. Witnesses include former USPTO Directors Iancu and Kappos, among others. The session may signal Congress’s direction on eligibility reform across AI, diagnostics, and software. https://lnkd.in/e9wVWadU

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FDA recently announced a new program that is worth noting, particularly for anyone innovating in the digital health and remote monitoring spaces. The “Reducing Readmissions through Device Innovation for the Home (READI-Home)” initiative focuses on technologies that support post-acute care in the home setting and aim to reduce hospital readmissions. This includes a broad range of home-use and digitally enabled medical devices that may operate outside traditional clinical environments. The program reflects several important regulatory themes: ➡️ Continued FDA emphasis on decentralized and home-based care models ➡️ Increasing attention to usability, human factors, and caregiver interaction in non-clinical settings ➡️ Growing importance of interoperability, remote monitoring, and software-enabled functionality ➡️ Recognition that device performance, cybersecurity, and risk management considerations may differ significantly in the home vs. institutional care settings. The initiative also raises interesting questions around evidentiary expectations, post-market surveillance, and how sponsors will demonstrate safety and effectiveness for increasingly complex home-use technologies. If you're interested in submitting a Q-sub to apply, or have opinions on the program, I'd love to chat.

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Partner Kyle Faget shared insights with Medtech Insight on AI’s growing role and the importance of stable user fee funding ahead of the next MDUFA reauthorization.

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Great MedTech Dive article below by Elise Reuter digging into WHOOP’s FDA warning letter and the bigger question everyone in digital health should be asking right now: When does a “wellness” feature cross the line into an FDA-regulated medical device? Elise interviewed me for the piece and I shared my thoughts: “The fact that they think they can just add a blood pressure feature and do these things without getting them approved by the FDA… it’s just not going to happen.” Wearables want to move fast. FDA, providers, and consumers (me included—I wear a WHOOP) want accuracy and accountability. That tension is only getting louder, and this WHOOP situation is a preview of where the whole sector is headed.

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Interesting Wall Street Journal column from ŌURA CEO Tom Hale re: the regulatory scheme facing wearable device manufacturers. Oura suggests a new device classification called “digital health screeners”—software features that can warn users of trouble but stop short of diagnosis. I've previously reported on Whoop's interaction with the FDA. https://lnkd.in/gkgjeYe7

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