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Both Sides Equal Under the First Amendment

by Reed Smith on

There’s a problem with attorney advertising in the prescription medical product space – but it’s not the one you normally hear us defense-side litigators kvetching about. Quite apart from its litigation-generating effects,...more

Senators Urge the Administration to Certify Imports of Prescription Drugs from Canada, Pharmaceutical & Medical Device Update,...

by Jones Day on

On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more

Public-Private Partnerships Could Bolster Healthcare Cybersecurity Efforts

by Jackson Lewis P.C. on

Protecting data in the healthcare industry continues to be an area of focus for regulators and lawmakers. HIPAA Journal noted that in 2016 more HIPAA covered entities reported breaches than in any other year since the U.S....more

MedPAC Takes Anti-POD Stance in Report to Congress, Echoing an Increasingly Uniform Consensus

by Ropes & Gray LLP on

On June 15, 2017, the Medicare Payment Advisory Commission (MedPAC), a non-partisan group that advises Congress on Medicare policy, released its annual Report to the Congress on Medicare and the Health Care Delivery System...more

Health Alert (Australia) 19 June 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 9 June 2017 - Health Services Union v St John of God Health Care [2017] FWC 2981 - Alleged dispute arising under an enterprise...more

My Entity Just Experienced a Cyber-Attack! What Do We Do Now?

by Balch & Bingham LLP on

On June 9, 2017, the U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) released a cyber-attack “Quick Response” checklist (the Checklist) for the benefit of HIPAA covered entities and business...more

Update on Regulatory Compliance in the Global Health Care Industry

by Baker Ober Health Law on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

Enforcement Considerations for the Health Care Industry in the Wake of the WannaCry Ransomware Attack

by Ropes & Gray LLP on

On May 12, 2017, the WannaCry ransomware cryptoworm attacked over 230,000 computers in over 150 countries, holding data on the computers for ransom. WannaCry spread rapidly through networked systems that had not been updated...more

EHR Vendors Beware: eClinicalWorks Settles with DOJ for $155 Million

by Dorsey & Whitney LLP on

The Department of Justice (“DOJ”) announced on May 31, 2017, a $155 million settlement of its lawsuit alleging False Claims Act (“FCA”) and Anti-Kickback Statute (“AKS”) violations committed by eClinicalWorks (“eCW”), one of...more

Japan Legal Update - Volume 25 | May 2017

by Jones Day on

Bill to Partially Amend the Civil Code was Passed by the House of Representatives - On April 14, 2017, the House of Representatives passed a bill to partially amend the Civil Code ("Bill"). The Bill is under deliberation in...more

The State AG Report Weekly Update

by Cozen O'Connor on

2018 Election Update- Michael Dougherty Announces Bid for Colorado Attorney General- Michael Dougherty formally announced his candidacy to become Colorado AG. Dougherty is the third Democrat to formally enter the...more

Weapons in the Cyber Defense Arsenal

by Wilson Elser on

In May 2017, the world experienced an unprecedented global cyberattack that targeted the public and private sectors, including an auto factory in France, dozens of hospitals and health care facilities in the United Kingdom,...more

AGG Food and Drug Newsletter - May 2017

by Arnall Golden Gregory LLP on

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

ALERT: Ransomware – a Global Wake-Up Call

by Sedgwick LLP on

U.S. Regulator Warns of “Evidence” of Global Cyber Assault Occurring Inside the U.S. and Steps Your Company Should Take Against a Ransomware Attack - On Friday, May 12, 2017, Laura Wolf, Critical Infrastructure...more

New Mexico Enacts Data Breach Notification Law

by King & Spalding on

On April 6, 2017, New Mexico became the 48th state to enact a data breach notification law; the Data Breach Notification Act (the “Act”) will go into effect on June 16, 2017. The good news for many in the health care...more

Why Healthcare and Life Sciences Companies Need to Step Up Their Compliance Efforts in Advance of a U.S. Government Investigation

by Hogan Lovells on

In this hoganlovells.com interview, Hogan Lovells partner Gejaa Gobena discusses how the perception of compliance, remediation, and self-disclosure has evolved in the eyes of government prosecutors from how they factor at...more

$2.5 Million Settlement Reached as HIPAA Crackdown Continues on Unsecured Portable Devices

by Jones Day on

A recent settlement of $2.5 million for alleged violations of the Health Insurance Portability and Accountability Act ("HIPAA") continues a trend of government enforcement targeting health care providers and vendors that fail...more

HIPAA and the Cloud’s Shared Responsibility Models

by Snell & Wilmer on

Cloud-based service providers (CSPs), like Amazon Web Services and Microsoft Azure, offer online access to shared computing resources. As such, they have developed a “shared responsibility model” for how CSPs and companies...more

Deeper Dive: Frequency and Severity

by BakerHostetler on

All industries are affected by cyberattacks, but how often and to what extent they occur vary greatly by industry type. As for frequency, the healthcare industry in 2016, for the third year in a row, saw the greatest...more

EU-U.S. Agreement for Mutual Recognition of GMP Inspections Entered Into Force

by Jones Day on

On March 4, 2017, the "Decision No 1/2017 of March 1, 2017, of the Joint Committee established under Article 14 of the Agreement on Mutual Recognition between the European Community and the United States of America, amending...more

Chicago Proposes Pharma Rep Licensing Rules and Ethical Standards

by Dechert LLP on

The City of Chicago Commissioner of Public Health on Friday, March 17, published proposed Rules to implement the highly-publicized pharmaceutical representative licensing ordinance enacted in November 2016....more

The Cross-Industry Promise of Blockchain

The blockchain protocol (a form of a ‘distributed ledger system’) was originally designed as a platform to process Bitcoin transactions. The protocol enables peer-to-peer transactions and eliminates the need for a trusted...more

Pro Te: Solutio - Vol.9 No.3 – Fall 2016

by Butler Snow LLP on

The Fall 2016 issue of Pro Te is about all things regulatory, including a peek at the newly developing issue of crowdfunding for medical devices. In EMA Guidance on Clinical Data Publication, we discuss recent guidance...more

Outsourcing of Services in the Medical Device Industry

by Knobbe Martens on

As the medical device market continues to grow, the medical device industry has strived to reduce costs through outsourcing. An industry report has found that the global medical device outsourcing market was valued at $33.2...more

Insider Trading Around Private Placements: Was Tom Price’s Investment Down Under Above Board?

On February 10, the Senate confirmed Representative Tom Price (R-GA) as Secretary of Health and Human Services, where he will oversee the U.S. Food and Drug Administration (FDA). His nomination has not been without...more

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Cybersecurity

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