Healthcare Medical Devices

News & Analysis as of

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

Off-Label Promotion —To Speak or Not To Speak?

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications...more

Health Care E-Note - August 2016

The Alabama Natural Death Act contains the provisions on how an individual may plan for end-of-life decisions. Specifically, it outlines the requirements for a valid Advanced Directive and the removal and withdrawal of life...more

FDA Issues Draft Guidance on Use of "Real-World Evidence" in Medical Device Decision-Making

The U.S. Food and Drug Administration (FDA) issued on July 27, 2016, a draft guidance document addressing how it may use data and evidence collected outside of the traditional clinical trial context to support medical device...more

Could Your Medical Device Be a Hacker’s Gateway into a Hospital Network?

This has been a big year for health care data breaches. In January, the data of 80 million Anthem members was compromised; in March, a cyberattack exposed the data of 11.2 million Premera BlueCross BlueShield members and...more

The Netherlands Publishes Report on Nanotechnologies in Medical Devices

The Netherlands National Institute for Public Health and the Environment (RIVM) posted on December 17, 2015, a report entitled Nanotechnologies in medical devices. RIVM conducted an investigation to provide insights into and...more

The Silent Threats of Breaches to Medical Devices are Starting to Make Noise

The U.S. Food and Drug Administration (FDA), which is responsible for guidance on medical devices, has acknowledged that certain devices are susceptible to breaches. The FDA has identified cybersecurity vulnerabilities in...more

Medical Devices And Risks Of Unauthorized Disclosure Of Protected Health Information

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) kicked off the holiday season by publishing a settlement agreement under the Health Insurance Portability and Accountability Act of 1996 (HIPAA)...more

Increased risk of ‘Medjacking’ calls for better security measures on medical devices

Did you know that right now we have about 5 billion connected smart devices in use? Is it surprising that it is predicted that by 2020 that number will skyrocket to 25 billion? Of all these connected devices, a significant...more

Health Care E-Note - November 2015

With medical device related acquisitions at all-time highs, and regulatory interest intense from the Federal Trade Commission, the Food and Drug Administration, the Securities and Exchange Commission, and the Office of...more

Areas of Unique Legal Concerns and Solutions in Device M&A

With medical device related acquisitions at all-time highs, and regulatory interest from the Federal Trade Commission, the Food and Drug Administration, the Securities and Exchange Commission, and the Office of Inspector...more

OIG Issues HHS Fiscal Year 2016 Work Plan

The Work Plan describes more than 100 initiatives, including 43 new initiatives for the upcoming year. On November 2, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued its...more

Abbott Secures Preliminary Injunction in Gray Market Case

On November 6, 2015, Abbott Laboratories and its diabetes care units secured a preliminary injunction against multiple pharmacies, distributors and associated individuals engaged in the sale of gray market Abbott FreeStyle...more

Ignorance is Not Bliss: Get to Know the OIG FY 2016 Work Plan

The Department of Health and Human Services Office of Inspector General (HHS-OIG) recently released its FY 2016 Work Plan, in which it identified key areas of focus for the upcoming year. Consistent with its mandate to detect...more

Health Alert (Australia) - November 16, 2015

In This Issue: -Judgments; Legislation; and Reports. - Excerpt from Judgments: Commonwealth. Federal Court 11 November 2015 - Ramsay Health Care Australia Pty Ltd v Compton [2015] FCA 1207 The Federal...more

AdvaMed 2015 Highlights – Part One of Two

On October 5-7, 2015, the Advanced Medical Technology Association (“AdvaMed”) held its 40th Annual Meeting for the first time on the West Coast—San Diego, California. This year also signaled a change of AdvaMed’s membership...more

OIG Hospital Compliance Audits: Is Your Number Up? Are You Ready?

In its Work Plan for Fiscal Year 2012, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) announced it would begin reviews of Medicare payments to hospitals to determine compliance...more

Government Finally Investigating Power Morcellators

Patients undergoing medical treatments expect that their physicians will utilize tools that will assist in the treatment without causing undue harm or damage to their bodies. One of these tools, a power morcellator which is...more

Amendments in Kazakhstan’s medicinal products registration system: new hope for rights holders

In January and June 2015 Kazakhstan’s legislation was amended in order to protect the interests of developers of new pharmaceuticals and apparatus used in healthcare....more

Washington Healthcare Update

On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

The SEC’s FCPA enforcement action for $14.6 million against Bristol Meyers Squibb (“BMS”) in China provides a textbook example of how things can go wrong in China. For the compliance practitioner (as well as CEO and...more

Health Alert (Australia) - October 5, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: Victoria. Epichealth Pty Ltd v Yang [2015] VSC 516 The Supreme Court has granted an interlocutory...more

Some Useful Insights from Steris-Synergy Merger Case

The Federal Trade Commission suffered a rare loss when, on Sept. 24, the U.S. District Court for the Northern District of Ohio denied its request for a preliminary injunction, despite having accepted the FTC’s “actual...more

Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014

The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2014. This marks the first time the DOJ...more

Dirty Instruments Pose Threat to Outpatients, Too

Earlier this year, both patients and providers were shocked when a rash of hospital patients got seriously ill or died after medical devices used to examine their gastrointestinal tracts infected them because they were not...more

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