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.

Read More

Senior citizen woman in wheelchair in a nursing home.

Telehealth and the Future of Long-Term Care

Join us on Wednesday, April 7 for further discussion of these issues during our virtual event, “Triumphs & Tensions of the Telehealth Boom.

By Tara Sklar

The COVID-19 pandemic accelerated the trend away from providing health care and long-term care in institutional settings in ways not previously imagined; the result of a reckoning with the massacre that disproportionately killed hundreds of thousands of older adults living in nursing homes or similar congregate facilities, along with the staff who cared for them.

Beyond the immediate staffing and infection control issues at hand, this juncture leads to a larger question, in the U.S. and abroad: how can we best care for an older population in the decades — and not just years — ahead?

The major advances and shortfalls that have surfaced during the pandemic around telehealth and its related technologies in digital home health care are essential to this discussion.

Read More

Doctor Holding Cell Phone. Cell phones and other kinds of mobile devices and communications technologies are of increasing importance in the delivery of health care. Photographer Daniel Sone.

Viewing Telehealth Policymaking Through the Lens of Disability

Join us on Wednesday, April 7 for further discussion of these issues during our virtual event, “Triumphs & Tensions of the Telehealth Boom.

By Laura C. Hoffman

As a means for delivering health care, telehealth will only be as successful as it is accessible to our most vulnerable populations.

Although the utilization of telehealth has the great potential to increase access to health care while simultaneously reducing barriers to access for individuals, people with disabilities face multiple barriers to telehealth. The COVID-19 pandemic has further highlighted these challenges.

Read More

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.

Read More

Apple watch and fit bit.

Beyond HIPAA: A Proposed Self-Policing Framework for Digital Health Products

By Vrushab Gowda

As digital health products proliferate, app developers, hardware manufacturers, and other entities that fall outside Health Insurance Portability and Accountability Act (HIPAA) regulation are collecting vast amounts of biometric information. This burgeoning market has spurred patient privacy and data stewardship concerns.

To this end, two policy nonprofits – the Center for Democracy and Technology (CDT) and the eHealth Initiative (eHI) – earlier this month jointly published a document detailing self-regulatory guidelines for industry. The following piece traces the development of the “Proposed Consumer Privacy Framework for Health Data,” provides an overview of its provisions, and offers critical analysis.

Read More

Code on computer.

How to Secure Our Digital Health Infrastructure Against Cyber Attacks

By Vrushab Gowda

Our health information infrastructure is highly susceptible to cyber attacks. At the time of writing, the Department of Health and Human Services (HHS) is actively investigating over 700 major breaches over the past 24 months alone.

It is incumbent upon our institutions to proactively guard against these threats, with our federal government leading the charge.

Read More

Cartoon of contact tracing for COVID-19.

The Constitutionality of Technology-Assisted Contact Tracing

Cross-posted from COVID-19 and The Law, where it originally appeared on December 1, 2020. 

By

The COVID-19 pandemic has posed an impossible set of choices for governments, forcing them to weigh the competing interests of protecting public health, ending social isolation, and safeguarding privacy and civil rights. Each of these ends offer distinct societal benefits, but without a vaccine or effective COVID treatment, governments can only accomplish two of the three at one time. South Korea provides an interesting example of the tradeoffs countries have made in pursuit of these competing objectives. The country is widely regarded as a model for successfully managing the pandemic, averaging approximately 77 new cases a day since April—roughly the equivalent of 480 cases a day in U.S. population terms. South Korea’s story is especially impressive given that, in March, the country was considered one of the biggest infection hot spots outside of China. Comparing these statistics with the actual infection rate in the U.S. illustrates the success of the South Korean approach: on November 23, 2020, the CDC reported 147,840 new cases, for a total of 12,175,921 known infections in the U.S. since the pandemic began.

Click here to read the full post on COVID-19 and The Law.

Doctor Holding Cell Phone. Cell phones and other kinds of mobile devices and communications technologies are of increasing importance in the delivery of health care. Photographer Daniel Sone.

Clash of Titans? A Brewing Dispute between Telehealth Giants

By Vrushab Gowda

Competition between rival telehealth providers spilled into open conflict last month, as incumbent Teladoc Health, Inc. (Teladoc) filed a patent infringement suit against relative upstart American Well Corporation (Amwell).

This development marks a significant escalation in what has been a lengthy arms race between the two publicly traded entities. Both having witnessed skyrocketing sales in recent months, aided by a shift to virtual care and a host of regulatory flexibilities, although neither has turned a profit to date.

Read More

Illustration of cell phones and prescription pill bottles

Access as Equity: Efforts to Use Telemedicine to Expand Abortion Access

By Oliver Kim

I’ve written here before about areas where technology could play a role in providing access to complicated, controversial healthcare services. Earlier this year, I presented a forthcoming paper co-authored with a colleague on how technology can be used to provide greater equity in women’s health and how the law is being used to encourage such advances or block them. Given the political battles over women’s health, it should be no surprise that technology’s role in abortion access is under increasing scrutiny from lawmakers.

A medication abortion involves a two-step regimen: the woman first takes mifepristone, generally in a clinical setting, and 24 to 48 hours later, she takes misoprostol, generally in the privacy of her home. Recent research, though, suggests that women may not need to take mifepristone in a clinical setting: the World Health Organization revised its guidelines on whether the medications require “close medical supervision,” and a recent op-ed in the New England Journal of Medicine called on the Food and Drug Administration to revise its restrictions on mifepristone.

Given these findings, abortion providers have recognized that telemedicine could be utilized to expand access into areas where abortion services are limited due to geography, legal restrictions, or both. Since 2008, Planned Parenthood in Iowa has used telemedicine to overcome both provider shortages and geographic challenges: a physician can use video conferencing services to appear virtually at health centers across the state, reviewing a patient’s ultrasound and medical history remotely and providing counseling over a secure, private system. The majority of the medical literature finds that using telemedicine to provide medication abortions is just as safe and effective as if a woman met with a clinician in person.

As we discuss in our paper, when technology expands access to care that is politically controversial, policymakers may use the law to restrict such technological advances. In response to this use of telemedicine, states hostile to abortion began passing bans. When Iowa’s medical board attempted to restrict such a use of telemedicine, the Iowa Supreme Court struck down the board’s regulation, holding that it would be an undue burden on a woman’s right to an abortion. Some hailed the Iowa decision as groundbreaking and hopefully influential on other state supreme courts. (Later that same year, the U.S. Supreme Court in Whole Woman’s Health would strike down two Texas statutory restrictions on abortion providers as undue burdens on a woman’s right to an abortion.)

What I find interesting—and what came out after we submitted our paper—is how telemedicine and abortion are being treated in neighboring Kansas and how it reflects the larger legal debate over these issues. In 2011, Kansas first attempted to ban telemedicine abortions by requiring a physician to be physically present when administering mifepristone, thus eliminating the value of telemedicine. Subsequently, the Kansas state legislature modified the ban in 2015 by clarifying that a physician would not need to be physically present in a medical emergency; in 2018, the legislature passed explicit language in the Kansas Telemedicine Act that nothing in this new telemedicine legislation authorized the use of telemedicine for abortion. However, a Kansas court enjoined the Kansas attorney general, the only defendant in this line of cases, from enforcing this provision or the in-person requirements under the court’s prior 2011 decision.

Even more remarkable, in the same state that elected Sam Brownback governor twice, the Kansas Supreme Court recently held in Hodes & Nauser v. Schmidt that the Kansas constitution provided a fundamental right to an abortion.

Thus, it may seem surprising that in a subsequent decision, a district court refused to grant a preliminary injunction for Trust Women, a Wichita-based abortion provider, to prohibit the state from enforcing the telemedicine abortion restrictions. Part of this new case turns on standing as well as recognizing that the prior line of telemedicine-abortion cases only enjoined the state attorney general and was silent on whether the state health department or county attorneys were similarly enjoined from enforcing the telemedicine-abortion bans.

Further, the court also turned part of its decision on whether Trust Women would suffer an irreparable injury: the court found that there was insufficient evidence of an injury because Trust Women still required patients to be present physically at its Wichita clinic in its telemedicine pilot, and Trust Women had taken no preliminary steps to open clinics in remote rural parts of the state. Indeed, the court decried the prior telemedicine-abortion rulings as “a growing procedural backwater” and suggested that the court needs to be able “to resolve the underlying merits of the telemedicine abortion issue,” necessitating that “the parties… present additional evidence and more probing legal analysis than has occurred at this early stage.”

While the district court has significant discretion in considering a request for a preliminary injunction, it does feel troubling that the court suggests that Trust Women should have invested time and resources into a telemedicine strategy that might be illegal before seeking relief. In light of the bans and the legislature’s hostility, it seems unlikely that Trust Women could have raised the funds necessary to create a telemedicine infrastructure and build clinics in remote rural areas. After all, although the Kansas Supreme Court’s decision was not on the telemedicine restrictions, it seems unlikely that they would survive a strict scrutiny review under Hodes since the state will bear the burden of justifying the law. Moreover, it’s also likely that the restrictions might not survive review under Whole Woman’s Health given the weight of medical evidence that suggests singling out abortion from all other services provided by telemedicine, is suspect.

This is also playing out on the national stage as the Fifth Circuit in June Medical v. Gee seemingly sent a direct challenge to Whole Woman’s Health where the Fifth Circuit upheld Louisiana abortion restrictions that were basically identical to the Texas restrictions that were struck down. How June Medical is ultimately resolved will have ramifications for telemedicine in this particular context.

While medical evidence demonstrates that telemedicine is a safe means of providing medication abortion (as well as providing other benefits for women such as privacy), there are of course those that dispute this notion. One could see a conservative court finding that a telemedicine ban is not an undue burden: under the Trust Women preliminary injunction ruling, women in rural areas are no worse off than they were before since they never had access to abortion via telemedicine to begin with. Further, if waiting periods and similar barriers are upheld post-Whole Woman’s Health, this could put rural access even further at risk. In other words, a woman still has access to abortion, just not via telemedicine. Of course many such arguments could be applied to any telemedicine application, so the question turns back again: Why place restrictions just on abortion services?

In so many areas, though, telemedicine has been hailed as a way to increase access for all patients. The issues arise in the same areas where there have always been strong opinions, but the evidence and the trend lines are overwhelmingly in favor of expanded telemedicine access. The law should follow.

Zoom in of a dashboard focusing on the "App Store" widget

Nobody Reads the Terms and Conditions: A Digital Advanced Directive Might Be Our Solution

Could Facebook know your menstruation cycle?

In a recent Op-ed Piece, “You Just Clicked Yes. But, Do you Know Terms and Conditions of that Health App?,” I proposed that a mix of factors have given rise to the need to regulate web-based health services and apps. Since most of these applications do not fall under the Health Insurance Portability and Accountability Act (HIPAA), few people actually read through the Terms and Conditions, and also, the explosive growth of web-based health applications, the need for solutions is dire. Read More