On December 14, 2018, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published a Request for Information (RFI) about ways to modify the HIPAA Privacy and Security Rules[1]to promote the transition of the health care industry to a value-based Medicare payment model and improve care coordination for patients. See “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care,” 83 FR 64302 Page:64302-64310 ...
The tsunami of consolidation activity in the dental services industry has created remarkable financial opportunities for dentists and investors. Primarily, these opportunities play out in the form of Dental Services Organizations formed by entrepreneurial dentists and/or private financial interests through the acquisition of established, profitable practices ...
Law No. 21,121 (the “Law”), which came into force on November 20, 2018, amends the Criminal Code, Law No. 20,393 on Criminal Liability of Legal Entities, and Law No. 19,913 on Money Laundering, in connection with various criminal conducts relating to corruption and conflicts of interest. The following is a summary of the main aspects of the Law: 1.Domestic Passive and Active Bribery ...
While buzzwords like consolidation and price transparency continue to dominate headlines, major players throughout the healthcare ecosystem are working tirelessly behind the scenes to deploy creative and complex service methods that leverage a smarter, more holistic approach to care. The goal? Control escalating costs and deliver tangible value to patients – all while maintaining a healthy balance sheet ...
Under its Article 88(1), the GDPR allows Member States to draw up their own rules for the area of employee data protection. Germany has taken advantage of this option with Section 26 of the Federal Data Protection Act (BDSG). The first sentence of Section 26(1) already applies while the decision to establish an employment relationship is made and hence it needs to be taken into account early in the application process ...
Background The UK invoked the exit procedure under Article 50 of the Treaty on European Union in March 2017. Unless the UK's decision is withdrawn or the period is extended, this will become effective in a little over 80 days ...
To protect and stimulate creators to increase innovation and encourage entrepreneurship, Norwegian authorities are changing the law. In 2018 we received several proposals towards strengthening the rights of those who create new ideas or build their business on intellectual property. Looking back at 2018, we see a year in which the Norwegian intellectual property (IP) legislation has been in movement. Technology is developing fast, and so must the law protecting technology ...
As one of the final acts of its 99th Legislative Session, the Michigan Legislature passed amendments to the Medical Marihuana Facilities Licensing Act (MMFLA), as well as changes to the Marihuana Tracking Act. These amendments were signed by outgoing Governor Rick Snyder on December 28, 2018, with the MMFLA amendments effective January 1. The Tracking Act amendments took effect immediately ...
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 ...
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 ...
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 the last day of the legislative session, the Michigan Legislature passed House Bills 6330, 6331, and 6380 to create the Industrial Hemp Research and Development Act (IHRDA). If signed by the Governor, IHRDA will require the registration of industrial hemp growers and processors as a prerequisite to grow or sell industrial hemp. Oversight authority is given to the Michigan Department of Agriculture and Rural Development (MDARD) ...
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 ...
In the latest development in an eventful year, Federal Decree-Law 24 of 2018 introduces amendments to the Federal Penal Code, originally enacted as Federal Law 3 of 1987. The amendments are designed to make the Penal Code consistent with other recent federal legislation and current federal enforcement policies. Only ten provisions of the statute have been affected, out of the more than 400 total articles contained in the statute ...
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) ...
Capturing lightning in a bottle: As fast-growing San Francisco concludes its largest rezoning in 10 years, will its novel new urban-planning guidelines for South of Market represent what the city's downtown needs in a fast-moving business, cultural and economic environment? In early December 2018, the San Francisco Board of Supervisors gave final approval of the "Central SOMA Plan," (the Plan) resulting in the largest rezoning of the commercial heart of the city since the renowned Downt
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 ...
Michigan voters approved Proposal 1 and made Michigan the twelfth U.S. jurisdiction to legalize recreational marijuana. The Michigan Regulation and Taxation of Marihuana Act (MRTMA) went into effect December 6. What has been lost in all the smoke from the past several weeks is how MRTMA impacts the regulation of industrial hemp ...
"What are the 'waters of the United States'? As it turns out, defining that statutory phrase—a central component of the Clean Water Act—is a contentious and difficult task." This observation, recently made by Justice Sonia Sotomayor, understates the difficulty in answering what should otherwise be an anodyne question: Does my project require a Clean Water Act permit? At this moment, answers to this question may be far from certain ...
Last week, State Senator Scott Weiner (D-San Francisco) announced new legislation intended to immediately encourage more residential construction in areas near public transit and job centers. Entitled the More Housing, Opportunity, Mobility, Equity and Stability (More HOMES) Act, SB 50 is essentially version 2.0 of SB 827, a similar housing bill proposed by Senator Weiner that failed in committee earlier this year ...
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 ...
