After Admitting Mistake, AstraZeneca Faces Difficult Questions About Its Vaccine

Some trial participants only got a partial dose of AstraZeneca’s vaccine. Experts said the company’s spotty disclosures have eroded confidence.

#astrazeneca-plc, #clinical-trials, #coronavirus-2019-ncov, #oxford-university, #vaccination-and-immunization

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Johnson Basks in a Rare Burst of Good U.K. News

The current lockdown is ending and a successful British vaccine could vanquish the virus by spring. But will that be enough to rebuild his sagging political fortunes?

#astrazeneca-plc, #conservative-party-great-britain, #coronavirus-2019-ncov, #great-britain, #johnson-boris, #oxford-university, #shutdowns-institutional, #vaccination-and-immunization

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AstraZeneca and Oxford Say Vaccine Is Up to 90 Percent Effective

In an early analysis, the drug maker zeroed in on a promising dosing plan for its vaccine.

#astrazeneca-plc, #clinical-trials, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #drugs-pharmaceuticals, #oxford-university, #vaccination-and-immunization

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Oxford University’s COVID-19 vaccine shows high efficacy, and is cheaper to make and easier to store

Oxford University’s COVID-19 vaccine, being developed in partnership with drugmaker AstraZeneca, has shown to be 70.4% effective in preliminary results from its Phase 3 clinical trial. That rate actually includes data from two different approaches to dosing, including one where two full strength does were applied, which was 62% effective, and a much more promising dosage trial which used one half-dose and one full strength dose to follow – that one was 90% effective.

Oxford’s results may not have the eye-catching high efficacy headline totals of the recent announcements from Pfizer and Moderna, but they could actually represent some of the most promising yet for a few different reasons. First, if that second dosage strategy holds true across later results and further analysis, it means that the Oxford vaccine can be administered in lower amounts and provide stronger efficacy (there’s no reason to use the full two-dose method if it’s that much less effective).

Second, the Oxford vaccine can be stored and transported at standard refrigerator temperatures – between 35° and 45°F – whereas the other two vaccine candidates require storage at lower temperatures. That helps obviate the need for more specialized equipment during transportation and on-site at clinics and hospitals where it will be administered.

Oxford’s COVID-19 vaccine also uses a different approach to either Moderna’s or Pfizer’s, which are both mRNA vaccines. That’s a relatively unproven technology when it comes to human therapeutics, which involves using messenger RNA to provide blueprints to a person’s body to build proteins effective at blocking a virus, without any virus present. The Oxford University candidate is an adenovirus vaccine, which is a much more established technology that’s already been in use for decades, and which involves genetically altering a weekend common cold virus and using that to trigger a person’s own natural immune response.

Finally, it’s also cheaper – in part because it uses tried and tested technology for which there’s already a robust and mature supply chain, and in part because it’s easier to transport and store.

The Phase 3 trial for the Oxford vaccine included 24,000 participants, and it’s expected to grow to 60,000 by the end of the year. Safety data so far shows no significant risks, and among the 131 confirmed cases in the interim analysis that produced these results, none of those who received either vaccine dosage developed a severe case, or one requiring hospitalization.

This is great news for potential vaccination programs, since it introduces variety of supply chain into an apparently effective vaccine treatment for COVID-19. We’re much better off if we have not only multiple effective vaccines, but multiple different types of effective vaccines, in terms of being able to inoculate widely as quickly as possible.

#astrazeneca, #biotech, #health, #medical-research, #medicine, #messenger, #moderna, #oxford-university, #pfizer, #tc, #unproven-technology, #vaccination, #vaccine, #vaccines

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Central Europe Suffers as Coronavirus Surges

The Czech Republic, with the highest transmission rate in Europe, closed schools, bars and restaurants. In some countries in Central Europe, there is a critical shortage of doctors and nurses.

#bucharest-romania, #budapest-hungary, #bulgaria, #central-europe, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #czech-republic, #disease-rates, #europe, #european-union, #gazeta-wyborcza, #gdansk-poland, #hospitals, #hungary, #kaczynski-jaroslaw, #orban-viktor, #oxford-university, #pew-research-center, #politics-and-government, #prague-czech-republic, #romania, #shutdowns-institutional

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Vaccine Makers Keep Safety Details Quiet, Alarming Scientists

Researchers say drug companies need to be more open about how vaccine trials are run to reassure Americans who are skittish about getting a coronavirus vaccine.

#astrazeneca-plc, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #krumholz-harlan-m, #moderna-inc, #offit-paul-a, #oxford-university, #pfizer-inc, #research, #trump-donald-j, #vaccination-and-immunization

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“Not uncommon at all”: AstraZeneca pauses COVID-19 vaccine trial

A double-masked health care worker jabs a needle into the arm of a seated woman in a mask.

Enlarge / A volunteer receives an injection of AZD1222 from a medical worker during the country’s first human clinical trial for a potential vaccine against COVID-19 at the Baragwanath Hospital on June 28, 2020, in Soweto, South Africa. It is reported that Africa’s first COVID-19 vaccine trial began on June 24 in South Africa. (credit: Getty Images | Felix Dlangamandla)

With the coronavirus crisis gripping the globe, all eyes are on every bump and dip on the path to the pandemic’s end. So, of course, news that researchers triggered a common pause to the clinical trials of a leading COVID-19 vaccine candidate made swift and alarming headlines late Tuesday.

The global phase III trials for the vaccine AZD1222 (formerly ChAdOx1)—developed by the University of Oxford and pharmaceutical giant AstraZeneca—were put on a “temporary” and “voluntary” pause for a “standard review process,” AstraZeneca said in a statement Wednesday.

According the company, the pause was triggered by a “potentially unexplained illness” in one of thousands of participants involved in its trials. Per standard protocol, researchers must pause the trial to investigate whether the illness is related to exposure to the experimental vaccine or not.

Read 15 remaining paragraphs | Comments

#adverse-event, #astrazeneca, #clinical-trial, #covid-19, #oxford-university, #pandemic, #sars-cov-2, #science, #vaccine

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Diffblue launches a free community edition of its automated Java unit testing tool

Diffblue, a spin-out from Oxford University, uses machine learning to help developers automatically create unit tests for their Java code. Since few developers enjoy writing unit tests to ensure that their code works as expected, increased automation doesn’t just help developers focus on writing the code that actually makes a difference but also lead to code with fewer bugs. Current Diffblue customers include the likes of Goldman Sachs and AWS.

So far, Diffblue only offered its service through a paid — and pricey — subscription. Today, however, the company also launched its free community edition, Diffblue Cover: Community Edition, which doesn’t feature all of the enterprise features in its paid versions, but still offers an IntelliJ plugin and the same AI-generated unit tests as the paid editions.

The company also plans to launch a new lower cost ‘individual’ plan for Diffblue Cover soon, starting at $120 per month. This plan will offer access to support and other advanced features as well.

At its core, Diffblue uses unsupervised learning to build these unit tests. “What we’re doing is unique in the sense that there have been tools before that use what’s called static analysis,” Diffblue CEO Mathew Loge, who joined the company about a year ago, explained. “They look at the program and they basically understand the path through the program and try and work backwards from the path. So if the path gets to this point, what inputs do we need to put into the program in order to get here?” That approach has its limitations, though, which Diffblue’s reinforcement learning method aims to get around.

Once the process has run its course, Diffblue provides developers with readable tests. That’s important, Loge stressed, because if a test fails and a developer can’t figure out what happened, it’s virtually impossible for the developer to fix the issue. That’s something the team learning the hard way, as early version so Diffblue used a very aggressive algorithm that provided great test coverage (the key metric for unit tests), but made it very hard for developers to figure out what was happening.

With the community edition, which doesn’t offer the command-line interface (CLI) of Diffblue’s paid editions, developers can write their code in IntelliJ as before and then simply click a button to have Diffblue write the tests for that code.

“The Community Edition is designed to be very accessible. It is literally one click in the IDE and you get your tests. The CLI version is more sophisticated and it covers more cases and solves for teams and large deployments inside of an organization,” Loge explained.

The company plans to add support for other languages, including Python, JavaScript and C# over time, but as Loge noted, Java has long been a mainstay in the business world and the team felt like that would be the best language to start with. As Loge noted, though, the technology

Diffblue has actually been around for a bit. The company raised a $22 million Series A round led by Goldman Sachs and with participation from Oxford Sciences Innovation and the Oxford Technology and Innovations Fund in 2017. You obviously don’t raise that kind of money to focus only on unit tests for Java code. Besides support for more language, unit tests are just the first step in the company’s overall goal of automating more of the programming process with the help of AI.

“We started with testing because it’s an important and urgent problem, especially with the impact that it has on DevOps and the adoption of more rapid software cycles,” Loge said. The next obvious step is to then take a similar approach to automatically fixing bugs — and especially security bugs — in code as well.

“The idea is that there are these steppingstones to machines writing more and more code,” he said. “And also, frankly, it’s a way of getting developers used to that. Because developer acceptance is a crucial part of making this successful.”

#artificial-intelligence, #aws, #ceo, #developer, #devops, #diffblue, #goldman-sachs, #java, #javascript, #machine-learning, #oxford-university, #python, #recent-funding, #software-development, #software-testing, #startups, #tc, #test

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What We Know About the C.D.C.’s Covid-19 Vaccine Plans

The agency told public health agencies that two unidentified vaccines might be ready by October or November. We explain how vaccine trials work, when one might be ready, and who may get them first.

#advisory-committee-on-immunization-practices, #astrazeneca-plc, #centers-for-disease-control-and-prevention, #clinical-trials, #coronavirus-2019-ncov, #medicine-and-health, #moderna-inc, #oxford-university, #pfizer-inc, #vaccination-and-immunization, #your-feed-science

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Coronavirus Crisis Has Made Brazil an Ideal Vaccine Laboratory

Widespread contagion, a deep bench of scientists and a robust vaccine-making infrastructure have made Brazil an important player in the quest to find a vaccine.

#astrazeneca-plc, #brazil, #coronavirus-2019-ncov, #oxford-university, #pfizer-inc, #vaccination-and-immunization

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The Vaccine Trust Problem

Why developing a coronavirus vaccine may be easier than persuading people to get it.

#coronavirus-2019-ncov, #oxford-university, #rumors-and-misinformation, #trump-donald-j, #vaccination-and-immunization

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State-backed COVID-19 disinfo spreads faster and farther than local news outlets in 4 languages

Questionable stories on COVID-19 from state-backed outlets in Russia, China, Turkey, and Iran are being shared more widely than reporting by major news organizations around the world, according to Oxford analysts. French German, Spanish and English news sites see far less social engagement than these foreign-originated ones in their languages.

The study is part of ongoing monitoring of COVID-19 disinformation campaigns by the Computational Propaganda Project. The group found that major outlets like Le Monde, Der Spiegel, and El Pais are being outshared four or five to one in some metrics by content from Russia Today, China Radio International, and other state-backed organizations.

Earlier reports focused on English-language sharing of this type of media, which can be generally described as act-adjacent with a strong emphasis on certain narratives. The repeated finding was that although mainstream news outlets have an overall stronger presence, state-backed and junk news is way ahead in engagement per post or article. In the latest report it is shown that on average, mainstream articles collect about 25 engagements per post, while state-backed items get 125. When multiplied by millions of users and followers, that becomes an enormous discrepancy.

There is more nuance to the data than that, of course, but it gives a general idea of what’s happening: disinformation is being spread widely, whether by bots or organic reach, while ordinary news sources only reach a similar amount of people through more output and wider initial reach. It wasn’t, however, clear whether this was the case outside English-language media.

It certainly seems to be, according to data collected over three weeks from a variety of news sources. Mainstream media had a larger overall reach but state-backed media often produced far higher engagement per article. This is perhaps explained by the fact that the state-backed organizations tended to pursue and push controversies and divisive narratives. As the study puts it:

  • Russian outlets working in French and German consistently emphasized weak democratic institutions and civil disorder in Europe, but offered different kinds of conspiracy theories about the pandemic;
  • Chinese and Turkish outlets working in Spanish promoted their own countries’ global leadership in combating the pandemic, while Russian and Iranian outlets generated polarizing content targeted at Latin America and Spanish-speaking social media users in the United States.

That sort of clickbait spreads like wildfire on social media, of course, and few of those who thoughtlessly hit that share button will have the inclination to check whether the source is a government-backed news agency plainly attempting to sow discord.

On the other hand, it seems as if some consider turnabout fair play. For example: a Chinese state-backed news countering the flourishing U.S. conspiracy theory that the virus is a Chinese bioweapon with a counter-theory that it is a U.S. bioweapon released in and blamed on China.

“Many of these state-backed outlets blend reputable, fact-based reporting about the coronavirus with misleading or false information, which can lead to greater uncertainty among public audiences trying to make sense of the Covid-19 pandemic,” said Oxford’s Katarian Rebello in a news release.

The countries and state-backed outlets mentioned also have a major presence in Arabic language markets and the researchers are working on a follow-up study inclusive of those.

#coronavirus, #covid-19, #oxford, #oxford-university, #pandemic, #science, #social

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Breakthrough Drug for Covid-19 May Be Risky for Mild Cases

That study about dexamethasone has arrived with a big asterisk: While it appears to help severely ill patients, it harms others.

#clinical-trials, #coronavirus-2019-ncov, #dexamethasone-drug, #drugs-pharmaceuticals, #immune-system, #oxford-university, #steroids, #your-feed-science

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U.K. Grapples With Its Role in Atlantic Slave Trade

Two prominent firms, Lloyd’s of London and Greene King, have acknowledged their ties to the slave trade and pledged to make amends.

#black-lives-matter-movement, #bristol-england, #caribbean-area, #churchill-winston-leonard-spencer, #colston-edward-1636-1721, #george-floyd-protests-2020, #greene-king-plc, #johnson-boris, #liverpool-england, #lloyds-of-london, #oxford-university, #reparations, #slavery-historical

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Dexamethasone Reduces Coronavirus Deaths, Scientists Say

A steroid, dexamethasone, is the first drug shown to help save severely ill coronavirus patients, according to scientists in Britain.

#clinical-trials, #coronavirus-2019-ncov, #dexamethasone-drug, #drugs-pharmaceuticals, #oxford-university

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‘Get Rid of Them’: A Statue Falls as Britain Confronts Its Racist History

When demonstrators dumped the monument to a slave trader into Bristol Harbor, they galvanized a debate that echoes conversations happening in the American South about statues of Confederate generals.

#bristol-england, #coronavirus-2019-ncov, #demonstrations-protests-and-riots, #george-floyd-protests-2020, #johnson-boris, #monuments-and-memorials-structures, #oxford-university, #police-brutality-misconduct-and-shootings, #rhodes-cecil, #slavery-historical

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U.K. Lab to Sidestep Drug Industry to Sell Potential Virus Vaccine

Imperial College aims to develop a vaccine that is cheaper and easier to manufacture and is forming a partnership to sell it in low-income countries and Britain.

#coronavirus-2019-ncov, #great-britain, #imperial-college-london, #morningside-ventures-inc, #oxford-university, #vaccination-and-immunization

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Trump Narrows Search for Coronavirus Vaccine to Five Firms

The White House is eager to project progress, but the public-private partnership it has created still faces scientific hurdles, internal tensions and questions from Congress.

#astrazeneca-plc, #azar-alex-m-ii, #clinical-trials, #coronavirus-2019-ncov, #coronavirus-aid-relief-and-economic-security-act-2020, #drugs-pharmaceuticals, #health-and-human-services-department, #johnsonjohnson, #marks-peter, #merckcompany-inc, #moderna-inc, #oxford-university, #perna-gustave-f, #pfizer-inc, #public-private-sector-cooperation, #slaoui-moncef-m, #trump-donald-j, #vaccination-and-immunization

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The Coronavirus Vaccine May Have a Shortcut: Infecting Volunteers

Should we take it?

#clinical-trials, #coronavirus-2019-ncov, #debatable, #ethics-personal, #oxford-university, #respiratory-diseases, #smallpox, #viruses

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In Race for a Coronavirus Vaccine, an Oxford Group Leaps Ahead

As scientists at the Jenner Institute prepare for mass clinical trials, new tests show their vaccine to be effective in monkeys.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #epidemics, #great-britain, #jenner-institute, #laboratories-and-scientific-equipment, #oxford-university, #tests-medical, #vaccination-and-immunization

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EU lawmakers set out guidance for coronavirus contacts tracing apps

The European Commission has published detailed guidance for Member States on developing coronavirus contacts tracing and warning apps.

The toolbox, which has been developed by the e-Health Network with the support of the Commission, is intended as a practical guide to implementing digital tools for tracking close contacts between device carriers as a proxy for infection risk that seeks to steer Member States in a common, privacy-sensitive direction as they configure their digital responses to the COVID-19 pandemic.

Commenting in a statement, Thierry Breton — the EU commissioner for Internal Market — said: Contact tracing apps to limit the spread of coronavirus can be useful, especially as part of Member States’ exit strategies. However, strong privacy safeguards are a pre-requisite for the uptake of these apps, and therefore their usefulness. While we should be innovative and make the best use of technology in fighting the pandemic, we will not compromise on our values and privacy requirements.”

“Digital tools will be crucial to protect our citizens as we gradually lift confinement measures,” added Stella Kyriakides, commissioner for health and food safety, in another supporting statement. “Mobile apps can warn us of infection risks and support health authorities with contact tracing, which is essential to break transmission chains. We need to be diligent, creative, and flexible in our approaches to opening up our societies again. We need to continue to flatten the curve – and keep it down. Without safe and compliant digital technologies, our approach will not be efficient.”

The Commission’s top-line “essential requirements” for national contacts tracing apps are that they’re:

  • voluntary;
  • approved by the national health authority;
  • privacy-preserving (“personal data is securely encrypted”); and
  • dismantled as soon as no longer needed

In the document the Commission writes that the requirements on how to record contacts and notify individuals are “anchored in accepted epidemiological guidance, and reflect best practice on cybersecurity, and accessibility”.

“They cover how to prevent the appearance of potentially harmful unapproved apps, success criteria and collectively monitoring the effectiveness of the apps, and the outline of a communications strategy to engage with stakeholders and the people affected by these initiatives,” it adds.

Yesterday, setting out a wider roadmap to encourage a co-ordinated lifting of the coronavirus lockdown, the Commission suggested digital tools for contacts tracing will play a key role in easing quarantine measures.

Although today’s toolbox clearly emphasizes the need to use manual contact tracing in parallel with digital contact tracing, with such apps and tools envisaged as a support for health authorities — if widely rolled out — by enabling limited resources to be more focused toward manual contacts tracing.

“Manual contact tracing will continue to play an important role, in particular for those, such as elderly or disabled persons, who could be more vulnerable to infection but less likely to have a mobile phone or have access to these applications,” the Commission writes. “Rolling-out mobile applications on a large-scale will significantly contribute to contact tracing efforts also allowing health authorities to carry manual tracing in a more focussed manner.”

“Mobile apps will not reach all citizens given that they rely on the possession and active use of a smart phone. Evidence from Singapore and a study by Oxford University indicate that 60-75% of a population need to have the app for it to be efficient,” it adds in a section on accessibility and inclusiveness. “However, non-users will benefit from any increased population disease control the widespread use of such an app may bring.”

The toolbox also reiterates a clear message from the Commission in recent days that “appropriate safeguards” must be embedded into digital contacts tracing systems. Though it’s less clear whether all Member States are listening to memos about respecting EU rights and freedoms, as they scrambled for tech and data to beat back COVID-19.

“This digital technology, if deployed correctly, could contribute substantively to containing and reversing its spread. Deployed without appropriate safeguards, however, it could have a significant negative effect on privacy and individual rights and freedoms,” the Commission writes, further warning that: “A fragmented and uncoordinated approach to contact tracing apps risks hampering the effectiveness of measures aimed at combating the COVID-19 crisis, whilst also causing adverse effects to the single market and to fundamental rights and freedoms.”

On safeguards the Commission has a clear warning for EU Member States, writing: “Any contact tracing and warning app officially recognised by Member States’ relevant authorities should present all guarantees for respect of fundamental rights, and in particular privacy and data protection, the prevention of surveillance and stigmatization.”

Its list of key safeguards notably includes avoiding the collection of any location data.

“Location data is not necessary nor recommended for the purpose of contact tracing apps, as their goal is not to follow the movements of individuals or to enforce prescriptions,” it says. “Collecting an individual’s movements in the context of contact tracing apps would violate the principle of data minimisation and would create major security and privacy issues.”

The toolbox also emphasizes that such contacts tracing/warning systems be temporary and voluntary in nature — with “automated/gentle self-dismantling, including deletion of all remaining personal data and proximity information, as soon as the crisis is over”.

“The apps’ installation should be consent-based, while providing users with complete and clear information on intended use and processing,” is another key recommendation. 

The toolbox leans towards suggesting a decentralized approach, in line with earlier Commission missives, with a push for: “Safeguards to ensure the storing of proximity data on the device and data encryption.”

Though the document also includes some discussion of alternative centralized models which involve uploading arbitrary identifiers to a backend server held by public health authorities. 

Users cannot be directly identified through these data. Only the arbitrary identifiers generated by the app are stored on the server. The advantage is that the data stored in the server can be anonymised by aggregation and further used by public authorities as a source of important aggregated information on the intensity of contacts in the population, on the effectiveness of the app in tracing and alerting contacts and on the aggregated number of people that could potentially develop symptoms,” it writes. 

“None of the two options [decentralized vs centralized] includes storing of unnecessary personal information,” it adds, leaving the door open to states that might want their public health authorities to be responsible for centralized data processing.

However the Commission draws a clear distinction between centralized approaches that use arbitrary identifiers and those that store directly-identifiable data on every user — with the latter definitely not recommended.

They would have “major disadvantage”, per the toolbox, because they “would not keep personal data processing to the absolute minimum, and so people may be less willing to install and use the app”.

“Centralised storage of mobile phone numbers could also create risks of data breaches and cyberattacks,” the Commission further warns.

Discussing cross-border interoperability requirements, the toolbox highlights the necessity for a grab-bag of EU contacts tracing apps to be interoperable, in order to successfully break cross-border transmission chains, which requires national health authorities to be technically able to exchange available information about individuals infected with and/or exposed to COVID-19.

“Tracing and warning apps should therefore follow common EU interoperability protocols so that the previous functionalities can be performed, and particularly safeguarding rights to privacy and data protection, regardless of where a device is in the EU,” it suggests.

On preventing the spread of harmful or unlawful apps the document suggests Member States consider setting up a national system of evaluation/accreditation endorsement of national apps, perhaps based on a common set of criteria (that would need to be defined).

“A close cooperation between health and digital authorities should be sought whenever possible for the evaluation/endorsement of the apps,” it writes. 

The Commission also says “close cooperation with app stores will be needed to promote national apps and promote uptake while delisting harmful apps” — putting Apple and Google squarely in the frame.

Earlier this week the pair announced their own collaboration on coronavirus contracts tracing — announcing a plan to offer an API and later opt-in system-level contacts tracing, based on a decentralized tracking architecture with ephemeral IDs processed locally on devices, rather than being uploaded and held on a central server.

Given the dominance of the two tech giants their decision to collaborate on a decentralized system may effectively deprive national health authorities of the option to gain buy in for systems that would give those publicly funded bodies access to anonymized and aggregated data for coronavirus modelling and/or tracking purposes. Which should, in the middle of a pandemic, give more than a little pause for thought.

A note in the toolbox mentions Apple and Google — with the Commission writing that: “By the end of April 2020, Member States with the Commission will seek clarifications on the solution proposed by Google and Apple with regard to contact tracing functionality on Android and iOS in order to ensure that their initiative is compatible with the EU common approach.”

#android, #api, #apple, #apps, #articles, #contact-tracing, #digital-rights, #europe, #european-commission, #european-union, #food-safety, #google, #health, #human-rights, #identity-management, #law, #mobile-app, #oxford-university, #privacy, #singapore, #smart-phone, #terms-of-service, #thierry-breton

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