More perils of U.S. sectoral privacy law

By Leslie Francis

A recent unpublished decision of the Minnesota Court of Appeals brings the perils of sectoral privacy law into sharp focus: Furlow v. Madonna Summit of Byron, 2020 WL 413356 (Minn. App. 2020) (unpublished).  Minnesota protects patient health records but not, apparently, photographs of patients posted on social media by health care facility staff.

V.F. was a patient at Madonna Summit of Byron, a senior living facility with independent living, assisted living, and memory care units. Jane Doe was a nursing assistant at Madonna. After V.F. pulled a fire alarm, annoying Jane, Jane snapped a photograph of V.F. and posted it on her personal social media page.  Jane captioned the photo: “This little sh-t just pulled the fire alarm and now I have to call 911!!! Woohoo.” The photo contained no further identifying information.  It didn’t name V.F., say where she lived, or identify Jane Doe or where she worked. It was, however posted on Jane Doe’s personal account, thus identifying Jane Doe to those with access to her account. V.F.’s personal representative sued for damages under the Minnesota Health Records Act. The Minnesota Court of Appeals upheld dismissal of the complaint, concluding that the social media post was not release of a “health record” under Minnesota law. Read More

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Can Bedside Consent Apps Improve Informed Consent During Childbirth?

By Alexa Richardson

Informed consent in childbirth is under fire by advocates, who stress that there is a widespread absence of meaningful informed consent during birth. While informed consent in medical settings always poses challenges, informed consent in childbirth raises particular concerns. Labor unfolds in real-time, and people are heavily reliant on their provider for information during birth. Providers may not adequately seek informed consent out of a belief that they should make decisions in the fetal interest, rather than the parent. Furthermore, laboring people make choices that are more than medical: birth is a value-laden process entwined with beliefs about parenting, life-meaning, and fetal interests.  A new solution is on the table that could help improve the process of informed consent in childbirth: guided decision-making apps. This year, multiple mobile apps are in the works that would assist laboring people and clinicians in real-time decision-making during labor and birth.

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A surveillance camera in focus in the foreground of hospital hallway.

When AI is watching patient care: Ethics to consider

This post was originally published in Scope, Stanford Medicine’s blog, on February 10, 2020.

By: Laurie Flynn

The potential benefits of artificial intelligence to health care are enormous, but these emerging technologies also raise a number of ethical and legal considerations.

These questions are particularly relevant to a subset of AI known as computer vision-based ambient intelligence, which uses a video camera or sensors to monitor activity in a physical space, such as a patient room or hospital hallway. The technology analyzes — in real time — the resulting video data, which can appear as standard footage, depth or thermal data captured as silhouette-like moving images, or in other forms.

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Photograph of a report on a table, the report is labeled, "NHS"

The NHS In England: Patient Safety News Roundup

By John Tingle

There is always a lot happening with patient safety in the NHS (National Health Service) in England. Sadly, all too often patient safety crises events occur. The NHS is also no sloth when it comes to the production of patient safety policies, reports, and publications. These generally provide excellent information and are very well researched and produced. Unfortunately, some of these can be seen to falter at the NHS local hospital implementation stage and some reports get parked or forgotten. This is evident from the failure of the NHS to develop an ingrained patient safety culture over the years. Some patient safety progress has been made, but not enough when the history of NHS policy making in the area is analysed.

Lessons going unlearnt from previous patient safety event crises is also an acute problem. Patient safety events seem to repeat themselves with the same attendant issues

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A calculator, a stethoscope, and a stack of money rest on a table.

Why Our Health Care Is Incomplete: Review of “Exposed” (Part II)

By: Daniel Aaron

Just last month, Professor Christopher T. Robertson, at the University of Arizona College of Law, released his new book about health care, entitled Exposed: Why Our Health Insurance Is Incomplete and What Can Be Done About It. Part II of this book review offers an analytical discussion of “cost exposure,” the main subject of his book with a focus on solutions. Read Part I here.

Baby solutions

Prof. Robertson writes two chapters on solutions. In the first, titled “Fixes We Could Try,” he offers reforms, from mild to moderate, that would make cost exposure less harmful. The chapter largely retains the analytical nature of the prior chapters, but it comes across like a chapter he might have rather not written. This is evident in the following chapter’s title, “What We Must Do.” It’s also evident because some of the proposals do not seem fully considered, and in some ways appear more controversial than the more comprehensive solution offered later. Read More

A calculator, a stethoscope, and a stack of money rest on a table.

Why Our Health Care Is Incomplete: Review of “Exposed” (Part I)

By: Daniel Aaron

Just last month, Professor Christopher T. Robertson, at the University of Arizona College of Law, released his new book about health care, entitled Exposed: Why Our Health Insurance Is Incomplete and What Can Be Done About It. This book review will offer an analytical discussion of “cost exposure,” the main subject of his book.

What is cost exposure in health care?

Cost exposure is payments people make related to their medical care. There are many ways patients pay – here are a few common ones.

  • Deductible – Patient is responsible for the first, say, $5,000 of their medical care; after this point, the health insurance kicks in. Resets each year.
  • Copay – Patient pays a specific amount, say $25, when having an episode of care.
  • Coinsurance – Patient pays a specified percentage, say 20%, of care.

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New TWIHL with Christopher Robertson

I am joined by Christopher Robertson, Associate Dean for Research and Innovation and Professor of Law at the University of Arizona. He is also an Academic Fellow Alumnus of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. His scholarship is well known to most of you including publications in leading law reviews and outlets such as the New England Journal of Medicine. He is routinely featured in national media, such as the Wall Street Journal and the Washington Post, and on NBC News and National Public Radio. His latest book is Exposed, published this month by Harvard University Press.

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Scientist analyzes DNA gel used in genetics, forensics, drug discovery, biology and medicine

Time to Ban Heritable Genome Editing

By Jeffrey R. Botkin, MD, MPH, Professor of Pediatrics and Medical Ethics at University of Utah

We are at a critical crossroad in reproductive medicine.  How should science and society more broadly manage the powerful new technologies that can alter the genes of human embryos?  In a recent paper published in Genetics in Medicine, the official journal of the American College of Medical Genetics and Genomics (ACMG), I argue that banning the use of this technology editing human embryo is the right direction.

Concerns over theoretical capabilities of “designer babies” have been with us for generations.  The ability screen and test for embryos and fetuses with undesirable characteristics and forestall their birth is well-developed and familiar. But the actual ability to add, subtract or alter genes in the embryo is quite new.  The CRISPR-Cas9 technology and related technologies burst on the scene in the last decade and the ability to relatively easily and cheaply to alter human embryos is no longer science fiction.

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Practice Fusion: it’s data use, not de-identification, that matters

By Leslie Francis

Practice Fusion, an electronic health record (EHR) vendor, just settled with the Department of Justice to pay a $145 million fine for alleged kickbacks from an unnamed pharmaceutical company.  The DOJ contended that the company had taken kickbacks in exchange for including practice alerts to encourage physicians to prescribe opioids.  But paid-for prescription alerts were not the only practices engaged in by Practice Fusion with de-identified patient data.

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Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.

The Rise of Biosimilars: Success of the BPCIA? (Part III)

By Jonathan Darrow

This is Part III in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines.  Part III considers a path forward in the regulation of biologics.  For Part I, click here.  For Part II click here.

A Path Forward

The small number of biosimilar approvals compared to generic drug approvals cannot establish the failure of the BPCIA due to differences in industry familiarity with each follow-on pathway, the number of reference products available for copying, patient population sizes, patent barriers, and drug costs. The later arrival of US laws and guidance documents—not inadequate legal design—is the most straightforward explanation of why the first US biosimilar approvals were delayed compared to those in Europe.

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