Technology’s dark side may well be the silent threat to democracy. A year ago, Americans installed a reality TV star in the White House who doesn’t seem to let the facts get in the way of a good tweet. Trump’s shambolic management style has given America’s enemies a perceived opportunity to drive their country’s agendas ...
Legal entities that contract insurance to protect their own assets qualify as consumers within the meaning of the consumer code, says the brazilian Superior Court of Justice (STJ) "[...] the legal entity that takes out insurance seeking to protect its own assets shall be end user of insurance services, thus calling for the application in its favor of the rules provided for in the Consumer Code ...
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 ...
As technology has advanced, cyber extortion attacks have risen, and they will continue to be a major security issue for organizations. Cyber extortion can take many forms, but it typically involves cybercriminals demanding money to stop or delay their malicious activities, which include stealing sensitive data or disrupting computer services. Health care and public health sector organizations that maintain sensitive data are often targets for cyber extortion attacks ...
In an increasingly connected world, the protection of privacy and personal data has become a key concern for legislators in a number of jurisdictions. In South Africa, an attempt to give effect to the constitutional right to privacy resulted in the Protection of Personal Information Act, 2013 (“POPI”), which was gazetted on 26 November 2013 ...
This year has already been a busy one for seismic activity. In the first weeks of 2018 alone, there have been reports of a 7.9 magnitude quake off the shores of Kodiak, Alaska, a 6.2 magnitude temblor in Japan, and a series of tremors in California. And, few will forget the catastrophic earthquakes that struck Mexico City and the Iraq-Iran border last year ...
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 ...
At a time when tolerance seems to be an increasingly precious commodity, society can celebrate an awakening intolerance for sexual harassment. For all of the scandal and salacious detail dominating the media in recent months, there is the hope that victims of depravity can find empowerment and healing, if not justice, too ...
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 ...
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 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 ...
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 ...
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 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 ...
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 ...
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 ...
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 ...
