The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”)[1] was enacted on October 24, 2018. Among other things, the SUPPORT Act amended the Physician Payments Sunshine Act (“Sunshine Act”)[2] to expand the definition of “covered recipients”[3] for payment tracking and reporting purposes ...
Federal and state government enforcers have been turning their focus to nursing homes, skilled nursing facilities, and other long-term care facilities. While this enforcement priority is not tied specifically to the COVID-19 pandemic, facilities can expect additional scrutiny as they are considered “ground zero” for infections ...
As states are beginning to open back up amid the COVID-19 pandemic, nursing homes and other long-term care facilities are still at the highest risk of infection and should continue to be cautious. One-third of all COVID-19 deaths are attributed to long-term care residents and workers.[1] Facilities need to take steps to manage the spread of the disease and protect their residents and staff as states begin to allow more flexibility around long-term care quarantine practices ...
As an update to our April 24 alert, the United States Health and Human Services Department (“HHS”) has continued to provide a string of updates over the past month regarding the funds allocated to provide financial relief for eligible health care providers by the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act ...
On May 26, 2020, Ohio Governor Mike DeWine announced the formation of new Congregate Care Unified Response Teams to test residents and staff members in Ohio's nursing homes. Ohio Department of Health (“ODH”) Director Amy Acton, M.D., MPH, subsequently issued a Director’s Order on May 27, 2020 requiring all nursing homes to cooperate with this testing ...
The Centers for Medicare and Medicaid Services (CMS) announced on March 13, 2020 enhanced penalties for infection control survey non-compliance amid the COVID-19 pandemic.[1] On June 1, 2020, CMS announced significant changes related to nursing home surveys. The new changes require states to complete 100 percent of their Focused Infection Control nursing home surveys by July 31, 2020 ...
The Ohio House of Representatives has voted overwhelmingly in favor of House Bill 606, known as the “Good Samaritan Expansion Bill.” The bill grants temporary immunity from civil liability and professional disciplinary actions to a wide range of health care providers for injury, death, or damages arising from health care services rendered in response to the COVID-19 pandemic ...
Congress passed legislation amending the Paycheck Protection Program (“PPP”) in hopes of making the program more useful to small businesses. Prior to the amendment, the PPP required loan proceeds to be spent during an eight-week covered period for a loan to be eligible for forgiveness. Additionally, 75 percent of the proceeds had to be used on payroll costs, so only 25 percent could be spent on certain eligible non-payroll expenses (e.g ...
On June 2, 2020, Ohio Department of Health (ODH) Director Amy Acton, M.D., MPH, issued a new comprehensive order permitting all surgeries to resume, effective immediately ( Surgery Resumption Order). The Surgery Resumption Order is available here. We have previously written about the March 17, 2020 ODH order that cancelled all non-essential or elective surgeries and procedures that use personal protective equipment (PPE) ...
Even though OSHA has advised that no specific standard covers the novel coronavirus, human resource and safety personnel must be mindful of the generally-applicable standards that might apply. OSHA has issued several guidelines that, while not the rule of law, do offer guidance on addressing COVID-19 issues, including recordkeeping and 300 log reporting obligations. On April 10, OSHA issued guidance that appeared to limit what cases would be required to be reported on OSHA 300 logs ...
On May 27, 2020, the U.S. Patent and Trademark Office issued a further extension of certain deadlines that were about to expire on May 31. The latest order provides until July 1, 2020 for certain actions delayed due to COVID-19. For small and micro entities only, filings that would have been accepted if filed by June 1, 2020, will now be deemed timely if filed by July 1, 2020 ...
As dealer networks in the automotive sector re-open for business following the COVID-19 lockdown, we share below our main competition law watch outs for suppliers over the coming weeks and months. We know that current market conditions are tempting some people to reach out to their competitors – any competitor contact needs to be managed carefully from a competition law perspective ...
This time we address solutions from the front lines: devices for remote diagnostics which can improve effective detection of the coronavirus and also unburden the health service in other areas. These solutions can also serve as aproving ground for the regulatory approach to oversight of algorithms. The immediate inspiration for writing this text was asolution from the company StethoMe presented at the DemoDay organised by the MIT Enterprise Forum CEE ...
Last week, the U.S. Food and Drug Administration (FDA) issued guidance for the health care industry, titled “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency ...
The Federal Communications Commission (“FCC”) established the COVID-19 Telehealth Program (the “Telehealth Program”) on April 2, 2020 in response to the COVID-19 pandemic. The Telehealth Program provides $200 million in funding, appropriated by Congress as part of the CARES Act,[1] to assist certain non-profit and public healthcare providers in making telehealth services available to patients who cannot be seen in person ...
Hand sanitiser production is just one aspect of business that's altered for £5bn industry, writes George Frier of Shepherd and Wedderburn The whisky industry continues to captivate consumers and entrepreneurs. Record exports continue and, within the sector, the emergence of new brands and the rejuvenation of existing brands demonstrate a vibrant sub-set of the Scottish food & drink economy ...
MDR postponement On 17 April 2020 the European Parliament decided to postpone the transition timeline to implement the EU Medical Device Regulation (MDR), which was set to expire on 26 May 2020, until 26 May 2021. The EU MDR postponement was published in the Official Journal of the European Union and entered into force on 24 April 2020 ...
The controversial issue of whether employers can check their employees' temperatures has been much debated. Both the Employment Ministry and the Data Protection Authority (DPA) have recently changed their positions in this respect ...
Amid the unprecedented changes wracking the business world in 2020, one certainty remains: many industries will look very different in future years as strategic responses to COVID-19 gain traction and become permanent. In the healthcare REIT sector, we are beginning to see trends that may shape industry norms long after the dust has settled from the chaos of 2020. 1 ...
Vietnam, a country of 97 million people, has been widely recognized for its successful handling of the novel coronavirus outbreak. On January 27, as the country celebrated the Lunar New Year holiday, Prime Minister Nguyen Xuan Phuc declared war on the coronavirus, having said "fighting this epidemic is like fighting the enemy". The Prime Minister and his cabinet acted expediently in controlling the spread of the virus ...
Pharmaceuticals and medical devices in Malaysia are governed by the following main legislation and regulations:the Sale of Drugs Act 1952 (SODA 1952);the Control of Drugs and Cosmetics Regulations 1984 (CDCR 1984);the Dangerous Drugs Act 1952 (DDA 1952);the Poisons Act 1952 (PA 1952);the Medicines (Advertisement and Sales Act) 1956 (MASA 1956); andthe Medical Device Act 2012 (MDA 2012) ...
Report of the Department of Banks and Financial Institutions Health Emergency - BCRA Communication “A” 7048: adjustments to the national payment system. Yesterday, the Central Bank of the Argentine Republic (BCRA) issued Communication "A" 7048 (the " Communication "), through which certain adjustments were established on the national payment system. The Communication was issued in accordance with the provisions of Decree No ...
Foreign brand owners have often questioned whether they need a trademark registration in the PRC when engaging PRC factories for Original Equipment Manufacturing (OEM) activities. Previously, a pure OEM arrangement with proper authorisation from the owner of a trademark registration in the exporting country, would generally not be considered infringement of identical or similar PRC trademarks ...
On June 16, 2020 the German government released its Corona-Warn-App. There are some key points employers should be aware of concerning the app: NO OBLIGATION FOR EMPLOYEES TO USE THE APP ON THEIR PERSONAL SMARTPHONES An employer may be thinking about instructing its employees to install and use the Corona-Warn-App on their own devices to reduce the infection risk among its employees. That is not permitted ...
