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 ...
Considering the Covid-19 pandemic, the Agriculture and Livestock Service (Servicio Agrícola y Ganadero, "SAG") issued the Exempt Resolution No. 3,439, dated May 19, 2020 to update the Program of Exports of Origin. (View update here.) This Resolution was published in the Official Gazette on June 10, 2020 ...
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 ...
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 ...
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 ...
Myanmar continues to generate intense investor interest in what remains one of the world’s largest frontier markets. Ever since 2011 when the country first opened its doors to foreign investment and participation, its economy has continued to surge with greater diversification of its markets and deepening sophistication of its consumer base ...
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 ...
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 20 May 2020, the State Administration of Foreign Exchange of China issued the Circular on Supporting the Development of New Forms of Trade (Circular). The Circular summarised previous pilot experiences and, established foreign exchange (forex) policies that are meant to optimise new forms of trade[1]. The Circular has been implemented since the date of its promulgation ...
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) ...
The following are general considerations for health care employers who are strategizing their employees’ return to work. Note that each employer and health care environment is different and will need a specifically tailored plan. Further, there is a wealth of detailed guidance regarding various aspects of operating during the COVID-19 pandemic, including detailed guidance regarding proper PPE and patient treatment ...
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 ...
The state contribution for commercial rents to entrepreneurs with forcibly closed establishments is gaining more concrete outlines. If an entrepreneur negotiates a 30% discount on rent from his landlord, he will be able to apply for state support in the amount of 50% up to a ceiling of CZK 10 million for the period from April to June. However, the program has yet to be notified to the European Commission before it can be launched ...
Category B has been extended until the end of August 2020 and the government has approved a new form of support – Category C! Are you considering how to maintain employment of your employees and minimize economic losses? Take a look at what financial instruments the state has prepared for entrepreneurs whose employees have been affected, directly or indirectly, by government measures taken to combat coronavirus ...
Covid III is starting and you need to act fast! At its meeting on 18 May 2020, the Government approved by Resolution No. 553 the Covid III guarantee program for self-employed persons and companies employing up to 500 employees. Immediately afterwards, the websites of Českomoravská záruční a rozvojová banka, a.s. ("ČMZRB") published the conditions of the program ...
On 2 June 2020 an amendment to the Compensation Bonus Act was published in the collection of laws, thanks to which, in addition to self-employed persons, some shareholder/members in limited liability companies will also receive this support. Financial offices should commence paying out the bonus to shareholders on the basis of submitted applications no later than 3 June 2020, i.e. the date of effectiveness of the legislative amendment ...
On 19 May 2020, an Act On certain measures to mitigate the effects of the coronavirus epidemic known as SARS CoV-2 on cultural events (Act No 247/2020 Coll, the “Act” ), entered into force. Not only for the field of tourism, but also for the field of culture, the possibility of the organizer to issue a voucher for a cultural event instead of refunding the entrance ticket fee was introduced ...
