Medical Devices Healthcare

News & Analysis as of

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

MedPAC Convenes to Discuss Open Payments, Payment for Post-Acute Care, and Other Issues

On September 10-11, 2015, MedPAC held a meeting to discuss several issues related to the Medicare program, including (1) improving the Open Payments program, which makes public the payments from drug and device manufacturers...more

Fitbit Agrees to Sign Business Associate Agreements and Take on HIPAA Compliance

Is your Fitbit data covered by HIPAA? It depends upon where you got it (kind of). If you go to the store and pick up a Fitbit on your own, the data it generates is governed by the user agreement that you click through...more

Drug and Device Companies May Soon Face Less Burdensome FDA Approval Process

On July 10, 2015, Congress passed H.R. 6, the 21st Century Cures Act, with a bipartisan vote of 344 to 77. The 352-page bill seeks to make the U.S. Food and Drug Administration (FDA) drug and device approval process less...more

Delivering Health Care Services to Consumers through eHealth Devices: The Role of State Professional Practice Laws

Smart medical devices that can deliver health care services are increasingly consumer friendly. Using the latest technologies and sophisticated algorithms, some devices are capable of collecting data directly from consumers...more

Health Care and Life Sciences Practice Newsletter

Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business - An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...more

August Whistleblower News Digest | News Your CCO Needs to Know

Morgan Stanley is in the news once again for whistleblower retaliation in a new lawsuit that mentions some of the same staff members involved in the last suit against them. Progenics was found guilty of retaliation, NuVasive...more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

Federal Judge in Ohio Accepts Future Competition Theory: Parties Should Proceed with Caution in Deals to Acquire Potential...

The court’s decision in FTC v. Steris demonstrates the importance of conducting a thorough antitrust analysis of all aspects of a merger or acquisition from every possible angle, including likely future competition. On...more

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