Category: Privacy

hands hold phone with app heart and activity on screen over table in office

Perspectives on Data Privacy for Direct-to-Consumer Health Apps

Sara Gerke Leave a comment

By Sara Gerke and Chloe Reichel

Direct-to-consumer (DTC) health apps, such as apps that manage our diet, fitness, and sleep, are becoming ubiquitous in our digital world.

These apps provide a window into some of the key issues in the world of digital health — including data privacy, data access, data ownership, bias, and the regulation of health technology.

To better understand these issues, and ways forward, we contacted key stakeholders representing a range of perspectives in the field of digital health for their brief answers to five questions about DTC health apps.

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COVID-19 and the New Reproductive Justice Movement

The Petrie-Flom Center Staff Leave a comment

By Mary Ziegler

The COVID-19 pandemic has transformed advocacy for reproductive rights and reproductive justice in what previously had been called an endless, unchanging, and intractable abortion conflict.

The pandemic — and the stay-at-home orders it required — finally shifted the movement’s focus to abortion access, rather than abortion rights, as exemplified by its emphasis on medication and telehealth abortion.

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

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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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A Proposal for Localized Review to Safeguard Genetic Database Privacy

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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

Chloe Reichel Leave a comment

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

The Petrie-Flom Center Staff Leave a comment

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

Carmel Shachar Leave a comment

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?

The Petrie-Flom Center Staff Leave a comment

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

Chloe Reichel Leave a comment

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-Enabled Pharmaceutical Delivery: Navigating Regulatory Turbulence

Vrushab Gowda Leave a comment

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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