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 [...]

California passed a new law, effective January 1, 2023, that permits nurse practitioners in specific settings to provide care (under certain conditions) that does not meet “standardized procedures.”

California passed a new law, effective January 1, 2023, that permits nurse practitioners in specific settings to provide care (under certain conditions) that does not meet “standardized procedures.”

We review in more detail the role of the FDA in the regulation of medical imaging analysis software – whether it’s used as part of a mobile application, laboratory analysis, or for other medical [...]

New medical imaging software benefits many different types of health practices. Key compliance issues include HIPAA and FDA oversight.

What mobile mental health app manufacturers and the physicians who recommend and use these apps need to understand about FDA regulation of medical devices.

What are mental health mobile apps? What are the benefits and some of the concerns, such as privacy, about manufacturing and recommending these apps.

Administrative and legal issues involved with the CMS’s Sunshine Rule including reviewing and disputing payments manufacturers of drug and medical device report to CMS.

The Sunshine Rule of the Affordable Care Act requires that drug and medical device manufacturers disclose to CMS any payments they made for the benefit of physicians regarding the drugs or devices.

Health and Human Service’s healthcare compliance guide for new physicians includes the billing requirements for submitting claims to federal programs and commercial insurers.

An interactive questionnaire for mobile health app and medical device developers that covers compliance issues for HIPAA, the FDA&C Act, and the FTC Act

Medical practices and developers need to understand the federal regulations that govern the development and use of digital health products including medical device data systems, mobile medial [...]

The FDA does have authority to regulate medical devices – including digital health technologies that qualify as medical devices. Digital health includes SaMD, AI, ML, medical mobile apps, and [...]

There are numerous types of drugs, cosmetics, and other products used to treat skin disorders. FDA does regulate these products to ensure the products are safe for patients.

Immunotherapy drugs are showing promise for treating cancer. Manufacturers of these therapies and doctors must understand the FDA, HIPAA, and other compliance requirements.

Physicians and other healthcare providers must comply with the Good Faith Estimate Requirement. Disputes between the estimate and final bill will be resolved through a PPDR process.

Doctors and other healthcare providers need to comply with the Good Faith Estimate Requirement which ensures that non-insured and self-paying clients can anticipate their costs.

Physicians and medical practices should review their MSO and referral arrangements to help comply with the new Stark Law and AKS changes.

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.

New biotech and digital trends for 2022 include personalized medicine, faster pharmaceutical testing, artificial intelligence, blockchain technology, virtual and augmented reality, and other [...]