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 CPA appointed the National Bureau of Investigation (NBI) and Philippine National Police (PNP) as enforcement authorities and regulates their access to computer data, creating the Cybercrime Investigation and Coordinating Center (CICC) as an inter-agency body for policy coordination and enforcement of the national cybersecurity plan, and an Office of Cybercrime within the Department of Justice (DOJ-OC) for international mutual assistance and extradition ...
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 ...
Strong contracting processes and communications which establishes clearly the expectations of each of the parties reduces disputes and costs and strengthens relationships. The key to strong contracting processes is to approach contracts in a holistic manner making sure all documents interconnect in a logical uniform manner. Because manufacturing processes can be complex, this is often not as easy as it sounds ...
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 ...
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 ...
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 ...
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 ...
The U.S. International Trade Commission (“ITC”) issued a determination at the end of 2017, finding that solar panel imports are hurting domestic businesses that operate in the solar industry. The ITC’s determination was issued in connection with a trade case filedby a Georgia-based company, Suniva, Inc., shortly after filing for bankruptcy protection. SolarWorld Americas, Inc. joined Suniva’s petition ...
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 ...
