Certain health care providers, health information technology (IT) developers, and health plans could see the way they share patient information transformed following the release of two new final rules issued by the U.S. Department of Health and Human Services. The rules address interoperability and information blocking. Reed Smith partner Nancy Bonifant Halstead and senior associate … Continue Reading
Several states are following the path of Illinois’ Biometric Information Privacy Act (BIPA), a law that has led to a rise in the volume of class action privacy litigation and underlined the significance of enterprise-level management of biometric data (e.g., fingerprint, voiceprint, and retina, facial, or iris image). Organizations that gather and utilize biometric data … Continue Reading
Reed Smith presents the latest installment in our Countdown to CCPA Compliance webinar series, “Privacy by Accident”, now available to watch on demand. Whether by accident or by design, many organizations have implemented privacy practices or programs that will help toward compliance with the CCPA. This webinar will discuss these practices and how they can … Continue Reading
Over the past few years, genetic testing services have become a widespread phenomenon. Companies providing these services gather certain biological data from consumers who sign up for their services and then analyze this data to ascertain information about the consumer’s ancestry and/or genetic traits, among other things. These companies, however, are typically considered “non-covered entities” … Continue Reading
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) released a new fact sheet outlining and clarifying violations of HIPAA (Health Insurance Portability and Accountability Act of 1996) for which a business associate can be held directly liable. Published shortly after the release of new guidance from OCR in the form … Continue Reading
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) released a new set of HIPAA FAQs addressing the applicability of HIPAA to certain health apps and the covered entities and business associates that interact with them. These FAQs build upon prior guidance from OCR that outlined the framework for evaluating whether a … Continue Reading
On December 21, 2016, the U.S. Food and Drug Administration (“FDA”) posted a Consumer Update and accompanying video on the “The 3Rs of 3D Printing: FDA’s Role,” which reconfirms its position on the importance of 3D printed medical devices. The FDA sums up its role in this “innovative space” as regulate, research, and resource (i.e., … Continue Reading
Following up the success of its first, medical device-focused 3D printing white paper, 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles, Reed Smith’s 3D Printing Task Force has now launched a second edition of its 3D printing publication white paper addressing 3D printed products more broadly: 3D Printing of Manufactured Goods: … 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
The Reed Smith Information Technology, Privacy & Data Security Group will be hosting an upcoming webinar “The Biggest Shake Up of European Data Protection Law in 20 Years: What Your Organisation Needs to Do to Comply with the General Data Protection Regulation“ on June 7, 2016 at 11:00 a.m. ET, 16:00 p.m. BST and 17:00 … Continue Reading
By Jennifer Pike and Brad Rostolsky on Posted in Privacy & HIPAA
In a joint effort by the Federal Trade Commission (FTC), Office for Civil Rights (OCR), HHS Office of National Coordinator for Health Information Technology (ONC), and Food and Drug Administration (FDA), a new web-based tool has been released that is designed to help developers of mobile health apps understand the multitude of federal laws and … 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
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
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
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
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
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
The Reed Smith Life Sciences Health Industry (LSHI) Group will be hosting an upcoming webinar “Cross-Border E-Discovery & New Ruling Regarding the US-EU Safe Harbor Framework” on November 24, 2015 from 9:00 a.m. PT, 12:00 p.m. ET, 5:00 p.m. GMT until 10:00 a.m. 1:00 p.m. ET, 6:00 p.m. GMT. Reed Smith presenters including London based … Continue Reading
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
As previously discussed here and here the Court of Justice of the European Union (CJEU) handed down its judgment in Maximillian Schrems v Data Protection Commissioner (Case C-362/14) that the Safe Harbor Decision no longer provides adequate protection for data transferred between the EU and the U.S. In light of this ruling, Reed Smith will be … Continue Reading
In a decision with significant potential ramifications for flows of personal data from the European Union to the United States, the Court of Justice of the European Union (CJEU) handed down its judgment in Maximillian Schrems v Data Protection Commissioner (Case C-362/14) that the Safe Harbor Decision no longer provides adequate protection for data transferred between … Continue Reading
