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Telehealth: Regulatory Questions Amid Legislative Uncertainty

One year on from the end of the COVID-19 public health emergency, the Medicare restrictions on telehealth that Congress waived to allow for and expand the use of telehealth and other forms of virtual care are set to expire. Congress has already acted twice to extend the waivers, most recently in the Consolidated Appropriations Act, 2023, which extended them until the end of this calendar year. Thus, starting on January 1, 2025, these waivers will disappear without further Congressional action. The uncertainty about whether Congress will again extend the telehealth waivers (and for how long) will create numerous questions and cause confusion for health plans, patients and providers.

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FTC Amends Health Breach Notification Rule to Regulate Health Apps and Expand Breach Notification Requirements

On April 26, 2024, the Federal Trade Commission (FTC) issued a final rule to amend its Health Breach Notification Rule (HBN Rule). The HBN Rule works as a compliment and counterpart to the breach notification requirements established under the Health Insurance Portability and Accountability Act (HIPAA) for HIPAA-regulated entities. Specifically, the HBN Rule requires that vendors of personal health records (PHRs) and related entities that are not covered by HIPAA notify individuals, the FTC and, in some cases, media outlets of a breach of unsecured personally identifiable health data. Stakeholders should carefully review the final rule to understand how organizations will be impacted.

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State Regulators Address Insurers’ Use of AI: 11 States Adopt NAIC Model Bulletin

In December 2023, the National Association of Insurance Commissioners (NAIC) adopted a Model Bulletin on the Use of Artificial Intelligence (AI) Systems by Insurers. The model bulletin reminds insurance carriers that they must comply with all applicable insurance laws and regulations (e.g., prohibitions against unfair trade practices) when making decisions that impact consumers, including when those decisions are made or supported by advanced technologies, such as AI systems. To date, 11 states have adopted the model bulletin, thereby applying the standards to insurers that operate in the states.

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OCR Update on Tracking Technologies Provides Little Relief for HIPAA-Regulated Entities

On March 18, 2024, the US Department of Health and Human Services Office for Civil Rights (OCR) issued an update to its December 1, 2022, bulletin titled “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates.” In releasing the 2024 update, OCR stated that its purpose was to “increase clarity for regulated entities and the public.” While the update appears to narrow the scope of what OCR considers to be HIPAA-protected health information (PHI) in the context of online tracking technologies, it largely reconfirms prior guidance in the 2022 bulletin and will likely have limited practical impact for HIPAA-covered entities and business associates that have already heeded the 2022 bulletin.

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2024: The Year of the Telehealth Cliff

What does December 31, 2024, mean to you? New Year’s Eve? Post-2024 election? Too far away to know?

Our answer: December 31, 2024, is when we will go over a “telehealth cliff” if Congress fails to act before that date, directly impacting care and access for Medicare beneficiaries. What is this telehealth cliff?

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States Move to Amend, Clarify Telehealth-Related Standards of Care

Multiple states – including Alaska, Wisconsin and New Jersey – have been busy finalizing legislation and rulemaking to adopt interstate compacts and amend and clarify telehealth-related standards of care.

What else have these states been up to over the last month?

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Healthcare Payors and Providers and AI Companies Voluntarily Commit to AI Principles

The Biden administration recently announced that 28 healthcare payors and providers intend to implement and adhere to voluntary commitments for the safe, secure and trustworthy development and deployment of artificial intelligence (AI) in healthcare. The signatory companies aligned around the FAVES principle—namely, that AI should lead to healthcare outcomes that are fair, appropriate, valid, effective and safe.

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States Advance Telehealth Legislation and Rulemaking

Numerous states—including Alaska, Florida, Texas, Utah and Washington—have been busy finalizing and proposing rulemaking and legislation impacting telehealth-related care. Washington’s Department of Health, for example, published a proposed rule focused on implementing the multistate nurse licensure compact.

What else have these states been up to over the last month?

Read more here.




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