Healthcare Law

The FDA new guidelines on minimal manipulation include questions and answers. Meeting the minimal manipulation test can save companies a fortune in IND studies and clinical trial tests.

The CMS and HHA are proposing new rules, such as the Patients over Paperwork Initiative, where the focus of Stark and AKS will be on value-based arrangements

The DOJ reported several new cases in which health care companies and doctors agreed to pay millions to settle claims of healthcare fraud due to AKS and Stark violations.

Experienced healthcare lawyers advise doctors, physicians, and medical practices or a full range of regulatory and compliance issues including HIPAA, Stark Law, and the AKS.

Experienced healthcare lawyers advise doctors, physicians, and medical practices or a full range of regulatory and compliance issues including HIPAA, Stark Law, and the AKS.

The DOJ reported several new cases in which health care companies and doctors agreed to pay millions to settle claims of healthcare fraud due to AKS and Stark violations.

Doctors, medical practices, and health businesses in California need to be aware of the relevant federal and state laws that regulate their practice and industry – including those on the CHHS website.

Key provisions of the FDA’s proposed regulatory framework of software that uses and adapts to artificial intelligence and machine learning

The California Consumer Privacy Act Affects the Healthcare Industry goes into effect on January 1, 2020. Failure to comply with the data protection requirements can result in fines and penalties.

OIG Compliance guidelines for physicians (MDs, Dos) and small medical practices

Federal Drug Administration continues to send warning letters to companies that boast products can treat, diagnose, prevent, or cure COVID-19 or boost immunity.

Physician recruitment agreements involve the rights and duties of three parties. Experienced healthcare lawyers craft the proper exceptions to the Anti-Kickback Statute and Stark Law

Federal Drug Administration has started sending warning letters to companies that boast their products can treat, diagnose, prevent, or cure COVID-19 or boost immunity.

The Federal Trade Commission (FTC) announced the agency is sending warning letters to companies that claim its products can treat or prevent coronavirus (COVID-19) due to lack of scientific evidence

The healthcare industry is a complicated, multi-trillion-dollar gargantuan and require that a healthcare law firm deploy its specialized knowledge across multiple domains.

The OCR of the DHHS announced a new online decision tool to help HIPAA covered entities understand protected health information compliance during the COVID-19 emergency

The Department of Human Service’s Office of Civil Rights offers new HIPAA guidance during the COVID-19 public health emergency

Both the FTC and FDA are reviewing your web and print marketing materials. If you make unsupported medical and treatment claims about your CBD promotions, you will receive a warning letter.

As gyms and medical fitness centers expand the services and products they offer and depend more on physician referrals and doctor employment, compliance review becomes a must.

California passes its own versions of the federal EKRA law. The legislation was enacted due to the increase of opioid deaths and cases of addiction. Failure to comply with the new law can result [...]

Medical providers must abide by Stark Law and the AKS. Referrals must be based on what is best for the patient. If profit is the driver, the providers will often pay a substantial settlement or [...]

As gyms and medical fitness centers expands the services and products they offer and depend more on physician referrals and doctor employment, compliance review becomes a must.

The California Department of Managed Health Care’s (DMHC) passed a new regulation, effective July 1, 2019 that expands the types of healthcare companies that must be licensed

As gyms and medical fitness centers expands the services and products they offer and depend more on physician referrals and doctor employment, compliance review becomes a must.

Doctors, hospitals, med spas, pharmacies and other healthcare providers may violate the False Claims Act if they violate Stark Law or the Anti-Kickback Statute in addition to inflating bills, [...]

California, New York, and doctors everywhere need to understand what state laws apply to telemedicine including who can offer telemedicine, what consents from the patient are needed, and whether [...]

Case study of a pain management doctor starting a new medical spa. Why a managed service organization is a smart consideration is the focus of the discussion.

Doctors need to understand what laws apply to telemedicine including who can offer telemedicine, what consents from the patient are needed, and whether prescriptions require an in-office visit.

Doctors must comply with California’s Professional Corporation Act. A professional medical corporation provides many advantages over a partnership or sole proprietorship.

Stem cell therapies, where chiropractors and medical doctors work together, raise challenges for healthcare lawyers…

Physicians providing aesthetic and cosmetic medical services and healthcare startups involved in aesthetic, medspa and cosmetic medicine, need to understand corporate practice of medicine issues, [...]

Managed Services Organizations help physicians focus on practicing medicine by freeing doctors from many administrative tasks. Failure to consult with an MSO healthcare lawyer can cause civil and [...]

Whether your healthcare venture involves digital health, mobile health, or a physical health and wellness center, strong vs. weak corporate practice of medicine prohibitions can be deadly.

Healthcare Law a Labyrinth. It's a maze. It's a regulatory maze. What makes us different? People come to us for legal strategies and solutions. We provide legal strategies and solutions to [...]

Buying and selling a medical practice is much different than selling a commercial business. Due diligence must address special healthcare legal compliance issues, licensing requirements, patient [...]

Registered nurses, nurse practitioners, nurse specialists, and all nurses need to understand HIPAA, fee-splitting and revenue laws, a doctor’s duty of supervision, and other legal issues that [...]