On September 28, 2024, California Governor Gavin Newsom vetoed California Assembly Bill 3129 (the Bill). The Bill, if enacted, would have imposed new notice and consent requirements for private equity investors involved in healthcare transactions. Governor Newsom’s veto statement clarifies the Bill’s vetoing, stating that the Office of Health Care Affordability (OHCA) “was created as
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A Federal Court in Texas Strikes Down the FTC’s Nationwide Non-Compete Ban
On August 20, 2024, the United States District Court for the Northern District of Texas (Dallas Division) struck down the Federal Trade Commission’s (FTC) non-compete rule, 16 CFR § 910.1-6, that was set to take effect on September 4, 2024. A summary of this ruling, which has significant implications for employers nationwide, is included below.
DOJ Announces $1.3 Million Settlement Involving a Laboratory Marketer, Physicians, and the Physicians’ Medical Practices
This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement and White-Collar Defense Team.
On April 29, 2024, the Department of Justice (DOJ) announced a $1.3 million settlement (Settlement) with a South Carolina clinical laboratory marketer and his marketing company, and three physicians and their medical practices in North Carolina…
Additional States Implement Notice Requirements for Healthcare Transactions
In a prior blog post, we noted the trend of states enacting legislation implementing reporting requirements for certain healthcare transactions. On March 13, 2024, Indiana joined this trend as Indiana Governor Eric Holcomb enacted Senate Enrolled Act No. 9 (the Act). The Act mandates that, effective July 1, 2024, Indiana health care entities involved…
Forecasting the Integration of AI into Health Care Compliance Programs
This post was co-authored by Josh Yoo, legal intern at Robinson+Cole. Josh is not admitted to practice law.
Health care entities maintain compliance programs in order to comply with the myriad, changing laws and regulations that apply to the health care industry. Although laws and regulations specific to the use of artificial intelligence (AI) are limited at this time and in the early stages of development, current law and pending legislation offer a forecast of standards that may become applicable to AI. Health care entities may want to begin to monitor the evolving guidance applicable to AI and start to integrate AI standards into their compliance programs in order to manage and minimize this emerging area of legal risk.
Executive Branch: Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence
Following Executive Order 13960 and the Blueprint for an AI Bill of Rights, Executive Order No. 14110 (EO) amplifies the current key principles and directives that will guide federal agency oversight of AI. While still largely aspirational, these principles have already begun to reshape regulatory obligations for health care entities. For example, the Department of Health and Human Services (HHS) has established an AI Task Force to regulate AI in accordance with the EO’s principles by 2025. Health care entities would be well-served to monitor federal priorities and begin to formally integrate AI standards into their corporate compliance plans.
- Confidentiality and Security: Federal scrutiny of the privacy and security of entrusted information extends to AI’s interactions with data as a core obligation. This general principle also manifests in more specific directives throughout the EO. The EO also orders the HHS AI Task Force to incorporate “measures to address AI-enhanced cybersecurity threats in the health and human services sector.”
- Transparency: The principle of transparency refers to an AI user’s ability to understand the technology’s uses, processes, and risks. Health care entities will likely be expected to understand how their AI tools collect, process, and predict data. The EO envisions labelling requirements that will flag AI-generated content for consumers as well.
- Governance: Governance applies to an organization’s control over deployed AI tools. Internal mechanical controls, such as evaluations, policies, and institutions, may ensure continuous control throughout the AI’s life cycle. The EO also emphasizes the importance of human oversight. Responsibility for AI implementation, review, and maintenance can be clearly identified and assigned to appropriate employees and specialists.
- Non-Discrimination: AI must also abide by standards that protect against unlawful discrimination. For example, the HHS AI Task force will be responsible for ensuring that health care entities continuously monitor and mitigate algorithmic processes that could contribute to discriminatory outcomes. It will be important to permit internal and external stakeholders to have access to equitable participation in the development and use of AI.
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Remote Patient Monitoring Enforcement Initiatives
Below is an excerpt of an article published in the American Bar Association Health Law Section’s March 2024 Health eSource issue.
In recent years, there has been a significant increase in the use of digital technologies and innovative solutions in healthcare, including the increased use of remote patient monitoring (RPM) services. Telehealth and other digital…
HHS Addresses the Growing Influence of Artificial Intelligence in Health Care
This post was co-authored by Blair Robinson, a member Robinson+Cole’s Artificial Intelligence Team.
Artificial Intelligence (AI) has emerged as a major player in the realm of health care, promising to completely transform its delivery. With AI’s remarkable ability to analyze data, learn, solve problems, and make decisions, it has the potential to enhance patient…
Advisory Opinion 23-05: OIG Warns Sanctions Would Likely be Issued in Response to Certain Proposed Contractual Joint Venture
On August 18, 2023, the Office of Inspector General (OIG) published Advisory Opinion 23-05 (Advisory Opinion), in which the OIG warned that it would likely issue sanctions under the Federal anti-kickback statute (AKS) if a proposed contractual joint venture for the provision of certain surgical monitoring services was carried out.Continue Reading Advisory Opinion 23-05: OIG Warns Sanctions Would Likely be Issued in Response to Certain Proposed Contractual Joint Venture
Connecticut Supreme Court Issues Opinions Addressing Scope of Immunity for Health Care Workers Under Governor Lamont’s Executive Order No. 7V
On August 8, 2023, the Connecticut Supreme Court issued opinions in Mills v. Hartford HealthCare Corp. and Manginelli v. Regency House of Wallingford, Inc. that addressed the scope of immunity for health care workers and facilities under Governor Ned Lamont’s Executive Order No. 7V. Executive Order No. 7V provided immunity for health care professionals and facilities from civil suits when providing health care services in support of the state’s COVID-19 response. Interestingly, the Mills ruling notes that this was the first time the Connecticut Supreme Court addressed the principles that govern interpretation of executive orders. Summaries of these two decisions appear below.Continue Reading Connecticut Supreme Court Issues Opinions Addressing Scope of Immunity for Health Care Workers Under Governor Lamont’s Executive Order No. 7V
Connecticut Adds Requirements for Opioid Prescribing and Expands Provider Licensure and Credentialing Avenues
On June 28, 2023, Connecticut Governor Ned Lamont signed Public Act No. 23-97, “An Act Concerning Health and Wellness for Connecticut Residents.” The Act includes a wide range of provisions aimed at supporting health care workforce development and improving access to health care. Some of the provisions of the Act are summarized below.Continue Reading Connecticut Adds Requirements for Opioid Prescribing and Expands Provider Licensure and Credentialing Avenues