Health Law and Policy Commons^™

Democratizing Health Data: A Legal Framework For Privacy-Preserving, Government-Led Ai Collaboration, Nicole Nigri

Cybaris®

No abstract provided.

Keynote Address: The Movement To Protect Kids From Addictive Technologies, Gaia Bernstein

Seattle University Law Review

In this keynote address, I describe my personal journey starting with a school outreach program I created in 2017 to address technology overuse among kids. While I initially advocated for self-help methods, I grew to recognize that the tech industry bore responsibility. This realization led me to write Unwired: Gaining Control over Addictive Technologies, which focused on collective action to pressure the tech industry to redesign its addictive products.

I then describe the movement to control addictive technologies and protect kids, which has gained momentum since the end of the pandemic. This movement combines grassroots parent activism with legal-political action. …

Responding To Digital Addiction, Ned Snow

Seattle University Law Review

In Unwired: Gaining Control over Addictive Technologies, Professor Gaia Bernstein calls our attention to the growing problem of digital addiction. Digital addiction may sound like something out of a science-fiction novel or something that does not raise the same sort of real-life practical concerns as are present in a physical health crisis or an economic decline. But as Bernstein presents the evidence, we learn that the consequences of digital addiction can be just as harmful as a serious disease or a financial depression. Cognitive development disorders, anxiety, emotional depression, social isolation, and other mental health ills can be debilitating—as much …

Neurotechnology Works Its Way Forward, Jeremy Ben Merkelson, Wendy Kearns, David Rice, Elyse Sparks

Seattle University Law Review Online

Neurotechnology is an emerging and rapidly advancing field of technology used to collect, process, and analyze brain or nervous system activity. The market is expected to reach $21 billion by 2026.

In a previous article, published in October 2023, we explored the potential of neurotechnology applications in the workplace, like electroencephalogram (EEG) headbands that monitor fatigue and boost safety, software and EEG combination technologies that creates a shortcut to the human brain and optimizes complex decision-making, and earbuds that track focus and stress.

We have continued to study and speak about these issues in various forums, and meanwhile, technology and …

Artificial Intelligence And The Hipaa Privacy Rule: A Primer, Stacey A. Tovino

Faculty Articles

No abstract provided.

Drug Clinical Trials Legislation In The European Union, Paola Sangiovanni, Flavio Monfrini, Marco Bertucci

Indian Journal of Law and Technology

The purpose of this article is to illustrate the basic tenets of European Union law on clinical trials. Such body of law has been progressively harmonized in the European Union over the years with the aim of subjecting interventional clinical trials conducted in any of the 27 European Union Member States to identical rules.

The article initially describes the reasons why clinical trials are important to measure the safety, efficacy and cost-effectiveness of innovative medical treatment. It then continues by illustrating the scope and basic principles of the current EU Regulation, as well as its main changes over the previous …

On The Human Right To Healthy Menstruation, Bridget J. Crawford

Elisabeth Haub School of Law Faculty Publications

This short essay introduces the Bellagio Declaration on the Human Right to Healthy Menstruation, a statement signed by an interdisciplinary group of academics, artists, policymakers, clinicians, and practitioners in 2024. The Declaration frames the human right to healthy menstruation as including (1) non-discrimination on the basis of menstruation; (2) dignity in all matters related to menstruation; (3) access to facilities, resources, and supplies that facilitate the management of menstruation in a manner that is affordable and safe and that fosters a clean, healthy, and sustainable environment; (4) lifelong access to timely and medically accurate information about all aspects of menstruation; …

Personal Data And Vaccination Hesitancy: Covid-19’S Lessons For Public Health Federalism, Charles D. Curran

Catholic University Law Review

During the COVID-19 vaccination campaign, the federal government adopted a more centralized approach to the collection of public health data. Although the states previously had controlled the storage of vaccination information, the federal government’s Operation Warp Speed plan required the reporting of recipients’ personal information on the grounds that it was needed to monitor the safety of novel vaccines and ensure correct administration of their multi-dose regimens.

Over the course of the pandemic response, this more centralized federal approach to data collection added a new dimension to pre-existing vaccination hesitancy. Requirements that recipients furnish individual information deterred vaccination among undocumented …

Forensic Genetics In The Shadows, Teneille R. Brown, Sarah Duensing, Bob Wong

Utah Law Faculty Scholarship

This article examines the controversial and growing practice of law enforcement agencies searching clinical and public health genetic databases—without a warrant or consent. While police have previously used online public genealogy databases for this purpose, our article describes how they are secretly accessing private genetic information from newborn screening programs and medical tests. We argue this raises serious ethical and legal concerns, blurring the line between healthcare and law enforcement and infecting clinical encounters with the goals of prosecution. This in turn may discourage people from seeking important medical care due to distrust and privacy concerns.

To explore public attitudes …

Synthetic Health Data: Real Ethical Promise And Peril, W. Nicholson Price Ii, Daniel Susser

Other Publications

Modern health research and development faces a dilemma. On the one hand, there is more data than ever — in electronic health records, in lab research, in public datasets, and on the internet — from which to extract potentially transformative scientific insights and to use as the basis for developing breakthrough health care technologies. On the other hand, using this data entails various risks: threats to patient privacy, skewed samples and approaches to analysis that can perpetuate demographic and other biases, and uneven access to data about rare conditions and small patient subgroups. Generating synthetic data has emerged as one …

Continuous Reproductive Surveillance, Michael Ulrich, Leah R. Fowler

Faculty Scholarship

The Dobbs opinion emphasizes that the state’s interest in the fetus extends to “all stages of development.” This essay briefly explores whether state legislators, agencies, and courts could use the “all stages of development” language to expand reproductive surveillance by using novel developments in consumer health technologies to augment those efforts.

J Mich Dent Assoc August 2023

The Journal of the Michigan Dental Association

Every month, The Journal of the Michigan Dental Association brings news, information, and features about Michigan dentistry to our state's oral health community and the MDA's 6,200+ members. No publication reaches more Michigan dentists!

In this issue, the reader will find the following original content:

• A cover story on new dentist’s perceptions of professionalism.
• A feature on legal considerations when addressing employee wellness.
• A feature on the meaning of wellness by ADA Trustee Dr. Brett Kessler.
• Practice guidance on conducting a HIPAA security risk analysis.
• Commentary “The New Golden Age of Dentistry.”
• Editorial and regular department articles on MDA Foundation …

Femtechnodystopia, Leah R. Fowler, Michael Ulrich

Faculty Scholarship

Reproductive rights, as we have long understood them, are dead. But at the same time history seems to be moving backward, technology moves relentlessly forward. Femtech products, a category of consumer technology addressing an array of “female” health needs, seem poised to fill gaps created by states and stakeholders eager to limit birth control and abortion access and increase pregnancy surveillance and fetal rights. Period and fertility tracking applications could supplement or replace other contraception. Early digital alerts to missed periods can improve the chances of obtaining a legal abortion in states with ever-shrinking windows of availability or prompt behavioral …

A Game Theoretic Approach To Balance Privacy Risks And Familial Benefits, Ellen W. Clayton, Jia Guo, Murat Kantarcioglu, Et Al.

Vanderbilt Law School Faculty Publications

As recreational genomics continues to grow in its popularity, many people are afforded the opportunity to share their genomes in exchange for various services, including third-party interpretation (TPI) tools, to understand their predisposition to health problems and, based on genome similarity, to find extended family members. At the same time, these services have increasingly been reused by law enforcement to track down potential criminals through family members who disclose their genomic information. While it has been observed that many potential users shy away from such data sharing when they learn that their privacy cannot be assured, it remains unclear how …

Pandemics And The Protection Of Privacy And Personal Information: Issues Concerning The Restriction On The Right To Privacy In Emergencies, Fumio Shimpo

Japanese Society and Culture

This article focuses on issues which need to be considered in aiming to ensure both the effectiveness of infectious disease control measures and the protection of the right to privacy from the following perspectives.

(1) Issues regarding the restriction of the right to privacy in emergency situations, including (i) the types of measures taken in emergency situations and issues with respect to the restriction of the right to privacy in emergency situations, (ii) the normalisation, constancy and fixation of exceptional measures in emergency situations, (iii) dual-use and use for purposes different from those originally intended, (iv) acquisition of secondary information …

Perlindungan Atas Privasi Konsumen Dalam Layanan Reservasi Tiket Online Dari Pt. Kereta Api Indonesia, Aprilia Susanti

"Dharmasisya” Jurnal Program Magister Hukum FHUI

The significant increase in online activities cannot be separated from the many active internet users who use mobile internet connections to carry out their daily activities, one of which is for the convenience of making ticket reservations at PT. Indonesian Railways (KAI). The purpose of this research is to find out the study of the business law of protecting consumer privacy in the online ticketing service of PT. KAI. Data collection was carried out by means of a literature study of the relationship between laws and regulations in consumer protection and the position of PT. KAI as business actors and …

Hipaa V. Dobbs, Wendy A. Bach, Nicolas Terry

Scholarly Works

A few days after the Supreme Court’s decision in Dobbs v. Jackson Women’s Health, the Biden administration issued guidance seeking to reassure doctors and patients that the federal HIPAA Privacy Rule would allow women to feel confident that they could still seek reproductive healthcare without worrying that the information in their medical records would end up in the hands of police. As scholars focused respectively on the criminalization of poverty and reproductive conduct (Wendy Bach) and health policy and privacy (Nicolas Terry), we were less than reassured. We write this essay to emphasize how, rather than revealing the strength of …

Forensic Microbiome Evidence: Fourth Amendment Applications And Court Acceptance, Trason Lasley

Catholic University Journal of Law and Technology

No abstract provided.

Inadequate Privacy: The Necessity Of Hipaa Reform In A Post-Dobbs World, Katherine Robertson

Seattle University Law Review

Part I of this Comment will provide an overview of HIPAA and the legal impacts of Dobbs. Part II will discuss the anticipatory response to the impacts of Dobbs on PHI by addressing the response from (1) the states, (2) the Biden Administration, and (3) the medical field. Part III will discuss the loopholes that exist in HIPAA and further address the potential impacts on individuals and the medical field if reform does not occur. Finally, Part IV will argue that the reform of HIPAA is the best avenue for protecting PHI related to reproductive healthcare.

Dobbsmacked By The Dobbs Decision: The Need For More Privacy Protection For Personal Health Information, Morgan Vanden Heuvel

Mitchell Hamline Law Review

No abstract provided.

Sunshine Laws Behind The Clouds: Limited Transparency In A Time Of National Emergency, Ira P. Robbins

Scholarly Articles in Law Reviews & Journals

The COVID-19 pandemic dramatically changed the way citizens lived their lives, businesses operated, and governments functioned. With most people forced to stay home, the pandemic also disrupted how people received their news and other essential information. Public records and public meetings had to adapt to face the growing challenges in a locked-down world. While some governmental bodies were able to keep up with the threat that COVID-19 posed against transparency, others either failed to acclimate to the new normal or actively took advantage of the circumstances to limit how much the public knew not only about the crisis, but about …

Transcript: Presentation On Artificial Intelligence And Discrimination In Healthcare, Sharona Hoffman

Journal of Law and Health

The following is a transcription from The Digital Health and Technology Symposium presented at Cleveland-Marshall College of Law by The Journal of Law & Health on Friday, April 8, 2022. This transcript has been lightly edited for clarity.

Big Data, Big Gap: Working Towards A Hipaa Framework That Covers Big Data, Ryan Mueller

Indiana Law Journal

One lasting impact of the Health Insurance Portability and Accountability Act (HIPAA) is the privacy protections it provides for our sensitive health information. In the era of Big Data, however, much of our health information exists outside the traditional doctor-patient dynamic. From wearable technology, to mobile applications, to social media and internet browsing, Big Data organizations collect swaths of data that shed light on sensitive health information. Big Data organizations largely fall outside of HIPAA’s current framework because of the stringent requirements for when the HIPAA protections apply, namely that the data must be held by a covered entity, and …

The End Of Roe V Wade And New Legal Frontiers On The Constitutional Right To Abortion, I. Glenn Cohen, Melissa Murray, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

On June 24, 2002, the US Supreme Court ended the constitutional right to abortion in Dobbs v Jackson Women’s Health Organization. The Court’s majority decision authored by Justice Samuel Alito was substantially the same as a draft opinion leaked a month earlier. The regulation of abortion will now be decided by the states, with about half currently or will soon ban or severely restrict abortion access. In this Viewpoint, we explain the Dobbs ruling and what it means for physicians, public health, and society.

We focus on new legal frontiers in the constitutional right to abortion, including medication abortion …

The Case For A Liberal Communitarian Jurisprudence, Amitai Etzioni

Journal of the National Association of Administrative Law Judiciary

This article seeks to show that courts face difficulties without a principled, constitutional anchoring for the conception of the common good. Courts could divine the common good from the penumbra of the Fourth Amendment in the same way the Supreme Court created a right to privacy. In addition to creating a “common good” constitutional principle, the judicial branch should establish criteria to determine when this principle should take precedence over individual rights expressly preserved in the Constitution.

Managing And Monitoring The Menopausal Body, Naomi R. Cahn, Bridget J. Crawford, Emily Gold Waldman

Elisabeth Haub School of Law Faculty Publications

This Essay explores how menopausal bodies are managed and monitored through both menopausal hormone therapy (MHT) and the burgeoning market for technology-driven menopause products and services. While each of these allegedly improves the menopause experience, a closer investigation reveals a more complex interaction of profit motives and traditional notions of gender identity. The Essay identifies problems with—and suggests some solutions for reforming—current practices of monitoring and managing the menopausal body.

Careful consideration of menopause brings this Essay into ongoing conversations about theorizing beyond the gender binary and stereotypical notions of femininity. Purveyors of both MHT and menopause-related digital products and …

A Proportionality-Based Framework For Government Regulation Of Digital Tracing Apps In Times Of Emergency, Sharon Bassan

Dickinson Law Review (2017-Present)

Times of emergency present an inherent conflict between the public interest and the preservation of individual rights. Such times require granting emergency powers to the government on behalf of the public interest and relaxing safeguards against government actions that infringe rights. The lack of theoretical framework to assess governmental decisions in times of emergency leads to a polarized and politicized discourse about potential policies, and often, to public distrust and lack of compliance.

Such a discourse was evident regarding Digital Tracing Apps (“DTAs”), which are apps installed on cellular phones to alert users that they were exposed to people who …

Direct-To-Consumer Genetic Testing, Ellen W. Clayton, Et Al.

Vanderbilt Law School Faculty Publications

Direct-to-consumer genetic testing is marketed as a tool to uncover ancestry and kin. Recent studies of actual and potential users have demonstrated that individuals’ responses to the use of these tests for these purposes are complex, with privacy, disruptive consequences, potential for misuse, and secondary use by law enforcement cited as potential concerns. We conducted six focus groups with a diverse sample of participants (n = 62) who were aware of but had not used direct-to-consumer genetic tests, in an effort to understand more about what people considering these tests think about the potential value, risks, and benefits of such …

Comparative Limitations On Abortions: The United States Supreme Court V. The European Court Of Human Rights, Sunaya Padmanabhan

Northwestern Journal of Law & Social Policy

This Note compares the balancing tests implemented by the United States Supreme Court and the European Court of Human Rights to determine the legal status of abortion within their jurisdictions. This Note will argue that the Supreme Court’s balancing test better protects a woman’s legal path to an abortion because it A) limits states’ restrictions to specific categories and B) regulates the extent to which states can restrict a woman’s pre-viability abortion.

This Note will also examine the ways in which each court’s abortion jurisprudence substantively restricts a woman’s ability to obtain an abortion, even where legal avenues to the …

Becoming Visible, Jennifer B. Shinall

Vanderbilt Law School Faculty Publications

This Article will consider the consequences of a large number of workers making their health conditions known to their employers during the pandemic. Becoming visible will likely have short-term costs for both employers and employees-—in terms of health-status discrimination, privacy, and administrative burdens. Nonetheless, this Article will ultimately argue that becoming visible also has a major benefit: improved information flow between employers and employees. Although the long-run cost-benefit analysis of increased health-status visibility during the pandemic remains to be seen, increased visibility ultimately has the potential to improve the employer-employee relationship.