BradleyMerrillThomps

Attorney focused on artificial intelligence and FDA regulation of medical devices, digital health and combination products.

[BradleyMerrillThomps @BradleyMerrillT]

What biases do FDA regulatory affairs professionals –at FDA and in industry –have? For my post this month, I conducted a study where I used a corpus of about 600 medical device guidance documents written by FDA officials and about…https://t.co/8gD6MVGcU9 https://t.co/vzbe7lv5He

[BradleyMerrillThomps @BradleyMerrillT]

We had over 400 people sign up for this program on algorithmic bias and the law, but many other people couldn't attend on the date it was scheduled. So below we are releasing a recording of the session. I hope you find it useful. https://t.co/x8uSbV1yUg

[BradleyMerrillThomps @BradleyMerrillT]

ICYMI: Last week, I shared my latest blog post discussing the impact of societal bias, including racial bias, on scientific algorithms. If you’re interested in this topic, you might want to attend our upcoming Virtual Briefing, “Ac…https://t.co/pLr1Q3b0ZO https://t.co/2mzu9DUAe1

[BradleyMerrillThomps @BradleyMerrillT]

In this month's post, I tackle the issue of how societal bias, including racial bias, can enter into what looks like a purely scientific algorithm. I use for the case study sepsis prediction because it's one of the most common and…https://t.co/V9PasaXWR3 https://t.co/tJgS2L7KT5

[BradleyMerrillThomps @BradleyMerrillT]

An interesting read. https://t.co/aVmL8Krcon

[BradleyMerrillThomps @BradleyMerrillT]

Looking forward to hearing what the panel thinks are the best way to build up health equity through digital health as a part of the annual meeting of the Food and Drug Law Institute on May 17, 4:30 pm. Algorithmic bias is a serious threat, but one that w…https://t.co/W18uYLefEW

[BradleyMerrillThomps @BradleyMerrillT]

While much of the media attention this morning is on the fact that President Biden is meeting with tech leaders to talk about algorithmic bias, hopefully not lost in the shuffle is this significant announcement by OMB:

The Office…https://t.co/jBeNwWj5eq https://t.co/UnFy5onvfL

[BradleyMerrillThomps @BradleyMerrillT]

Part 3 of 3 in my series analyzing FDA's data on FOIA requests. In this analysis, I focus on using topic modeling to assess relative success in obtaining FDA documents. I find it interesting and a little bit surprising that only…https://t.co/ZtCK7jVXCI https://t.co/fzr7UzuhLy

[BradleyMerrillThomps @BradleyMerrillT]

Data scientists and attorneys have to work together to fight algorithmic discrimination. Neither can do the necessary work by themselves. In this article, I analyze where collaboration is essential. The Journal of Robotics, Artif…https://t.co/L6JYQTo23C https://t.co/vA0TlXOoRg

[BradleyMerrillThomps @BradleyMerrillT]

In a proposed rule to be released tomorrow, ONC is trying to advance health equity by proposing to require that companies certify EHR modules that use algorithms as containing certain elements designed to achieve transparency. Sma…https://t.co/uxpjeHDxyC https://t.co/kwAg8VwZNF

[BradleyMerrillThomps @BradleyMerrillT]

Post 2 of 3 on data I obtained from FDA on its FOIA program. Diving into the topics of the FOIA requests, discerned by NLP, and how FDA response time varies by topic. Interesting data on FOIA requests for 510(k)s. #fda #nlp https://t.co/Cw4TWK9qrR

[BradleyMerrillThomps @BradleyMerrillT]

Here is a deeper assessment of the draft guidance FDA released last week on predetermined change control submissions for ML-driven medical devices. #fda #ml https://t.co/VpWbd0X5zN

[BradleyMerrillThomps @BradleyMerrillT]

We have been waiting years for this from #fda . It's huge for #ai, enabling more practical premarket oversight on AI that evolves. https://t.co/RvEW1KRFT9

[BradleyMerrillThomps @BradleyMerrillT]

FDA issued the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development. The Digital Health Technology (DHT) framework document is intended to guide the use of DHT-derived data in regulatory d…https://t.co/zpE6Zj6nar https://t.co/fpOWdGIL4h

[BradleyMerrillThomps @BradleyMerrillT]

This month I got my hands on a new data set, one not previously analyzed to my knowledge. It's FDA's performance in responding to FOIA requests over the last 10 years, ironically obtained through a FOIA request. In this first pos…https://t.co/edL56nSPDI https://t.co/CU0z1bnWnb

[BradleyMerrillThomps @BradleyMerrillT]

Today, FDA released an update on its breakthrough medical device program. In FY 2022, the number of products admitted to that program declined. Typically, the number of breakthrough products is a matter of both the nature of devices brought to FDA, and t…https://t.co/lOrS4Z4OfO

[BradleyMerrillThomps @BradleyMerrillT]

Check out section 1 of this Executive Order released today where it observes that the goal of the federal government should be to "promote equity in science and root out bias in the design and use of new technologies, such as artif…https://t.co/nEab9SI9NE https://t.co/zucObYIrXC

[BradleyMerrillThomps @BradleyMerrillT]

Here's a discussion of the activities of the Clinical Decision Support Coalition in opposing the FDA's final guidance. For anyone interested in joining the coalition, membership is free and by design it's a big tent. We want all points of view. https://t.co/946nfOYnq7

[BradleyMerrillThomps @BradleyMerrillT]

In this podcast, I explain why this past Monday we filed a citizens petition at FDA asking the agency to rescind its final guidance on clinical decision support software. #fda #software https://t.co/pORymf2BID

[BradleyMerrillThomps @BradleyMerrillT]

And now for something completely different. In this month's post, I experiment with using data science techniques to help analyze a legal question, i.e. whether a final guidance is the logical outgrowth of the proposal. For a pro…https://t.co/YSC4skElZ3 https://t.co/EHaAgGEm26