Health Care Counsel

Arent Fox's health care law blog offers news, analysis, and insights for the health care industry.

Health Care Counsel
E-Health, HIPAA / Health Privacy & Security
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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.

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Pharmaceutical & Device Compliance, Prescription Drug Pricing & Government Price Reporting, Wholesaler & Pharmacy Benefits Compliance
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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). The provisions of the Final Rule are effective March 6, 2017, and HHS indicated that it will begin enforcing the requirements of the Final Rule at the beginning of the second quarter of 2017, meaning April 1, 2017. 
 
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Affordable Care Act
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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

By Jenny Gold

December 19, 2016

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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

This unique conference is dedicated to equipping your medical staff team with the most current skills, tools, and information to navigate challenging issues and provide effective leadership. This year’s conference will address recent legal and regulatory updates and explore significant new laws and cases impacting medical staffs. Among other topics, we will address SB 1177 and its impact on impaired physicians, as well as the latest developments relating to government investigations and compliance with the False Claims Act. We will also cover recent trends in medical staff litigation and explore the post-election impact of the new president and Congress on the health care industry.

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Prescription Drug Pricing & Government Price Reporting
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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. Arent Fox health care partner Stephanie Trunk and associate Erin Atkins will be publishing a detailed client alert soon, in which they will analyze the provisions of the final rule and how they impact 340B covered entities and participating drug manufacturers. Please stay tuned to the Health Care Counsel blog for further updates!  

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Medical Device Compliance
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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 

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Pharmaceutical & Device Compliance
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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.

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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. TJC has been grappling with this issue for several years, having originally issued the ban in 2011, which was lifted in April and then reinstated in July of this year.

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Pharmaceutical & Device Compliance
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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. The FTC also alleged that Aura’s owner had provided a positive review and “five star” rating for the app without disclosing his connection to the company. A link to the FTC’s Press Release announcing the settlement can be found here.

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Pharmaceutical & Device Compliance
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Bristol-Myers Settlement Illustrates Continuing Enforcement Trend Against Allegedly Deceptive Promotion of Medical Products

Late last week, the Attorneys General of 43 states announced that they reached a $19.5 million dollar agreement with Bristol-Myers Squibb Company to settle allegations that the company engaged in deceptive trade practices with respect to the marketing of a drug intended for treating schizophrenia.

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ABOUT ARENT FOX LLP

Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.