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 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 ...
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 ...
Uganda has enacted the Investment Code Act, 2019 (the “Code”). The previous Code was enacted in 1991 and was long overdue for amendment given the changes in approach to attracting investment and the glaring weaknesses in the old Code. The new Code strengthens the Uganda Investment Authority (the “Authority”), establishing it as a one-stop investment centre, and also provides for the financing and auditing of the Authority ...
AFRICA: African Continental Free Trade Area Agreement developments Botswana and Zambia signed the African Continental Free Trade Area Agreement (“ACFTA”) on 10 February 2019 at the 32nd summit of the African Union in Addis Ababa, whereas the Ethiopian Council of Ministers approved the ACFTA on 2 February 2019 and the Parliament of Senegal on 23 January 2019 ...
We bemoan the lacklustre stock exchange and complain that the government isn’t doing enough. We point to greener trading pastures in Hong Kong. Is it time to re-look at the role of the stock market and how we benchmark ourselves?This February,Bloombergpublished an article headlined The Incredible Shrinking Singapore Stock Market, which stated that overthe past five years, more companies had exited than joined the SGX, leading the bourse to suffer a net outflow of S$19 ...
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 ...
Beginning March 19, 2019, naltrexone drug products, including Vivitrol, dispensed pursuant to an outpatient prescription and indicated for the treatment of alcohol dependence or the prevention of relapse to opioid dependence must be reported to the Ohio Automated Rx Reporting System (OARRS) ...
One of the key issues raised consistently in the discussions around a no-deal Brexit is the impact it would have on the customs duties payable on goods that are imported in to the UK. Whilst MPs have now voted against a no-deal Brexit, this does not change the legal position – that unless a deal is agreed, there will be a no-deal Brexit, (or no Brexit at all) ...
Sponsored wellness plans that include incentives to employees who voluntarily disclose personal health information as part of disability-related inquiries or medical examinations are in legal limbo after the EEOC removed the underlying rules from the Americans with Disabilities Act (“ADA”) and Genetic Information Nondiscrimination Act (“GINA”) ...
Senate Bill 273 goes into effect on March 20, 2019, and creates new requirements for Ohio insurance companies, including health insurance plans, to develop and implement specific information security programs to safeguard nonpublic business and personal information. Senate Bill 273 is based upon the National Association of Insurance Commissioners’ Insurance Data Security Model Law (also referred to as "MDL-668") ...
The Ohio medical marijuana market saw a robust start to sales on January 16, 2019. First-day sales totaled more than $75,000, per the state’s Medical Marijuana Control Program, and total sales exceeded $330,000 in the first several weeks. This initial sales boom is magnified by the fact that only five of the 50-plus state-approved provisional dispensaries are operational (and only four on the initial date of sales) ...
On February 13, 2019, Assembly Member Ash Kalra, District 27 (San Jose), introduced AB-506. If passed, AB-506 would amend California Health and Safety Code Sections 1423, 1424, and 1424.5 to grant the Department of Public Health the authority to issue more citations and higher penalty amounts ...
One of the few things that is becoming clearer amidst the Brexit fog is that a ‘no-deal’ is no longer a fanciful possibility. The UK Government, in itsWhite Paper on Immigration Reformpublished at the end of last year, claimed the changes it proposed would lead to the most significant changes to immigration control in 45 years. However, that historic change, scheduled for December 2021, may come sooner than anticipated ...
The Scottish Government has published its first two Scottish Procurement Policy Notes (SPPNs) for 2019, both of which relate to public procurement in Scotland in the event that the UK exits the European Union without an agreement (a ‘no-deal’ Brexit), and has published accompanying draft legislation to implement the changes it proposes. The first policy note (SPPN 1/2019) sets out the Scottish Government’s proposed changes to public procurement legislation ...
Introduction The United Arab Emirates (the UAE) promulgated legislation to specifically address the regulation of competition (being Federal Law 4 of 2012, or the Competition Law) several years ago but until recently, it has been the case that the requisite implementing regulations and processes were not in place. This is no longer the case ...
On January 31, 2019, the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced a proposed rule that would significantly change the federal Anti-Kickback Statute (AKS) regulatory safe harbors regarding prescription drug rebates and discounts ...
The Financial Conduct Authority (FCA) recently launched a consultation on its proposed guidance on cryptoassets (CP19/3) which can be read in fullhere. The move comes as part of the UK Cryptoasset Taskforce's wider look into the regulation of the cryptoasset market. The consultation follows a report published in October 2018 by the Taskforce, which consists of the Bank of England, HM Treasury and the FCA. Our discussion of that report can be readhere ...
One of the biggest challenges that micro, small and medium enterprises face when trying to settle in and achieve success as profitable businesses is to obtain capital and sources of financing ...
On December 28, 2018, the Department of Health and Human Services (HHS), in partnership with the Health Sector Coordinating Council (HSSC), published the “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” (HICP Publication), which is a four-volume publication designed to provide voluntary cybersecurity practices to health care organizations of all types and sizes, ranging from local clinics to large health care systems ...
The Department of Health and Human Services Office for Civil Rights (OCR) has published a Request for Information on Modifying HIPAA Rules to Improve Coordinated Care (RFI). OCR announced the publication of the RFI through a December 12, 2018 press release available here. OCR Director Roger Severino stated that OCR is “looking for candid feedback about how the existing HIPAA regulations are working in the real world and how we can improve them ...
In late November 2018, the Securities and Commodities Authority (SCA), the Dubai Financial Services Authority (DFSA) of the Dubai International Financial Centre (DIFC) and the Financial Services Regulatory Authority (FSRA) of the Abu Dhabi Global Market (ADGM) announced that they had reached agreement on facilitating the licensing of domestic funds by each authority for promotion across the UAE. This is a potentially significant development ...
Eliminating Kickbacks in Recovery Act Overview On October 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) as part of the SUPPORT Act, which is a comprehensive attempt to combat the opioid epidemic. EKRA established an all-payer anti-kickback prohibition that extends to arrangements with recovery homes, clinical treatment facilities, and laboratories. Unlike the Anti-Kickback Statute (AKS) under 42 U.S ...
