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Failure to Timely Notify Results in Enforcement Action and Significant Settlement

For the first time, on January 9, 2017, the Department of Health and Human Services, Office for Civil Rights (HHS/OCR) settled a HIPAA enforcement action based on the untimely reporting of a breach of unsecured protected...more

Joint Commission Confirms Ban on Texting of Patient Care Orders

After briefly considering a reversal of its prohibition on texting orders, The Joint Commission (TJC), in consultation with the Centers for Medicare & Medicaid Services (CMS), announced last month that its ban would continue...more

2016 Nerve-of-a-Burglar Award

Competition for the 2016 Nerve-of-a-Burglar Award was fierce, with health care providers constantly coming up with new and different ways to scam Medicare and Medicaid. Nevertheless, we have a clear winner: the Michigan...more

Happy Holidays from FDA: The Agency Issues Four Enforcement Letters for Unlawful Promotion

The Food and Drug Administration recently issued holiday gifts, in the form of enforcement letters, to four pharmaceutical companies. The letters are reminders that FDA is not in a partying mood when it comes to unlawful...more

FDA Issues Final Guidance on Postmarket Cybersecurity

Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices. On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more

Lipitor MDL Court Grants Pfizer’s Omnibus Summary Judgment Motion: No Evidence of Causation

For those of us who spend large chunks of our professional lives in mass tort MDLs, expressions like “settlement inventory” are ubiquitous. It is too easy to lose sight of the fact that these expressions put the rabbit in the...more

FDA Releases Guidance on Cybersecurity and Medical Devices

The FDA represents the latest federal agency to show a focus on cybersecurity issues with the release December 28 of new guidance. While the prospect of network-enabled medical devices increasingly offers the promise of...more

[Webinar] What to Expect in Trump's First 100 Days - January 18th, 11:00am ET

After years of gridlock, Congress is poised to unleash a flurry of legislative activity early in 2017. The agenda is jam-packed as the Republican-led Congress targets major changes to the Affordable Care Act, Dodd-Frank,...more

Radiopharmacies Celebrate the New Year with Long-Awaited FDA Guidance

On December 29, 2016, the U.S. Food and Drug Administration (“FDA”) surprised many in the radiopharmacy industry by issuing a long-awaited draft guidance entitled “Compounding and Repackaging of Radiopharmaceuticals by...more

2016 Antitrust Case Law And FTC Action Highlights FTC Agency’s Approach To Hospital Mergers

In 2016, the Federal Trade Commission prevailed in litigation before the Third and Seventh Circuit Courts of Appeal related to two high-profile hospital mergers. In both cases, the courts of appeal overturned the federal...more

FDA Consumer Update: The 3Rs of 3D Printing – FDA’s Role

On December 21, 2016, the U.S. Food and Drug Administration (“FDA”) posted a Consumer Update and accompanying video on the “The 3Rs of 3D Printing: FDA’s Role,” which reconfirms its position on the importance of 3D printed...more

OCR’s 2016 Ransomware ‘Guidance’: A Health Care Provider’s New Best Friend?

Background on Ransomware Attacks - Doomsday-esque ransomware scenarios are having an increasing impact on the health care industry, becoming commonplace in 2016. Security experts and the media have reported that health...more

The Pits – The Worst Prescription Drug/Medical Device Decisions Of 2016

The “pits of hell,” “black as a pit,” a “bad feeling in the pit of my stomach” – that’s how we feel about 2016’s bottom ten decisions of the year arising from prescription medical product liability litigation. This year’s...more

AGG Food and Drug Newsletter - December 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

California’s Surprise Medical Bill Statute: Part 2: Comparison to New York’s Emergency Medical Services and Surprise Bills Law

Executive Summary - On September 23, 2016, the California Legislature passed, and Governor Jerry Brown signed, Assembly Bill 72 (“the Law”), creating a new regime for the regulation of “surprise bills.”...more

Six Ways U.S. Joint Strategic Plan on IP Enforcement Impacts Public Health and Safety

On December 12, 2016, the Office of the U.S. Intellectual Property Enforcement Coordinator (IPEC) in the Executive Office of the President issued a much-awaited interagency plan on intellectual property (IP) enforcement. The...more

Additional Clarification regarding HHS OCR Phishing Email Alert

More information from HHS OCR about the phishing threat... ..On November 28, 2016, the HHS Office for Civil Rights issued a listserv announcement warning covered entities and their business associates about a phishing...more

OCR Provides Additional Clarification on Phishing Scam

As we reported earlier this week, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights described a phishing campaign that is attempting to convince recipients of their inclusion in OCR’s Phase 2...more

HHS OCR Alert: Phishing Email Disguised as Official OCR Audit Communication

This alert just in from HHS OCR: “It has come to our attention that a phishing email is being circulated on mock HHS Departmental letterhead under the signature of OCR’s Director, Jocelyn Samuels. This email appears to...more

OCR Warns of Phishing Campaign Disguised as Official OCR Communication

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published an alert on Monday describing a phishing campaign disguised as an email from OCR. The email is being circulated on mock HHS...more

FTC Announces New Guidance on Ransomware

On November 10, 2016, the U.S. Federal Trade Commission (FTC) released new guidance for businesses and consumers on the impact of, and how to respond to ransomware. Ransomware is a form of malicious software that infiltrates...more

More on HIPAA Audits for 2016 and 2017–Desk Audits and On-Site Audits

As part of the ongoing HHS OCR HIPAA audit initiative, it is conducting “HIPAA desk audits.” These audits don’t involve auditors coming in your facility. Instead, covered entities are being asked to submit documents on...more

Cybersecurity 2017 – The Year In Preview: HIPAA Compliance

Editor’s Note: This is the third in a continuing end-of-year series. The year ahead promises to be a busy one for those with responsibility for HIPAA compliance, as the Office of Civil Rights (OCR), charged with...more

Health Update - November 2016

Post-Election Analysis: Healthcare Antitrust in a Trump Administration - In a Republican sweep of all the elected branches of the federal government, Donald Trump won the presidential election and Republicans retained...more

Awful Missouri Venue/Joinder Ruling Offers Way Out – Take It!

Even after having read it through twice, we find the result in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), hard to fathom, and even harder to stomach. For several years after...more

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