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Keeping you afloat admidst the rising sea of regulations

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 

FDA Regulation of HCT/Ps: What Wound Care Practitioners Need to Know

This article was originally published in Today's Wound Clinic. Editor’s Note: The following article discusses products characterized as “cellular and/or tissue-based products” (CTPs) by ASTM International. For purposes of this article, the legal and regulatory definition “human cells, tissues, and cellular- and tissue-based products” (HCT/Ps) – is used.

To Text or Not to Text . . . That is the Question: TJC Publishes Updated Guidance for Healthcare Providers

Just before Christmas, The Joint Commission (TJC) published an update clarifying its previous guidance regarding practitioners’ use of text messaging. TJC now says that practitioners may communicate with each other via secure text messaging systems. Practitioners are still banned, however, from issuing orders via text message, even though TJC’s previous concerns regarding data privacy and security were addressed.

Under Pressure: Mobile Medical App Settles Deceptive Ad Charges

Once again, a mobile medical app manufacturer has been caught in the Federal Trade Commission's enforcement web as a result of allegedly deceptive ad practices. Earlier this week, the FTC announced that Aura Labs, Inc. (doing business as AuraLife and AuraWare) agreed to settle charges that Aura violated the FTC Act by deceiving consumers with claims that its “Instant Blood Pressure (IBP)” app was as accurate as a traditional blood pressure arm cuff.