Judicial Decisions Constraining Public Health Powers During COVID-19: Implications For Public Health Policy Making.

Public health legal powers are increasingly under pressure from the courts in the United States. During the COVID-19 pandemic, individuals and organizations successfully challenged many community mitigation orders (for example, mask mandates, vaccination mandates, and restrictions on gatherings), demonstrating the legal vulnerability of disease control measures. Analyzing 112 judicial decisions in which the plaintiff prevailed from March 2020 through March 2023, we examined the ways in which courts constrained public health powers during the COVID-19 pandemic. We found that in these 112 decisions, courts shifted how they analyze religious liberty claims and reviewed challenges to the exercise of statutory powers by health officials in novel ways. We discuss implications for public health policy going forward, and we recommend ways in which legislatures and health officials can design policies to maximize their prospects of surviving legal challenges.

Data stewardship in FTLD research: Investigator and research participant views.

INTRODUCTION: Federal policies and guidelines have expanded the return of individual results to participants and expectations for data sharing between investigators and through repositories. Here, we report investigators' and study participants' views and experiences with data stewardship practices within frontotemporal lobal degeneration (FTLD) research, which reveal unique ethical challenges. METHODS: Semi-structured interviews with (1) investigators conducting FTLD research that includes genetic data collection and/or analysis and (2) participants enrolled in a single site longitudinal FTLD study. RESULTS: Analysis of the interviews identified three meta themes: perspectives on data sharing, experiences with enrollment and participation, and data management and security as mechanisms for participant protections. DISCUSSION: This study identified a set of preliminary gaps and needs regarding data stewardship within FTLD research. The results offer initial insights on ethical challenges to data stewardship aimed at informing future guidelines and policies.

Denial-Artificial Intelligence Tools and Health Insurance Coverage Decisions.

This JAMA Forum discusses the potential and the pitfalls in the use of artificial intelligence in the coverage decisions made by health insurance companies.

President Biden's Executive Order on Artificial Intelligence-Implications for Health Care Organizations.

This Viewpoint discusses a recent executive order by US President Joe Biden about the development and implementation of AI, including the role of government vs the private sector and how the order may affect health care.

Accommodating Religious Objections to Vaccination Mandates-Implications of Groff v DeJoy for Health Care Employers.

This JAMA Forum discusses Title VII challenges to vaccination mandates, the Groff v DeJoy decision, and the implications of the decision for health care employers.

Vaccination Mandates-An Old Public Health Tool Faces New Challenges.

This Viewpoint discusses how federal vaccine requirements have helped thwart vaccine-preventable diseases as well as how growing public resistance to vaccines and judicial and legislative limits to vaccination mandates may change that.

Ethical Responsibilities for Companies That Process Personal Data.

It has become increasingly difficult for individuals to exercise meaningful control over the personal data they disclose to companies or to understand and track the ways in which that data is exchanged and used. These developments have led to an emerging consensus that existing privacy and data protection laws offer individuals insufficient protections against harms stemming from current data practices. However, an effective and ethically justified way forward remains elusive. To inform policy in this area, we propose the Ethical Data Practices framework. The framework outlines six principles relevant to the collection and use of personal data-minimizing harm, fairly distributing benefits and burdens, respecting autonomy, transparency, accountability, and inclusion-and translates these principles into action-guiding practical imperatives for companies that process personal data. In addition to informing policy, the practical imperatives can be voluntarily adopted by companies to promote ethical data practices.

ChatGPT and Physicians' Malpractice Risk.

This JAMA Forum discusses the possibilities, limitations, and risks of physician use of large language models (such as ChatGPT) along with the improvements required to improve the accuracy of the technology.

Decisions about College Football during Covid-19: An Ethical Analysis.

This manuscript uses competitive college football as a lens into the complexities of decision-making amid the Covid-19 pandemic. Pulling together what is known about the decision-makers, the decision-making processes, the social and political context, the risks and benefits, and the underlying obligations of institutions to these athletes, we conduct an ethical analysis of the decisions surrounding the 2020 fall football season. Based on this ethical analysis, we provide key recommendations to improve similar decision processes moving forward.

Examining Opportunities to Increase Savings From Medicare Price Negotiations.

Importance: Allowing the US Centers for Medicare & Medicaid Services to negotiate prescription drug prices for Medicare may improve drug affordability. Objective: To estimate savings from Medicare price negotiation under the Inflation Reduction Act (IRA) and examine opportunities to increase savings. Design, Setting, and Participants: This cross-sectional, population-based study used data from 2020 Medicare prescription drug claims. The study was conducted and data were analyzed in 2022. Exposures: Eligibility for Medicare price negotiation under the IRA and alternative criteria. Main Outcomes and Measures: Minimum savings under the IRA's eligibility criteria were estimated and compared with savings within alternative scenarios, including (1) selecting drugs for negotiation based on net spending after rebates rather than gross spending; (2) extending eligibility to drugs with biosimilar or generic competitors; (3) reducing the minimum years since US Food and Drug Administration approval for eligibility; and (4) changing 2 or 3 of these factors. Estimated savings were calculated at different levels of scale-up of price negotiation under the IRA, from 10 Part D drugs in 2026 to 60 Part B and D drugs in 2029. Gross spending was calculated using the US Centers for Medicare & Medicaid Services 2020 Medicare drug spending dashboard. Rebates were estimated using SSR Health data. Information on FDA approvals, generics, and biosimilars was obtained from FDA websites. Results: Under IRA rules, estimated minimum savings from price negotiation in 2026 for 10 Part D drugs would be $3.2 billion. For 2029 for 60 Part D and B drugs, estimated savings were $16.0 billion. Selecting drugs for negotiation based on net rather than gross spending would be associated with estimated savings of $4.6 billion (a 45% increase) in 2026 and $18.9 billion (an 18% increase) in 2029. Including drugs with generic competitors or biosimilars would be associated with an estimated savings of $6.6 billion (a 109% increase) in 2026 and $24.9 billion (a 56% increase) in 2029. Making both changes would be associated with savings of $9.5 billion (a 200% increase) in 2026 and $28.3 billion (a 77% increase) in 2029. A sensitivity analysis suggested that reducing the required number of years since marketing approval by 2 years would be associated with increased estimated savings of 4% when 10 Part D drugs are negotiated and 12% when 60 Part D and B drugs are negotiated. Changing all 3 criteria would be associated with the greatest increase in estimated savings in 2029 (119% increase when 10 Part D drugs are negotiated and 93% increase for 60 Part D and B drugs). Conclusions and Relevance: The results of this cross-sectional study suggest that adjusting the eligibility criteria for Medicare prescription drug price negotiation to permit inclusion of drugs with biosimilar or generic competitors and selecting drugs based on net rather than gross spending may be a promising approach to substantially increase estimated savings.

Public Health Law Modernization 2.0: Rebalancing Public Health Powers And Individual Liberty In The Age Of COVID-19.

Public health emergency powers laws in the US underwent a profound stress test during the COVID-19 pandemic. Designed with bioterrorism in mind, they struggled to meet the challenges of a multiyear pandemic. Public health legal powers in the US are both too limited, in that they don't clearly permit officials to implement measures necessary to combat epidemics, and too broad, in that their accountability mechanisms fall short of public expectations. Recently, some courts and state legislatures have cut deeply into emergency powers, jeopardizing future emergency response. Instead of this curtailment of essential powers, the states and Congress should modernize emergency powers laws to balance powers and individual rights in more productive ways. In this analysis we propose reforms including meaningful legislative checks on executive power, stronger substantive standards for executive orders, mechanisms for public and legislative input, and clearer authority to issue orders affecting groups of people.

The Public Health Fixes That Missed the Omnibus.

This JAMA Forum discusses the $1.7 trillion omnibus bill passed in December 2022 and the areas of pandemic preparedness and the public health system it addresses and misses.