Healthcare Law

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

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

Developers and manufacturers of stem cell therapies need to understand how to conduct clinical trials in order to process FDA investigational new drug (IND) applications.

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

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 and other electronic prescription laws for healthcare providers and pharmacies.

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

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

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.

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

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

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

Helping oncology practices understand their legal compliance issues include the use of telemedicine, health coaching, and informed consent

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

As the pandemic hopefully winds down, there will be changes to the ability to use and bill for telehealth services. Our lawyers explain the latest developments.

Doctors who enter into contracts with hospitals need to understand the federal and state laws that regulate the terms of these professional service agreements – and the practical medical and [...]

3D printing is being used for prosthetics, orthodontics, surgical preparation, and other applications. These devices may be subject to FDA regulation, Stark and AKS compliance, and FTC oversight.

Drone technology has many different medical applications including the delivery or medications and medical services. Developers and medical practices need to understand the healthcare compliance [...]

As the pandemic hopefully winds down, there will be changes to the ability to use and bill for telehealth services. Our lawyers explain the latest developments.

IV therapy owners and practitioners need to discuss with experienced healthcare lawyers who can prescribe IV therapy, who can prepare the solution, and who can administer the therapy.