Daily Archives: March 21, 2021

How will cryptocurrency earnings be taxed? – Fox Business

Posted: March 21, 2021 at 5:08 pm

Geltrude & Company founder Dan Geltrude provides insight into how cryptocurrency is taxed.

The phenomenon of underground cryptocurrency and its economic boom is raising questions as to how, or if, earnings are taxable.

Geltrude & Company founder and CPA Dan Geltrude explained to Cavuto: Coast to Coast Thursday that if crypto earnings areconsideredcapital gains, then they must be filed as such on a tax return.

Every time you use, lets say, Bitcoin, youre actually potentially triggering a taxable transaction, he said. Because when you use that Bitcoin if youre getting value greater than what you paid, what the basis was, its like a stock. You now have a gain and its taxable. So its got to be reported.

BITCOIN HITS $60,000 IN RECORD HIGH

According to Geltrude, the Internal Revenue Service (IRS) is hot on the issue. The Fraud Enforcement Office has launched Operation Hidden Treasure in search of unreported income in the form of transactional cryptocurrency.

1040 tax return forms for 2020 now question taxpayers if they have transacted in cryptocurrencies, Geltrude added, and prompt a signature under penalty of perjury.

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For Americans who have been paid in cryptocurrency, Geltrude explained thosetransactions becomea basis as would any other form of payment.

When you got paid, its no different than getting paid by credit card or cash, so whatever profit you had in the transaction, you pay there, he said.

Now youve received the Bitcoin, now you have to track what your basis is as of that transaction. Because when you go to use the cryptocurrency, you are creating potentially another taxable event. Its going to be nuts!"

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The Grocer’s Guide to Cryptocurrency – Progressive Grocer

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In 2021, food retailers need to educate themselves about digital currencies and the looming reality that businesses will eventually need the ability to accept various digital currencies. Already there are currency kiosks in place capable of processing Bitcoin and 30 other digital variants.

It can quickly become overwhelming, but knowing how the currencies are mined and tracked to say nothing of blockchain and associated technologies is hardly the most important thing for food retailers in 2021, according to Chris McAlary, CEO of Las Vegas-based digital currency services firm CoinCloud.

If they wanted to go down that rabbit [hole] now, they could, but there is no reason, says McAlary, adding that one doesnt have to know how mobile phone service works at its technological core to craft a mobile marketing program.

Whats more vital is that all age groups are using digital currency the companys largestconsumer group by volume is women age 45 and older and that the transaction technology is quickly gaining legitimacy in the financial world. In addition, payment services such as PayPal are enabling digital currency transactions. No doubt, food retail consumers will one day expect such options while buying groceries.

Thats not the only positive change, according to McAlary. Compliance has caught up, he says about digital currencies in general. Any company like us has to follow a KYC process. KYC is an acronym for know your customer, and such processes require financial services providers to verify that their customers are indeed legitimate, in hopes of preventing fraud and other illegal activities.

For now, though, the main intersection between food retail and these forms of paymentinvolves the location of digital currency ATMs or, as CoinCloud calls them, digital currencymachines (DCMs) inside supermarkets, which are themselves becoming centers of bankingactivity. Those machines in turn draw traffic into stores and are paving the way for moreadoption of digital currency in the food retail space.

Mass adoption is here, says McAlary, referring to the companys base of 1,500 machines in 45 states. Its no longer underground. There are a lot of different use cases for these digital currencies, not just investing, but payment and smart contracts and gaming.

Further evidence of mass adoption is evident from the growing partnership between Coinstar and Coinme. The companies said last December that their installed base of Bitcoin-enabled kiosks had surpassed 5,000 locations.

The fast-moving expansion of Bitcoin-enabled Coinstar kiosks means that more Americans than ever now have the power to invest in digital currencies and stake their claim in the future of money even on a quick trip to the grocery store, notes Neil Bergquist, CEO of Seattle-based Coinme.

Meanwhile, CoinFlip says that it grew its ATM network from 441 ATMs in January 2020 to more than 1,400 by the end of that year, with locations in 45 states. The Chicago-based company adds that it saw an average 48% increase in the amount per customer transaction in 2020. According to CEO and founder Daniel Polotsky, a single machine can bring in from 100 to 200 people into a store who otherwise wouldnt visit it. Whats more, food retail stores get a cut of that business.

As digital currency continues to gain ground, food retailers should, at the very least, startplanning their moves by treating Bitcoin and its competitors as another form of alternativepayment.

Do your homework and understand on a higher level how it works, advises CoinClouds McAlary, directing retailers to blogs run by companies such as his. If they are not thinking about it now, they are probably going to be left behind.

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Cashing in on bitcoins: French government to pocket $30 mn from first-ever cryptocurrency auction – Economic Times

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Paris, March 17, 2021 -Governments might look askance at bitcoin, but it does not mean they do not want to cash in on its soaring value and France is set to pocket nearly $30 million from its first-ever action of the cryptocurrency, a minister said on Wednesday.

The sale was of more than 600 coins seized as part of an investigation and were valued at more than $30 million based on current market prices.

Held online by the Kapandji Morhange auction house, the sale attracted nearly 1,600 bidders.

"It's a sale that will raise 24 million euros ($29 million) in proceeds for the government", the minister of public finances, Olivier Dussopt, told the television channel, BFM Business, at the end of the auction.

When preparations got underway in September, bitcoin was trading around $10,000, far from the $60,000 it struck over the weekend, putting the sale of 611 coins in an altogether different league.

When bidding began at 9:00 am (0800 GMT), the starting price stood at 23,250 euros per coin, but most of the coins sold for around 40,000 euros apiece, more or less in line with the current market price minus exchange rate rates and commission.

No information has been disclosed about the provenance of the bitcoins as the legal process is underway.

If the defendant wins, they'll receive the funds from the auction minus commissions paid to the auction house.

Otherwise, the French state will pocket any money not awarded by the court to victims or charity.

France is far from the first to auction cryptocurrencies, with the United States doing so in 2014, followed by Canada, Australia, Belgium and Britain, according to the auction house.

Entrepreneurs are a high-risk group whenever the markets catch a cold. Heres how they invested to keep themselves, and their companies, in the pink of health.

Jyotsna Uttamchandani, Executive Director, Syska GroupIf I had to stress about investing in something this year, it would be health. A gym, at this point, is accessible to us on our smartphones. We can always do group exercise classes online or even group challenges for steps with our friends. From a business point of view, investing in AI solutions to drive productivity will be a year-round focus. It will prioritise product sales, optimise our pricing, and provide seamless forecasting.

Gautam Das, CEO, Oorjan CleantechI have participated in almost 50 marathons, including an 87-km comrade run. Spending time outdoors running, doing yoga or meditation, swimming or playing a sport is how I invest in my mental and physical well-being. Good health is the biggest wealth. I believe in financial investments in new ventures that create value and jobs. Success and money are the by-products.

Dhruvil Sanghvi, CEO, LogiNextIn 2021, I am going to double down on efforts to maintain good health by regular exercise and meditat ion. For our employees too, we are envisaging more ways for people to invest in their mind and body. As for wealth, I actively help upcoming technology entrepreneurs with mentorship and angel investments. Ill be expanding horizons here to build more pathbreaking global companies from India.

Ameera Shah, MD, Metropolis HealthcareLife is all about tradeoffs. Keep a mental and emotional balance and deal with your anxiety in a positive way. Regular exercise and spending quality time nurturing myself and my family are some of my priorities. On wealth, for those investing in markets, it is better to be diversified and to stay liquid. For entrepreneurs, there needs to be a strong back-up plan. Wealth-creation is a process, but solving customer problems and impacting lives positively is the true purpose.

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Cryptocurrency businesses can now open offices within DMCC freezone in Dubai – Gulf Business

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Businesses dealing with crypto assets can now obtain bespoke licences offered by the DMCC Crypto Centre in Dubai.

The DMCC freezone and Government of Dubai Authority on commodities, trade and enterprise signed an MoU with the the Securities and Commodities Authority (SCA) to establish a regulatory framework for businesses offering, issuing, listing, and trading crypto assets in DMCC.

Working closely with DMCCs onboarding teams, the SCA will issue approvals for crypto-related businesses seeking to establish themselves in DMCC.

The SCA will subsequently regulate the crypto activities in line with their policies that were introduced in October 2020 to develop an integrated ecosystem for the crypto and blockchain industries.

In 2020, DMCC launched DigitalSugar, a blockchain-enabled trading platform for sugar, and the Agriota e-Marketplace, an agri-commodity trading and sourcing platform that uses blockchain to help bridge the gap between millions of rural farmers in India and the UAEs food industry.

In line with DMCCs #digital strategy, we have signed an MoU with @sca_uae to provide a regulatory framework for crypto-related businesses to operate through @dmcccrypto in Dubai. Read more: https://t.co/IoHN5TJT1G pic.twitter.com/mqEAGQSc0O

DMCC (@DMCCAuthority) March 20, 2021

The latest MoU with the SCA is expected to promote the development of blockchain applications in Dubai.

Through this agreement with the SCA, DMCC is expanding its current range of crypto assets licences, which perfectly complement the existing business licence options. In early 2020, we signed an agreement with CV VC and CV Labs, a Swiss Government-supported initiative that will bring the worlds leading blockchain and cryptographic technologies ecosystem to Dubai. This agreement also builds the foundation for our future partnerships in the crypto space and is a major step in the launch of the DMCC Crypto Centre, which we will bring to the market in the near future, said Ahmed bin Sulayem, executive chairman and CEO of DMCC.

Read: Dubais DMCC registered 2,025 companies in 2020

As we continue to make strides within the crypto and blockchain space, DMCC is making it easier for crypto and blockchain businesses to set up and operate in Dubai. Cutting-edge technologies are at the forefront of our strategy and they will play an instrumental role in driving increased trade through Dubai in the future.

By working with SCA, we are able to extend the centralised supervision of the crypto market to our business district in the heart of Dubai, bolstering its standing as a hub for crypto assets.

In related cryptocurrency news from the region, the Central Bank of Bahrain (CBB) recently issued cryptocurrency exchange, CoinMENA, with a Crypto Asset Services Company License Category 2. CoinMENA is Sharia-compliant exchange, certified by the Shariyah Review Bureau. CoinMENAs services will initially be available to residents of Bahrain, the UAE, Saudi Arabia, Kuwait and Oman.

Read: Central Bank of Bahrain licences Sharia-compliant cryptocurrency exchange CoinMENA

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Arrival of first wave consignment of COVAX COVID-19 vaccine doses to the State of Palestine – UNICEF

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RAMALLAHand GAZA CITY, 21 March 2021- On 17 March, the State of Palestine received the first shipment of 37,440 doses of the Pfizer COVID-19 vaccine and 24,000 doses of the Astra Zeneca COVID-19 vaccine from COVAX facility as part of the first wave allocation. These vaccine doses were transferred to the Ministry of Healths ultra-cold chain and vaccine storage facilities in the West Bank and the Gaza Strip.

Further consignments of COVAX vaccine doses are planned for the State of Palestine to cover 20 per cent of the population approximately 1 million people. As with the current consignments, these doses are for both the West Bank and the Gaza Strip, according to the prioritization criteria of the National Deployment and Vaccination Plan.

COVAX is a global facility representing partnership between the World Health Organization (WHO), Global Alliance for Vaccines and Immunization (GAVI), United Nations Children Fund (UNICEF) and the Coalition for Epidemic Preparedness Innovations (CEPI) working on the equitable distribution of COVID-19 vaccines. It includes 190 countries with a total population of more than 7 billion people and ensures fair and equal access to COVID-19 vaccines supplied through UNICEF. WHO and UNICEF are supporting the Government of the State of Palestines national vaccination campaign.

Dr Ayadil Saparbekov, acting WHO Head of Office for West Bank and Gaza said: WHO welcomes the opportunity to be able to help Palestinians fight the Corona virus with this important delivery of vaccines aimed initially at frontline healthcare workers. People in both the West Bank and Gaza desperately need these vaccines, which is an effective tool in the fight against COVID-19, in addition to the public health measures already in place. Were proud to play our part in the global COVAX initiative, alongside our partners, as it helps to fill the gaps where vaccines are needed and in short supply. Todays delivery can give Palestinians a sense of hope that life can return to normal.

We have been battling COVID-19 for one year now. These vaccine doses provide us with another tool in fighting the spread of this virus a critical tool. Nevertheless, it is critical that, alongside the vaccination of the frontline health workers and vulnerable groups, we also continue to reinforce public health measures such as correctly using masks, handwashing, and physical distancing. This vaccine will help return the Gaza Strip and the West Bank closer to normal daily life. Children in the State of Palestine have endured much this last year. It is a privilege for UNICEF to support the Ministry of Health and our partners to ensure equity of vaccine delivery to both the Gaza Strip and the West Bank, starting with health care workers and the most vulnerable groups, said Lucia Elmi, UNICEF Special Representative to the State of Palestine.

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COVID-19 Vaccination Has Been Conjuring Up Emotions And Memories – NPR

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The emotions around receiving the COVID-19 vaccine have been overwhelming for some and resonate with earlier experiences. Allen J. Schaben/Los Angeles Times via Getty Images hide caption

The emotions around receiving the COVID-19 vaccine have been overwhelming for some and resonate with earlier experiences.

After a year of fear, stress and isolation, the COVID-19 vaccine often produces more than a little pinch of sensation in your arm.

The experience also stirs strong emotions. Some feel relief. Others gratitude. Many are overcome and start crying.

Some people say the freedom squelched by the pandemic is beginning to return. That feeling of liberty is familiar to those who have survived previous epidemics.

On a spring afternoon in 1954, 1-year-old Gloria Anderson played with a group of toddlers in Billings, Mont. Two days later her mother learned that one of the other children had contracted polio. Within days Anderson started feeling sick first a bit of nausea, then fever. Her mom gasped when she put Anderson in a high chair and saw that she could only move her right leg.

"I was kicking one leg," Anderson says. "And my mom stuck the pin in my left leg, and I didn't move it."

They rushed her to the hospital where she quarantined for three weeks. Even her mother couldn't visit. The left side of her body was paralyzed, and the prognosis was tragic she would never walk again.

But Anderson was one of the lucky ones. Her immobility was temporary, and six months later she took her first steps.

In rare cases, you can contract polio twice. So when the polio vaccine arrived in 1955, Anderson's mother raced her two daughters to the doctor's office.

"It was a sugar cube," Anderson says. "And we all took it. And my mom was radiant!"

Radiant because her girls were safe. But the disease scarred Anderson both physically and emotionally for life. The left side of her body never fully recovered, and she's had to endure numerous medical procedures over the years. Now in her 60s, Anderson started falling a lot and eventually had to get fitted for a leg brace. It's a daily reminder of her illness as a small child.

Because a virus almost killed her and still affects her life today, Anderson took the coronavirus seriously from the start. She and her husband religiously sheltered in place, and if they had to leave their home they wore masks. They desperately missed their grandchildren.

"There's heartache," Anderson says. "These are hard times. But we do it for one another."

Gloria Anderson receives her second COVID-19 vaccination. David Anderson /Gloria Anderson hide caption

Gloria Anderson receives her second COVID-19 vaccination.

Like her mother six decades ago, Anderson was beaming after recently receiving her second vaccine shot.

Viral trauma

Leo Herrera also felt a familiar sense of relief when a nurse inserted a second dose of the COVID-19 vaccine into his arm. The past 12 months marked the second time the 39-year-old watched a virus rip through his community. COVID-19 has disproportionately hit both Latinos and LGBTQ people.

"I'm a gay man," says the San Francisco resident. "I have a lot of viral trauma from the HIV pandemic. I'm also a first-generation Mexican immigrant who grew up undocumented. So there's a lot of overlap between the two pandemics."

Back in 2012, Herrera was dating an HIV-positive man. That same year PrEP, a daily pill that prevents the user from contracting the virus, hit the market. But, just like the vaccine rollout today, access tilted toward affluent communities with good insurance.

"It took years for PrEP to be distributed widely to folks of color and folks without health care," Herrera says.

And just like today, a lot of media focused on unknowns. Would the pill lead to toxicity? Bone density issues? Maybe kidney problems?

In the end, Herrera took a leap of faith. The mental health benefits outweighed the potential physical risks.

"The first time I had sex without a condom with an HIV-positive person was a freedom and a loss of shame and anxiety that was phenomenal," he says.

Jonathan Salinas can relate. Even though the 23-year-old San Francisco resident didn't endure the AIDS crisis, the virus haunts his generation, as well.

"When I was growing up as a gay man I was told that HIV should always be in the periphery or around the conversations of sex," he says. So, when he learned about PrEP during a visit to Planned Parenthood he was thrilled to start taking the daily pill.

"As soon as I got on PrEP, that anxiety, that weight off of my shoulders, it lifted almost immediately because I felt empowered," he says.

Salinas was filled with a similar sense of relief when he received his COVID-19 vaccine. He hasn't visited his relatives for months out of fear he'd bring the virus home.

"I just felt so much hope," he says about getting the vaccine.

A beat too long

While driving to get his second COVID-19 shot, Leo Herrera stopped for gas. When he walked inside the station to pay, he passed a group of people not wearing masks.

"And I thought, 'Oh, man. I cannot wait for this to be the last time that I have to focus on what everybody else is doing to take care of me. I can finally take that power back, ' " he says, grinning.

He's looking forward to the time when most people are vaccinated. When he finds himself at a wedding reception or a bar, and without thinking he can open his arms to hug a stranger. "And the hug is going to go on for a beat too long," he says. "And you're going to hold on to that stranger, and you're both going to realize what that hug means."

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Covid-19 Is Surging in India, but Vaccinations Are Slow – The New York Times

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MUMBAI India is racing to contain a second wave of the coronavirus, but its vaccination campaign is running into doubters like Akbar Mohamed Patel.

A resident of Mumbais densely populated slum area of Dharavi, Mr. Patel survived a severe bout of the coronavirus in May. The first wave prompted Mumbai officials to seal off his housing complex, confining thousands of people for nearly two months.

Still, the current campaign has been marred by a slow initial government rollout, as well as skepticism and apathy from people like Mr. Patel and his neighbors. On social media we come to know this is all a big game to make money, Mr. Patel said. Of the vaccine, he said, many things have been hidden.

The coronavirus, once seemingly in retreat, is again rippling across India. Confirmed infections have risen to about 31,600 daily from a low of about 9,800 in February. In a recent two-week period, deaths shot up 82 percent.

The outbreak is centered on the state of Maharashtra, home to Mumbai, the countrys financial hub. Entire districts of the state have gone back into lockdown. Scientists are investigating whether a new strain found there is more virulent, like variants found in Britain, South Africa and Brazil.

Officials are under pressure from Prime Minister Narendra Modi to aggressively ramp up testing and vaccination, especially in Mumbai, to avoid disruptions like last years dramatic nationwide lockdown and resulting economic recession.

I am very categorical that we should stop it, contain it, just here, said Dr. Rahul Pandit, a critical care physician at a private hospital in Mumbai and a member of the Maharashtra Covid-19 task force.

Indias vaccination campaign could have global consequences.

Last week, Prime Minister Boris Johnson said that an expected drop in Britains Covid-19 vaccine supplies stemmed from a nearly monthlong delay in delivery of five million doses of the Oxford-AstraZeneca vaccine being manufactured in India. The reasons for the delay are not clear, but the manufacturer, Serum Institute of India, has said shipments will depend in part on domestic Indian needs.

India is a crucial link in the vaccination supply chain. Amid hoarding by the United States and other wealthy countries, India has given away or sold tens of millions of doses to other countries, even as it struggles to vaccinate its own people. Subrahmanyam Jaishankar, the foreign minister, has said that the availability of vaccines in India will determine how many doses go overseas.

While vaccinations were initially available only in public hospitals, India is now giving jabs in private clinics and enormous makeshift vaccination centers, and it is considering making them available in pharmacies, too. Vaccination hours have been extended, and those eligible can register in person and receive a shot the same day, bypassing an online scheduling system.

The Indian government is playing catch-up. Since it launched a nationwide vaccination drive two months ago, uptake has been disappointing. Less than 3 percent of the population has received a jab, including about half of health care workers. At the current rate, it will take India about a decade to vaccinate 70 percent of its people, according to one estimate. By comparison, roughly a quarter of the population of the United States has had at least one jab.

Not everybody in India has the internet access needed to register for a shot online. But the campaign has also been plagued by public skepticism. The government approved a domestically developed vaccine, called Covaxin, before its safety and efficacy trials were even over, though preliminary findings since then have suggested it works.

March 21, 2021, 3:14 p.m. ET

The other jab available in India is the Oxford-AstraZeneca vaccine, which was suspended in some countries after a number of patients reported blood clots and strokes, though scientists havent found a link between the shots and the afflictions.

Some of the tepid response may come down to apathy. A nationwide study released in February found that one in five Indian people were likely to have already had Covid-19. Surveys in cities show even higher prevalence rates. The disease is just one among many that people in India worry about, joining tuberculosis, dengue fever and avian flu. Many people are struggling to recover from the huge financial hit of Indias lockdown last year and cant afford to take time off work to stand in line for a shot.

These are hand-to-mouth people. Bread, butter depends on their daily work. They cant sit back and relax and wait for the wave to go, said Kiran Dighavkar, the assistant commissioner of the Mumbai ward that includes Dharavi. They cant afford quarantine, so the only option is to vaccinate these people as early as possible.

Health experts are prodding Mr. Modi to do more, including making the vaccine available to more people. Older adults, health-care and frontline workers and some people with medical conditions are currently eligible for shots.

I would try to put the injection in the arm of every Indian that is 18 years and above, and I would do it now, said Dr. N.K. Ganguly, the president of a medical research institute in New Delhi.

Persuading the 800,000 residents of Dharavi, Asias largest slum, to get vaccinated is seen as critical. Residents travel for work to every corner of the city of 20 million. Officials are reintroducing what earlier in the pandemic they called the Dharavi model: If the disease can be contained there, transmission can be curbed citywide and even further afield.

It wont be easy, even though just three miles away, a jumbo vaccination center is administering about 15,000 shots a day, free of charge.

Day and night, Dharavi is teeming with life. People overflow from thin, corrugated metal houses, stacked on top of each other like matchboxes, onto crowded, mostly unpaved lanes strung with loose electrical wire. Animals skitter between parked motorcycles and piles of debris. Shops, tanneries and factories are squeezed next to houses of worship and community toilets.

We have been OK all this while, Abdul Razad Rakim, a 61-year-old diabetic, said from a foldout chair in front of the tiny apartment he shares with his wife, Shamim. Why do we have to go?

A short walk away, Janabai Shinde, a former janitor for the city health department, was squatting on her front step, rising every few minutes to spit red tobacco juice into a drain.

I take walks in this lane. I sit here for fresh air. I have not stepped out much since the lockdown, Ms. Shinde said. Her son, who works for the city, has already registered her for a turn at a vaccination center. She said she hoped her neighbors would join her.

Its for our good, she said.

The Mumbai government has enlisted aid groups to set up help desks in Dharavi, where residents can ask questions and complete online registration to make an appointment for a free shot.

Plans are underway to set up a vaccination center within the confines of the slum, and to reopen an institutional quarantine center with thousands of beds, according to Mr. Dighavkar, the assistant commissioner.

Last week, as Maharashtra recorded its highest new case numbers since September, the chief executive of a disaster relief group delivered a pep talk at Gold Filled Heights, an apartment complex largely occupied by members of the Jain religious group, who run many of the jewelry businesses in Dharavi.

We cant let the virus spread again, said the chief executive, Shantilal Muttha. If it spreads in Dharavi, it becomes a threat for the entire Mumbai and Maharashtra.

Jyoti Shelar contributed reporting.

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Coronavirus (COVID-19) Update: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19…

Posted: at 5:07 pm

For Immediate Release: March 19, 2021

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first machine learning-based Coronavirus Disease 2019 (COVID-19) non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation (a condition causing blood to clot more easily than normal).

The Tiger Tech COVID Plus Monitor is intended for use by trained personnel to help prevent exposure to and spread of SARS-CoV-2, the virus that causes COVID-19. The device identifies certain biomarkers that may be indicative of SARS-CoV-2 infection as well as other hypercoagulable conditions (such as sepsis or cancer) or hyper-inflammatory states (such as severe allergic reactions), in asymptomatic individuals over the age of 5. The Tiger Tech COVID Plus Monitor is designed for use following a temperature reading that does not meet criteria for fever in settings where temperature check is being conducted in accordance with Centers for Disease Control and Prevention (CDC) and local institutional infection prevention and control guidelines. This device is not a substitute for a COVID-19 diagnostic test and is not intended for use in individuals with symptoms of COVID-19.

The FDA is committed to continuing to support innovative methods to fight the COVID-19 pandemic through new screening tools, said Jeff Shuren, M.D., J.D., director of FDAs Center for Devices and Radiological Health. Combining use of this new screening device, that can indicate the presence of certain biomarkers, with temperature checks could help identify individuals who may be infected with the virus, thus helping to reduce the spread of COVID-19 in a wide variety of public settings, including healthcare facilities, schools, workplaces, theme parks, stadiums and airports. The device is an armband with embedded light sensors and a small computer processor. The armband is wrapped around a persons bare left arm above the elbow during use. The sensors first obtain pulsatile signals from blood flow over a period of three to five minutes. Once the measurement is completed, the processor extracts some key features of the pulsatile signals, such as pulse rate, and feeds them into a probabilistic machine learning model that has been trained to make predictions on whether the individual is showing certain signals, such as hypercoagulation in blood. Hypercoagulation is known to be a common abnormality in COVID-19 patients. The result is provided in the form of different colored lights used to indicate if an individual is demonstrating certain biomarkers, or if the result is inconclusive.

The clinical performance of the Tiger Tech COVID Plus Monitor was studied in hospital and school settings. The hospital study, which was considered a validation study, enrolled 467 asymptomatic individuals, including 69 confirmed positive cases, and demonstrated that the Tiger Tech COVID Plus Monitor had a positive percent agreement (proportion of the COVID-19 positive individuals identified correctly by the device to possess certain biomarkers) of 98.6% and a negative percent agreement (proportion of the COVID-19 negative individuals identified correctly by the device to not possess certain biomarkers) of 94.5%. The school study, which was considered a confirmatory study, showed similar performance.

The Tiger Tech COVID Plus Monitor is not a diagnostic device and must not be used to diagnose or exclude SARS-CoV-2 infection. The device is intended for use on individuals without a fever. An individuals underlying condition may interfere with the COVID-19 related performance of the device and could lead to an incorrect screening result.

The FDA issued the EUA to Tiger Tech Solutions, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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03/19/2021

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Coronavirus (COVID-19) Update: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19...

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When will we declare victory over COVID-19? – Marin Independent Journal

Posted: at 5:07 pm

A year into the pandemic, infection rates are falling. Hospitals are quieter; morgues are emptier. Emboldened by vaccines, were dropping our masks and stepping closer. Slowly were reopening indoor dining, theaters, museumsand schools.

Will we declare victory over COVID-19?

No, say public health experts. But well negotiate an uneasy truce. Rather than completely eliminating the virus, we can create a strict containment strategy, building public health bulwarks to help fend off an enemy that is wily, adaptive and enduring.

This means accepting a certain level of risk as society returns to normal, they add.

Heres what we can call victory: Learning how to live with this virus in a way that allows us to continue to enjoy life, says Dr. John Swartzberg of UC Berkeleys School of Public Health.

Over time as vaccines improve, death tolls fall and we adopt new behaviors, like wearing masks when were sick well accommodate it, just as we do with other deadly infectious diseases, he says.

In the past year, there have been unimaginable strides against the virus. With accelerated plans for manufacturing vaccines, President Joe Biden now promises enough vaccine supply for every adult in America by the end of May. Some states, such as Texas, are already racing to fully reopen.

But there is increasing consensus that COVID-19 is here to stay, causing intermittent, limited outbreaks in the U.S. and other countries with well-developed vaccination programs but causing significant ongoing disease in parts of the world where access to vaccines is more limited.

Unless youve completely eradicated a disease, youre always at risk for having an outbreak, says Stanford infectious disease epidemiologist Dr. Yvonne Maldonado.

Why is eradication so hard? Its because pathogens, once established, hardly ever go extinct.

Weve succeeded in eliminating only one major infectious killer: smallpox. A terrible disease that killed 30% of all victims, smallpox was last reported in 1977 in Somalia. Just two remnants of the virus, stored in tightly controlled government laboratories in the United States and Russia, survive.

To be sure, weve scored notable victories in conquering disease in specific geographic areas. In the U.S., there has been a declining trend of infectious disease. For example, the nation reported just 13 cases of measles and one isolated outbreak of mumps in 2020. Fewer than 10 Americans contract rubella each year; of these, everyone is infected while traveling overseas. The original SARS disease SARS-CoV-1 no longer haunts us.

But attempts to eliminate historic global killers such as hookworm, yellow fever and malaria have been frustrating failures. The polio eradication program is now in the 32nd year of what was intended to be a 12-year effort. Scientists have unsuccessfully sought an HIV vaccine ever since the virus was identified in 1984.

The easiest diseases to control are those that are quickly diagnosable or recognizable, according to the American Society of Microbiology. But COVID-19 is hidden, spreading before people get sick. And up to 40% of cases are surreptitious, causing no symptoms. Additionally, a COVID-19 diagnosis requires testing by skilled medical professionals.

A disease can also be readily controlled if, like polio, it lives only in humans and has no animal reservoir where it persists. Thats not COVID-19, which is presumed to have originated in bats.

Diseases that are geographically limited, like river blindness, can be pushed to the brink of extinction by a targeted campaign. But COVID-19 is nearly everywhere. It has spread to 219 countries and territories around the world, causing 118 million confirmed infections.

Also simpler are diseases that can be subdued by a single vaccine with life long immunity, like measles. We dont yet know how durable our COVID-19 vaccines will be.

With COVID-19, its definitely not about getting to zero risk. Because thats not feasible, Californias surgeon general Dr. Nadine Burke Harris said this past week.

So what is an acceptable number of deaths?

Its likely that well accede to a disease that behaves like influenza, public health experts say. While deadly, especially for elders, the flu isnt seen as a special threat that requires an exceptional societal response.

We just seem to take it, on faith, that every year theres going to be a flu epidemic, says Maldonado.

Dr. Joshua Adler, vice dean for clinical affairs at UCSF, imagines a day when the incidence of COVID declines to the level where we no longer need to have special processes. It becomes like another infectious disease thats part of our general environment.

We will simply have a number of patients that may have COVID, just like we have a number of patients that have flu, or severe herpes infection, or what have you, he says.

Thats still a far way off. California reported 137 deaths per 100,000 people due to COVID-19 as of March 8.According to the Centers for Disease Control and Prevention, thats nearly tenfold the rate of deaths 15.2 per 100,000 people caused by flu plus pneumonia in 2019, the last year those numbers were available.

Other infectious diseases are far lower: Respiratory Syncytial Virus, a common virus that infects the lungs and breathing passages, kills 2.1 to 6 per 100,000 people nationwide, according to an extensive National Institutes of Health study published in 2014. Diarrheal disease, such as rotavirus, kills 2.4 per 100,000 people nationwide; HIV/AIDS, 2.4; meningitis, 0.4; hepatitis, 0.29 and tuberculosis, 0.25, according to the Journal of the American Medical Association.

In the meantime, we should set intermediate goals, says UC San Francisco epidemiologist Dr. George Rutherford.

One goal is to prevent another surge of cases, so hospitals arent overwhelmed. Additionally, we need to offer better medications, so people who become infected rarely die. Currently, patients hospitalized with COVID-19 face nearly five times the risk of death than those with the flu, according to a major study published last December.

And when variants emerge, we must be poised to respond, Rutherford says.

Then, like influenza, new strains will fade into the background and become part of the milieu, transmitted every year but at much, much lower levels, he says.

Over time, the risk will recede, experts predict. Thats because the COVID-19 vaccines are better than flu vaccines, and can be promptly modified.

I am confident that things will get quite a bit better than they are today. Does that mean that you can live completely risk-free? I dont think so, says Adler. But it may be a low enough risk that most of us feel comfortable with it.

Eventually, so-called community immunity, or herd immunity, will protect us.

At that point when 70% to 90% of the population is protected through vaccination or prior illness it is much harder for the virus to move through a population. The risk to people who cannot get vaccinated drops dramatically. Thats when it feels safer to go back to our cherished gatherings. Think big weddings. Football games. Music festivals.

Right now, thats a challenging target. Why? Children account for about 22% of the population and they wont be vaccinated until clinical trials are completed later this year. Reluctant adults could represent another shortfall. According to U.S. Census data released in late January, about 14% of adults said they would probably not and 10% said they would definitely not get vaccinated.

Yet even as we work toward more complete vaccination, well slowly inch toward safety. Even partial herd immunity can save lives.

But managing our new relationship with COVID-19 will require constant monitoring, potential revaccination, treatment of isolated cases and rigorous contact tracing.

Its not over, says Adler, but its certainly heading in the right direction.

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Kaptur announces that Erie County and Cleveland health centers join COVID-19 vaccination program – The Morning Journal

Posted: at 5:07 pm

United States Rep. Marcy Kaptur (D-OH) announced March 19 that Neighborhood Health Care Inc. in Cleveland and the Erie County Community Health Center are invited to join the Health Center COVID-19 Vaccine Program over the next six weeks.

The Health Resources and Services Administration (HRSA) and the Centers for Disease Control and Prevention launched this program to directly allocate novel coronavirus vaccine to HRSA-supported health centers to ensure that the nation's underserved communities and those disproportionately affected by COVID-19 are equitably vaccinated, according to a new release from Kaptur.

This designation will help Ohioans in Sandusky and Cleveland get vaccinated as soon as possible that is a triumph for our community after more than a year of living with the pandemic, she said. Im immensely thankful for those at the Erie County Health Center and Neighborhood Health Care for their selfless work helping to vaccinate our neighbors here in northern Ohio.

"Thanks to them and with federal support, we are going to beat this virus together.

With assistance from the Health Resource Services Administration and the CDC, the Erie County Community Health Center, a Federally Qualified Health Center, will now expand COVID-19 vaccinations to those in our region here in Ohio, said Pete Schade, Erie County health commissioner. We are extremely fortunate to be a provider with the ability to order vaccine direct from the supplier.

"This type of activity will continue to assure our communities that all people will have an opportunity to become fully vaccinated against the virus. We will join our stakeholders in promoting vaccine and administering it to all as we fight this pandemic together.

Neighborhood Family Practice is grateful for the opportunity to get more vaccines into the arms of our patients as they are often the most at risk for COVID-19 and have struggled to get sufficient vaccination opportunities, said Dr. Chad Garven, associate medical director at Neighborhood Health Care Inc.

Today, an additional 700 health centers were invited to participate in the next phase of the program and include those that serve high proportions of low income and minority patients, provide services to rural/frontier populations, operate Tribal/Urban Indian Health Programs, and/or utilize mobile vans to deliver services.

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Kaptur announces that Erie County and Cleveland health centers join COVID-19 vaccination program - The Morning Journal

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