How do healthcare certification, accreditation, and licensing differ?

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

Corporate Integrity Agreements and Exclusions from Medicare and Medicaid

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 [...]

Modernizing the New Drugs Regulatory Program

The Center for Drug Evaluation (CDER), in 2017, developed an initiative to modernize CDER’s New Drugs Regulatory Program (NDRP). The initiative focuses on scientific leadership, benefit-risk [...]

Compliance Requirements for the Ryan Haight Online Pharmacy Consumer Protection Act of 2008

The Ryan Haight Online Pharmacy Protection Act of 2008 regulates how pharmacists can dispense certain controlled substances and how practitioners should comply.

FDA Approves Kisunla, the third in a new class of Alzheimer’s Drugs

The FDA approved a new Eli Lilly drug, Kisunla, that may help reduce the cognitive decline of Alzheimer’s patients by attacking the patient’s amyloid. The drug is the third FDA-approved drug of [...]

US Preventive Services Tasks Force Recommends Interventions (Not Drugs) for Children and Teens with High BMI

The US Preventive Services Task Force recently recommended that children and teens with a high BMI receive treatment interventions. The US PSTF did not include chronic weight loss medications in [...]

What Does a Medical Compliance Officer Do?

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 [...]

US HHS and HIPAA’s New Rule for Reproductive Health Care Disclosures

At the direction of the Biden-Harris administration, the US HHS issued a Final Rule prohibiting the disclosure or protected reproductive healthcare information unless an exception applies.

Can the Federal Trade Commission File Complaints Against Businesses That Target Consumer Locations Without the Consent of the Consumer?

The Federal Trade Commission is beginning to require that marketing companies understand that the collection, use, and sale of consumer location information requires the consent of the consumer

FDA Guidance on Direct-to-Consumer Prescription Drug Advertisements

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