Healthcare Law

Doctors, registered nurses and EMTs should review with an experienced healthcare attorney - corporate practice of medicine issues, medical and business practices, and other legal issues before [...]

Physicians and medical practices who merge their practices, sell, or acquire a medical practice need to notify their clients about the transaction so they can make informed decisions about their [...]

A MSO helps separate the medical side of a med spa from the business side of the med spa. A properly drafted MSA helps clarify the roles of the MSO and federal and state compliance issues.

Durable medical equipment companies need to review the Anti-Kickback Statute, Stark Law, HIPAA, CMS requirements, and other federal and state requirements before marketing their business.

Mobile health apps must comply with FDA regulations, HIPAA privacy laws, and FTC advertising guidelines to avoid enforcement actions. Learn how to determine if your app is a medical device, [...]

Direct-to-consumer genetic testing companies must navigate complex FDA regulations, HIPAA compliance, and state laws to avoid enforcement actions. Learn how to structure your business legally, [...]

Health coaching businesses must comply with state licensing laws, corporate practice of medicine rules, HIPAA, and FTC regulations when offering services. Learn legal strategies to structure your [...]

The Food and Drug Administration has numerous guidance articles about premarket submissions for the developers of medical devices. We discuss steps one and two.

Explore essential legal considerations for healthcare mergers and acquisitions, covering due diligence, regulatory compliance, and structuring agreements. Insights from Cohen Healthcare Law Group.

California’s “Physicians Make Decisions Act,” effective January 1, 2025, requires human oversight of the use of artificial intelligence in medical treatments and decisions.

Discover legal compliance strategies for medical spa ownership, covering corporate practice of medicine, MSO structures, and physician partnerships. Insights from Cohen Healthcare Law Group.

Doctors and nurses in California and many other states can provide certain medical procedures if those standard procedures are set forth in a practice agreement/collaborative agreement.

Explore essential HIPAA compliance guidelines for telehealth platforms, covering data security, privacy requirements, and best practices for protecting patient information. Insights from Cohen [...]

Learn essential compliance strategies for value-based care, covering regulatory requirements, Anti-Kickback Statute, Stark Law, and risk mitigation for healthcare providers. Insights from Cohen [...]

Medical manufacturers and medical practitioners need to understand the FDA rules for developing and prescribing emergency use authorization vaccines and medical devices during pandemics and other [...]

Explore key legal and compliance guidelines for functional medicine practices, covering scope of practice, informed consent, and multistate licensing. Insights from Cohen Healthcare Law Group.

Explore essential strategies to maintain compliance with corporate practice of medicine laws for healthcare entities, covering ownership structures, management agreements, and risk management. [...]

Learn essential compliance tips for nutritional supplement companies to meet FDA and FTC standards, covering labeling, health claims, and risk mitigation strategies. Insights from Cohen [...]

Discover key FDA compliance tips for cosmetic companies, including labeling, claims, and ingredient safety to avoid regulatory issues. Insights from Cohen Healthcare Law Group.

Learn key legal compliance essentials for providing coaching and counseling services across state lines, including licensing, scope of practice, and patient privacy regulations. Insights from [...]

Explore key compliance essentials for functional and integrative medicine practices, including licensing, scope of practice, and patient privacy requirements. Insights from Cohen Healthcare Law Group.

Learn about essential licensing and accreditation requirements for healthcare providers and facilities, including key differences and compliance strategies. Insights from Cohen Healthcare Law Group.

Learn essential FDA and healthcare compliance requirements for dietary supplements, including labeling, marketing claims, and manufacturing practices. Insights from Cohen Healthcare Law Group.

Learn how to legally structure your medical spa using Professional Medical Corporations (PMCs) and Management Services Organizations (MSOs) to ensure compliance. Insights from Cohen Healthcare [...]

The popularity of medical spas has soared, offering clients advanced treatments like IV hydration, injectables, and aesthetic enhancements. However, medical spas operate within a highly regulated [...]

Explore essential legal tips for telemedicine compliance across state lines, including licensing, patient privacy, and prescribing standards. Insights from Cohen Healthcare Law Group.

The FDA’s Center for Drug Evaluation and Research conducted a study examining the relationship between disease communications and prescription drug advertising. The results are discussed

Generally, nurses must obtain their state nursing license by having the proper degree(s) and passing a state nursing exam. Nurses can be certified in specialties. EMTs must obtain their [...]

Healthcare licenses generally require that applicants have specific educational degrees and pass appropriate exams. Certifications generally confirm an individual has specialized knowledge. [...]

Healthcare practitioners and healthcare entities can enter into corporate integrity agreements with the OIG (of HHS) to ensure compliance in return for continued participation in federal [...]

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 [...]

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

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.

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.

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