This month, I explore just how old medical devices are as measured by the date they were cleared or approved by the FDA, using the Global Unique Device Identification Database....more
I may be jumping the gun here, but I’m anxious to understand how the new flurry of AI medical devices is performing in the marketplace, or more specifically, whether the devices are failing to perform in a way that...more
When I was working on my Masters in data science, one of the projects I did was to create an algorithm that would take an intended use statement for a medical device and predict whether FDA would require a clinical trial. It...more
Most people have seen the growth in artificial intelligence/ machine learning (AI/ML)-based medical devices being cleared by FDA.
...more
At the end of 2022, FDA published a draft guidance on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The draft guidance explains several aspects of the VMSR Program, including FDA’s approach to...more
Turns out, ignorance really is bliss, at least according to the Office of Civil Rights (“OCR”) within the Department of Health and Human Services (“HHS”), in publishing its final rule on algorithmic discrimination by payers...more
4/29/2024
/ Affordable Care Act ,
Algorithms ,
Artificial Intelligence ,
Bias ,
Department of Health and Human Services (HHS) ,
Discrimination ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Machine Learning ,
OCR
Combination products present a tremendous opportunity to improve health outcomes, because they leverage multiple disciplines. If we were, for example, to focus on drugs alone with little thought to how they might be...more
FDA’s January 3, 2024, Federal Register notice soliciting comments on the agency’s plan to implement best practices for guidance development got me thinking. What do the data show regarding FDA’s performance in moving...more
As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs. In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that...more
2/6/2024
/ Business Development ,
Data Collection ,
Demographic Targeting ,
Disparate Impact ,
FOIA ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Request For Information ,
Risk Management
Frequently, I am asked by clients to predict how long it will take for FDA to review and clear a 510(k). At a high level, I observe that on average clearance can take 160 days according to the data. Then, beyond that, I...more
Those who have been reading this blog know that I like to analyze collections of documents at FDA to discern, using natural language processing, whether, for example, the agency takes more time to address certain topics than...more
Our latest focus is trying to bring data to bear on common questions we get asked by clients. Last month the topic was: how well does my device need to perform to get premarket clearance from FDA? This month it is: how big...more
On October 30, 2023, President Joe Biden signed the first ever Executive Order (EO) that specifically directs federal agencies on the use and regulation of Artificial Intelligence (AI). A Fact Sheet for this EO is also...more
This month I wanted to take a data-driven look at FDA’s treatment of citizen petitions, and specifically as a starting point how quickly the agency resolves those petitions. Make no mistake, I have an interest in this...more
It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is adequate to obtain FDA...more
Introduction -
Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...more
8/10/2023
/ 21st Century Cures Act ,
Artificial Intelligence ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Innovative Technology ,
Interstate Commerce ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Popular ,
Regulatory Requirements ,
Software
Recently Colleen and Brad had a debate about whether Medical Device Reports (“MDRs”) tend to trail recalls, or whether MDRs tend to lead to recalls. Both Colleen and Brad have decades of experience in FDA regulation, but we...more
This post explores how bias can creep into word embeddings like word2vec, and I thought it might make it more fun (for me, at least) if I analyze a model trained on what you, my readers (all three of you), might have written....more
We’ve all heard troubling stories involving emerging tools powered by artificial intelligence (AI), in which algorithms yield unintended, biased, or erroneous results. Here are a few examples:
- A monitoring tool for...more
6/8/2023
/ Algorithms ,
Artificial Intelligence ,
Bias ,
Consumer Product Companies ,
Employer Liability Issues ,
Facial Recognition Technology ,
Health Care Providers ,
Life Sciences ,
Privacy Laws ,
Race Discrimination ,
Risk Management ,
Webinars
Would it surprise you if I told you that a popular and well-respected machine learning algorithm developed to predict the onset of sepsis has shown some evidence of racial bias? How can that be, you might ask, for an...more
In prior posts here and here, I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests. I looked at response times and then started to dive into the topics that requesters were asking...more
Continuing my three-part series on FOIA requests using a database of over 120,000 requests filed with FDA over 10 years (2013-22), this month’s post focuses on sorting the requests by topic and then using those topics to dive...more
Federal agencies in health care publish large amounts of data, and my posts typically analyze that data. To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional...more
The U.S. Food and Drug Administration (FDA) recently issued a final guidance document clarifying how the agency intends to regulate clinical decision support (CDS) software.
How has this document caused confusion for...more
Introduction -
Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA...more