Category: Medical devices

U.S. Patent and Trademark Office building

Patent Fakes: How Fraudulent Inventions Threaten Public Health, Innovation, and the Economy

Jorge Contreras Leave a comment

By Jorge L. Contreras, JD

The U.S. patent system gives inventors a 20-year exclusive right to their inventions to incentivize the creation of new technologies.

But what if you have a great idea for a new technology, but never actually create it, test it, or determine that it works? Is that patentable? Conversely, should the U.S. Patent and Trademark Office (PTO) grant patents covering imaginary, fraudulent and otherwise non-existent inventions? Probably not, but it happens with alarming frequency, and it is causing serious problems.

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an ambulance parked at the entrance of an emergency department

Racial Disparities Persist in Human Subjects Research

Beatrice Brown Leave a comment

By Beatrice Brown

Human subjects research has long been plagued by racial inequality. While flagrant abuses have been curtailed, disparities have, unfortunately, persisted.

One area ripe for scrutiny is clinical trial enrollment. A 2018 study by William Feldman, Spencer Hey, and Aaron Kesselheim in Health Affairs documents racial disparities in trials that are exempt from typical requirements for informed consent from study participants.

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Doctor or nurse wearing PPE, N95 mask, face shield and personal protective gown standing beside the car/road screening for Covid-19 virus, Nasal swab Test.

COVID-19 Highlights Need for Rights to Repair and Produce in Emergencies

The Petrie-Flom Center Staff Leave a comment

By Joshua D. Sarnoff

In response to the COVID-19 pandemic, companies, organizations, and individuals have sought to address supply chain gaps for needed medical equipment. Spare parts and products created during the COVID-19 pandemic include ventilator tube splitters, nasopharyngeal swabs, and face shields.

In the past, outside of the context of a public health crisis, I have discussed the need to adopt legislation to create a narrow exemption from design patent liability to assure a competitive supply of automobile repair parts. The current pandemic makes a stronger case for the need to explicitly incorporate into our legal system a right to repair and supply products in emergencies.

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TeleSitters are entering hospital rooms. How will they change patient care?

Adriana Krasniansky Leave a comment

By Adriana Krasniansky

In many medical circumstances, clinicians and caregivers may choose not to leave a patient alone. For example, a patient may present a fall risk, experience confusion and agitation, or be at risk of self-harm.  Traditionally, in such situations, a hospital assigns the patient a sitter, or a caregiver who provides patients patient supervision and companionship. 

The need for sitters in hospital settings is rising, as patient loads increase and fewer patients have family members who are able to stay with them for long periods of time. Sitters are also a considerable investment for hospitals; one community hospital reported employing 14 sitters a day, totaling $425,000 in costs annually. Many healthcare networks are exploring the possibility of TeleSitters, or virtual monitoring systems to support patient care. In this article, we review the national adoption of TeleSitters and point out benefits and considerations to their implementation.  Read More

New technologies are empowering persons with disabilities. But are they Assistive?

Adriana Krasniansky Leave a comment

Consumer tech has reduced daily friction for countless individuals, making it easier to control households, shop for groceries, and connect with loved ones. These technologies can be especially empowering for persons with disabilities, increasing accessibility and resolving frustrations of everyday activities. You may have seen related news in press releases and popular headlines: “Alexa is a Revelation to the Blind,” “Disabled Americans Deserve the Benefit of Self-Driving Cars,” “Amazon Alexa Can Help People With Autism Do More On Their Own.”

But are these technologies assistive? Disability nonprofit Understood.org defines assistive technology as “any device, software, or equipment that helps people work around their challenges.” Classifying a device or software as assistive technology (and/or related regulatory labels) can lead to insurance coverage and tax incentives. It can change how devices are viewed in healthcare settings and impact product research and design. In this article, we speak with bioethicist and disability scholar Dr. Joseph Stramondo about how to define assistive technologies in today’s consumer tech revolution. 

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