Healthcare Law

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

FDA is sending warning letters to companies that claim the company can diagnose COVID-19. FDA has granted an Emergency Use Authorization) for at least one at-home testing kit.

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, [...]

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.

FDA sends warning letter to a company because its website and social media accounts made claims about CBD products that suggest they are drugs or dietary supplements and were misbranded.

These are two more of the non-fulfillment exceptions to the ONC rule. Another three fulfillment exceptions follow. The exceptions try to balance the ability of the developers and practitioners to [...]

The Office of the National Coordinator for Health Information Technology (ONC), which is part of the Department of Health and Human Services, approved a final rule which implements certain [...]

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

What is it that you want to get out of talking to a healthcare lawyer, an FDA lawyer or really any lawyer?

FDA and FTC warning letters continue to find violations of the FD&C Act when companies boast their products can cure or treat diseases such as COVID-19.