Understanding HIPAA: The Privacy Rule

Understanding HIPAA: The Privacy Rule

The Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”) establishes a set of national standards to address the use and disclosure of protected health information (“PHI”) by covered entities and business...
Why do healthcare providers need a good healthcare lawyer?

Why do healthcare providers need a good healthcare lawyer?

Healthcare providers need a good healthcare lawyer. But do you have one who can spot those hidden issues specific to the healthcare field? How does healthcare law fit into the legal practice? As a corporate attorney, I provide services to a client across the different...
State Healthcare Laws Regarding Patient Referrals

State Healthcare Laws Regarding Patient Referrals

The federal standards set to regulate referrals are known as the Stark Law and the Anti-Kickback Statute. The Stark Law prohibits a referral by a physician of a Medicare or Medicaid patient to an entity for the provision of “designated health services” if the...
An Overview on the Regulation of Medical Devices

An Overview on the Regulation of Medical Devices

The US Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 (the FD&C Act), which empowered the US Food and Drug Administration (the FDA) to oversee the safety of, among other things, medical devices. Generally, the FDA is charged with approving...
State Healthcare Laws Regarding Patient Referrals

What is Pre-Market Notification or 510(k)?

The US Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 (the FD&C Act), which empowered the US Food and Drug Administration (the FDA) to oversee the safety of, among other things, medical devices.  The FDA establishes strict requirements for...