Tag: Medical Devices Regulation

A Brief Quantum Medicine Policy Guide

The Petrie-Flom Center Staff Leave a comment

by Mauritz Kop, Suzan Slijpen, Katie Liu, Jin-Hee Lee, Constanze Albrecht & I. Glenn Cohen

 

I. Introduction: Harnessing Quantum and AI in Precision Medicine

The convergence of artificial intelligence (AI) and quantum technology (QT) in precision medicine promises to revolutionize healthcare by enabling hyper-personalized treatment.

Fundamentally, for our purposes, quantum technology leverages unique properties of quantum physics—such as superposition and entanglement—to solve problems beyond classical capabilities. Second-generation (2G) quantum technologies harness these principles to achieve quantitative (speed, fidelity) and qualitative (novel functionality) advantages over other methods. Quantum-classical hybrids (frameworks, algorithms or devices that integrate both quantum and classical computing resources such as qubits and digital bits) combine elements from both macroscopic and microscopic worlds to solve complex problems.

Read More

Home innovation technology concept illustration.

Call for Abstracts — 2022 Petrie-Flom Center Annual Conference: Diagnosing in the Home

The Petrie-Flom Center Staff Leave a comment

Contribute to the 2022 Petrie-Flom Center Annual Conference and subsequent book project!

Through October 14, 2021, the Petrie-Flom Center is accepting abstracts for its annual conference. The 2022 annual conference will focus on ethical, legal, and regulatory challenges and opportunities around at home digital health technology.

This conference will engage with the vision for a 21st century health care system that embraces the potential of at home digital products to support diagnoses, improve care, encourage caregivers, maximize pandemic resilience, and allow individuals to stay within the home when preferable. The goals of this conference and subsequent book project are to consider the ethical, sociological, regulatory, and legal challenges and opportunities presented by the implementation of digital products that support clinical diagnosis and/or treatment in patients’ homes over the next decade.

Interested in submitting an abstract, but want to know more about what we’re looking for? Read through the following frequently asked questions.

Read More

Code on computer.

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

Jenna Becker Leave a comment

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.

Read More

AI concept art.

Health Care AI in Pandemic Times

Jenna Becker Leave a comment

By Jenna Becker

The early days of the COVID-19 pandemic was met by the rapid rollout of artificial intelligence tools to diagnose the disease and identify patients at risk of worsening illness in health care settings.

Understandably, these tools generally were released without regulatory oversight, and some models were deployed prior to peer review. However, even after several months of ongoing use, several AI developers still have not shared their testing results for external review. 

This precedent set by the pandemic may have a lasting — and potentially harmful — impact on the oversight of health care AI.

Read More

NHS building

First Do No Harm: The Independent Medicines and Medical Devices Safety Review

John Tingle Leave a comment

By John Tingle

A new hard-hitting report on medicines and medical device safety published in the U.K. presents controversial proposals that have the potential to improve National Health Service (NHS) patient safety.

The report, The Independent Medicines and Medical Devices Safety Review, was published on July 8th, 2020 after a two year investigation chaired by Baroness Julia Cumberlege. The review investigated two medications — Primodos and sodium valproate — and one medical device — pelvic mesh.

The reviews remit was to examine how the healthcare system in England responded to reports about harmful side effects from medicines and medical devices and how best to respond in the future.

Read More