On September 30, 2016, the Department of Health and Human Service’s Office of the Inspector General (OIG) issued an “Early Alert” to the Centers for Medicare & Medicaid Services (CMS) on “Incorporating Medical Device-Specific Information on Claim Forms”. This Early Alert urges CMS to update Medicare claims forms to include the “device identifier” (DI) portion … Continue Reading
Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist. The FDA has announced a two-day public hearing on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” In-person … Continue Reading
Following a recent U.S. government interagency report indicating that, on average, there has been an alarming 300 percent spike in daily ransomware attacks since early 2016 as compared with 2015, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) released new Health Insurance Portability and Accountability Act (“HIPAA”) guidance on … Continue Reading
The EU-U.S. Privacy Shield has been adopted by the European Commission. On July 12, 2016, following a positive vote from the member states (the Article 31 Committee) on July 8, the EU College of Commissioners formally adopted the Privacy Shield. The Privacy Shield enters into force immediately in the EU. In the U.S., the Privacy … Continue Reading
For global pharmaceutical and medical device companies handling personal data in the European Union (EU) or engaged in transatlantic data transfers, some of the many questions created by the Brexit vote include what its impact will be on the United Kingdom’s (UK) data protection laws. These questions also arise in the context of the EU’s … Continue Reading
Pharmaceutical and medical device manufacturers are increasingly finding themselves resolving disputes through international arbitration. After London, Singapore is now arguably the second most important arbitration center in the world, meaning the Singapore International Arbitration Centre’s (SIAC) new arbitration rules, which were due to come into effect on June 1, 2016, but will now come into … Continue Reading
The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “Personal Jurisdiction: What Bauman Does and Doesn’t Mean, the Other Side’s Response, and Why Corporations Should Care” on June 14, 2016 at 12 p.m. ET. Reed Smith presenters Jim Beck and Steve McConnell will be discussing how plaintiffs’ lawyers are … Continue Reading
The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “Telehealth Policy Update: Keep Calm, Changes Are Coming” on June 8, 2016 at 10:00 a.m. PT and 1:00 p.m. ET. Reed Smith presenters Paul Pitts and Trey Andrews will be discussing recently adopted and proposed changes to state and federal … Continue Reading
The U.S. Food and Drug Administration (FDA) has approved more than 80 medical devices that involve 3D printing and one prescription drug. It also held a public workshop to obtain information and input about 3D printing issues on October 8 and 9, 2014. FDA brought together technical 3D printing expertise from various industries and sectors … Continue Reading
In a ruling particularly meaningful to health care companies, who are responsible for patients’ protected, personally-identifiable information, the U.S. Court of Appeals recently upheld a lower court’s decision finding coverage under a healthcare company’s comprehensive general liability (CGL) policy. When the health care company inadvertently made certain confidential medical records accessible to the public online … Continue Reading
The European Commission has published its draft adequacy decision on the EU-U.S. Privacy Shield, the proposed data transfer framework that would replace the defunct Safe Harbor program. The draft adequacy decision formally supports the view that the proposed EU-U.S. Privacy Shield will ensure an adequate level of protection for the transfer of personal data from … Continue Reading
We have been closely following Amarin Pharm, Inc. v. FDA with respect to the preliminary injunction granted by the Southern District of New York that prohibited the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug Vascepa. We’ve also been following the similar Pacira Pharm., Inc. v. FDA case, which … Continue Reading
President Obama signed the U.S. Judicial Redress Act (JRA) into law on 24 February 2016, giving European citizens the same right as U.S. citizens to bring actions against the U.S. government if their personal data are misused. While the JRA is not a formal prerequisite to finalizing the EU-U.S. Privacy Shield transatlantic data-sharing framework, it’s … Continue Reading
It has been a busy winter for the US Department of Health and Human Service, Office for Civil Rights (“OCR”). Since November 2015, the agency has announced three settlements and one civil money penalty judgment amounting to over $5 million in fines and settlements. Most recently, on February 3, 2016, a U.S. Department of Health … Continue Reading
European Union and United States authorities have announced the “EU-U.S. Privacy Shield,” a new transatlantic data transfer framework to replace Safe Harbor, which was invalidated by the European Court of Justice in October in Maximillian Schrems v. Data Protection Commissioner (C-362-14). Since this issue has clear implications for our pharmaceutical and medical device clients, we’ve … Continue Reading
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
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
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 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
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
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
3D printing has been a common topic of discussion of the blog. We’ve written about it here and in a more in-depth review of the legal issues raised by the emergence of 3D printing in the medical device industry in our September 2015 white paper. 3D printing is in the news again thanks to the … Continue Reading
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
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
