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FDA's Regulatory Approach to AI-Powered Clinical Decision Support Software in Telehealth
The FDA regulates AI-powered Clinical Decision Support (CDS) software, particularly when it functions as a Medical Device Data System (MDDS) or Software as a Medical Device (SaMD), impacting its use within telehealth platforms. Healthcare providers leveraging these tools must understand the FDA's risk-based framework to ensure compliance and patient safety. This framework distinguishes between regulated SaMD and lower-risk CDS tools that may be exempt from active regulation.
Navigating Chiropractic Scope of Practice for Telehealth-Based Functional Medicine and Nutrition Counseling
The scope of practice for chiropractors engaging in functional medicine and nutrition counseling via telehealth varies significantly by state. While many states permit these services, the specific regulations regarding diagnosis, treatment, and the use of telehealth modalities require careful review to ensure compliance and avoid practicing outside of licensure.
Illinois Supervision and Delegation Requirements for PAs and NPs in Telehealth and Medspa Settings
Illinois law outlines specific requirements for physician supervision of Physician Assistants (PAs) and collaborative agreements with Advanced Practice Registered Nurses (APRNs), including Nurse Practitioners (NPs). These regulations are critical for healthcare businesses operating telehealth platforms and medspas in Illinois, dictating the scope of practice and the necessary oversight for non-physician providers.
FDA Clarifies DTC Telehealth Pharmaceutical Advertising Requirements
The FDA has issued guidance clarifying its expectations for direct-to-consumer (DTC) advertising of prescription drugs, particularly as it pertains to telehealth platforms. This guidance emphasizes the need for clear, balanced, and accurate information, ensuring that promotional materials do not mislead consumers about drug efficacy, risks, or appropriate use in a telehealth context.
FDA Oversight of At-Home Diagnostic Tests in Telehealth: Navigating Regulatory Compliance
The FDA plays a critical role in regulating at-home diagnostic testing kits, including those used in conjunction with telehealth services. Healthcare businesses leveraging these tests must understand FDA classifications, emergency use authorizations, and labeling requirements to ensure compliance and patient safety. Non-compliance can lead to significant regulatory penalties and reputational damage.
Washington State Telehealth Prescribing: Establishing a Valid Provider-Patient Relationship
Washington State regulations require a valid provider-patient relationship to be established before prescribing via telehealth, with specific criteria for what constitutes such a relationship. This includes a patient-initiated contact, a health history, and a physical examination, which may be conducted remotely under certain conditions, to ensure appropriate care and prevent improper prescribing.
Navigating Supervision Requirements for Dental Auxiliaries in Teledentistry
Teledentistry is rapidly expanding, but the supervision requirements for dental hygienists and assistants performing services remotely or in satellite locations remain a critical regulatory consideration. State dental boards are actively defining or clarifying the level of supervision required, impacting the scope of practice and operational models for dental practices utilizing virtual care.
FDA Intensifies Scrutiny on Marketing Claims for Telehealth Weight Loss and Hormone Therapy Programs
The FDA is increasing its enforcement actions and issuing warning letters to telehealth providers and related businesses making unsubstantiated or misleading marketing claims for weight loss and hormone therapy products and services. This heightened scrutiny emphasizes the need for strict adherence to FDA regulations regarding product promotion, particularly for unapproved drugs or off-label uses.
FDA Intensifies Scrutiny on Marketing Claims for Telehealth Weight Loss and Hormone Therapy Programs
The FDA is increasing its enforcement actions and issuing warning letters to companies making unsubstantiated or misleading marketing claims for telehealth-provided weight loss and hormone therapy products and services. This heightened scrutiny targets products marketed as unapproved drugs, misbranded devices, or those making false efficacy claims, emphasizing the need for strict adherence to FDA regulations in promotional materials.
FDA Clarifies Direct-to-Consumer Telehealth Pharmaceutical Advertising Requirements
The FDA has provided guidance clarifying how existing pharmaceutical advertising regulations apply to direct-to-consumer (DTC) promotions conducted through telehealth platforms. This guidance emphasizes the need for truthful, balanced, and non-misleading information, particularly regarding prescription drug indications, risks, and benefits, regardless of the promotional channel.
Utah Medical Board Scrutiny Intensifies for Telehealth and Medspa Operations: Key Disciplinary Trends
The Utah Division of Occupational and Professional Licensing (DOPL) continues to actively monitor and enforce professional practice standards, with a growing focus on telehealth and medspa operations. Recent disciplinary actions highlight concerns regarding scope of practice, appropriate supervision, patient safety, and adherence to established practice guidelines, particularly in aesthetic and remote care settings. Healthcare businesses operating in Utah, especially those leveraging telehealth or offering medspa services, must ensure strict compliance with state regulations to mitigate enforcement risks.
DEA Registration Requirements for Telehealth Prescribing Across State Lines: Navigating Post-PHE Regulations
This article details the Drug Enforcement Administration (DEA) registration requirements for telehealth providers prescribing controlled substances, particularly when crossing state lines. It focuses on the evolving regulatory landscape following the COVID-19 Public Health Emergency (PHE) and the implications of the Ryan Haight Act's 'telemedicine exception.' Providers must understand the current temporary rules and proposed permanent changes to maintain compliance.
Navigating Telehealth and Scope of Practice in Dental Sleep Medicine
The integration of telehealth into dental sleep medicine presents both opportunities and regulatory complexities, particularly concerning scope of practice, patient evaluation, and treatment delivery. Healthcare providers must understand state-specific dental board regulations and professional guidelines to ensure compliant and ethical care for sleep-related breathing disorders. This article explores key considerations for dental practices leveraging telehealth for sleep medicine services.
Understanding North Dakota's Corporate Practice of Medicine Doctrine for Telehealth and Medspas
North Dakota maintains a Corporate Practice of Medicine (CPOM) doctrine, generally prohibiting corporations from employing physicians or controlling medical decisions. While not as strictly enforced as in some states, this framework significantly impacts business structures for telehealth providers and medspas, requiring careful consideration of management services organizations (MSOs) and professional corporations (PCs).
FDA Intensifies Scrutiny of Marketing Claims for Telehealth Weight Loss and Hormone Therapy Programs
The FDA is increasing its enforcement actions against companies making unsubstantiated or misleading marketing claims for telehealth-provided weight loss and hormone therapy products and services. This heightened scrutiny targets products marketed as drugs or medical devices without proper FDA approval or clearance, or those making unproven efficacy claims.
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State-by-state requirements for medical director oversight in telehealth, medspas, IV therapy clinics, and other healthcare operations.
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Regulatory requirements for GLP-1 weight loss medication prescribing via telehealth.
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State-specific CPA templates and guidance for physician-NP collaborative arrangements.
Read guideStay Ahead of Every Regulatory Change
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