Archive for the ‘European Union’ Category

Blackbaud Data Breach: Do You Need to Notify Affected Individuals or EU Data Protection Authorities? – Lexology

On July 16, 2020, Blackbaud, a U.S. based cloud computing provider and one of the worlds largest providers of education administration, fundraising, and financial management software, notified users of its services that it had suffered a ransomware attack in May 2020 in relation to personal data stored on their servers. Numerous colleges, universities, foundations, and other non-profits across the U.K., U.S. and Canada were affected.

Blackbauds handling of the attack has raised some questions. Blackbaud has confirmed in a statement on its website that they paid the cyber-criminals ransom demand in return for confirmation that the stolen data had been destroyed. Paying ransom demands is not unlawful, but it goes against the official advice issued by many law enforcement agencies, including the FBI. In addition, Blackbaud has faced criticism for taking many weeks to inform its customers of the breach.

Much of the affected data was of a nature that would not trigger notice requirements in the United States, because the elements that constitute sensitive data in the U.S. (such as usernames, passwords and social security numbers) were encrypted. However, there are a handful of states (notably Washington and North Dakota) that have notification statutes requiring notice to affected individuals if other kinds of information is accessed, such as names together with dates of birth, and was the case for many of Blackbauds customers.

The bigger issue, however, is for those U.S.-based entities who actively target individuals in the European Union. For example, many colleges and universities in the United States actively recruit prospective students or donors in the European Union. These types of recruitment activities are likely to bring them in scope of the EUs General Data Protection Regulation (GDPR).

The GDPR is a far-reaching piece of European legislation which applies to organizations outside the EU and includes draconian financial sanctions for non-compliance. Moreover, the standard for notification to individuals and data protection authorities in the EU is much lower than in most U.S. states. The GDPR requires that data breaches are reported to European data protection supervisory authorities unless the breach is unlikely to result in a risk to the rights and freedoms of individuals. This requires the affected institution to perform a thorough, documented risk assessment in each case.

Larger institutions may have already analyzed the need to comply with the GDPR and will therefore be aware that, if they are in scope of the GDPR, they may be required to report the breach both to the individuals concerned and to the relevant data protection supervisory authority in the EU. However, many smaller institutions may not have performed that analysis. This situation may find them needing to report the breach, but in doing so perhaps also alerting the data protection authorities to the fact that they may be subject to GDPR and may not be compliant in other ways. For instance, the GDPR requires specific contractual terms (including terms relating to the handling of data breaches) to be in place between customers and vendors where vendors process personal data on behalf of the customer.

The attack on Blackbaud is a major data breach. It may serve as a catalyst for U.S. non-profits to take a longer look at the GDPR and analyze their own need to comply.

Affected organizations both in and outside the EU should be working to determine what data has been compromised and whether they need to notify the local supervisory authority. The breach should also prompt all organizations to review any vendor contracts where personal data is involved, with a particular focus on ensuring that (a) the responsibility for data breach falls on the vendor and (b) strict notification timescales are imposed on the vendor (with the aim of preventing the lengthy delay in informing customers that has occurred in the Blackbaud case). Organizations that are subject to GDPR should also ensure that they implement GDPR-compliant vendor contracts.

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Blackbaud Data Breach: Do You Need to Notify Affected Individuals or EU Data Protection Authorities? - Lexology

Proposed US tariffs on EU seafood products nearing end of consultation period – SeafoodSource

A bevy of seafood products from the European Union could be the target of new tariffs by the United States, stemming from a dispute over European subsidies for Airbus.

Starting in October, several mainly premium goods from the E.U. such as Scotch whisky, cashmere, cheeses, and others have carried a 25 percent tariff, with salmon and other seafood products barely avoiding a tariff in the trade spat. The tariffs stem from U.S. criticisms of what it calls over-subsidization of Airbus by European governments, with the World Trade Organization (WTO) allowing the U.S. to take USD 7.5 billion (EUR 6.3 billion) in retaliatory tariffs, BBC news reported.

The tariffs have already been impacting certain seafood products from Europe from other regions prepared or preserved mussels, clams, cockles, razor claims, and molluscs have all been hit with the 25 percent tariffs, according toa list released by the USTR.

For years, Europe has been providing massive subsidies to Airbus that have seriously injured the U.S. aerospace industry and our workers. Finally, after 15 years of litigation, the WTO has confirmed that the United States is entitled to impose countermeasures in response to the EUs illegal subsidies, U.S. Trade Representative Robert Lighthizer said at the time.

Now, the WTO has agreed to even more U.S. claims about Airbus subsidies, opening the door for more potential tariffs. That means more seafood products could be on the chopping block. In June, the U.S. Trade Representative put out a notice that it is considering expanding the potential items being tariffed. The majority of the seafood items were considered for tariffs in the first round implemented in October, but were subsequently excluded from tariffs.

Included on that list of new products that could be tariffed are:

A decision on the products is expected to take place some time after 12 August, when a U.S. consultation ends.

Photo courtesy of barmalini/Shutterstock

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Proposed US tariffs on EU seafood products nearing end of consultation period - SeafoodSource

Partnering with the European Union and Global Regulators on COVID-19 – FDA.gov

By: Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs and Mark Abdoo, Associate Commissioner for Global Policy and Strategy

The European Union (EU) is one of the U.S. Food and Drug Administrations most important collaborators in tackling public heath challenges. The FDA and the European Commission (EC) and its European Medicines Agency (EMA) have long leveraged each others expertise and experience to promote the safety, effectiveness, and quality of medical products to advance the health of our citizens. Now, our work, built together over more than a decade, has paved the way for a multitude of critical collaborations on many scientific and regulatory fronts as part of our COVID-19 response.

What has helped drive this collaboration are the 30 technical expert groups, or clusters that the FDA and the EMA have established since 2003. These clusters meet regularly for regulatory discussions held under confidentiality commitments and were well positioned to pivot to focus on COVID-19 because of our ongoing work together. Since the start of the pandemic, many of these groups which often also include regulatory authorities from Japan, Canada, Australia, and other countries have shifted their work priorities to focus on COVID-19. For example, our expert group on vaccines has expanded into a multilateral forum to discuss regulatory issues related to the development of SARS-CoV-2 vaccines, whereas the pharmacovigilance group has begun to identify opportunities for collaboration on observational studies related to COVID-19 natural history and interventions. Similarly, our standing meetings on blood products are now focusing on developments related to COVID-19 convalescent plasma. The drug shortages discussions revolve around information sharing on strategies for COVID-19 related shortages and supply disruptions of medicines.

In these expert group discussions, the FDA and the EMA have been exchanging information on the rapidly evolving scientific landscape of products and clinical trials and, as possible, discussing the interpretation of data supporting regulatory decisions. For example, two days after the release of results from a clinical trial that the National Institute of Allergies and Infectious Diseases (NIAID-ACTT study) conducted, the FDA authorized the emergency use of the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. The FDA subsequently hosted a virtual meeting of key regulatory partners, including from Europe, Canada, and Japan, to discuss the safety and efficacy of remdesivir as a treatment for COVID-19. At the time, Japan had announced their version of early access to the drug and most of the other participating authorities were about to begin their own reviews for making such a decision, with EMA issuing a recommendation to expand remdesivir compassionate use shortly thereafter.

Against this backdrop of robust collaboration, on June 18-19, the FDA hosted virtual bilateral meetings with the EC and EMA to review progress on ongoing activities and share horizon scanning across high-priority areas. For example, public and private sector entities are proactively exploring strategic partnerships to address the anticipated challenges related to manufacturing and rapid scale-up of potential COVID-19 vaccines or therapeutics. As two-prominent international regulatory bodies, the FDA and the EC/EMA can help inform global regulatory strategies to accelerate production and global access of products. In addition, the application of real-world data to understand the natural history of COVID-19, treatment patterns, and the performance of diagnostics is of keen interest for both the FDA and the EU.

The FDA and the EU are also promoting engagement with global regulators, under the International Coalition of Medicines Regulatory Authorities (ICMRA) forum, which is comprised of 28 regulatory authorities from around the globe. For example, in March, as vaccine candidates began to be identified, the FDA and the EMA jointly chaired the first global regulators meeting to discuss regulatory strategies to facilitate the development of SARS-CoV-2 vaccines. Subsequent ICMRA workshops that are focused on COVID-19 therapeutic development, observational studies, and real-world data as well as policy approaches are helping to support mutual awareness and consideration of potential guidance alignment. Such vigorous efforts are reflected in the ICMRA joint statement, which was issued in April 2020, with global regulatory authorities expressing their collective support in countering COVID-19.

To maintain strong oversight of foreign-manufactured medical products, the FDA is leveraging inspection reports completed by the EU and United Kingdom under the Pharmaceutical Annex to the US-EU Mutual Recognition Agreement (MRA). The MRA creates an environment in which FDA and the EU may rely on inspections performed by each others regulatory authorities to inform our regulatory decisions, such as drug approvals or addressing drug shortages.

We are also leveraging our international collaborations in our medical device work. The FDA and global partners (including the EC and other European partners) regularly exchange information on medical device safety issues and regulatory developments. These international relationships have never been more important as we work to maintain critical supplies of medical devices such as personal protective equipment, ventilators and ventilator accessories, as well as diagnostic testing supplies and test kits for COVID-19. Our interactions have included working through our embassies and European contacts to address supply chain disruptions, medical device shortages, and removal of fraudulent and poor-quality products from the market. Moving forward, shared learnings about antibody tests, otherwise known as serology tests their validation, results of ongoing epidemiological studies, and potential use in broader testing programs will inform our continued efforts to confront this pandemic.

Our work in these endeavors is, as always, rooted in the FDAs unwavering commitment to helping to foster the development of safe and effective medical products. We recognize the shared challenges of public health authorities across the world in fighting this pandemic as well as the tremendous opportunities to accelerate our mission critical work through robust scientific collaboration. We will continue to collaborate with our global regulatory counterparts as we seek to bring safe and effective COVID-19 vaccines and treatments to our citizens as quickly as possible and as part of advancing our vital mission to protect and promote public health.

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Partnering with the European Union and Global Regulators on COVID-19 - FDA.gov

European Union likely to keep ban on Americans because of coronavirus fears as it reopens its borders – ABC News

June 24, 2020, 11:19 PM

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With the highest reported coronavirus case load, Americans will likely be barred from traveling to more than 30 European countries when the European Union moves to reopen its borders to outside travel next week.

The decision has been seen as a rebuke of how the Trump administration has handled the coronavirus pandemic, with the outbreak's spread surging to its highest level in two months, even as other countries start to reopen.

The EU's member states are actively debating a list of countries from which to allow tourism and business travel, a spokesperson for the European Union's mission in Washington told ABC News.

The list will be "based on objective criteria, the first among them being the epidemiological situation in a given country, which should be as good as or better than in the EU," the spokesperson said, without listing specific countries.

A man looks at mostly empty flight schedule screens in the Atlanta International Airport as the coronavirus outbreak continues in Atlanta, May 29, 2020.

That almost certainly means travel from the U.S., which has reported over 2.3 million cases as of Wednesday, will be banned, especially as certain parts of the country have seen dramatic rises in cases in recent days.

More than 15 million Americans usually travel to Europe each year, with Italy, France and Germany topping the list of countries most visited by Americans. All non-essential travel to Europe has been shut down since March.

The U.S. still bars any foreign citizen who has traveled in the prior two weeks in 28 European countries, Brazil and China. Those 28 European countries include the United Kingdom and Ireland, as well as the Schengen Area -- a group of 26 nations that have looser border restrictions between them, including France, Germany, Greece, Italy, Portugal and Spain.

Outbreaks in Russia, Brazil and India are also mushrooming, leaving those major countries likely barred by the EU as well, whose member states have largely contained the coronavirus' spread.

A passenger walks to Lufthansa check in counter at Frankfurt Airport during the novel coronavirus pandemic, June 15, 2020, in Frankfurt am Main, in Germany.

EU countries are set to reopen their borders to one another on July 1, with the list of permitted outside travelers updated "regularly ... to take into account the evolving health situation," according to the EU spokesperson.

Secretary of State Mike Pompeo said the U.S. and EU are working together "to make sure that we have all of the elements in place to reopen travel."

"It's important for the United States to get Europeans the capacity to travel back to the United States. It's important, very important for the Europeans to fully reconnect with the American economy as well," he told reporters, a nod to the desperation in some European countries for tourism to resume amid deepening economic pain.

"We certainly don't want to reopen in a way that jeopardizes the United States from people traveling here, and we certainly don't want to cause problems anyplace else," Pompeo added.

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European Union likely to keep ban on Americans because of coronavirus fears as it reopens its borders - ABC News

Europe Travel Ban on U.S. Visitors Would Be a Blow to Airlines – The New York Times

Last year, flights across the Atlantic, to Europe and other destinations, accounted for about 17 percent of passenger revenue for United Airlines, or about $7.4 billion. Such flights generated about 15 percent of all passenger revenue for Delta, or $6.4 billion; and about 11 percent of passenger revenue, or $4.6 billion, for American Airlines. They were particularly important to United and Delta, generating a quarter of passenger profits last year, according to the Transportation Department.

Tens of millions of people flew between the United States and European Union countries in 2019. Many traveled for business to and from cities like New York, Los Angeles and San Francisco and Amsterdam, London, Paris and Frankfurt. Many others fanned out further to vacation, particularly in the summer when international flights are often nearly full as American families jet off to Italy and Greece, and Europeans check out New York and California.

Of course, travel between the United States and the European Union has been restricted since March, when governments on both sides of the Atlantic barred most visitors to prevent the spread of the coronavirus, with exceptions for repatriations and essential travel by medical professionals. At the time, the United States had just over 1,100 coronavirus cases as the virus spread extensively in Italy and Spain. Today, the United States leads the world with about 2.4 million cases, and infections are surging in Arizona, California, Florida, Texas and other states.

Because of the countrys size, the vast majority of tickets sold by U.S. airlines are for domestic travel. Those flights have led the industrys recovery, as Americans slowly start to visit friends and family and make limited vacation plans, a pattern unfolding in countries around the world. Higher-profit business and international travel are expected to follow far behind.

I think international travel is probably going to lag domestic by up to 12 months, Ed Bastian, Deltas chief executive, told shareholders on a call last week, citing travel bans around the world as one reason.

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Europe Travel Ban on U.S. Visitors Would Be a Blow to Airlines - The New York Times