Illustration of multicolored profiles. An overlay of strings of ones and zeroes is visible

We Need to Do More with Hospitals’ Data, But There Are Better Ways

By Wendy Netter Epstein and Charlotte Tschider

This May, Google announced a new partnership with national hospital chain HCA Healthcare to consolidate HCA’s digital health data from electronic medical records and medical devices and store it in Google Cloud.

This move is the just the latest of a growing trend — in the first half of this year alone, there have been at least 38 partnerships announced between providers and big tech. Health systems are hoping to leverage the know-how of tech titans to unlock the potential of their treasure troves of data.

Health systems have faltered in achieving this on their own, facing, on the one hand, technical and practical challenges, and, on the other, political and ethical concerns.

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Illustration of a man and a woman standing in front of a DNA helix

A Proposal for Localized Review to Safeguard Genetic Database Privacy

By Robert I. Field, Anthony W. Orlando, and Arnold J. Rosoff

Large genetic databases pose well-known privacy risks. Unauthorized disclosure of an individual’s data can lead to discrimination, public embarrassment, and unwanted revelation of family secrets. Data leaks are of increasing concern as technology for reidentifying anonymous genomes continues to advance.

Yet, with the exception of California and Virginia, state legislative attempts to protect data privacy, most recently in Florida, Oklahoma, and Wisconsin, have failed to garner widespread support. Political resistance is particularly stiff with respect to a private right of action. Therefore, we propose a federal regulatory approach, which we describe below.

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Washington, DC, USA - Closeup view of December, 23, 2020: COVID-19 Vaccination Record Card by CDC on blurred documents background.

Key Considerations for the Ethical Design of COVID-19 Vaccine Passports

By Chloe Reichel

States, employers, retailers, and other industries are now grappling with how to update mask policies in light of recent CDC guidance, which suggests vaccinated individuals may remove their face coverings indoors. 

But without a system in place to discern who has been vaccinated, the guidance poses a major risk: unvaccinated individuals, who can still contract and spread the virus, may also opt to go maskless. 

COVID-19 digital health passes, often called vaccine passports, may prove useful as a tool to relax mask policies. Vaccine passports can help to verify whether individuals may safely enter a space without a face covering.

Their ethical implementation, however, is contingent upon a number of factors: first and foremost, equitable access to vaccines. Other considerations include minimizing distrust, accessibility, risks of discrimination, and privacy protections.

For policy makers considering the implementation of COVID-19 vaccine credentialing programs, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Edmond J. Safra Center for Ethics at Harvard University have developed a road map highlighting key considerations for their ethical design.

This post provides a summary of key considerations and responsive policy recommendations presented in the paper to guide more equitable implementation of vaccine passports and to minimize distrust.

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Key Takeaways from Petrie-Flom Center Discussion on Vaccine Passports

As mask mandates fall to the wayside, COVID-19 digital health passes, often called vaccine passports, hold promise as a tool to verify whether individuals may enter a space without a face covering.

Vaccine passports, however, also pose a number of ethical and legal challenges. Panelists discussed these concerns during an April 28 webinar hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics titled, “Vaccine Passports: A Path to the New Normal?”

This article highlights key points made during the conversation.

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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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globe.

‘I Think of It in Terms of Years’: The Future of the COVID-19 Pandemic in South Africa

By Chloe Reichel

“No One Is Safe Until Everyone Is Safe” goes the rallying cry for global vaccine equity.

We would think that the COVID-19 pandemic already has made this point clear enough.

And yet, pundits are heralding the “end” of the pandemic in the U.S., all while viral variants that may be capable of evading the protection of vaccines continue to crop up both domestically and internationally.

In this Q&A, South African journalist and human rights activist Mark Heywood offers a look at the national COVID-19 epidemic in South Africa. The sobering reality there, in terms of morbidity and mortality, and in terms of expectations for the future, underscores the urgency for globally coordinated leadership and action to address the pandemic.

Our conversation from late March 2021, which has been edited and condensed, follows.

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Drone hovering in air above mountain range.

Drone-Enabled Pharmaceutical Delivery: Navigating Regulatory Turbulence

By Vrushab Gowda

The burgeoning industry of drone-enabled pharmaceutical delivery offers a number of advantages over its low-tech forebears, not least including patient convenience.

It minimizes exposure to infection and potentially protects patient anonymity, all while reducing wait times relative to in-person or traditional mail-order pharmacies. Additionally, drones can broaden access to medications in resource-poor areas, including locations with low densities of health care facilities, and those where underdeveloped transportation links hinder ground delivery.

However, drone delivery of pharmaceuticals enters into a nebulous legal environment, sitting as it does at the intersection of healthcare, privacy law, and aviation regulation. It is, moreover, a dynamic landscape, which continues to evolve with new federal rules, judicial decisions, and corporate practices.

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Cape Town, South Africa - 6 April 2020 : Empty streets and stay home sign in Cape Town during the Coronavirus lockdown.

One Year Later: COVID-19, Human Rights, and the Rule of Law in South Africa

By Chloe Reichel

South Africa has faced a devastating national COVID-19 epidemic, with over 1.5 million confirmed cases, and over 50,000 confirmed deaths.

The true toll, in terms of cases and deaths, is likely much higher. Research shows the country has recorded 150,000 excess deaths since May 2020.

The pandemic has also profoundly affected South Africans’ constitutionally recognized rights.

Since the start of the pandemic, the country has experienced varying degrees of lockdown, which, at different points, included a curfew, bans on the sale of alcohol and tobacco, and the closure of most businesses. The lockdown has been enforced strictly, resulting in hundreds of thousands of arrests for violations.

Mark Heywood highlighted some of these rights concerns last June in “Human Rights, the Rule of Law, and COVID-19 in South Africa,” a contribution to Bill of Health‘s digital symposium on global responses to COVID-19.

I spoke with Heywood in late March 2021 to get an update on the state of human rights and the rule of law in South Africa one year into the COVID-19 pandemic. Our conversation, which has been edited and condensed, follows.

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Passport in suitcase.

Ethical, Legal, and Scientific Challenges for COVID-19 Vaccine Passports

By Chloe Reichel

As COVID-19 vaccines become more widespread, passports that certify immunization status may facilitate a return to normalcy, write Lawrence O. Gostin, I. Glenn Cohen, and Jana Shaw in a viewpoint published today in JAMA.

But these vaccine passports, or digital health passes, are not without scientific, legal, and ethical challenges.

I asked Gostin, Faculty Director of the O’Neill Institute for National and Global Health Law at Georgetown University Law Center, Cohen, Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and Shaw, a professor of pediatrics at Upstate Medical University, about the key areas of concern and promise for vaccine passports. Our conversation, which has been edited and condensed, follows.

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