Over the past 1-2 years, a great deal of information concerning the revolutionary technology that is “blockchain” has been published on many business, legal and technology news sources, and innumerable self-proclaimed authorities on the subject have emerged to contribute articles and presentations (ourselves among them) ...
The manufacturer of a product generally has a duty to warn the end-consumer of any serious risks associated with that product. In the context of prescription drugs and medical devices, however, the “learned intermediary” doctrine holds that the manufacturer need not warn the end-consumer (i.e., patient). Instead, the manufacturer discharges its obligations by warning the prescribing physician ...
Artificial intelligence is a burning topic in many sectors today and the legal industry is no exception. Recently, at the World Services Group's annual employment law conference held in February, AI was heavily debated along with its' impact not only on the legal profession, lawyers, clients, the way business is done, but also our traditional understanding of concepts such as "law" or "justice" ...
By one account, “the cost of global ransomware attacks will exceed $11.5 billion annually by 2019, up from $5 billion last year and $325 million in 2015” – a 35X increase in just four years.1Relative to other cyber crime, ransomware is an equal opportunity enterprise—striking individuals as well as businesses of all kinds ...
In 2015, the Federal Communications Commission expanded the reach of the Telephone Consumer Protection Act (TCPA) in several respects. Petitioners appealed Declaratory Ruling 15-72 challenging four findings that turned TCPA law on its head. On March 16, 2018, the DC Circuit issued a decision on that petition in ACA International v. FCC, et. al, setting aside two major FCC rulings and upholding two others ...
More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was re-evaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities ...
New rules will apply to disability benefit claims and appeals under certain plans that are subject to the Employee Retirement Income Security Act of 1974 (ERISA), effective for claims made after April 1, 2018. According to the Department of Labor (DOL), the new rules are intended to provide greater protection to claimants, and are modeled on the enhanced claims and appeals procedures that apply to health benefit claims under the Affordable Care Act (ACA) ...
Last week, United States Attorney General Sessions announced the creation of the Department of Justice Prescription Interdiction & Litigation (PIL) Task Force to combat the prescription opioid crisis. According to the Department of Justice (Justice), the PIL Task Force will rely on “all available criminal and civil enforcement tools” to hold those at “at every level of the [opioid] distribution system” accountable for unlawful conduct ...
Earlier this year the enhanced Nurse Licensure Compact (eNLC) was implemented in all 29 participating states including Colorado, West Virginia and Kentucky. Illinois[1] and Michigan[2] are among the states with current legislation pending to adopt the eNLC, while Indiana, Ohio, Pennsylvania, California and a handful of other states do not yet have pending legislation ...
The State Medical Board of Ohio (Medical Board) recently released proposed rules that will create a non-disciplinary, confidential monitoring program for licensees with mental or physical illnesses. Historically, licensees with a mental or physical illness could not only be subject to formal disciplinary action pursuant to the Medical Board’s rules, but the licensee’s mental or physical illness became public information as a result of the disciplinary process ...
As the new year started, two Department of Justice memoranda began circulating that may bring a change in the way the United States focuses its efforts in the FCA arena. The first, entitled, “Factors for Evaluating Dismissal Pursuant to 31 U.S.C ...
The GDPR contains rules on when it is mandatory for controllers and processors to designate a data protection officer. The Article 29 Data Protection Working Party (WP29) issued guidelines on the data protection officers (DPOs) interpreting the respective provisions of the GDPR (Articles 37-39 and Recitals 77 and 97). The Data Protection Officer (DPO) The GDPR contains rules on when it is mandatory for controllers and processors to designate a data protection officer ...
Since not only individual people, but also the overall project, are being presented, online presentation can be divided into two main parts. First is the management of personal social media. Avoid any disrespectful or offensive discourse, as well as any ambiguous posts and photos. Or as a minimum , do not display them publicly. Secondly, visual communication is absolutely crucial to protect the name of a reliable project ...
Fresenius Medical Care North America (FMCNA), a provider of products and services for people with chronic kidney failure, has agreed to pay $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopt a comprehensive corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules ...
The Serbian Competition Commission (the "Commission") recently finished sector inquiries concerning quite distinct industries – raspberries and the public procurement for software and hardware. The aim behind the inquiries was to perform extensive market research and analysis in order to acquire a clearer picture of the possible antitrust issues and risks in two sectors widely perceived as strategic for the development of the Serbian economy ...
The State Medical Board of Ohio recently proposed amendments to the existing regulations governing light-based medical devices (lasers), which will significantly impact the provision of laser services in Ohio. While the proposal adds a new category to existing delegation authority, it also imposes new regulatory requirements to existing delegation authority which will impact Ohio physicians providing laser services ...
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 ...
Last week, the U.S. Department of Labor (DOL) issued proposed rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer association to provide health coverage for their employees ...
Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. The Federal Circuit’s first decision under the Biologics Price Competition and Innovation Act (BPCIA) involved Zarxio, Sandoz’s Neupogen biosimilar product. Amgen v. Sandoz, 794 F.3d 1347 (Fed Cir. 2015) ...
Earlier this year, Decree No. 1 of the Ministry of Health (herein, the "Decree") was published on the Official Gazette. The Decree sets forth the graphic characteristics of the message for the promotion of healthy life habits that must be included in the advertisement of foodstuff products established in Article 5 of Law No. 20,606 -those that qualify as "High in" one or more critical nutrients- made through mass communication ...
How new technologies and changing consumer expectations is signaling disruption to the health industry and the importance of finding ways to better measure and translate patient satisfaction and outcomes. Do you know if your clinician is doing a good job? What about the track record of your surgeon? Should you be entitled to know as a consumer? The industry is being disrupted – no longer is the family GP the dispenser of all health advice ...
One step closer to implementation of the reforms relating to EU data protection regulation, this article looks at some of the implications that the reforms are likely to have for SMEs. Key progress was made in the reform of EU data protection regulation on 12 March 2014 with the European Parliament voting in support of reform and the draft General Data Protection Regulation (the "Regulation"). The Regulation must now be adopted by the Council of Ministers in order to become law ...
Cloud computing, along with Big Data, social media, and mobility, is one of the current megatrends that will drive huge changes to the business ecosystem in the upcoming decade. Surveys held over the recent years unanimously confirm that organisations across the globe are rapidly and continuously moving to the cloud ...
Ohio prescribers need to be aware of new rules for prescribing controlled substances that will take effect on December 29, 2017. First, prescribers will be required to include the first four characters of the ICD-10 diagnosis code or the full CDT procedure code on all prescriptions for opioids.[1] Similarly, beginning June 1, 2018, prescribers will need to include the ICD-10 diagnosis or CPT procedure code on prescriptions for all other controlled substances ...
