Health Science, Computers & Technology

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Connecticut Enacts Act concerning the facilitation of telehealth

Public Act 15-88 is the first comprehensive law in Connecticut to address telemedicine (also referred to as “telehealth”), and to establish regulatory requirements for providing telehealth services, and mandates certain...more

Part D Woes, According to the OIG

On June 23, 2015, the OIG issued two reports focusing on fraud, waste, and abuse in the Part D program, the first “Ensuring the Integrity of Medicare Part D” and the second “Questionable Billing Practices and Geographic...more

Minnesota Joins 9-State Compact Expediting Telemedicine Across State Lines

Effective July 1, 2015, Minnesota will join the Interstate Medical Licensure Compact, a group attempting to expedite the licensing of physicians seeking to provide telemedicine services to patients located in other states....more

FDA Provides 11th Hour Delay of Product Tracing Requirements for Pharmacies

On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until...more

IEEE Releases Med Device Cybersecurity Guidelines

Amid myriad media reports about potential vulnerabilities in medical device cybersecurity and the FDA’s efforts to strengthen medical device cybersecurity, the IEEE Cybersecurity Initiative released a report entitled...more

Unfortunately Disappointing 3D Printing Law Review Article

We’ve blogged before about the interesting product liability issues created by 3D printing/additive manufacturing, in particular the novel separation that these techniques create (at least potentially) between “manufacturing”...more

Acelity Reported to Plan $1 Billion IPO

San Antonio, Texas based medical device company Acelity LP Inc. is reported to be considering an initial public offering that could raise up to $1 billion, according to the Wall Street Journal. Acelity has reportedly...more

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

Southern Spine Announces 2015 MDEA Honor for StabiLink® MIS Spinal Fixation System

Southern Spine announced recently that StabiLink® MIS Interlaminar Spinal Fixation System has been chosen as the Silver Winner in the Implant and Tissue Replacement category of the 18th Annual Medical Design Excellence Awards...more

FDA Approves St. Jude Medical’s Upgradeable, MRI-Compatable Spinal Cord Stimulation System

St. Jude Medical, Inc., a global medical device manufacturer, announced that it has received FDA approval of the company’s Protégé MRI™ spinal cord stimulation (SCS) system, along with approval for related percutaneous leads,...more

Patients poised to record doctor's visits?

The question of whether patients should be permitted to record interactions with their doctors, and when and how it is best to do so, has become a highly contentious issue to navigate in today’s increasingly complex medical...more

FDA Reports Results of Annual Crack Down on Illegal Internet Pharmacies

Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international...more

Expect Focus - ONLINE HEALTH CARE: NOT SO FAST Telemedicine Hits A Few Speed Bumps, Volume II, Spring 2015

In This Issue: - IN THE SPOTLIGHT • Risky Business: Common Cyber Security Risks, Expensive Consequences - LIFE INSURANCE • Ninth Circuit Finds Bonus Indexed Annuity Delivers Exactly...more

FIN4 May Have Embarked on a Risky Hacking/Insider Trading Strategy

I haven’t yet turned to a life of crime, so far be it from me to criticize actual criminals’ profit-maximizing strategies. It’s easy for me to nitpick, but I’m not the one strapping on my mask and trying to earn a...more

Laws Governing Data Security and Privacy – U.S. Jurisdictions at a Glance

The below chart constitutes a summary of the laws of various jurisdictions that govern data breach notifications...more

All About That Base: Claim Against Fat Loss Supplement Maker Fails For Lack of Ascertainability

Adam Karhu bought a dietary supplement called VPX Meltdown Fat Incinerator (“Meltdown”) in reliance on advertising by Vital Pharmaceuticals, Inc. (“VPX”) that Meltdown would result in fat loss. Concerned that Meltdown did not...more

Molex Acquires ProTek Medical

On May 19, 2015, Molex Incorporated announced that Molex Ireland Holdings B.V. has acquired ProTek Medical Ltd. According to the press release, ProTek Medical, based in Sligo, Ireland, specializes in cleanroom injection...more

Cardinal Health to Acquire The Harvard Drug Group for $1.1 Billion

Ohio-based Cardinal Health (CAH) has agreed to buy Michigan-headquartered The Harvard Drug Group (THDG) for $1.12 billion. According to press releases, THDG, which is currently owned by Court Square Capital Partners, is a...more

No Prescription For Consumer Protection

Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a square peg into a ham sandwich. It doesn’t fit, and the combination isn’t very...more

Two House Bills seek to address sharing of mental health information under HIPAA

The Health Subcommittee of the U.S. House Energy and Commerce Committee held a hearing last week to consider two bills addressing current limits on the sharing of mental health information under HIPAA. The first bill, the...more

Blog: OIG Reports Targeting Medicare Part D Fraud Issued on the Heels of National Medicare Fraud Sweep

The Health and Human Services (HHS) Office of Inspector General (OIG) released two reports yesterday related to Medicare Part D fraud. The OIG report, Ensuring the Integrity of Medicare Part D, “synthesizes numerous OIG...more

OIG Advisory Opinion 15-07: An Indicator of Clinical Trial Copayment Change?

“You scratch my back, I scratch yours” arrangements are common in business transactions. These agreements are risky in the healthcare space, however, with the potential to implicate civil and criminal sanctions. Whether...more

Federal court blocks rule restricting telemedicine practice in Texas

A federal court has temporarily enjoined the Texas Medical Board (TMB) from implementing and enforcing a rule restricting the practice of telemedicine pending resolution of an antitrust lawsuit filed by Teladoc, Inc. The...more

OIG Approves Charitable Organization's Patient Assistance Program

On May 28, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued an advisory opinion approving a charitable organization’s proposal to provide financial assistance to individuals with...more

VertiFlex Announces FDA Approval of Superion Interspinous Spacer System

VertiFlex, Inc., announced that it has been granted pre-market approval by the FDA for its minimally invasive treatment of lumbar spinal stenosis, the Superion Interspinous Spacer System.  This approval comes after a...more

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