Earlier this month, FDA finalized Guidance for Industry, Assessment of Abuse Potential of Drugs. This guidance is intended to assist researchers and sponsors of new drugs that may have central nervous system (CNS) activity evaluate whether the drug has abuse potential.
Last week, FDA issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers, describing the Agency’s expectations for drug and device manufacturers’ communication of health care economic information (HCEI) about their products t
What’s the News?On January 9, 2017, Presence Health agreed to settle with the U.S. Department of Health and Human Services (HHS) potential violations under the Breach Notification Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This is HHS’ first enforcement action against a covered entity that reported a breach, but did not do so timely.
Ransomware is a living-nightmare for the health care industry, with attacks or threats of attacks increasing and the consequences potentially devastating to patients and businesses. The Federal Trade Commission recently issued guidance for both businesses and consumers on defending against ransomware, which Arent Fox attorneys Sarah Bruno, Eva Pulliam, and Lourdes Turrecha analyze in the article below.What’s the News?
The Health Resources and Services Administration, part of the Department of Health and Human Services, published a Final Rule on January 5, 2017 addressing how 340B covered outpatient drug “Ceiling Prices” are to be calculated under the 340B Drug Pricing Program, and how participating drug manufacturers may be subject to certain monetary penalties for violation of the 340B statute (the Final Rule).
Arent Fox LLP counsel Lanhee Chen recently was interviewed by the publication California Healthline, discussing what a Republican replacement plan to the ACA might look like. The full text of the article, originally published in California Healthline, can be read below or by clicking this link.For Conservatives, It’s A New Day In Health Care
Please join Arent Fox on Friday, February 3 from 7:00 AM – 5:00 PM Pacific for our annual Medical Staff Leaders and the Law Conference being held at the Avenue of the Arts Hotel in Costa Mesa. About this Arent Fox Conference