pills

What Does It Mean That Oracle is Partnering with the Trump Administration to Study Unproven COVID-19 Drugs?

Cross-posted from Written Description, where it originally appeared on March 30, 2020. 

By Lisa Larrimore OuelletteNicholson PriceRachel Sachs, and Jacob Sherkow

One of the dizzying stream of innovation and health law stories to emerge last week is Oracle’s partnership with the White House to study unproven pharmaceuticals for treating COVID-19. We decided to unpack this story for ourselves and then to collectively share our thoughts in a short explainer.

Click here to read the full post at Written Description.

Call for Submissions: Journal of Law and Biosciences, “Law and Ethics in the Time of a Global Pandemic”

The Journal of Law and the Biosciences (JLB) is soliciting essays, commentaries, or short articles for a special issue on “Law and Ethics in the Time of a Global Pandemic.” For this issue we especially encourage shorter pieces, of roughly 1500 to 5000 words. If any particular aspect of how this pandemic will affect some part of the law—from lease terms to courtroom procedures to constitutional questions about mandatory testing—intrigues you, write it up and send it in.

Read More

Hand signs a contract

Meeting the Challenges of Advance Care Planning for Advanced Dementia – A Social Justice Imperative.

By Dr. Stanley Terman

It is not easy to die of advanced dementia. Yet almost everyone has this goal: a dying that is private, peaceful, and timely.

Dementia patients cannot qualify for Medical Aid in Dying (Physician-Assisted Suicide). Usually, their only legal, peaceful option is to stop ingesting food and fluid. Yet some authorities strongly oppose this way of dying. Knowing that traditional advance directives are not effective, and learning that authorities may oppose newer “dementia-specific” directives/living wills, many patients harbor the “Dementia Fear.” They have reason to worry that others will force them to endure prolonged dying, possibly with increased suffering, perhaps for years.

Read More

a covid 19 swab test being inserted into a vile

Protecting our Most Vulnerable Populations in the COVID-19 Pandemic

By Sharona Hoffman

A recent news story focused attention on the plight of the elderly during the COVID-19 crisis.  A young woman named Rebecca Mehra heard someone calling her from a car in a grocery store parking lot.  When she approached, an elderly couple told Rebecca that they were afraid to enter the store.   Because they were in their eighties, they were very anxious about exposure to the novel coronavirus.  Rebecca won much praise for doing the couple’s shopping for them.

The elderly are not the only people with special needs during a public health emergency.  Additional vulnerable groups include individuals with disabilities, prisoners, people with language barriers, the impoverished, and others.  Years ago, I spent a sabbatical semester at the Centers for Disease Control and Prevention’s (CDC) Public Health Law Program.  We worried a lot about vulnerable populations in public health emergencies, and I wrote a long article on the topic.  It is critical to plan for the needs of all vulnerable populations while preparing emergency response strategies.

Read More

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.

Read More

Large pile of amber prescription pill bottles

Recent Litigation Developments Regarding Drug Pricing and Access

This post originally appeared on SLS Blogs and is reposted with permission of the author. You can read the piece in its entirety here.

By Rebecca Wolitz

With multi-million dollar treatments entering the market, prescription drug costs accounting for between 15-17% of healthcare expenditures, and nearly 1 in 4 Americans unable to afford a prescription medication in the past 12 months, it is no wonder that prescription drug costs remain an important topic of national discussion. There has been a flurry of legislative proposals at both the federal and state levels this year, with Nancy Pelosi’s H.R. 3 recently passing the House. And, within the executive branch, HHS just issued its drug importation proposal. Both of these developments have been within the past few weeks; there is a lot going on. Not to mention we are heading into an election year. Read More

Illustration of a man and a woman standing in front of a DNA helix

The End of Privacy?

By Rachele Hendricks-Sturrup

“Any idea we had about privacy is over,” says Dr. Julia Creet, leading international scholar in Cultural Memory Studies, Professor of English at York University, and author of the upcoming book, The Genealogical Sublime. In 2017, Dr. Creet received a York Research Leader Award in part for her investigative work and documentary entitled, “Data Mining the Deceased: Ancestry and the Business of Family,” which received critical acclaim and is streaming on demand in the U.S., Canada, and abroad. Dr. Creet also received a York President’s Research Impact Award in 2019 for her research on digital privacy, data mining, genealogy, and memory.

Dr. Creet’s work builds on Bill of Health’s key ethical and legal discussions around the direct-to-consumer (DTC) genetic testing and health data privacy. Dr. Rachele Hendricks-Sturrup, genetics and privacy scholar and research fellow at Harvard Pilgrim Health Care Institute and health policy counsel at the Future of Privacy Forum, recently sat down with Dr. Creet to discuss emerging issues and concerns about genetic privacy (or a perceived lack thereof) in an increasing information and genealogical age. The following interview has been edited for length and clarity.

 

Dr. Rachele Hendricks-Sturrup: Regarding genealogical recording in the era on increasing DTC genetic testing, you’ve mentioned in your upcoming book, “Any idea we had about privacy is over.” Tell us a little more about your thoughts here. Read More

Illustration of a family and large clipboard with items in a list checked off. All are underneath a large blue umbrella

Universal Coverage Does Not Mean Single Payer

This post is part of our Eighth Annual Health Law Year in P/Review symposium. You can read all of the posts in the series here. Review the conference’s full agenda and register for the event on the Petrie-Flom Center’s website.

By Joseph Antos, American Enterprise Institute

Health spending in every major developed country is substantially below that of the U.S., and measured health outcomes appear to be better. Progressives have jumped to the conclusion that adopting single-payer health care would yield a simpler system in which everyone is covered, costs are reduced, and outcomes are improved. The truth is far more complicated.

Most other countries have a mix of public and private coverage. One size does not fit all, even in Europe. The government is the predominant purchaser of medical services in Canada and the U.K. In France and Australia, the government is the primary purchase but many people purchase private supplemental coverage. The government subsidizes individually-purchased insurance in Germany, the Netherlands, and Switzerland. Germany relies on employer coverage, akin to employer-sponsored coverage in the U.S. Read More

U.S. Patent and Trademark Office building

Laws and Facts of Patent Eligibility and Medical Diagnostics

This post is part of our Eighth Annual Health Law Year in P/Review symposium. You can read all of the posts in the series here. Review the conference’s full agenda and register for the event on the Petrie-Flom Center’s website.

By Jacob S. Sherkow

For this year’s Health Law Year in P/Review, I’ll be talking about § 101, that most enigmatic of laws from the patent statute. Like many other areas of intellectual property, patent law has a threshold subject matter inquiry embodied in statute—this is § 101—which reads, “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” But because any “competent draftsman” of patent applications could claim an invention as, say, “a process” rather merely an idea, courts have, almost since the statute’s first enactment in 1790, ignored the language of the text entirely. You should too. Instead, it has for almost all of its history, been interpreted in the following manner: “Anything under the sun made by man” is patentable subject matter, save “abstract ideas” or “natural laws, phenomena, or products.” Sure: defining what is a “natural” law is tough, but it’s not a phrase so devoid of application as to make it nonsense. (Unless you’re a complexity theorist.) Read More

Pile of colorful pills in blister packs

Promises and Perils of Prescription Drug Monitoring Programs: Workshop Report

This piece was part of a symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. The symposium was originally posted through the Northeastern University Law Review Online Forum.

Promises and Perils of Emerging Health Innovations Blog Symposium

We are pleased to present this symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. As a note, additional detailed analyses of issues discussed during the conference will be published in the upcoming Winter Issue of the Northeastern University Law Review.

Throughout the two-day conference, speakers and attendees discussed how innovations, including artificial intelligence, robotics, mobile technology, gene therapies, pharmaceuticals, big data analytics, tele- and virtual health care delivery, and new models of delivery, such as accountable care organizations (ACOs), retail clinics, and medical-legal partnerships (MLPs), have entered and changed the healthcare market. More dramatic innovations and market disruptions are likely in the years to come. These new technologies and market disruptions offer immense promise to advance health care quality and efficiency, as well as improve provider and patient engagement. Success will depend, however, on careful consideration of potential perils and well-planned interventions to ensure new methods ultimately further, rather than diminish, the health of patients, especially those who are the most vulnerable.

In the final post of the Promises and Perils of Emerging Health Innovations blog symposium, Leo Beletsky and the team from Health in Justice Action Lab provide a summary of an event held in conjunction with the Center for Health Policy and Law’s 2019 annual health law conference. The Promises and Perils of Prescription Drug Monitoring Programs (PDMPs) workshop was held on April 13, 2019 and convened experts, practitioners, experts, and other stakeholders to brainstorm strategies with the goal to “maximize the benefits of PDMPs, while minimizing harms.” Visit the Health in Justice Action Lab website (linked below) for information on this and other projects underway. 

Promises and Perils of Prescription Drug Monitoring Programs: Workshop Report

By Health in Justice Action Lab

Read More