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Keeping you afloat amidst the rising sea of regulations

The Secret's Out: FDA Allows Drug and Device Manufacturers to Share HCEI Prior to Product Approval

Last week, FDA issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers, describing the Agency’s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

How Millennials Will Change Health Care IT

* The following article was originally published by Healthcare Business & Technology. To read it on the Healthcare Business & Technology website, click here. 

CMS Rule Prohibiting Binding Arbitration Put on Hold

* The following article was originally published by California Healthcare News. To read it on the California Healthcare News website, click here. 

Life’s a Breach - Sitting on that HIPAA Breach Notification Could Burn You

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.

FTC Arms Businesses and Consumers Against Ransomware

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?

New Year…Same Rules? HHS Makes Few Changes in Recent 340B Drug Pricing Program Final Rule

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).

For Conservatives, It’s A New Day In Health Care

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

Arent Fox’s Medical Staff Leaders and the Law Conference 2017 – Costa Mesa

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

340B Drug Pricing Program Ceiling Price Final Rule Released

The 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties final rule is scheduled to be published in the Federal Register on January 5, 2017. A link to the advance copy of the final rule can be accessed here.

Changes to Iran Sanctions Regulations Means Good News for US Medical Device Manufacturers

OFAC Expands General Licenses to Export Medical Devices, and Associated Services, to Iran; OFAC Also Redefines “Iranian-Origin” Goods Eliminating Its Unintended Capture of Goods Just Passing Through Iranian Ports and Airports