View a PDF of the November 2017 edition of the Haynes and Boone Health Law Vitals newsletter. FDA Improving Regulatory Oversight of Stem Cell Therapies and Regenerative Medicine Products Regenerative medicine is a burgeoning interdisciplinary research field aiming to offer new therapies that replace or regenerate human cells, tissues, or organs with the goal of restoring or establishing normal function ...
How retailers can harness technology to beat e-commerce at its own game. “It's official: Singapore malls are dead, as occupancy reaches its lowest level in 10 years,” screams one headline. “At some suburban malls, retailers confront the sound of silence,” another chimes in. As e-commerce takes hold, shoppers are eschewing brick and mortar in favour of the convenience of point and click ...
The California Office of Environmental Health Hazard Assessment (OEHHA) announced on November 9, 2017 that it was adding two widely used perfluorinated chemicals to the Proposition 65 list of chemicals known to cause reproductive toxicity: perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) ...
On October 13, 2017, Governor Brown signed SB 798, amending Business and Professions Code Section 805, Civil Code Sections 43.7 and 43.8, and Evidence Code Section 1157 to include licensed midwives within their scope. Notably, these changes only apply to licensed midwives, those professionals who pass the North American Registry of Midwives examination and are licensed by the Medical Board of California ...
The forthcoming General Data Protection Regulation also results in adaptations with regard to the protection of social data. On May 25, 2018, an amended Code of Social Law will therefore come into effect simultaneously with the General Data Protection Regulation. Above all, the Code of Social Law (SGB) X is affected. Many of the adaptations are editorial changes that have become necessary, but the content has also been amended ...
The revised Phase 2 Requirements of Participation for long-term care facilities will go into effect November 28, 2017. While multiple provider groups have requested a delay of some of the rule's provisions to allow time for additional revisions, officials at the Centers for Medicare and Medicaid Services ("CMS") have indicated that they will not act on those requests at this time and plan to move forward with the November 28, 2017, implementation date for Phase 2 ...
The term “dawn raid” refers to an unanticipated visit to commercial premises by a regulatory authority. Examples of this could include a squad of policemen entering a warehouse, a team from a financial-services regulator checking trading records at a bank, or an official from the UAE Ministry of Human Resources and Emiratisation entering your office to check the work permits of all employees present there (an increasingly common practice) ...
Californians diverting water should take notice of new measurement and reporting requirements with quickly approaching deadlines. Water right holders diverting between 10 and 100 acre-feet per year have until January 1, 2018, to either (1) install and maintain a measurement device, (2) employ a measurement method capable of measuring the rate of diversion, or (3) submit an alternative compliance plan ...
Governor Jerry Brown approved California Senate Bill 798 on October 13, 2017. One provision of this bill imposes penalties for failure to file required reports under Business and Professions Code Section 805.01. Beginning January 1, 2018, individuals and entities with reporting obligations under Section 805.01 are subject to fines of up to $100,000 per violation for willful failures to file a Section 805 ...
In August 2016, the Office of the National Coordinator for Health Information Technology (ONC) and the National Institute of Standards and Technology (NIST) co-sponsored the Use of Blockchain in Health IT and Health-related Research Ideation Challenge, soliciting whitepapers on how blockchain technology can be used in health care ...
The Bavarian Data Protection Authority ("BayLDA") has published an online test on its website that can be used by companies to determine how well they are prepared on key topics of the General Data Protection Regulation ("GDPR"). The GDPR will apply directly in the member states of the European Union with effect from May 25, 2018. This will result in significant changes to data protection law in many areas ...
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 ...
The Sixth Circuit Court of Appeals recently affirmed dismissal of an FCA complaint that failed to meet the FCA’s stringent pleading requirements. See United States ex rel. Ibanez v. Bristol-Myers Squibb Co., No. 16-3154, 2017 U.S. App. LEXIS 21328 (6th Cir. Oct. 27, 2017) ...
In October 2017, the Eleventh Circuit Court of Appeals reversed a district court’s grant of summary judgement, finding that a college has potentially protectable rights that extend beyond the scope of its federal service mark registrations. Savannah College of Art & Design, Inc. v. Sportswear, Inc., No. 15-13830 (11th Cir. Oct. 3, 2017) ...
The Trademark Trial and Appeal Board (Board) held that the plaintiff licensee in an opposition and cancellation proceeding could not establish priority of use over the defendant based on any common law rights previously acquired by the plaintiff’s licensor. Julie A. Moreno v. Pro Boxing Supplies, Inc., 124 USPQ2d 1028 (TTAB Sept. 8, 2017). Julie A ...
A rash of lawsuits are being filed around the country against businesses and retailers, claiming their websites are not accessible to those with visual or hearing impairments. These lawsuits are being filed under Title III of the Americans with Disabilities Act ("ADA"). Title III of the ADA requires equal access for persons with disabilities in places of public accommodation. This is not a new provision of the ADA, but the focus on websites has been a relatively recent development ...
The national competition authorities in South Eastern Europe are evidently increasing and strengthening their cross-border cooperation and communication, allowing for a more effective regional approach in the protection of competition. Taking into account common challenges and economic interdependence, as well as similar goals in EU integration, the authorities appear to have recognized significant merit in a broader regional framework for competition enforcement ...
The UK Corporate Governance Code (the Code) is undergoing a review by the Financial Regulatory Council (FRC) in the UK. A consultation process was announced by the FRC earlier this year, with a view to making changes to the Code to reflect the changing business environment in the UK ...
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 ...
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 ...
The federal agency now well-known as the Consumer Financial Protection Bureau was established by Congress in the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010. The CFPB is a uniquely independent agency, shielded from the executive branch in a way that other agencies are not. Doing away with that independence has the potential to significantly alter the CFPB and its regulatory work ...
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) ...
The Philippine Department of Labor and Employment (DOLE) recently issued guidelines to address safety and health issues faced by workers who, by the nature of their work, have to stand or sit for long periods. The DOLE noted that the wearing of high heeled shoes and/or standing at work for long periods or even frequent walking lead to health issues such as strain on the lower limbs, aching muscles, hazardous pressure on the hip, knee and ankle joints and sore feet ...
Parents seeking to enroll their children in schools located in another county are required to comply with the statutory requirements of W. Va. Code 18-5-16(b) and WVDE Policy 7212. Step One: The parent must first obtain the consent of the sending county board and the receiving county board. The WVDE in the past has recommended parents make the requests to the sending and receiving counties at the same time. Step Two: The sending county must approve the request ...
