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Postmarket Cybersecurity Recommendations for Medical Devices Issued by the FDA

We’ve blogged about medical device cybersecurity topics here and most recently here. The topic is in the news yet again with the FDA issuing a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks. The draft guidance recommends that manufacturers should execute a structured, systematic, and comprehensive cybersecurity risk management program … Continue Reading

Another Day, Another Whistleblower Retaliation Suit

A False Claims Act (“FCA”) retaliation claim, 31 U.S.C. 3730(h), filed January 26, 2016 in federal district court in Oregon, provides a perfect example of the type of challenging cases confronting health care employers today. Pediatrician Robert Dannenhoffer, MD, the former CEO of a joint venture between a hospital and physicians’ group, alleges that he … Continue Reading

Current State of “Safe Harbor 2.0” And Steps Your Business May Need to Take

Last year, the European Court of Justice issued a judgment invalidating the safe harbor framework for US-EU data sharing, creating uncertainty and a number of questions about what is, and is not, permissible when sharing data involving personal information across borders. The Safe Harbor decision has clear implications for our pharmaceutical and medical device clients, … Continue Reading

Russia to Increase Data Audits in 2016 With Data Localization Law & More News on The EU’s Safe Harbor Ruling

Russia announced its plan to increase data localization audits in 2016 pledging to conduct around 1,000 data localization compliance audits and 2,000 monitoring procedures, under Russia’s data protection authority, the Roskomnadzor. This stems from Russia’s data localization law which came into effect September 1, 2015, requiring that all companies that collect or process personal data … Continue Reading

UPDATE: Pacira Pharmaceutical Inc. v. FDA Lawsuit Settled

The Pacira Pharmaceutical Inc. v. FDA lawsuit has been a frequent topic of discussion on the blog, and now, in breaking news, the case has been settled.  Pacira will be receiving essentially everything it wanted in a “favorable resolution,” and the FDA is formally withdrawing its warning letter that attempted a retroactive reduction in the … Continue Reading

U.S. Supreme Court Will Review the Validity of “Implied Certification” Liability Under the FCA

On December 4, the U.S. Supreme Court granted certiorari in Universal Health Services, Inc. v. U.S. ex rel. Escobar, No. 15-7, raising the question of whether “implied certification” liability is permissible under the False Claims Act and, if so, under what circumstances. Under the implied certification theory, defendants are presumed to have certified that they … Continue Reading

U.S.-EU Safe Harbor Framework for Data Sharing

Exactly one month after the Court of Justice of the European Union (CJEU) released its judgment in Maximillian Schrems v Data Protection Commissioner (C-362-14), the European Union released a Communication discussing the implications of their decision on data sharing involving personal information. This topic is no stranger to the blog, as we’ve posted about it … Continue Reading

IEEE Developing New Standards for 3D Printers For Medical Uses

The Institute of Electrical and Electronics Engineers Standards Association (IEEE) is developing new interoperability standards for medical devices, 3D printers and other eHealth devices.  IEEE P3333.2.5, Draft Standard for Bio-CAD File Format for Medical 3D Printing is intended to develop standard methods for the printing of 3D-printed prosthetics and medical devices.  IEEE proposes to define … Continue Reading

Synopsis of Safe Harbor Guidance Issued by European Union Data Protection Authorities

Data privacy issues in the European Union seem to be a reoccurring theme here on the blog, following Court of Justice of the European Union’s judgment in Maximillian Schrems v Data Protection Commissioner (C-362-14)  on October 6. We’ve posted about it here and also had a recent Reed Smith Client Alert here. Last week, European … Continue Reading

HHS’ Selection of Contractor Provides Latest Update on Impending Second Round of HIPAA Audits

On October 27, 2015, a U.S. Department of Health and Human Services (“HHS”) official stated that the agency has hired FCi Federal, a provider of management and professional services to government agencies in Ashburn, VA, to conduct the second round of Health Insurance Portability and Accountability Act (“HIPAA”) data security audits.  Similar to the Phase … Continue Reading

GAO Report Regarding FDA-Ordered Postmarket Studies

Today, the Government Accountability Office (GAO) released a report entitled “Medical Devices: FDA Ordered Postmarket Studies to Better Understand Safety Issues, and Many Studies Are Ongoing.”   According to the report, “GAO was asked to report on the characteristics and status of postmarket studies. This report describes (1) the types of devices for which FDA has ordered … Continue Reading

Updates Regarding the Pacira Pharmaceutical Inc. v. FDA Lawsuit Regarding First Amendment and Off-Label Promotion Issues

As readers of this blog know, following Amarin’s success in obtaining a preliminary injunction limiting FDA enforcement action against it for truthful, non-misleading off-label promotion of its prescription drug Vascepa, Pacira Pharmaceuticals filed a similar lawsuit regarding off-label promotion of its prescription drug Exparel. While we await the FDA’s response to Pacira’s motion for preliminary … Continue Reading

FAQs Regarding the Safe Harbor Ruling

As you know, data privacy issues in the European Union are still fresh in the news, given the recent changes outlined in the Safe Harbor decision; we’ve written about it here, here and here. A recent Reed Smith Client Alert outlines frequently asked questions on what businesses need to know now in lieu of the … Continue Reading

Change Coming to FDA’s “Intended Use” Regulations?

Over at the Drug And Device Law Blog, our colleagues call attention to proposed changes to the “intended use” regulations for prescription drugs and devices, 21 C.F.R. §201.128 and 21 C.F.R. §804.1, somewhat hidden within a proposed rule regarding tobacco published in the Federal Register on September 25, 2015. As the FDA explained, the changes … Continue Reading

OSHA Initiative Regarding Workplace Safety For In-Patient Care Facilities

The Occupational Safety and Health Administration (OSHA) recently announced an initiative affecting inspections at in-patient care facilities. The Agency plans to: Expand the resources OSHA directs for inspections at these sites, and Direct inspectors to focus on five recently identified “key hazard” areas:  (1) musculoskeletal disorders related to patient and resident handling; (2) bloodborn pathogens; (3) workplace … Continue Reading

First Amarin Pharm v. FDA, Now Pacira Pharm, Inc. v. FDA

The Southern District of New York certainly is becoming a hotbed for issues relating to the FDA’s ability to take enforcement action against manufacturers who promote their FDA-regulated products for uses outside the approved label indications.  The Amarin Pharm v. FDA litigation has garnered a good deal of attention, and after Amarin and the FDA … Continue Reading

3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles

3D printing is quite possibly the next greatest chapter in the industrial revolution, and the technology is moving rapidly.  Reed Smith’s Life Sciences Health Industry Group recently launched its first 3D printing publication white paper – 3D Printing of Medical Devices:  When a Novel Technology Meets Traditional Legal Principles.  This paper explores unchartered legal issues … Continue Reading

Cybersecurity Concerns for Medical Device Companies: A Risk Mitigation Checklist

Cybersecurity issues are nothing new to those operating in the health care industry. But while these issues have most commonly been faced by hospitals and health care providers, medical device companies must now take note. As reported recently in the news, medical devices have increasingly become the targets for cybersecurity breaches, given the information contained … Continue Reading

First Opinion Issued on ACA “60-Day Overpayment Rule” in a FCA Case

In a case dating back several years, the first judicial opinion interpreting the Affordable Care Act’s “60-Day Overpayment Rule” in a False Claims Act case was recently issued by the Southern District of New York. In Kane v. Healthfirst, Inc., et al., the court found in favor of the DOJ, denying the defendant hospitals’ motion … Continue Reading

What Comes Next In Amarin Pharm v. FDA?

The Southern District of New York’s preliminary injunction in Amarin Pharm, Inc. v. FDA—prohibiting the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug Vascepa—understandably has been big news, analyzed here  and  elsewhere. Some are asking whether the FDA will pursue appellate review of the decision.  An indication about … Continue Reading
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