Medicine doctor and stethoscope in hand touching icon medical network connection with modern virtual screen interface, medical technology network concept

AI in Digital Health: Autonomy, Governance, and Privacy

The following post is adapted from the edited volume AI in eHealth: Human Autonomy, Data Governance and Privacy in Healthcare.

By Marcelo Corrales Compagnucci and Mark Fenwick

The emergence of digital platforms and related technologies are transforming healthcare and creating new opportunities and challenges for all stakeholders in the medical space. Many of these developments are predicated on data and AI algorithms to prevent, diagnose, treat, and monitor sources of epidemic diseases, such as the ongoing pandemic and other pathogenic outbreaks. However, these opportunities and challenges often have a complex character involving multiple dimensions, and any mapping of this emerging ecosystem requires a greater degree of inter-disciplinary dialogue and more nuanced appreciation of the normative and cognitive complexity of these issues.

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Businessman's hands typing on laptop keyboard in morning light

Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 3

By Alison Bateman-House, Hayley M. Belli, and Sage Gustafson

This series is adapted from a webinar hosted by PRIM&R on August 5, 2021: IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance. Read Part 1 and Part 2.

Part 3: What’s an IRB to do?

EA is considered treatment, not research. EA was not established as a means to collect research data, even though certain safety data must be collected and shared with the FDA and the sponsor. But, once sponsors decide to capture/share EA-derived data above and beyond that needed to report SAEs, what should IRBs do when reviewing such plans: view this as research, and thus hold it to (higher) research standards, or continue to view this as treatment?  This distinction is important for patients’ rights and welfare.

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Pile of envelopes with overdue utility bills on the floor.

The Unfurling Crisis of Unfunded Isolation, Testing, and Treatment of Infectious Disease in the US

By Steven W. Thrasher

For many politicians in the United States, the summer of 2022 was a time of trying not to think about the coronavirus pandemic—though, if they were concerned about the risk that they, their neighbors, and their constituents were facing, they should have been paying very close attention. By August, there were about 500 to 600 COVID deaths a day, accounting for more than a “9/11’s worth” every week, a level of death twice what it had been in the summer of 2021.

But for gay men in the United States, the summer of 2022 was a time of worrying about a whole new viral epidemic: monkeypox. The variant of the MPX orthopoxvirus circulating globally in 2022 has behaved very differently than it had in previous outbreak, acting as a sexually transmitted infection and moving almost exclusively through the bodies of gay men.

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SAINT LOUIS, MO. - August 2, 2021: A protestor holds a sign reading "Evictions Are Violence" at a protest held days after the federal eviction moratorium expired.

U.S. Eviction Policy is Harming Children: The Case for Sustainable Eviction Prevention to Promote Health Equity

By Emily A. Benfer

Without a nationwide commitment to sustainable eviction prevention, the United States will fail the rising number of renter households at risk of eviction. Worse still, the country will set millions of children on the path of long-term scarring and health inequity.

A staggering 14.8% of all children and 28.9% of children in families living below the poverty line experience an eviction by the time they are 15. For children, eviction functions as a major life event that has damaging effects long after they are forced to leave their home. It negatively affects emotional and physical well-being; increases the likelihood of emotional trauma, lead poisoning, and food insecurity; leads to academic decline and delays; and could increase all-cause mortality risk.

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Los Angeles, California / USA - May 1, 2020: People in front of Los Angeles’ City Hall protest the state’s COVID-19 stay at home orders in a “Fully Open California” protest.

The Supreme Court Threatens to Undermine Vaccination Decisions Entrusted to the States

By Donna Gitter

In 2021, the Supreme Court articulated in Tandon v. Newsom a legal principle that threatens to upend over a century of legal precedent recognizing the authority of state governments to ensure public health by mandating vaccines.

The ruling lays the groundwork for courts to force states to include religious exemptions to mandatory vaccines whenever they include secular exemptions, such as medical ones.

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Bill of Health - Gavel on mask during pandemic, class action lawsuits during pandemic

Relying on the Unreliable? COVID-19 Claims Can’t Proceed Without a Proper Standard of Care

By Michelle Richards

In the United States, the imposition of tort liability for the transmission of an infectious disease goes back more than a century. It is no surprise, therefore, that similar claims have been filed for damages arising from the transmission of the COVID-19 virus.

However, in order for these claims to be adjudicated fairly, they must be judged against a standard of care. A standard of care provides a benchmark for the level of caution a reasonable party would take in particular circumstances. If the standard of care is not met, liability may be imposed.

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Empty classroom.

Tort Liability for Faculty Who Fail to Tell the Class About COVID Cases in Their Midst

By Heidi Li Feldman

The more individuals must rely on their own judgment and effort to protect themselves from disease, the more they need information regarding the possibility of exposure to the cause of the disease.

This simple proposition, combined with changes in how governments and institutions are approaching COVID, means that university faculty should rethink their role in keeping their students informed about COVID cases among class members. To satisfy their legal obligations to protect students from harm, faculty must consider whether safeguarding their students from incurring COVID in their classrooms necessitates sharing such information. Fulfilling their legal duties to students may even require faculty to disregard administrative prohibitions against disseminating news of COVID cases in the class.

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Picture of doctor neck down using an ipad with digital health graphics superimposed

Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 2

By Alison Bateman-House, Hayley M. Belli, and Sage Gustafson

This series is adapted from a webinar hosted by PRIM&R on August 5, 2021: IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance. Read Part 1 here.

Part 2: Possible Value of “Real World Data” Collected from Expanded Access

Real world data (RWD) are data relating to patient health status and/or the delivery of health care such as medical bills/claims, electronic health records, and product/disease registries. RWD are derived from sources outside of randomized controlled trials (RCTs). Real world evidence (RWE) may be derived from the analysis of quality RWD.

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