Patient receives Covid-19 vaccine.

10 Design Considerations for Vaccine Credentials

By Adrian Gropper

As COVID-19 vaccines become widely, if not fairly, available in different regions, both the public and private sector are working to develop vaccine credentials and associated surveillance systems.

Information technology applied to vaccination can be effective, but it can also be oppressive, discriminatory, and counter-productive.

But these systems can be tuned to reflect and address key concerns.

What follows is a list of ten separable concerns, and responsive design strategies. The concept of separation of concerns in technology design offers a path to better health policy. Because each concern hardly interacts with the others, any of them can be left out of the design in order to prioritize more important outcomes. Together, all of them can maximize scientific benefit while enhancing social trust.

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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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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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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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green, red, and yellow qr codes on phones.

The Promise and Pitfalls of China’s QR Codes as Health Certificates

This article is adapted from a longer paper published in the Harvard Journal of Law and Technology (JOLT)’s Digest section. To access the original paper, please visit JOLT.

By April Xiaoyi Xu

At this point in the COVID-19 pandemic, China has successfully managed to contain the spread of the virus, due in large part to its technological strategy, which uses QR codes as a kind of health certificate.

These color-coded QR codes are automatically generated using cell phone data. Green indicates that an individual is healthy and can move freely, yellow signals that the user must quarantine for up to seven days, and red for fourteen days. The basis for these determinations, as well as the extent of the data collected in order to make them, remains opaque.

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lady justice.

Computational Psychiatry for Precision Sentencing in Criminal Law

By Francis X. Shen

A core failing of the criminal justice system is its inability to individualize criminal sentences and tailor probation and parole to meet the unique profile of each offender.

As legal scholar, and now federal judge Stephanos Bibas has observed, “All too often … sentencing guidelines and statutes act as sledgehammers rather than scalpels.”

As a result, dangerous offenders may be released, while offenders who pose little risk to society are left behind bars. And recidivism is common — the U.S. has an astounding recidivism rate of 80% — in part because the current criminal justice system largely fails to address mental health challenges, which are heavily over-represented in the justice system.

Advances in computational psychiatry, such as the deep phenotyping methods explored in this symposium, offer clinicians newfound abilities to practice precision psychiatry. The idea behind precision psychiatry is both simple and elusive: treat individuals as individuals. Yet advancing such a program in practice is “very ambitious” because no two individual brains — and the experiences those brains have had over a lifetime — are the same.

Deep phenotyping offers the criminal justice system the tools to improve public safety, identify low-risk offenders, and modify decision-making to reduce recidivism. Computational psychiatry can lead to what can be described as precision sentencing.

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phone camera

Deep Phenotyping Could Help Solve the Mental Health Care Crisis

By Justin T. Baker

The United States faces a growing mental health crisis and offers insufficient means for individuals to access care.

Digital technologies — the phone in your pocket, the camera-enabled display on your desk, the “smart” watch on your wrist, and the smart speakers in your home — might offer a path forward.

Deploying technology ethically, while understanding the risks of moving too fast (or too slow) with it, could radically extend our limited toolkit for providing access to high-quality care for the many individuals affected by mental health issues for whom the current mental health system is either out of reach or otherwise failing to meet their need.

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Life preserver on boat.

Incidental Findings in Deep Phenotyping Research: Legal and Ethical Considerations

By Amanda Kim, M.D., J.D., Michael Hsu, M.D., Amanda Koire, M.D., Ph.D., Matthew L. Baum, M.D., Ph.D., D.Phil.

What obligations do researchers have to disclose potentially life-altering incidental findings (IFs) as they happen in real time?

Deep phenotyping research in psychiatry integrates an individual’s real-time digital footprint (e.g., texts, GPS, wearable data) with their biomedical data (e.g., genetic, imaging, other biomarkers) to discover clinically relevant patterns, usually with the aid of machine learning. Findings that are incidental to the study’s objectives, but that may be of great importance to participants, will inevitably arise in deep phenotyping research.

The legal and ethical questions these IFs introduce are fraught. Consider three hypothetical cases below of individuals who enroll in a deep phenotyping research study designed to identify factors affecting risk of substance use relapse or overdose:

A 51-year-old woman with alcohol use disorder (AUD) is six months into sobriety. She is intrigued to learn that the study algorithm will track her proximity to some of her known triggers for alcohol relapse (e.g., bars, liquor stores), and asks to be warned with a text message when nearby so she can take an alternative route. Should the researchers share that data?

A 26-year-old man with AUD is two years into sobriety. Three weeks into the study, he relapses. He begins arriving to work inebriated and loses his job. After the study is over, he realizes the researchers may have been able to see from his alcohol use surveys, disorganized text messages, GPS tracking, and sensor data that he may have been inebriated at work, and wishes someone had reached out to him before he lost his job. Should they have?

A 35-year-old man with severe opioid use disorder experiences a near-fatal overdose and is discharged from the hospital. Two weeks later, his smartphone GPS is in the same location as his last overdose, and his wearable detects that his respiratory rate has plummeted. Should researchers call EMS? Read More

Pen hovering over words "I agree" with check box next to it.

Unique Challenges to Informed Consent in Deep Phenotyping Research

By Benjamin C. Silverman

Deep phenotyping research procedures pose unique challenges to the informed consent process, particularly because of the passive and boundless nature of the data being collected and how this data collection overlaps with our everyday use of technology.

As detailed elsewhere in this symposium, deep phenotyping in research involves the collection and analysis of multiple streams of behavioral (e.g., location, movement, communications, etc.) and biological (e.g., imaging, clinical assessments, etc.) data with the goal to better characterize, and eventually predict or intervene upon, a number of clinical conditions.

Obtaining voluntary competent informed consent is a critical aspect to conducting ethical deep phenotyping research. We will address here several challenges to obtaining informed consent in deep phenotyping research, and describe some best practices and relevant questions to consider.

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