Healthcare Law

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 the dividing lines between practicing medicine and the business side of the practice.

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 [...]

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.

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.”

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

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

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 [...]

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.

Diagnostic testing centers and the physicians who refer patients to them need to understand Stark Law, the AKS, Medicare requirements, HIPAA, and other compliance laws.

Integrative medicine practices need to understand HIPAA, the corporate practice of medicine, Stark Law, the AKS, unauthorized practice of medicine, and many other compliance issues.

Dentists need to understand how Stark Law and the AKS affect their referral arrangements. Dentists need to understand corporate practice of medicine, FDA, FTC, and other compliance issues.

Physicians and other healthcare providers and companies that submit bills for medical services may be subject to Stark Law, AKS, and False Claims Act charges

Regulatory compliance review and business review for psychologists, therapists, marriage counselors, health coaches, substance abuse centers, and other practices.

A pharmaceutical company sought an advisory opinion to determine if payment for travel, lodging, and other costs are an inducement that violates the federal Anti-Kickback Statute.

Regulatory compliance and business transactional review of digital health companies and practices including telemedicine, medical software, health hardware, and the IoT.

The US Department of Health and Human Services provides questions and answers to the HIPAA Privacy Rule’s Right of Access. These FAQs directly affect healthcare practices

Veterinary practices are subject to most of the regulations human medical practices are subject. The rules that govern veterinary practices do differ though because animals are different than people

Legal, business, compliance, and practice issues for the formation and day-to-day administrative and medical operations of medical practices and health specialties

The US Centers for Disease Control and Prevention has clinical care guidelines for the three vaccines that have been approved – the two mRNA vaccines and the Jansen vaccine.

Physicians who leave a practice need to balance any non-solicitation issues in their employment contracts with the need to inform patients that the patient may need a new doctor.

The HHS Office of Civil Rights has guidance on how and when covered entities should respond to a right of access request for the personal health information of a patient.

American physicians are working to benefit from medical tourism by targeting patients to come to America and by setting up practices in foreign countries.

Physicians who wish to work in the medical tourism sector need to be careful to separate their medical tasks from their business and marketing tasks and to avoid fee-splitting issues

As the population ages, health providers and health companies are developing and expanding their regenerative medicine and anti-aging practices. As with all healthcare services and products, [...]