INFARMED has published a set of exceptional measures – which will remain in force during the period of risk to public health – to be adopted by sponsors, clinical trial sites, and research teams, to guarantee the safety, protection and rights of clinical trial subjects.It has also defined INFARMED’s evaluation of trials intended to treat or prevent the new Coronavirus disease (SARS-CoV-2) as a priority ...
Through Resolution 2020012926 of April 3, 2020, INVIMA formalizes the measures adopted in connection with the person to person attention and proceedings that will be carried out before the entity during the health emergency, as well as the suspension of terms for some of INVIMA´s actions ...
In times of emergency, the Secretary of Health and Human Services (the "Secretary") has authority to issue temporary waivers or modifications of certain Medicare, Medicaid, CHIP, and HIPAA requirements. The Centers for Medicare and Medicaid Services ("CMS") has released a substantial number of waivers in response to the coronavirus national emergency ...
On March 17, 2020, the Trump administration announced an expansion of Medicare coverage for virtual health services. The Medicare expansion is intended to make medical offices more available to people who need to be seen in-person and to mitigate the spread of the novel Coronavirus. Medicare can now pay for office, hospital, and other visits furnished via virtual services across the country, including a patient’s place of residence, starting March 6, 2020 ...
Telehealth is not a new concept, but it has been accelerated to the forefront recently by government mandated social distancing. While all of the "stay-at-home" orders issued across the country to date have included exceptions that permit individuals to leave their homes to seek medical treatment, providers may feel an obligation to offer telehealth services to protect not only their patients, but also the provider's staff, and to support the national effort to "flatten the curve ...
The COVID-19 outbreak has impacted the manufacturing, transportation and supple chains underpinning countless aspects of trade and commerce on a global basis. Additionally, the shelter-in-place orders have caused nonessential businesses to shut down, resulting in many of them being unable to meet their contractual obligation. Force Majeure Whether coronavirus can be considered a force majeure depends on the wording of the provision ...
Due to the active spread of coronavirus infection COVID-2019, the Russian authorities, at both the federal and regional levels, are taking significant measures to ensure the self-isolation of citizens. These measures include increasing the liability for violation of measures for preventing the spread of coronavirus infection, which caused adoption of a number of legislative acts. 1 ...
While the financial impact of quarantines and shelter-in-place orders will inevitably reach into every industry and every corner of the economy, companies in the hotel, restaurant, travel, retail and manufacturing sectors have already sustained significant business interruption losses. Much of the commentary from insurers and even some government agencies has been presumptively negative about the prospects for coverage ...
COVID-19 brought a tremendous disruption of normal daily life/business affecting personal life and businesses alike. People and companies/ institutions alike are in continuous assessment of solutions and compromises to mitigate the impact of the COVID – 19 pandemic. In the context of a continuously evolving environment, we all need to adapt and try to keep control on negative impact ...
Faced with the COVID-19 pandemic, the Portuguese National Authority for Medicines and Healthcare Products (“INFARMED”) and the Directorate-General for Health (“DGS”) have issued guidelines for pharmacies. These guidelines address, in particular, the way pharmacies operate and manage medicines ...
Commentators and lawyers continue to make blanket statements regarding lack of business interruption coverage for losses caused by the novel coronavirus (COVID-19). They contend that coronavirus-related losses cannot satisfy the “direct physical loss of or damage to [covered] property” language contained in many policies to trigger coverage in the first place ...
Q&A procedures before the Public Health Institute (ISP) May I file for sanitary registrations? Requests for sanitary registrations for pharmaceutical products, cosmetics and others regulated, as well as for their modifications, may be filed for through the GICONA portal, and official tariffs shall be paid only through electronic transfer of funds ...
In the context of the current sanitary alert, several bills of law have been filed with Congress, seeking to regulate certain aspects associated to states of emergency and sanitary crises in particular.To such ends, the bills that stand out are:I. Bill prohibiting and penalizing price increases in the face of epidemics or pandemics:On Tuesday 17 March 2020, a bill was filed with the Lower Chamber (Newsletter 13 ...
The Coronavirus, COVID-19 has raised numerous important legal issues. However, one issue has assumed an even higher profile with the recent classification of the virus as a pandemic. This is the question of what claims can be made under the different insurance products on the market to cope with the losses, whether direct or indirect, that Portuguese businesses have been facing ...
The Minister of Health is issuing successive anti-export lists covering an increasingly wide catalogue of products at risk of shortages. This is to ensure access to drugs and medical devices for patients in Poland, especially during the difficult time of the COVID-19 pandemic ...
As a growing number of the workforce is being affected by the COVID-19 pandemic, employers are raising several benefit related questions, particularly with respect to group health plans. The Employee Benefits Group at Hanson Bridgett will be providing updated information on possible issues arising in the benefits area through Benefits Alerts and postings on Hanson Bridgett's Online COVID-19 Resource Center ...
The United States Trade Representative (USTR) announced a period for public comment on excluding medical goods from Section 301 China tariffs if they are needed to fight the coronavirus pandemic. The USTR notice was published in the Federal Register on March 25, 2020. The USTR previously granted approximately 200 exclusions from Section 301 tariffs for medical goods because they are needed to fight the COVID-19 pandemic. The U.S ...
With the onset of COVID-19, certain areas of academic and government-fueled research are exploding. However, universities and governments at all levels are also scaling down nonessential research tasks and limiting the enrollment of essential new human subjects or new animal experiments.[1] Similarly, private companies may be suspending or cancelling their research projects in an attempt to conserve financial resources and accommodate researchers working from home ...
Does your organization’s insurance program provide any protection from the economic disruption caused by the novel coronavirus pandemic? What steps should you take to assess and protect that insurance coverage? The Bradley Policyholder Insurance Coverage team has provided an informative webinar addressing insurance coverage and claims adjustment for event cancellation, business interruption, and third-party claims stemming from the pandemic ...
The impact of the novel coronavirus (COVID-19) across the globe remains a significant concern in every aspect of business – and the representation and warranty (R&W) insurance market is no different. The following Frequently Asked Questions are designed to address some of the more common questions that have arisen since the outbreak of the pandemic.As always, advice in this area is fact-sensitive ...
Covid-19 has had an impact on ongoing consumer contracts and their relations with suppliers. The rapid spread of the virus led the authorities to declare State of Disaster in the country, raising concern about the (i) fulfillment of consumer contracts of goods and services and (ii) an eventual price manipulation ...
An article establishing a procedure for the procurement of medical supplies was recently introduced. This new provision (Resolution No 53960) amended Resolution No 38941-2006-JD of February of 2006, which is the general procurement regulation for the Social Security Administration (CSS for its initials in Spanish) ...
FDA Takes Action to Increase U.S. Supplies in Response to COVID-19. The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices. The FDA is engaging the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S ...
FDA Warns Consumers About Unauthorized Fraudulent COVID-19 Products.The FDA issued a Consumer Update advising consumers to be beware of fraudulent coronavirus tests, vaccines and treatments. The FDA has seen unauthorized fraudulent test kits for COVID-19 being sold online. Currently, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19 ...
