FDA Approves Kisunla, the third in a new class of Alzheimer’s Drugs

The FDA approved a new Eli Lilly drug, Kisunla, that may help reduce the cognitive decline of Alzheimer’s patients by attacking the patient’s amyloid. The drug is the third FDA-approved drug of [...]

US Preventive Services Tasks Force Recommends Interventions (Not Drugs) for Children and Teens with High BMI

The US Preventive Services Task Force recently recommended that children and teens with a high BMI receive treatment interventions. The US PSTF did not include chronic weight loss medications in [...]

What Does a Medical Compliance Officer Do?

A medical compliance officer should work with a healthcare lawyer to understand the federal and state laws and regulations that govern the medical compliance officer’s medical practice or medical [...]

US HHS and HIPAA’s New Rule for Reproductive Health Care Disclosures

At the direction of the Biden-Harris administration, the US HHS issued a Final Rule prohibiting the disclosure or protected reproductive healthcare information unless an exception applies.

Can the Federal Trade Commission File Complaints Against Businesses That Target Consumer Locations Without the Consent of the Consumer?

The Federal Trade Commission is beginning to require that marketing companies understand that the collection, use, and sale of consumer location information requires the consent of the consumer

FDA Guidance on Direct-to-Consumer Prescription Drug Advertisements

Pharmaceutical companies and advertisers should consult FDA’s CNN rule when designing television and radio ads for direct-to-consumer drug advertisements

MSO Ownership issues for Medical Spas

Healthcare providers and non-healthcare providers who wish to operate a medical spa need to understand the laws in their state that determine who can own a medical spa and who can manage a medical spa.

Using the terms “Organic,” Healthy,” and “Natural” on Food Labeling

The FDA and Congress are reviewing proposals and legislation to regulate the use of the term “natural” and to address food labeling concerns in addition to the current Nutrition Label requirements.

Common Healthcare Compliance Mistakes

The first and most serious mistake medical companies, medical practices, doctors, nurses, and others make is – failing to make an appointment with an experienced healthcare lawyer – to discuss [...]

Weight Loss Drugs and FDA Compliance

The manufacturers of weight loss drugs and the doctors who prescribe weight loss drugs need to understand FDA compliance rules, how to prescribe the drugs, and how to monitor the use of the drugs

Aromatherapy and FDA Compliance

Individuals and companies that make and market aromatherapy products need to understand when the products may be considered drugs by the FDA and when the FDA will consider that the products are [...]

Artificial Intelligence Uses in The Healthcare Industry

Artificial manufacturers need to understand the FDA approval process for medical devices and drugs. Physicians need to understand AI uses and patient privacy issues.

Understanding the Different Types of Nursing Jobs and Corresponding Compliance Issues – Part Three

Nurses need to understand their education and certification requirements, unauthorized practice of medicine laws, scope of practice laws, and other compliance laws.

Understanding the Different Types of Nursing Jobs and Corresponding Compliance Issues – Part Two

Nurses work in many different environments and provide many various services. Nurses and nursing businesses need to understand the laws and regulations that must be followed.

Understanding the Different Types of Nursing Jobs and Corresponding Compliance Issues – Part One

The nursing profession includes many different levels of jobs based on a nurse’s education and job duties. All nurses are affected by federal and state laws and regulations that need to be understood.

FTC Proposes Amendments to its Health Breach Notification Rule

The Federal Trade Commission announced that the agency will be updating its Health Breach Notification Rule to include new apps and technologies

Collaborative Practice Agreements for Independent Pharmacies

Collaborative practice agreements help pharmacists and physicians provide better healthcare to patients. The agreements need to be reviewed for federal, state, and medical board compliance issues.

How Much is a Medical Practice Worth?

Experienced healthcare lawyers work with professional medical appraisers to properly appraise a medical business so doctors understand the value of the practice they’re buying or merging with.

MSOs and Compliance Issues for Anti-Aging Aesthetic Clinics

The doctors and owners of anti-aging medical practices need to understand what procedures and treatments require FDA approval, who can perform the procedures, and many other compliance issues. An [...]

The MSO/Physician Contract: Compliance with Stark Law’s personal service agreement and the fair market value compensation exceptions.

Managed service organizations are a common strategy for helping medical practices comply with Stark law, the AKS, and the corporate practice of medicine laws – including the relationship between [...]