On May 9, 2024, Connecticut Governor Ned Lamont signed into law Public Act No. 24-4, “An Act Concerning Emergency Department Crowding,” (The Act). The Act requires all Connecticut hospitals with an emergency department to, no later than January 1, 2025, and annually thereafter until January 1, 2029, analyze certain data with the goals of:
Hospitals and Health Systems
Connecticut Governor Signs Bill Prohibiting Health Care Providers from Reporting Medical Debt to Credit Reporting Agencies
On May 9, 2024, Connecticut Governor Ned Lamont signed into law Public Act No. 24-6, “An Act Concerning the Reporting of Medical Debt,” (The Act). The Act prohibits health care providers from reporting medical debt to credit rating agencies and makes various updates to existing laws regarding the reporting of medical debt already applicable…
Key Second Circuit Decision Defines AKS Willfulness Standard
By Conor Duffy & Leslie Levinson on
Posted in Academic Medical Centers, Ambulance, Ambulatory Surgical Centers (ASC), Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Home Health/ Home Care, Hospice, Hospitals and Health Systems, Medicare and Medicaid, Office of Inspector General, Physicians and Allied Health Professionals
On March 12, 2024, the U.S. Court of Appeals for the Second Circuit issued an important decision interpreting the “willfulness” standard necessary to find a violation of the federal Anti-Kickback Statute (AKS). The decision provides important guidance for health care and pharmaceutical organizations on what constitutes a knowing violation of the AKS and for counsel…
Forecasting the Integration of AI into Health Care Compliance Programs
By Kathleen Healy & Guest Contributor on
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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Status of 340B Payment Remediation and Manufacturer Litigation
Below is an excerpt of an article published in American Health Law Association’s Regulation, Accreditation, and Payment Practice Group on March 21, 2024.
The 340B program, as established under Section 340B to the Public Health Service Act (PHSA), Pub. L. No. 78-410, 58 Stat. 682 (1944) (“340B Statute”),[1] has experienced significant legal challenges…
OCR Updates Online Tracking Technologies HIPAA Guidance
On March 18, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) updated its guidance on the “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates” (Guidance). OCR’s Guidance was first published on December 1, 2022, and is the subject of a lawsuit brought by…
CMS Updates Guidance to Allow Texting of Patient Orders
On February 8, 2024, the Centers for Medicare and Medicaid Services (CMS) issued a quality standard memorandum (QSO Memo) updating and revising a memorandum it issued on January 5, 2018, to now permit the texting of patient orders among members of the patient’s health care team. CMS’s 2018 memorandum clarified CMS’s then-current position that texting…
HHS Finalizes Updates to “Part 2” Regulations to Align Disclosure Rules with HIPAA and Promote More Coordinated Substance Use Disorder Care
By Conor Duffy & Yelena Greenberg on
Posted in Academic Medical Centers, Accountable Care Organizations, Department of Justice, Government Enforcement, Health Information Exchanges and Electronic Medical Records (EMRs), Health Policy, HIPAA, Hospitals and Health Systems, Legislation, Medicare and Medicaid, Physicians and Allied Health Professionals, Privacy and Security
On February 8, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) updating federal “Part 2” regulations to more closely align the requirements applicable to substance use disorder (SUD) treatment records with the HIPAA privacy rule, and to make certain other changes. The regulations at 42…
ONC’s HTI-1 Final Rule Updates Information Blocking Regulations
On December 13, 2023, the Office of the National Coordinator for Health Information Technology (ONC) issued its final rule entitled “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing” and known as “HTI-1” (Final Rule). Among other issues addressed in the Final Rule, ONC revised the information blocking rules to add clarity and to create a new information blocking exception. We outline these changes in further detail below. The information blocking provisions of the Final Rule will be effective 30 days after it is published in the Federal Register.Continue Reading ONC’s HTI-1 Final Rule Updates Information Blocking Regulations
New York Implements Health Equity Impact Assessment as New Requirement for Certificate of Need Process
By Danielle Tangorre, Leslie Levinson & Guest Contributor on
On June 22, 2023, New York State Public Health Law § 2802-b, added a Health Equity Impact Assessment (HEIA) to the Certificate of Need (CON) process for certain health care facilities. The new requirement comes as part of larger legislative changes to the Public Health Laws passed in 2021. The new HEIA requirement applies to any CON applications submitted on or after June 22, 2023, except there is a partial carve out for Diagnostic and Treatment Centers whose patient population is 50 percent or more Medicaid eligible or uninsured. The Department of Health also issued regulations on June 29, 2023 (10 NYCRR 400.26). The purpose of the HEIA is to understand the health equity impact on a specific project, the impact it may have on medically underserved groups and to ensure community input and assessment are considered. The Department of Health has expressed that their vision is “to have health equity considerations meaningfully impact the planning and execution of health care facility projects.” (NYSDOH, Health Equity Impact Assessment, Webinar Series: Program Documents, September 14, 2023.)Continue Reading New York Implements Health Equity Impact Assessment as New Requirement for Certificate of Need Process