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CJ Rundell is an associate in the Corporate Practice Group in the firm's Chicago office and a member of the Healthcare Team.

In an era where artificial intelligence (AI) is reshaping landscapes in the healthcare industry and beyond, understanding the governance of AI technologies is paramount for organizations seeking to utilize AI systems and tools. AI governance encompasses the policies, practices, and frameworks that guide the responsible development, deployment, and operation of AI systems and tools within an organization. By adhering to established governance principles and frameworks, organizations can ensure their AI initiatives align with ethical standards and applicable law, respect human rights, and contribute positively to society. Various international organizations have set forth AI governance principles that provide organizations with a solid foundation to develop organizational AI governance based on widely shared values and goals.Continue Reading Navigating the Complex Landscape of AI Governance: Principles and Frameworks for Responsible Innovation

On May 16, 2024, the Subcommittee on Health of the House Committee on Energy and Commerce (the “Subcommittee”) announced that it advanced the Telehealth Modernization Act of 2024 (H.R. 7623) as amended (the “Bill”) during a markup session. The Bill is meant to extend a number of telehealth flexibilities under Medicare through 2026. This corresponded with 22 other bills advanced by the Subcommittee to strengthen access to healthcare.Continue Reading Congress Seeks to Extend COVID-19 Telehealth Flexibilities Through 2026 and Expand Reimbursement

Starting January 1, 2024, healthcare facilities and provider organizations engaging in certain transactions in Illinois, such as mergers and acquisitions, will have new reporting requirements. Illinois recently joined a growing number of states, including California and New York, in requiring expanded oversight and transparency of transactions involving healthcare facilities and provider organizations. Illinois’ Public Act 103-0526 (the “Act”), enacted in August 2023, amends the Illinois Antitrust Act, the State Finance Act and the Illinois Health Facilities Planning Act to increase oversight by the Illinois Attorney General’s (the “IL AG”) of certain “covered transactions” for healthcare facilities and provider organizations.Continue Reading Illinois Proposes Heightened Oversight for Healthcare Transactions

Last week’s historic executive order (EO) on the development and use of artificial intelligence (AI) is teeming with urgency, both in caution and optimism, to keep pace with the technological advancements. The EO addresses the duality of AI—its promising utility and disconcerting risks—across a range of public and private sectors, including healthcare. Below are five key takeaways from the EO for the healthcare industry.Continue Reading AI’s Executive Order and Its Key Healthcare Implications 

At HLTH 2023, we saw a focus on certain themes, including the shift in investments and M&A activity, hospital and health system innovation and transformation, the implementation of AI, and healthcare management. Below are our top 10 takeaways from what we heard, and did not hear, at HLTH 2023.Continue Reading Sheppard Mullin’s Top 10 Takeaways from HLTH 2023

The digital health market, as represented by the HLTH showroom floor, is packed with companies focused on care coordination and care management for various health and wellness specialties, diseases, and chronic conditions, as well as organizations focused on increasing consumer access to various types of healthcare. Despite the growth of data analytics and interoperability, the constellation of companies and points of access are decentralized and disconnected. While the abundance of choice and options enhancing accessibility for healthcare consumers are positive indicators of progress in this space, the lack of holistic care coordination across this fragmented landscape affects patient outcomes, causes patient confusion and decision fatigue, and leads to potential care and resource duplication and waste.Continue Reading At HLTH 2023: The Digital Health Symphony, A Care Coordination Orchestra with No Maestro

At the heart of our healthcare system lies two core, yet competing, philosophies: (1) clinical decisions must not be driven by profit, and (2) dollars drive behavior and, by harnessing this revenue, clinical outcomes can be vastly improved while the costs to the system of unnecessary care can be dramatically reduced. Here at HLTH, venture capital firm General Catalyst announced it is seeking to change that paradigm with the launch of its Health Assurance Transformation Corporation (HATCo), seeking to transform healthcare with global risk arrangements while leveraging data and technology. Continue Reading At HLTH 2023: General Catalyst’s HATCo Introduces a Radically Ambitious and Transformative Model for Healthcare

Industry stakeholders have been eagerly waiting for the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Secretary of HHS to provide more clarity on federal information blocking enforcement rules since the Office of the National Coordinator for Health Information Technology (ONC) issued its final information blocking rules in 2020.[i] Continue Reading HHS OIG Publishes Eagerly-Anticipated Federal Information Blocking Enforcement Final Rule

Recently, we were invited to speak on a panel at the Executive War College on Diagnostics, Clinical Laboratory and Pathology Management. We spoke about the federal information blocking rules, and highlighted how some actors are still engaging in conduct that the rules were intended to discourage, in part due to the lack of enforcement rules.Continue Reading Laboratory and Pathology Information Blocking Concerns

Under the 21st Century Cures Act information blocking requirements and the regulations promulgated thereunder by the Office of the National Coordinator for Health IT (ONC) (the Information Blocking Rules), certain actors, such as healthcare providers and certain electronic health record developers (Actors), are prohibited from engaging in information blocking of electronic health information (EHI). Information blocking is defined, in part, as a practice that “[e]xcept as required by law or covered by an exception [to the information blocking regulations], is likely to interfere with access, exchange, or use of electronic health information.”[1] Put simply, the Information Blocking Rules generally prohibit any act or omission by an Actor that interferes with the access, exchange, or use of EHI, subject to enumerated exclusions and exceptions. Continue Reading Navigating Permissive State Laws in Light of the Federal Information Blocking Rules