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Top Health Considerations in the European Commission’s ‘Harmonised Rules on Artificial Intelligence’

By Rachele Hendricks-Sturrup

On April 21, 2021, the European Commission released a “first-ever” legal framework on artificial intelligence (AI) in an attempt to address societal risks associated with AI implementation.

The EU has now effectively set a global stage for AI regulation, being the first nation of member states to create a legal framework with specific intent to address or mitigate potentially harmful effects of broad AI implementation.

Within the proposed framework, the Commission touched on a variety of considerations and  “high-risk” AI system scenarios. The Commission defined high-risk AI systems as those that pose significant (material or immaterial) risks to the health and safety or fundamental rights of persons.

This post outlines four key considerations in the proposal with regard to health: 1) prioritizing emergency health care; 2) law enforcement profiling as a social determinant of health; 3) immigrant health risk screening; and 4) AI regulatory sandboxes and a health data space to support AI product commercialization and public health innovation.

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Fake Vaccine Cards and the Challenges of Decentralized Health Data

By Carmel Shachar and Chloe Reichel

Soon the U.S. will have vaccinated all adults who are not vaccine hesitant. Our next key challenges will be reopening workplaces, restaurants, schools, and other public areas, as well as encouraging vaccine uptake among those who are hesitant or resistant to the vaccine.

Vaccine passports or certifications could be a tool used to address both of those challenges.

But our approach to health care data management may undermine this next stage of the pandemic response.

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EU flag and digital health pass.

Are COVID Certificates the Answer to Safe EU Travel During the Pandemic?

By Iris Goldner Lang

On March 17, the European Commission put forward its Proposal for a Regulation on Digital Green Certificates which would facilitate safe EU cross-border movement for purposes of work and tourism.

Considering the length of the EU decision-making process and the technical work that will need to be done, the digital green certificates will not be ready for use until late June or July this year.

The proposed certificates will include three categories of EU citizens and third-country nationals legally staying/residing in the EU: those who have been vaccinated against COVID-19, those who have recovered from COVID-19, and those who can produce a negative test result. A non-EU national travelling to the EU – such as a U.S. citizen – could request a digital green certificate from an EU Member State he/she is travelling to, by providing all the relevant information to the national authorities, which would then have to assess whether to issue the certificate.

The proposed EU certificates would also allow the Commission to issue a decision recognizing certificates issued by third countries to EU citizens and their family members, where such certificates meet quality standards and are interoperable with the EU system. Additionally, the Commission intends to make certificates compatible with systems in third countries, such as the U.S,, and is open to global initiatives.

EU Member States’ reactions to this initiative have been diverse. While some Member States – particularly those dependent on tourism – such as Cyprus, Greece, Italy, Portugal, Iceland, Denmark, and Spain – support the initiative, others – like Belgium, France, Germany and the Netherlands – express concerns. In the meantime, both Greece and Cyprus have reached agreements with Israel that should enable their citizens who have been vaccinated to travel between these two EU Member States and Israel without the need to quarantine.

This blog post examines what the European Commission sees as the three main advantages of its Proposal for digital green certificates – the first being that digital green certificates facilitate EU cross-border movement, the second that they preclude more restrictive national measures, and the third that they prevent discrimination.

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