Code on computer.

Building Trust Through Transparency? FDA Regulation of AI/ML-Based Software

By Jenna Becker

To generate trust in artificial intelligence and machine learning (AI/ML)-based software used in health care, the U.S. Food and Drug Administration (FDA) intends to regulate this technology with an eye toward user transparency. 

But will transparency in health care AI actually build trust among users? Or will algorithm explanations go ignored? I argue that individual algorithm explanations will likely do little to build trust among health care AI users.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Weaknesses in Medical Device Regulation Worsened by Trump Administration

By Jacob Howard

In the waning days of the Trump administration, a final push was made to fundamentally weaken regulation of medical devices.

Lambasted as a “full frontal assault on public health” by U.S. Food and Drug Administration (FDA) officials, key policy changes include proposed emergency exemptions to bring a multitude of devices to market without the necessary scientific backing. Justified as a strategy to expedite the delivery of life-saving products, this speed comes at a risk to millions of patients.

As the third most prevalent cause of death in the U.S., medical error continues to be a critical issue that is exacerbated by weakening integrity of the regulatory process. This issue is further compounded by the fact that past regulatory failures in the medical device sphere have not been adequately addressed. The surgical stapler offers an illustrative example.

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TWIHL: Innovation and Protection: The Future of Medical Device Regulation, Episode 3

This is the last of three episodes of “Innovation and Protection: The Future of Medical Device Regulation,” a podcast miniseries created to replace the 2020 Petrie-Flom Center Annual Conference in light of the COVID-19 pandemic.

These episodes highlight a selection of papers that were written for the conference, which was organized in collaboration with the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law (CeBIL) and the University of Arizona Health Law Program. All of the papers will be published in an edited volume.

This third episode looks at recent advances in medical device regulation in the U.S. and abroad, and the effects of the COVID-19 pandemic on national and international medical device regulation.

First, Timo Minssen, Professor of Law and Director, Center for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen and Researcher in Quantum Law, Lund University, interviews Helen Yu, Associate Professor at the University of Copenhagen, Faculty of Law and Associate Director of CeBIL about her paper “Regulation of Digital Health Technologies in the EU: Intended vs. Actual Use.”

Minssen returns to talk with Janos Meszaros, Postdoctoral Research Fellow at Taiwan’s National Academy of Science about “Challenges at the Interface of EU Medical Device Regulation and the GDPR: Do the Rules on Privacy and Scientific Research Impair the Safety of AI Medical Devices?”

Finally, Christopher Robertson discusses “Preventing Medical Device-Borne Disease Outbreaks: Improving High-Level Disinfection Policies for Scopes and Probes,” with author Preeti Mehrotra, Attending Physician, Beth Israel Deaconess Medical Center and Instructor of Medicine, Harvard Medical School.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find me on Twitter @nicolasterry or @WeekInHealthLaw.

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

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

Technical illustration of a respirator device

Why Medical Device Regulation?

By Carmel Shachar

The Petrie-Flom Center’s 2020 annual conference, Innovation and Protection: The Future of Medical Device Regulation, co-sponsored by the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law and the University of Arizona Health Law Program, was inspired by a growing sense that there is a need to reconsider our regulatory approach to medical devices as they become increasingly complex. Not only are medical devices becoming more mechanically complex, but they are also increasingly merging with digital technologies to expand capabilities.

Devices’ increasing complexity raises questions as to whether our regulatory pathways for medical devices are appropriate for ensuring safety and efficacy. The New York Times in a May 4, 2019 Editorial Opinion indicated that they believed the answer is no—that our current regulatory system, especially the 510(k) pathway and limited post-market surveillance, risk patient lives and health. The European Council is implementing new medical device regulations in May 2020 and 2022 to address similar concerns around safety and effectiveness in the EU. Both American and European regulators are struggling to find the best way to oversee the new hybrid medical devices that incorporate both hardware and software, as well as stand-alone algorithms.

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Medical devices in a doctor's office

What the Trade War with China Means to the Medical Industry

If you rely on a pacemaker, an implanted defibrillator, a prosthetic hip, wear contacts or need an MRI, then you should be concerned about the constant threat and imposition of tariffs on Chinese imports by the Trump Administration. Using Section 301 of the Trade Act of 1974, President Donald Trump imposed new tariffs on an array of Chinese imports based on the assertion that they were stealing United States intellectual properties. The first volley occurred in July 2018 when the administration applied tariffs of 25% to over $34 billion in Chinese imports, and then again in August 2018 when it added another $16 billion in products to the list.

In an ongoing tit-for-tat, on May 10, 2019, the United States raised tariffs from 10% to 25% on an additional $200 billion worth of Chinese goods, including many health care products, from surgical gloves to chemical reagents. While medical supplies are only a small, biopsy-sized sample of the goods that will face these tariffs, they are sure to have some impact on an already financially burdened health care delivery system here in the United States. This will result in higher prices for health care products, devices, and components that are all passed off to the consumer.

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Products Liability or Medical Malpractice? The Definition of a “Healthcare Provider”

By Alex Stein

Every defendant in a suit for medically inflicted injuries wants to be a “healthcare provider.” This status entitles the defendant to categorize the suit as “medical malpractice” and become eligible to special litigation advantages, which include shortened limitations and repose periods, dismissal of suits not verified by experts, and statutory caps on damages.

In Verticor, Ltd. v. Wood, — S.W.3d —- 2015 WL 7166024 (Tex.App.–Austin 2015), the manufacturer of Eclipse Shield – a spinal implant for fusion – claimed to be a “healthcare provider” for purposes of the Texas Medical Liability Act (TMLA). The purpose of this claim was to recharacterize the products liability action filed against Verticor into a “healthcare liability claim” that can proceed to court only upon showing of medical malpractice verified by an expert. To establish this claim, Verticor argued that it provides the Eclipse Shield “for, to, or on behalf of a patient during the patient’s medical care, treatment, or confinement” under its “device manufacturer” license. This service, explained Verticor, makes it a “healthcare provider.” Read More

UDI Adoption: A Necessary Step Towards Better Care for Patients with Implanted Devices

By Dalia Deak

In the United States, though many millions of individuals live with implanted devices, it may shock you to know that it is easier to recall tainted dog food than it is to recall a faulty pacemaker. This is due in large part to the lag of the medical device world behind most other industries in the implementation of a standardized system that can uniquely identify and track medical devices as they move through the supply chain to a patient. Such an identification system has existed for most products since stores implemented the UPC and Congress mandated that drugs be labeled with the National Drug Code, both of which were introduced in the early 1970s.

To remedy this lag, Congress, in FDAAA of 2007, tasked the FDA with the creation of a unique device identification (UDI) system. In 2013, FDA published a Final Rule regarding manufacturer labeling of UDIs, to be rolled out by class in the coming years. While the establishment of such a system would certainly constitute an important step forward, another number on a label will do little to enhance patient safety on its own. Rather, the value of UDIs is in the uptake of the identifier at each point in a medical device’s life—from manufacturer to distributor to provider to patient to payer (see this report I co-authored on this very issue). Read More