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 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.

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 [...]

HIPAA Compliance for Pharmacies – Violations and FAQs

Pharmacies should consult with experienced healthcare lawyers to understand what conduct may qualify as a HIPAA violation, the penalties for violations, and to get answers to HIPAA compliance [...]

Experienced Healthcare Lawyers Understand the Regulatory Compliance Issues for Medical Mergers and Acquisitions

There are federal and state laws that regulate the sale or merger of medical practices. Experienced healthcare lawyers review the rights and obligations of the physicians and medical practices – [...]

Why Posting Patient Photographs on Social Media Accounts May Violate HIPAA and FTC Advertising Regulations

Physicians and medical practices should review the HIPAA rules, FTC requirements, and local medical rules before posting any patient photographs on social media accounts. The civil fines for [...]

Physician Recruitment Compliance Issues, Stark Law Exceptions, and MSOs

Hospitals, medical practices, and physicians need to understand the laws that regulate physician recruitment. Stark Law exceptions may help. An MSO can help newly hired doctors focus on their [...]

Key Considerations When Merging or Acquiring A Medical Practice – Part Two

Medical practices that buy or merge with other practices need to review a range of legal and healthcare compliance issues – including integration planning, financing, cultural compatibility, and [...]

Key Considerations When Merging or Acquiring A Medical Practice – Part One

Medical practices that buy or merge with other practices need to review a range of legal and healthcare compliance issues – including integration planning, cultural compatibility, and performance [...]

Pfizer’s Bid to Help Pay Deductibles and Copays for a New Drug Denied Because the Bid Violates the AKS

A federal court and an appellate court ruled that Pfizer’s attempts to help patients with copay and deductible payments violates the AKS even if Pfizer acted with good intent.

5 Challenges in Healthcare Mergers: Lessons for Small Clinics to Expand Reach

In the dynamic landscape of the healthcare industry, mergers have become an increasingly common strategy for small clinics looking to expand their reach and improve operational efficiency.

How MSOs Can Help Medical Practices After a Merger or an Acquisition – Part Two

How a Managed Service Organization (MSO) can help a medical practice that recently acquired or merged with another medical practice address Stark Law and Anti-Kickback Statute requirements.

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

5 Exciting Benefits of Merging with a Healthcare Network for Small Clinics

This article delves into the myriad advantages of mergers, emphasizing how they not only enhance patient care but also contribute to the long-term sustainability of small clinics.

How MSOs Can Help Medical Practices After a Merger or an Acquisition – Part One

The advantages and risks of using an MSO after your medical practice buys another medical practice or merges with another medical practice.

HIPAA Compliance for Pharmacies Part One: HIPAA Rules and Best Practices

Pharmacies need to ensure their staff complies with HIPAA’s Privacy Rule, Security Rule, and Breach Notification Rule – and implement “best practices” to help ensure compliance.

FDA Grants Accelerated Approval for a New Alzheimer’s Disease Treatment

The FDA recently approved the drug, of Leqembi, a treatment of Alzheimer’s disease, through the accelerated approval process.

The Possibilities and Legal Risks of ChatGPT for Doctors and Medical Practices

ChatGPT will help doctors and medical practices keep better records, review medications, track diseases, and monitor patients. Healthcare providers need to understand the legal rules that govern [...]

The FDA Transcranial Magnetic Stimulation Approval Process

The FDA has approved Transcranial Magnetic Stimulation (TMS) treatments for depression and obsessive-compulsive disorders. Other treatments may be FDA-approved based on the substantial [...]

Understanding the Medical Device Classification and Approval Process – Part Two

Developers and manufacturers of medical devices need to understand 510 (k) approval of medical devices and other FDA compliance issues.

Understanding the Medical Device Classification and Approval Process – Part One

Developers and manufacturers of medical devices need to understand how FDA classifies the devices and the criteria for approval

How MSOs Help Medical Practices with Office and Equipment Rental

Managed Service Organizations Can Help Medical Practices Comply with Stark Law, the Anti-Kickback Statute (AKS), and Corporate Practice of Medicine Laws

Stem Cells Therapy Clinic Startups – Legal Compliance Issues

The FDA’s Center for Biologics Evaluation and Research (CBER) regulates stem cell products. Stem cells normally require an investigational new drug application.

New California Laws for Physicians and Surgeons for 2023

An update of California’s new laws such as AB 2178 that address many licensing, treatment, practice, and do’s and don’ts of the medical profession.

California’s New Electronic Prescription Law – AB 852

California’s new electronic prescription law and other electronic prescription laws for healthcare providers and pharmacies.

California Assembly Bill (AB)-890 and Two New Nurse Practitioner Categories

California AB-890 authorizes two categories of nurse practitioners who can practice without physician supervision if specific criteria are met.

SB 994 and AB 2685: California’s New Naturopathic Doctors’ Laws

How the passage of SB 994 and AB 2685 affect the ability of naturopathic doctors to practice medicine and hire LVNs.

Informed Consent and Risk Waivers

The doctrine of informed consent is based on the principle that adults of sound mind should have the right to decide what can be done to their bodies.

Compliance Issues for Consulting Fees, Honoraria, Medical Directorships, and Other Types of Remuneration

Physicians and healthcare companies such as pharmaceutical companies need to understand when remuneration violates the Anti-Kickback Statute. Some safe harbors may apply.

MSOs For Nursing Businesses

Nurse practices may consider using a managed service organization (MSO) to address corporate practice of medicine, anti-referral, and other compliance laws

MSOs For Oncology Practitioners

Oncology practices may consider using a managed service organization (MSO) to address corporate practice of medicine, anti-referral, and other compliance laws

FAQs For Oncology Practitioners – Part One

Helping oncology practices understand the dividing lines between practicing medicine and the business side of the practice.