Medical Devices Health Care Providers

News & Analysis as of

Managing the Risks and Benefits of an On-Site Automatic Defibrillator Program

Sudden cardiac arrest (“SCA”) is the largest cause of natural death in the United States and is responsible for approximately half of all heart disease deaths. SCA, however, is not a “heart attack” (i.e. an artery blockage)...more

Healthcare Law Update: December 2016

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

21st Century Cures Act: Key Provisions of Interest to Drug/Device Clients

Included in the many provisions contained in the 21st Century Cures Act are ones addressing drug, device, and biologic development and approval. Topics include the use of “real world evidence” in regulatory approvals, drug...more

21st Century Cures Act offers array of holiday gifts to healthcare providers

The 21st Century Cures Act, a rare beneficiary of broad bipartisan support, has been signed into law by President Barack Obama. The law has received much public acclaim for its $4.8 billion in new funding over the next...more

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...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

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

Health Alert (Australia) December 12, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Federal Circuit Court 5 December 2016 - Singh v Minister For Immigration & Anor [2016] FCCA 3061 - MIGRATION –...more

Locked in Sixty Seconds: Ransomware, Remote Access, and the Brave New Internet of Things

A few months ago, we analyzed ransomware incidents and offered some suggestions for handling an episode. Ransomware is a cyberattack in which a hacker uses malware to take control of computer systems. The system owner is...more

Blog: 21st Century Cures Clears Senate, President Expected to Sign into Law but Some Issues Remain

Today, the Senate voted overwhelmingly – 94-5 – to pass sweeping medical innovation legislation clearing the way for President Obama to sign it into law when it reaches his desk later this week. The 21st Century Cures Act,...more

Capitol Hill Healthcare Update

After months of debate and partisan wrangling, the House on Wednesday voted 392-26 to pass the “21st Century Cures” bill designed to accelerate the development of new drugs and medical devices as well as increase federal...more

Health Alert (Australia) November 21 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales - 16 November 2016 - Page v Healthscope Operations Pty Ltd [2016] NSWSC 1608 - PRACTICE AND PROCEDURE...more

Health Alert (Australia) October 17, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales 13 October 2016 - Coote v Kelly; Northam v Kelly [2016] NSWSC 1447 - On 23 May 2012, Mr Coote died...more

Health Alert (Australia) September 19, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: South Australia - 13 September 2016 - Dang Pharmacy P/L v Dang [2016] SADC 106 - This is a review of a decision by...more

Ninth Circuit Upholds Felony Conviction of Urologist, Under FDCA, for Reusing Single-Use Needle Guides During Prostate Biopsies...

In 2014, Las Vegas urologist, Dr. Michael Kaplan, was convicted by a federal jury for reusing single-use plastic needle guides during prostate biopsies. He was convicted of conspiracy to commit adulteration in violation of...more

OIG Work Plan: A Roadmap to Identify Health Care Compliance Risk

Each year, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issues a Work Plan that summarizes new and ongoing OIG reviews and areas of focused attention for the coming year and beyond....more

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

Hackers Steal 600K Records from Health Care Firms – Could Your Wearable Device Be Next?

Security firm InfoArmor published a report in late July 2016 stating that a group of attackers infiltrated American health care institutions, stole at least 600,000 patient records and attempted to sell more than 3 terabytes...more

Health Alert (Australia) August 8, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland - 28 July 2016 - Beven v Brisbane Youth Service Inc [2016] QSC 163 - The plaintiff, Lindsey Beven, was...more

3D Printing: Health Care Miracle, Product Liability Nightmare, or Both? Insights from Nutter’s David Ferrera and Robyn Maguire

David Ferrera, partner in Nutter’s Litigation Department and chair of the firm’s Product Liability and Toxic Tort Litigation practice group, and Robyn Maguire, partner in Nutter’s Litigation Department and a member of the...more

Health Update - July 2016

The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more

Another Jury Acquits in One of the First Few Prosecutions of Health Care Executives Following DOJ’s Yates Memo

Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”)...more

New Anti-Corruption Laws on the Health Care Sector in Germany: Is There Any Impact on the Food Industry?

Germany recently adopted new anti-corruption laws that now criminalize “taking bribes in the health care sector” and “giving bribes in the health care sector.” These new laws have implications for certain segments of the food...more

CMS Proposes Update to Medicare OPPS, ASC Rates and Policies for 2017

CMS has published its proposed rule to update the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System rates and policies for CY 2017. CMS proposes a 1.55%...more

New Proposed Legislation: Doctors Must Report Med Device-Related Deaths & Injuries

Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) announced plans to propose the Medical Device Guardians Act of 2016. According to a press release from Rep. Fitzpatrick, the Act is “a package of bills aimed...more

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