Medical Devices Health Care Providers

News & Analysis as of

Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more

Congressional Hypocrisy — Taking away your rights

As a part of the recent speed racing bills through Congress, they have put up HR 1215. Quite erroneously, they have titled it: “Protecting Access to Care Act of 2017”. A read of the act’s text quickly tells any objective...more

Medical Device Malware Medjack.3 Poses Threat to Hospitals

Medjack is a form of malware that was specifically developed to attack medical devices, such as heart monitors, CT and MRI machines, insulin pumps and PAC systems....more

Capitol Hill Healthcare Update

Meeting privately with Senate Republicans to discuss next steps on the ACA was among the first actions taken last week by the new Secretary of the U.S. Department of Health and Human Services Tom Price. But GOP senators left...more

Alert: 2016 Round-Up: Key Decisions Affecting Connecticut Health Care Providers

Connecticut state and federal courts faced a number of significant health care issues last year. We have summarized those cases that we think are particularly relevant to Connecticut hospitals, group practices and individual...more

Capitol Hill Healthcare Update

House Speaker Paul Ryan last week set a deadline of the end of March for repealing most of the Affordable Care Act (ACA), as other Republican leaders and conservative rank-and-file lawmakers advocated competing policy...more

RX IP Update - January 2017

Apotex’s Infringement of AstraZeneca’s Omeprazole Formulation Patent Upheld - As previously reported, the Federal Court of Appeal, in a unanimous decision released on January 12, 2017 (2017 FCA 9), has affirmed the...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

Health Alert (Australia) January 23, 2017

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Federal Court 13 January 2017 - Selia v Commonwealth of Australia [2017] FCA 7 - ADMINISTRATIVE LAW -...more

21st Century Cures: A Closer Look

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

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

124 Results
|
View per page
Page: of 5
Cybersecurity

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×