Innovative Technology Insights | Âé¶ą´«Ă˝ Legal services in Boston, Massachusetts Mon, 08 Jun 2026 20:28:58 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.5 /wp-content/uploads/2024/11/cropped-Âé¶ą´«Ă˝-Favicon-1-32x32.png Innovative Technology Insights | Âé¶ą´«Ă˝ 32 32 What Cross-Border M&A Teaches About the Limits of Legal AI /insights/publications/2026/06/what-cross-border-ma-teaches-about-the-limits-of-legal-ai/ Mon, 08 Jun 2026 20:28:56 +0000 /?p=120792 In due diligence, where the review of hundreds or thousands of agreements once set the cost and the calendar, a well-pointed model now does in an afternoon what a team of associates needed two weeks to finish. The most labor-intensive phase of diligence has become, for practical purposes, nearly free.

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AI, Virtual Care, and EHR Optimization: What Hospitals Should Watch as AHA and West Health Launch National Accelerator /insights/publications/2026/06/ai-virtual-care-and-ehr-optimization-what-hospitals-should-watch-as-aha-and-west-health-launch-national-accelerator/ Tue, 02 Jun 2026 13:41:19 +0000 /?p=120532 The American Hospital Association (AHA) and the West Health Institute recently announced the launch of the West Health Accelerator (Accelerator) at AHA’s Health Research & Educational Trust (HRET), a three-year national initiative designed to help hospitals and health systems operationalize and scale proven technologies across care environments. The initiative is supported by a $12 million commitment from West Health Institute and will focus on three priority areas: electronic health record (EHR) optimization, virtual care, and artificial intelligence (AI) utilization and integration.

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From Static Compliance to Living Compliance: How Agentic AI Can Make Health Care Operations Safer /p/102mr3g/from-static-compliance-to-living-compliance-how-agentic-ai-can-make-health-care/ Wed, 29 Apr 2026 17:50:05 +0000 /p/102mr3g/from-static-compliance-to-living-compliance-how-agentic-ai-can-make-health-care/ This piece was written in collaboration with Sam De Brouwer, co‑founder and CEO of XY.AI, and Lamara de Brouwer, co‑founder and CTO of...

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This piece was written in collaboration with Sam De Brouwer, co‑founder and CEO of , and Lamara de Brouwer, co‑founder and CTO of

Executive Summary

Health care compliance today is manual, retrospective, and brittle. Humans are expected to remember rules, document decisions, and reconstruct context months later during audits. The result is a system that doesn’t scale — one where patient safety, operational efficiency, and regulatory defensibility are perpetually at risk.

Agentic AI offers a fundamentally different approach. When designed with deterministic execution, constrained autonomy, and human-in-the-loop oversight, these systems enable continuous, auditable, real-time compliance. The result is not less control, but more.

This paper presents a joint legal and technical perspective on how health care organizations can transform compliance from a periodic burden into an always-on operational advantage — without venturing into clinical decision-making or creating new liability exposure.

1. The Compliance Reality Today

Walk into any health care organization, and you’ll find the same pattern: compliance lives in binders, spreadsheets, and the institutional memory of overworked staff. Regulatory requirements from HIPAA, CMS, state licensing boards, and payer contracts create a web of obligations that must be tracked, documented, and proven during audits that can occur months or years after the fact.

The fundamental problem is that human memory serves as the primary control layer. Staff must remember which forms require signatures, which authorizations need renewal, which coding guidelines changed last quarter, and which payer requires which documentation. When they forget — and they inevitably do — organizations face denied claims, audit findings, regulatory penalties, and in the worst cases, patient harm.

Current systems are fragmented by design. Electronic health records handle clinical documentation. Practice management systems handle billing. Separate platforms manage credentialing, contracting, and quality reporting. Each system maintains its own version of truth and reconciling them requires manual effort that rarely happens until an auditor demands it.

The result is retrospective compliance — organizations discover problems only when claims are denied, audits are scheduled, or regulators come calling. By then, the context that would explain decisions has evaporated, the staff who made those decisions may have moved on, and reconstruction becomes an expensive forensic exercise.

2. What Changes with Agentic AI?

Agentic AI represents a category shift from the chatbots and predictive analytics that have characterized health care’s AI adoption to date. Where traditional AI systems respond to queries or flag patterns, agentic systems act: they pursue goals, execute workflows, and interact with other systems — all within defined boundaries.

The distinction matters for compliance. A chatbot can tell a biller that a claim might be denied. An agentic system can validate that claim against payer requirements before submission, flag specific deficiencies, gather missing documentation, and either route for human review or proceed based on pre-defined rules. The compliance check becomes embedded in the workflow rather than layered on top of it.

This is what we mean by “compliance by design.” Instead of writing policies that humans must remember to follow, organizations encode those policies into executable logic that agents enforce automatically. The question shifts from “Did staff follow the policy?” to “Is the system configured correctly?” — a question that can be answered definitively and audited systematically.

Critically, effective agentic AI for compliance requires three architectural commitments: deterministic execution (the same inputs produce the same outputs), constrained autonomy (agents operate only within defined boundaries), and human-in-the-loop oversight (humans retain authority over consequential decisions). Without these, organizations simply trade one set of risks for another.

3. Safety, Accuracy, and Accountability

Health care leaders approaching agentic AI consistently raise three questions: What happens when the AI is wrong? Who is accountable? Can we explain this in an audit? These questions deserve serious answers, not dismissive assurances.

Deterministic vs. Probabilistic Systems

Large language models generate responses probabilistically — the same prompt can produce different outputs. This creates obvious problems for compliance, where consistency and predictability are paramount. Deterministic agentic systems address this by separating natural language understanding (which may use probabilistic models) from execution logic (which follows defined rules). The language model interprets the request; the execution engine performs the action. This architecture makes behavior predictable and testable.

Human-in-the-Loop Governance

Staged autonomy addresses the accountability question. For low-risk, high-volume tasks (verifying that a form is signed), agents can act autonomously. For higher-stakes decisions (submitting a complex claim, escalating a denial), agents surface recommendations for human approval. The threshold for autonomy becomes a policy decision that organizations can calibrate based on their risk tolerance and regulatory requirements. Humans remain in control; agents handle the mechanical burden.

Explainability and Replay

For audit defensibility, every agent action must be logged with sufficient context to reconstruct why it happened. This means capturing not just the action and outcome, but the inputs that triggered it, the rules that applied, and the human authorizations in effect. When an auditor asks, “Why was this claim submitted this way,” the organization should be able to replay the exact decision sequence rather than relying on someone’s recollection.

4. From Policies to Systems

The most profound shift that agentic AI enables is the transformation of compliance from documentation to infrastructure. This section explains what that transformation looks like in practice.

Policies become executable logic. Consider a payer contract that requires prior authorization for certain procedures. In traditional compliance, this policy exists as a document that staff must remember to consult. In living compliance, the policy is encoded as a rule that the system evaluates automatically: when a procedure code matches the authorization requirement, the system initiates the authorization workflow before scheduling can proceed. The policy enforcement is guaranteed, not hoped for.

Controls become automated checks. Manual compliance checklists — Did the patient sign the consent? Is the provider credentialed for this service? Does the documentation support the code? — become automated validations that run continuously. Deviations trigger alerts or blocks in real time rather than showing up in quarterly audits.

Audits become queries. When compliance state is maintained systematically, audit response transforms from investigation to reporting. “Show me all claims submitted without required authorization” becomes a database query that returns in seconds, not a weeks-long document review. The organization’s compliance posture becomes observable at any moment, not just during audit preparation.

5. Practical Use Cases

The principles above apply most naturally to operational workflows that are high-volume, rule-governed, and administratively burdensome — but not clinically sensitive. By focusing on operations rather than clinical decision-making, health care organizations can capture significant value while maintaining low risk and high adoption.

Revenue cycle workflows offer immediate opportunities. Agents can validate claims against payer requirements before submission, identify coding inconsistencies, manage denials by assembling required documentation automatically, and reconcile payments against expected reimbursement. Each of these tasks follows defined rules that can be encoded and executed systematically.

Prior authorization is perhaps the highest-impact application. The current prior authorization process is universally despised: providers spend hours gathering requirements, submitting requests, and tracking status across multiple payer portals. Agentic systems can verify eligibility, identify authorization requirements, assemble documentation from clinical records, submit requests, and monitor status — all while maintaining complete audit trails of every action taken.

Documentation integrity benefits from continuous monitoring. Agents can verify that required signatures are present, that documentation supports billed services, that all mandatory fields are completed, and that records maintain consistency across systems. Problems surface immediately rather than during retrospective audits.

Payer-provider data alignment addresses a chronic source of compliance failures. Agents can continuously verify that contracted rates match claim payments, that provider credentials remain current with all payers, and that network status is accurate across all platforms. Discrepancies trigger immediate investigation rather than accumulating until they become material.

The regulatory instinct when facing new technology is often to restrict until proven safe. With agentic AI in health care operations, this instinct may be counterproductive. Organizations using well-designed agentic systems will likely demonstrate better compliance than those relying on traditional manual processes. They’ll have more complete documentation, fewer errors, and faster response to requirements changes. Regulators should encourage the adoption of auditable systems by accepting system-generated compliance evidence and providing clear guidance on what constitutes acceptable automation in different contexts.

For Health Care Operators

Start with low-risk, high-burden workflows where the compliance rules are clear and the consequences of errors are financial rather than clinical. Revenue cycle and prior authorization are natural starting points. Build internal expertise by piloting with specific payers or service lines before expanding. Invest in change management: staff need to understand that agentic systems augment their capabilities rather than threaten their roles. Most importantly, insist on auditability — any system that cannot explain its actions is creating compliance risk rather than reducing it.

For Technology Builders

The temptation in AI development is to maximize capability. In health care compliance, the imperative is to maximize trustworthiness. This means separating language understanding from execution logic, maintaining deterministic behavior for all compliance-critical functions, building comprehensive audit trails, and designing for staged autonomy that keeps humans in control of consequential decisions. Token-heavy black-box approaches may be technically impressive but are fundamentally unsuitable for environments where explainability and consistency are requirements, not preferences.

Conclusion

Health care compliance doesn’t have to be a periodic scramble driven by audit calendars and institutional anxiety. Agentic AI, when designed with appropriate constraints and controls, can transform compliance into continuous, observable, and reliable infrastructure—reducing administrative burden, improving accuracy, and creating defensible records that serve organizations well when regulators come calling.

The technology is ready. The regulatory environment is receptive. The operational pain is acute. What remains is for health care leaders, technology builders, and legal advisors to work together in designing implementations that capture the benefits while managing the risks. This paper represents our commitment to that collaboration.

Compliance stops being a document. It becomes a system.

About the Authors

Natasha Allen is a partner at Âé¶ą´«Ă˝, and chairs its AI sector, specializing in health care regulatory compliance and operational risk management. She works with health systems, physician groups, and health care technology companies on compliance program design and regulatory strategy.

Sam de Brouwer is co-founder and CEO of (XYCorp Ltd), building agentic AI infrastructure for health care operations. Her work focuses on deterministic execution architectures while continuously learning that enable enterprise-grade automation with full auditability.

Lamara de Brouwer is co-founder and CTO of (XYCorp Ltd), where he leads engineering. He brings expertise in translating operational complexity into systematic, auditable processes.

Louis Lehot is a partner at Âé¶ą´«Ă˝, where he advises companies at the intersection of health care and technology on formation, financing, scaling, governance and exit planning. He has counseled numerous frontier-tech organizations on AI implementation strategies and regulatory frameworks.

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For Your Eyes Only? Not Quite: Shadow AI in the Workplace /insights/publications/2026/04/for-your-eyes-only-not-quite-shadow-ai-in-the-workplace/ Fri, 03 Apr 2026 19:54:29 +0000 /?p=119284 While many companies are still developing governance frameworks for authorized AI tools, an emerging risk has quietly surfaced: employees using unauthorized transcription tools without the company’s or participants’ consent.

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  1. National Cybersecurity Alliance & CybSafe, Oh, Behave! Then Annual Cybersecurity Attitudes and Behaviors Report 2025-2026, 93 (2026). ↩︎
  2. States requiring all‑party (or two‑party) consent before recording a conversation include California, Connecticut, Florida, Illinois, Massachusetts, Montana (knowledge rather than consent), New Hampshire, Oregon (in‑person only), Pennsylvania, and Washington. ↩︎
  3. See, e.g., In re Google Play Store Antitrust Litig., 664 F. Supp. 3d 981, 991-94 (N.D. Cal. 2023) (civil discovery sanctions to be imposed under FRCP 37(e)); 18 U.S.C. § 1519 (federal obstruction statute). ↩︎
  4. The DOJ and other federal agencies are increasingly evaluating companies’ use of AI and ability to maintain ephemeral data as part of their compliance assessments. See, e.g., Evaluation of Corporate Compliance Programs in Criminal Antitrust Investigations, U.S. DOJ Antitrust Division (Nov. 2024), . ↩︎

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The Compliance Tightrope: Balancing Uniformity and Precision Across U.S. State Consumer Privacy Laws /insights/publications/2026/04/the-compliance-tightrope-balancing-uniformity-and-precision-across-u-s-state-consumer-privacy-laws/ Wed, 01 Apr 2026 22:06:34 +0000 /?p=119229 This article is designed to provide an overview of the current state consumer privacy landscape in the United States, the key distinctions among these state laws, practical compliance approaches, and actionable takeaways for operationalizing privacy programs in a fragmented regulatory environment.

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White House Unveils Framework for Artificial Intelligence Regulation /insights/publications/2026/03/white-house-unveils-framework-for-artificial-intelligence-regulation/ Tue, 31 Mar 2026 22:30:18 +0000 /?p=119215 The Trump Administration has introduced the National Policy Framework for Artificial Intelligence, which calls on Congress to create a uniform federal standard that would preempt the current patchwork of state laws.

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Increased Flexibility for Graphical User Interface Design Patent Applicants /insights/publications/2026/03/increased-flexibility-for-graphical-user-interface-design-patent-applicants/ Fri, 13 Mar 2026 21:32:31 +0000 /?p=118789 On March 12, 2026, the U.S. Patent and Trademark Office ("USPTO") released new guidance that updates prior USPTO practice guidelines for the examination of design patent applications for computer-generated interfaces, commonly known as graphical user interfaces ("GUIs") and icons. In response to the evolution of computer technology, the USPTO highlighted additional design patent subject matter and eliminated historical drawing requirements to increase flexibility for applicants in the GUI space.

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Iran-Linked Cyberattack: What U.S. Companies Need to Know Now /p/102mmtc/iran-linked-cyberattack-what-u-s-companies-need-to-know-now/ Fri, 13 Mar 2026 16:54:40 +0000 /p/102mmtc/iran-linked-cyberattack-on-a-leading-u-s-medical-device-manufacturer-what-u-s/ Overview On March 11, 2026, independent reports confirmed that one of the largest medical device companies in the United States was the...

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Overview

On March 11, 2026, independent reports confirmed that one of the largest medical device companies in the United States was the target of a significant cyberattack attributed to Iran-linked threat actors. Although the investigation into the incident’s scope and impact is ongoing, preliminary findings indicate that the attack may be part of a broader campaign by state-sponsored Iranian cyber syndicates tasked with targeting U.S. companies – especially those in the health care and life sciences sector.

This alert provides an overview of the threat landscape, including the growing use of vishing (voice phishing) as an attack vector, summarizes the key legal and regulatory considerations, and offers practical steps that organizations should take immediately to strengthen their cybersecurity posture and preparedness. Although health care and life sciences companies face acute risk, the threat posed by Iran-linked threat actors is not limited to that sector. All U.S. companies should be evaluating their exposure and taking proactive steps. 

Why Health Care Companies Should Be on Heightened Alert

While the health care sector has long been recognized as a prime target for cyberattacks, recent changes in the threat environment reflect a significant escalation from foreign threat actors. Several factors make health care and life sciences companies especially vulnerable.  Notable examples include the following:

  • Geopolitical Risk.  The Federal Bureau of Investigation (FBI), the Cybersecurity and Infrastructure Security Agency (CISA), and other U.S. government agencies have repeatedly warned that Iranian state-sponsored threat actors are actively targeting U.S. critical infrastructure, including health care. These threat actors employ a range of sophisticated techniques, including spear-phishing, vishing, exploitation of known vulnerabilities, credential theft, and deployment of ransomware and data-wiping malware.
     
  • Sensitive Data. Health care companies hold vast quantities of Protected Health Information (PHI), Personally Identifiable Information (PII), financial and insurance records, and proprietary research data. These categories of sensitive personal data are highly valuable to threat actors engaged in espionage, extortion, and data brokering on illicit markets. State-sponsored threat actors, including those linked to Iran, are known to target U.S. companies to conduct economic and scientific espionage in addition to ransomware and extortion.
     
  • Intellectual Property and Trade Secrets. Beyond personal data, health care and life sciences companies often hold valuable intellectual property, including patented medical device designs, pharmaceutical formulations, clinical trial data, manufacturing processes, proprietary algorithms, and research and development pipelines. The exfiltration of trade secrets and proprietary research can cause irreparable competitive harm, undermine patent portfolios, and compromise years of R&D investment. And unlike personal data breaches, which are governed by well-established notification frameworks, the theft of intellectual property may go undetected for extended periods. These scenarios present distinct legal, commercial, and strategic challenges that require specialized attention.
     
  • Export Controlled Data.  In additional to sensitive personal data and intellectual property, some health care and life sciences companies may also possess technical data, technology, and other articles subject to U.S. export control laws. This may include dual-use commercial items governed by the Export Administration Regulations (EAR) or, in more serious cases, military-grade items subject to the International Traffic in Arms Regulations (ITAR). Because the EAR and ITAR prohibit technology transfers to Iran and Iranian persons, companies targeted by Iranian threat actors may be investigated by the FBI and other U.S. government enforcement agencies – even in cases where they are the victims.
     
  • Operational Urgency. Health care organizations often face intense pressure to maintain uninterrupted operations. This urgency can make them more likely to pay ransom demands quickly, which in turn makes them more attractive targets.
     
  • Complex Supply Chains. The health care ecosystem involves extensive networks of vendors, business associates, and technology partners, each of which may represent a potential point of entry for attackers.

The Vishing Threat: Voice Phishing as a Growing Attack Vector

Organizations should be aware that vishing, voice phishing conducted over the telephone, has become an increasingly prominent tool in the threat actor’s arsenal, including among state-sponsored groups. Unlike traditional email phishing, vishing exploits the inherent trust people place in voice communication and the difficulty of verifying a caller’s identity in real time.

In a typical vishing attack, a threat actor calls an employee and impersonates a trusted figure, such as an IT help desk technician, a senior executive, a government official, or a vendor representative. The caller may reference specific internal details (employee names, system names, recent events) to establish credibility. The objective is to manipulate the target by taking an action that compromises security, such as:

  • Disclosing credentials, including usernames, passwords, or multi-factor authentication (MFA) codes;
  • Granting remote access by installing remote desktop software or disabling security controls at the caller’s direction;
  • Authorizing financial transactions, such as fraudulent wire transfers or changes to payment routing information; or
  • Clicking a malicious link sent via text or email during or immediately after the call.

Vishing is particularly dangerous in health care and professional services environments, where employees routinely interact with a wide range of external parties and where the pace of operations creates pressure to respond quickly to urgent-sounding requests. It is also increasingly used as the first stage of a multi-step attack, with the phone call serving to bypass technical defenses and set up subsequent exploitation via email, malware, or credential abuse.

Organizations should treat vishing with the same seriousness as email phishing and ensure their security awareness programs, reporting protocols, and incident response plans address this vector explicitly.

Recommended Immediate Actions

In light of the current threat environment, we recommend that all clients, and particularly those in the health care sector, take the following steps without delay:

  • Review and Stress-Test Incident Response Plans. Every organization should have a written incident response plan that identifies key internal and external stakeholders, establishes clear lines of communication, and defines decision-making authority for critical actions such as system isolation, forensic engagement, regulatory notification, and public communication. If your plan has not been tested through a tabletop exercise in the past 12 months, now is the time to schedule one. The exercise should include scenarios involving vishing and other social engineering attacks, not just technical intrusions, to ensure employees and leadership are prepared for the full range of threats they may face.
     
  • Ensure All Employees Know Reporting Protocols. Adopt and reinforce a “if you see something, say something” culture across the organization. Employees at every level should know how to report suspicious emails, suspicious phone calls, unusual system behavior, unexpected multi-factor authentication prompts, or any other anomalies. Specifically, employees should be trained to recognize the hallmarks of a vishing attempt, urgency, authority, requests for credentials or access, and reluctance to allow callback verification, and instructed to hang up and independently verify the caller’s identity before taking any action. Speed of detection and reporting is one of the most significant factors in limiting the damage of a cyber incident.
     
  • Review Access Controls and Multi-Factor Authentication (MFA). Audit user access privileges across all critical systems to ensure they are limited to the minimum necessary for each role. Confirm that MFA is enabled for all remote access, privileged accounts, and cloud-based applications. Remove or disable accounts that are no longer needed, including those of former employees, contractors, and vendors. Critically, remind all personnel that MFA codes should never be provided to anyone over the phone, by text, or by email. A legitimate IT or security team will never ask for them. Health care organizations should note that the proposed HIPAA Security Rule update (discussed below) would make MFA a mandatory requirement for access to electronic protected health information (ePHI). Organizations that have not yet implemented MFA universally should treat this as an immediate priority, both to address the current threat and to prepare for the anticipated regulatory requirements.
     
  • Identify and Protect Critical Intellectual Property. Organizations should conduct or update an inventory of their most sensitive intellectual property assets, including trade secrets, proprietary research data, patent applications in progress, clinical trial data, manufacturing specifications, and source code, and confirm that these assets are subject to enhanced technical and access controls. Key steps include:
     
    • Classifying IP assets by sensitivity and ensuring that access is restricted to personnel with a demonstrated business need, using role-based access controls and the principle of least privilege.
       
    • Confirming that trade secret protections are in place, including confidentiality and invention assignment agreements with employees and contractors, nondisclosure agreements with business partners and collaborators, and clear internal policies governing the handling and marking of confidential and proprietary information. Under the federal Defend Trade Secrets Act (DTSA) and analogous state laws, trade secret status depends in part on the holder having taken “reasonable measures” to keep the information secret; organizations should ensure their security measures are sufficient to satisfy this standard.
       
    • Conducting export classification reviews to determine whether an organization’s technology, technical data, software, and other articles may be subject to control under the EAR and ITAR.
       
    • Implementing data loss prevention (DLP) tools and enhanced monitoring on repositories containing high-value IP to detect unauthorized access, bulk downloads, or exfiltration attempts, particularly in the current heightened-threat environment.
       
    • Reviewing collaboration and file-sharing practices to confirm that proprietary research and development materials are not being stored or transmitted through unsecured channels.
       
  • Assess Vendor and Third-Party Risk. Evaluate the cybersecurity practices of your key vendors and business associates, particularly those with access to sensitive data or critical systems. Confirm that vendor contracts include appropriate data security requirements, breach notification obligations, and audit rights. Consider whether any third-party connections should be restricted or subjected to additional monitoring in the current threat environment. Be aware that vishing attacks frequently involve impersonation of known vendors. Employees should verify any unexpected vendor requests through established, independently verified contact channels. Under the proposed “HIPAA 2.0” framework, business associates would be required to verify their compliance with applicable technical safeguards. Organizations should begin incorporating such verification mechanisms into their vendor management processes now. Organizations should also confirm that vendor and collaboration agreements contain robust intellectual property ownership, confidentiality, and use-restriction provisions; a supply chain compromise that exposes shared R&D data or jointly developed IP can create complex disputes over ownership, liability, and loss allocation.
     
  • Prioritize Patch Management and System Monitoring. Iranian-linked threat actors are known to exploit publicly disclosed software vulnerabilities, often within days of disclosure. Organizations should ensure that all systems, applications, and firmware are patched and updated promptly. Enhance monitoring of network traffic, endpoint activity, and access logs for indicators of compromise, and ensure that security information and event management (SIEM) systems are configured to detect known threat signatures associated with Iranian cyber groups. Health care organizations should also be aware that the proposed HIPAA Security Rule update would require vulnerability scanning at least every six months and penetration testing at least annually. Establishing these practices now will both strengthen defenses against current threats and position organizations favorably for compliance.
     
  • Invest in Employee Training and Phishing Awareness. Spear-phishing remains one of the most common and effective attack vectors, but vishing is rapidly closing the gap. Conduct targeted training for all employees, with an emphasis on recognizing phishing attempts, verifying requests for credentials or financial information, and avoiding interaction with suspicious links or attachments. Training should include realistic vishing simulations, not just email-based phishing tests, so employees experience the pressure and persuasion techniques used in live social engineering calls. Consider deploying simulated phishing campaigns to test and reinforce awareness.
     
  • Understand Your Regulatory Notification Obligations. In the event of a cyber incident involving the compromise of personal data or PHI, organizations may be subject to overlapping notification obligations under federal and state law. Key frameworks include:
     
    • HIPAA requires covered entities and business associates to notify affected individuals, the Secretary of Health and Human Services, and, in certain cases, the media, of breaches involving unsecured PHI, generally within 60 days of discovery. Importantly, health care organizations should be preparing for the proposed HIPAA Security Rule update, widely referred to as HIPAA 2.0, published by the U.S. Department of Health and Human Services (HHS) as a Notice of Proposed Rulemaking (NPRM) in late 2024. The proposed rule would represent the most significant modernization of the HIPAA Security Rule since its original adoption and would substantially heighten cybersecurity obligations for covered entities and business associates. Key proposed changes include:
       
      • Elimination of the “addressable” vs. “required” distinction for implementation specifications under the proposed rule would make all security measures mandatory, removing the discretion that currently allows organizations to implement alternative measures or to document why a specification is not reasonable and appropriate.
         
      • Mandatory encryption of ePHI both at rest and in transit, with very limited exceptions.
         
      • Mandatory multi-factor authentication (MFA) for all access to ePHI.
         
      • Technology asset inventories and network maps must be created and updated at least annually to provide organizations with a clear understanding of where ePHI resides and how it moves through their systems.
         
      • More prescriptive risk analysis requirements, including specific methodologies and documentation standards.
         
      • Vulnerability scanning every six months and penetration testing at least annually.
         
      • Business associate compliance verification of regulated entities would be required to obtain written verification that their business associates have implemented required technical safeguards, rather than relying solely on contractual representations.
         
      • Incident response plan testing requirements, reinforcing the need for regular tabletop exercises and plan updates.
         
      • While the final rule has not yet been issued as of the date of this alert, organizations should not wait for finalization to begin assessing their readiness. The proposed requirements reflect the direction of federal cybersecurity regulation for health care, and many of the contemplated measures: encryption, MFA, asset inventories, regular vulnerability scanning, and incident response testing are already recognized best practices that would materially strengthen an organization’s defenses against the types of state-sponsored attacks currently targeting the sector. We strongly recommend that organizations identify their applicable regulatory obligations in advance and incorporate notification procedures into their incident response plans, rather than attempting to navigate these requirements during an active incident.
         
    • CIRCIA requires covered critical infrastructure entities to report significant cyber incidents to CISA within 72 hours and ransomware payments within 24 hours. (Note: CISA is set to finalize the mandatory reporting regulations under CIRCIA by May 2026. While the final rule is pending, CISA currently encourages voluntary reporting.)
       
    • State breach notification laws impose a patchwork of requirements that vary by jurisdiction, including differing definitions of personal information, notification timelines, and obligations to notify state regulators or attorneys general. 
       
    • Economic sanctions compliance must be considered before making any ransom payment. Any payments to Iran, the Iranian government, or other Iranian parties are strictly prohibited under the economic sanctions programs administered by the U.S. Treasury’s Office of Foreign Assets Control (OFAC). The same is true for payments rendered to parties owned by (or working on behalf of) Iranian entities, or other parties appearing on OFAC’s list of Specially Designated Nationals. Knowingly making payments to sanctioned countries and parties is a crime under U.S. laws and, in certain instances, may constitute material support for terrorism. Even accidental payments to sanctioned countries and parties can have serious consequences, including U.S. government investigations, significant civil penalties, and the loss of banking relationships. 
       
    • Export control violations under the EAR and ITAR can also arise, even if there are no apparent economic sanctions risks. And because Iran is a “debarred” country under the ITAR, the transfer or theft of military-grade technology and technical data can trigger mandatory reporting to the U.S. State Department’s Directorate of Defense Trade Controls (DDTC). These mandatory reports invariably result in the DDTC notifying OFAC, the FBI, and other partner agencies – often resulting in overlapping government inquiries that must be managed carefully and concurrently.
       
    • U.S. government contracts may require prime contractors, subcontractors, and federal grant recipients to disclose material cybersecurity incidents and risks in a timely manner.  This is especially true for aerospace and defense sector contracts for projects involving Controlled Unclassified Information (CUI), which are likely to contain provisions mandating disclosure within 72 hours of discovery. Coordinating these disclosures with other disclosed addressing economic sanctions and export control risks is strongly recommended.
       
    • SEC disclosure obligations may require publicly traded companies to disclose material cybersecurity incidents and risks in a timely manner.
       
    • Defend Trade Secrets Act (DTSA) and state trade secret laws. While these statutes do not impose breach notification obligations in the traditional sense, they are critically relevant when a cyberattack results in the exfiltration or exposure of trade secrets. The DTSA provides a federal civil cause of action, and, in cases involving economic espionage benefiting a foreign government, criminal penalties under the Economic Espionage Act of 1996 (18 U.S.C. §§ 1831–1839) for the misappropriation of trade secrets. Organizations that discover or suspect theft of trade secrets in connection with a cyber incident should act swiftly to preserve forensic evidence, assess whether emergency injunctive relief (including ex parte seizure orders available under the DTSA) is warranted, and evaluate whether referral to the FBI or the Department of Justice National Security Division is appropriate, particularly where the theft appears linked to a foreign state actor. Critically, an organization’s ability to pursue trade secret claims depends on its ability to demonstrate that it took “reasonable measures” to maintain secrecy, making the preventive steps described above (access controls, classification, DLP tools, contractual protections) not only good security hygiene but essential legal prerequisites.

How We Can Help

Âé¶ą´«Ă˝ & Lardner’s Cybersecurity & Data Privacy Group is closely monitoring this incident and the broader threat landscape. Our team has extensive experience advising clients on cybersecurity preparedness, incident response, regulatory compliance, and breach-related litigation, across the health care sector and beyond.

We are available to assist with:

  • Reviewing and updating incident response and business continuity plans, including integrating vishing and social engineering scenarios into tabletop exercises
  • Conducting tabletop exercises and readiness assessments
  • Developing and reviewing employee security awareness programs that address phishing, vishing, and other social engineering threats
  • Advising on regulatory notification obligations under HIPAA, state law, CIRCIA, and other frameworks
  • Conducting HIPAA 2.0 gap analyses to assess organizational readiness against the proposed Security Rule requirements
  • Assessing OFAC sanctions exposure in connection with ransomware demands
  • Managing forensic investigations and coordinating with law enforcement
  • Evaluating vendor and third-party cybersecurity risk
  • Defending against regulatory inquiries and data breach litigation
  • Advising on trade secret protection strategies, including IP asset classification, “reasonable measures” assessments, and review of confidentiality, NDA, and invention assignment agreements to ensure trade secret status is preserved
  • Pursuing emergency injunctive relief and DTSA/state trade secret claims in the event of confirmed or suspected IP exfiltration
  • Assessing export control implications of cyber incidents involving controlled technology or technical data, and advising on reporting obligations under EAR and ITAR
  • Conducting IP risk assessments in connection with vendor, collaboration, and supply chain agreements to identify and mitigate exposure to IP loss in the event of a third-party compromise

If you have questions about the current threat environment, your organization’s preparedness, or any aspect of your cybersecurity and data privacy program, please do not hesitate to contact any member of the Cybersecurity & Data Privacy Group.

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This alert is provided by Âé¶ą´«Ă˝ for informational purposes only and does not constitute legal advice. The information contained herein is based on publicly available reporting as of March 11, 2026, and is subject to change as additional facts become available. Receipt of this alert does not create an attorney-client relationship. Readers should consult with qualified legal counsel regarding their specific circumstances and obligations.

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OCC Unveils Proposed Rulemaking to Implement the GENIUS Act: A New Era for U.S. Stablecoin Oversight /p/102mlp2/occ-unveils-proposed-rulemaking-to-implement-the-genius-act-a-new-era-for-u-s-s/ Mon, 02 Mar 2026 22:40:39 +0000 /p/102mlp2/occ-unveils-proposed-rulemaking-to-implement-the-genius-act-a-new-era-for-u-s-s/ The Office of the Comptroller of the Currency (OCC) took a significant step in shaping U.S. digital asset regulation on February 25,...

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The Office of the Comptroller of the Currency (OCC) took a significant step in shaping U.S. digital asset regulation on February 25, 2026, by issuing a notice of proposed rulemaking (NPRM) to implement the Guiding and Establishing National Innovation for U.S. Stablecoins (GENIUS) Act. The proposal introduces a comprehensive regulatory framework for certain permitted payment stablecoin issuers and opens a 60‑day period for public comment.

As the first federal statute to establish a unified national standard for stablecoins, the GENIUS Act imposes strict requirements on issuance, reserve assets, redemption rights, and supervisory oversight — and it expressly requires the OCC to promulgate regulations implementing these guardrails. The OCC is now proposing detailed rules to fulfill that mandate.

Below is a brief overview of key highlights. Our legal team is currently preparing a more comprehensive analysis of the OCC’s proposal — including interpretive nuances, potential impacts on banks and fintechs, and strategic considerations for market participants — which we will share soon.

Key Highlights from the Proposed Rulemaking

Comprehensive Supervisory Framework for Stablecoin Issuers: The NPRM proposes a new 12 CFR Part 15, setting standards for activities, reserve assets, redemption timelines, risk management, audits, reporting, and examinations. It applies to national banks, federal savings associations, qualifying nonbanks, and foreign payment stablecoin issuers under OCC oversight.

OCC PPSI Oversight: Applications to, and approval by, the OCC will be required to issue payment stablecoin for insured national banks, Federal savings associations, and insured Federal branches that seek to issue payment stablecoins through a subsidiary, as well as nonbank entities (e.g., fintechs), uninsured national banks, and uninsured Federal branches that seek to issue payment stablecoins as a Federal permitted payment stablecoin issuer (PPSI).

100% Reserve Backing and Mandatory Redemption: Consistent with the GENIUS Act, issuers must maintain high‑quality liquid assets, such as cash or short‑term Treasuries, and must honor redemption at par within generally two business days, reinforcing consumer protection and stability.

Capital and Operational Requirements: The OCC proposes a minimum $5 million capital floor for new issuers, along with tailored liquidity requirements and rigorous operational risk management standards, including cybersecurity and third‑party oversight. 

Yield Prohibition and Anti‑Evasion Measures: To enforce the GENIUS Act’s ban on interest or yield on payment stablecoins, the OCC introduces a rebuttable presumption that issuers are violating the prohibition if they funnel yield through affiliates or related third parties. This aims to prevent circumvention of the statutory ban against paying yield or interest to the holder of stablecoins. 

Areas Deferred for Separate Rulemaking: Issues relating to the Bank Secrecy Act, anti‑money laundering obligations, and OFAC sanctions will be addressed in a future joint rulemaking with the Treasury Department.

Looking Ahead

This proposed rulemaking is only the beginning. With a 60‑day public comment window and coordination expected among federal banking agencies, the regulatory landscape for stablecoins is likely to evolve rapidly in the coming months.

Stay tuned for our forthcoming deep dive.

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California Rolls Out New Venture Capital Diversity Reporting Requirements /insights/publications/2026/02/california-rolls-out-new-venture-capital-diversity-reporting-requirements-3/ Tue, 17 Feb 2026 16:12:34 +0000 /?p=118105 California’s new Fair Investment Practices by Venture Capital Companies Law (FIPVCC) is shaking up the Venture Capital (VC) industry with its first compliance deadlines right around the corner.

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