Brenna K. Legaard is a registered patent attorney with Schwabe, Williamson & Wyatt. Legaard wrote the following op-ed on the use of blockchain technology in health care. When health care professionals and consumers think of blockchain, their minds very likely go to famous cryptocurrencies like Bitcoin. But blockchain technology can be applied to so much more, including to the field of health care ...
A few years ago artificial intelligence was a concept applied to nothing else but science fiction films, nowadays, it has become a reality for many companies and industries in the development of their commercial, corporate and industrial activities. Before we start to understand the strengths or weaknesses of artificial intelligence and its perspective from the right of intellectual property, it is considered convenient to conceptualize it ...
On May 24, 2019, the U.S. Department of Health and Human Services (HHS) proposed revisions to regulations issued under Section 1557 of the Affordable Care Act (ACA) (the Proposed Rule). The Proposed Rule would revise certain provisions of the current Section 1557 rule that federal courts have ruled as likely unlawful, and eliminate the requirement that covered entities publish non-discrimination notices and include taglines in foreign languages on all significant publications ...
On May 24, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a new fact sheet providing a compilation of all provisions through which a business associate may be held directly liable with the HIPAA Privacy, Security, Breach Notification, and Enforcement regulations (collectively the HIPAA Rules) ...
Environmental Protection Agency (EPA) has issued a new rule that will impact the operations of a wide-range of health care facilities and the manner in which those facilities manage hazardous waste pharmaceuticals ...
On May 10, 2019, the Centers for Medicare & Medicaid Services (CMS) published its final rule, 42 CFR 403, requiring drug manufacturers to disclose the price of prescription drugs in direct to consumer (DTC) advertisements. Publication of the final rule was preceded by a lively comment period that commenced on October 18, 2018 ...
Dinsmore’s Government Relations team was involved in several significant legislative initiatives affecting the health care sector during the 2019 regular session of the West Virginia legislature. Most notably, Dinsmore was involved in the passage of HB 2010, relating to foster care ...
For businesses who care about their brands, Pofma may be not be such a bad idea after all.Beyond Meat Inc. makes cows happy and cardiologists sad. Its Beyond Burger uses no meat and has no cholesterol, and contains less fat, fewer calories and more protein than a typical burger ...
According to statistics released by the European Commission earlier in 2019, the term “GDPR” amassed more Google searches than either Beyoncé or Kim Kardashian during the month of May 2018. Now that “GDPR” has become a household term, what have we learntin the 12 months since the introduction of the GDPR? 1 ...
Trademark law in Canada is undergoing a major change this year that will go into effect on June 17, 2019. We have compiled the three things you need to know and important steps you may want to take before the June 17, 2019 date passes. 1 ...
‘Fake news’ - information or news that is proven to be either verifiably false or misleading - has become a major, global concern. As news and opinion pieces are increasingly pushed to readers via online and social media channels, the speed of their dissemination has accelerated exponentially, as have the challenges around regulating news and opinion ...
Many employers currently have employees on staff on temporary work visas, and employers likely know that in order to continue to employ employees not born in the U.S., the employer must sponsor the employee for permanent residency in the U.S. (i.e,. a green card). The green card process has multiple steps, which, depending on a variety of factors, may take several years to complete ...
FDA Announces Public Meeting for Responsible Innovation in Dietary Supplements Industry Recently, the Federal Food and Drug Administration (FDA) announced it will hold a full-day public meeting to discuss strategies for responsible innovation in the dietary supplement industry. The meeting will be held May 16, 2019, from 8:30 a.m. EST to 4 p.m. EST at the FDA Center for Food Safety and Applied Nutrition, Wiley Auditorium, located at 5001 Campus Dr., College Park, MD 20740 ...
In the year 2000, the United Nations General Assembly designated April 26 as World Intellectual Property Day. The purpose of this is to highlight the role thatintellectual propertyrights play in encouraging innovation and creativity. Across the globe, and at the initiative of the World Intellectual Property Organization (WIPO), there is a campaign every year to attract public interest to issues related to Intellectual Property ...
Recent events, including the investigations into Facebook’s handling of its users’ personal data, have highlighted the realization that personal data is, in today’s world, one of the most valuable resources for any business and that businesses not only collect and store their customers’ personal data but also use and even sell it for profit ...
In a recent case involving a health care facility, the NLRB issued a 3-1 decision that significantly changed a successor employer's bargaining obligations before imposing the initial terms and conditions of employment on a unionized workforce. While seemingly favorable to employers, the decision also serves as a reminder to companies that they should act cautiously and consult with counsel before they take over a business with a unionized workforce ...
The administrative fines that have been imposed by the different European supervisory authorities since the GDPR took effect vary enormously. While the highest administrative fines imposed by the German authorities to date have been EUR 20,000 and EUR 80,000 and have therefore remained well below the possible maximum fine of EUR 20 million or 4 % of worldwide annual turnover, other countries’ supervisory authorities have already delivered higher fines ...
The U.S. Food and Drug Administration (FDA) recently announced new steps it is taking to determine a framework for lawful marketing of appropriate cannabis and cannabis-derived products.[i] As expressed in the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), the FDA has the authority to regulate products containing cannabis or cannabis-derived compounds ...
This is to inform you that, on March 18 2019, the Federal Law of the Russian Federation on “Introduction of amendments to the first, second part and Article 1124 of the third part of the Civil Code of the Russian Federation” (the “Law”) was adopted ...
This is to inform you that, on March 18 2019, the Federal Law of the Russian Federation on “Introduction of amendments to the first, second part and Article 1124 of the third part of the Civil Code of the Russian Federation” (the “Law”) was adopted ...
The Department of Health and Human Services Office of Civil Rights (OCR) Spring 2019 Cybersecurity Newsletter includes new recommendations regarding how HIPAA covered entities can prepare to defend against cybersecurity attacks such as advanced persistent threats (APTs) and zero-day vulnerabilities ...
On April 1, 2019, the Health Resources and Services Administration (HRSA) launched a secure website that lists the maximum price drug manufacturers may charge 340B-covered entities for 340B-eligible drug purchases (the 340B Ceiling Price Site). Drug manufacturers and 340B-covered entities may access the 340B Ceiling Price Site through their HRSA Office of Pharmacy Affairs information system (the 340B OPAIS) account here: https://340bopais.hrsa ...
Even before the General Data Protection Regulation (GDPR) came into force, there were discussions as to whether the use of tracking cookies, which make it possible to analyze the usage and browsing behavior of a user on the Internet and use it for interest-based advertising, requires prior consent (opt-in) of the user or whether a dissent solution (opt-out) is sufficient. The German data protection authorities are of the opinion that users must give their consent ...
In a recent decision by the Technology and Construction Court (TCC), Judge Stewart-Smith has clarified the position when determining whether two adjudications are “the same or substantially the same” when a party challenges jurisdiction under Para 9(2) of the Scheme for Construction Contracts. He stated that thedecisionreached in the first adjudication must be considered as well as the disputesreferredto adjudication in each ...
A trio of federal statutes often referred to collectively as the P&A Acts, which includes the Protection and Advocacy for Individuals with Mental Illness Act (PAIMI), the Developmental Disabilities Assistance and Bill of Rights Act (PADD), and the Protection and Advocacy of Individual Rights Act (PAIR), authorize the creation and operation of a protection and advocacy system (P&A system) to monitor the care of individuals with mental illness and developmental disabilities ...
