Software is becoming the main part of an increasingly amount of products set on the market; a trend which will become more and more evident in the years to come. This fact challenges the legal landscape and interpretation of product liability laws, and contract makers must pay attention to potential new risks imposed on the parties. If a product causes damages to a third party, complex questions may arise with respect to liability and the chain of causation ...
The U.S. Centers for Medicare and Medicaid Services (CMS) has once again stepped up its oversight of Accrediting Organizations (AOs).[1] On December 18, 2018, CMS issued a Request for Information (RFI) seeking to determine whether AOs have a conflict of interest between their governmental contract and their private business. See “Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information,” 83 FR 65331 ...
On December 23, 2018, new State Medical Board of Ohio regulations became effective which marked another change in the legal standards governing provider use of opiates for treatment of pain ...
PSD2 came into effect in the European Union on January 13, 2018. PSD2 is important as it aims to further harmonise the EU payments market and break the banks' de facto monopoly on the provision of payment services and the use of their customer data. Below is a review of developments to date as they relate to transposing PSD2 into Norwegian law, including an update on the most recent developments ...
Most companies go to great lengths to protect and maintain their intellectual property (IP). These companies recognize the value of their IP and work towards its development, sustainability and commercialization. IP strategy customary includes where and when to file patent applications, how to choose a brand name and register it, how to protect and enforce copyrights, protect trade secrets, etc ...
The online retail sector has seen a considerable increase in intervention by the competition authorities both on a national level and in Brussels. Most recently, in December 2018, the European Commission fined the clothing company Guess € 39.8 million for applying online sales and advertising restrictions ...
The ePrivacy Regulation was actually supposed to enter into force on May 25, 2018 jointly with the EU General Data Protection Regulation. Now it is expected to go into effect in 2019 at the earliest. It has new provisions in store, particularly for online marketing. The ePrivacy Regulation is intended to replace the current European ePrivacy Directive (2002/58/EC) and the Cookie Directive (2009/136/EC) ...
Several years ago the U.S. Centers for Medicare and Medicaid Services (CMS) required skilled nursing facilities (SNFs) to report nurse staffing levels using the SNF’s payroll records, in an effort to obtain more accurate information about actual daily nurse presence in SNFs. CMS has collected this Payroll Based Journal (PBJ) information for a few quarters now ...
I. Introduction According to a Bitkom study from September 2018, German industry has incurred a total loss of 43 billion euros as a result of cyberattacks over the past two years. Seven out of ten industrial companies have been victims of such attacks during this period. At EU level, there has recently been a growing discussion on how to face this mounting danger ...
On December 7, 2018, the Food and Drug Administration (FDA) released a Proposed Rule that clarifies procedures and criteria for the de novo medical device clearance pathway. In a statement accompanying the Proposed Rule, FDA Commissioner Scott Gottlieb stated FDA believes the Proposed Rule will help facilitate classification of innovative low- to moderate-risk novel medical devices by providing more structure, clarity, and transparency to the de novo pathway ...
On December 11, 2018, Pennsylvania Auditor General Eugene A. Depasquale released a long-awaited report discussing the role of pharmacy benefit managers (PBMs) in Pennsylvania’s health care system ...
As an eventful 2018 comes to a close, we look ahead to 2019 and our “Top 10 List” of key issues U.S. financial institutions, non-banks providing financial services, and financial technology (fintech) entities should plan for and watch throughout the upcoming year. The first five items on the list are discussed below, and the remainder of our list will follow shortly in another post ...
The end is near. 2018 is fast coming to a close, and it is that time of year when corporate lawyers are counting—not the number of shopping days left until Christmas, but the number weeks, days and hours left before the end of the fiscal year. Admittedly, in the scramble to close deals, insurance requirements and indemnity provisions may not be at the top of the list of critical deal points for clients and counsel ...
Over the last several years, the emphasis on privacy and data protection has grown significantly. With the amount of data collected by companies and technology skyrocketing, the need to protect personal information has been at the forefront of states’ legislative agendas. While all 50 states now have breach notification statutes, states are now taking a closer look at issues such as tracking online behavior and the use of biometric data ...
Medicare and Medicaid certified nursing homes are frequently required to pay fines (called “civil money penalties” or “CMPs”) to the U.S. Centers for Medicare and Medicaid Services (“CMS”) when government surveyors find them out of compliance with the Requirements for Participation for Long-Term Care Facilities. It is not uncommon for CMS to assess CMPs in the hundreds of thousands of dollars ...
Executives and in-house counsel should be aware that traveling with sensitive data can lead to its seizure—with potentially severe consequences worldwide. Recently, Parliament in the United Kingdom seized from a traveling executive a USB drive containing data that had been produced in a United States lawsuit between Six4Three, a software company, and Facebook. Put simply, that data was in the wrong place at the wrong time ...
Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year using IRS Form 1095-C. The IRS uses the forms to assess whether an employer "shared responsibility" penalty applies. Employers also must provide copies of the forms to their full-time employees ...
Increased federal oversight may be on the horizon for skilled nursing facility involuntary transfers and discharges. The Office of Inspector General (OIG) included in its 2019 Work Plan reviewing SNFs’ involuntary transfers and discharges, focusing on reviewing whether State agencies have effectively investigated and enforced proper transfer and discharge procedures ...
In February of this year, the Securities Exchange Commission issued its updated Statement and Guidance on Public Company Cybersecurity Disclosures. In April, the SEC issued an Order that, among other things, levied a $35 million fine against Yahoo! Inc. for failing to properly report a 2014 data breach. These actions support the view that the SEC is consciously committing attention and resources to cybersecurity issues affecting public companies ...
Regulation (EU) 2018/302 of February 28, 2018, on addressing geo-blocking and other forms of discrimination based on customers' nationality, place of residence or place of establishment within the internal market (the "Regulation") came into force, December 3, 2018. The Regulation seeks to increase access for customers in the EU and EEA to goods and services by preventing unjustified geo-discrimination due to the customer's nationality, place of residence or establishment ...
Since the GDPR has been in force, almost every company has, among other things, dealt with issues of the permissibility of direct marketing and other marketing activities under data protection law. At their data protection conference on Nov. 07-08, 2018, the German data protection supervisory authorities issued a new "orientation guide" on this topic (as of November 2018) ...
The deadline for meeting the previously issued nursing home compliance mandate is approaching. The Centers for Medicare & Medicaid Services (CMS) issued the mandate in 2016 and gave facilities three years to become compliant. On November 28, 2019, skilled nursing facilities (SNF) and nursing homes will be required to adopt and implement a compliance program as a condition for participation in Medicare and Medicaid ...
Educational institutions (“recipient” or “recipient institutions”) have been waiting for the Department of Education to issue formal Title IX regulations after it issued interim guidance in September 2017. This interim guidance rescinded previous Obama-era guidance that called for strict enforcement of Title IX and indicated that new formal guidance would be forthcoming ...
The large number of vague terms as well as provisions requiring interpretation in the GDPR create significant application issues for companies. However, it becomes even more of a challenge if companies not established in the EU want to review whether the GDPR is applicable to them. Generally speaking, the European legislator set themselves the goal of creating the most extensive territorial scope of the GDPR possible ...
In a letter to state Medicaid directors on Nov.13, 2018, the Secretary of the U.S. Department of Health and Human Services, Alexander Azar, announced a new demonstration opportunity that will allow states to provide improved care for adults with a serious mental illness (SMI) and children with serious emotional disturbance (SED) ...
