Food and Drug Administration

Food Safety 2.0: FDA shares its vision for a digital, transparent food safety system

Posted on September 17, 2019September 17, 2019 by Luke Fretwell

In an interview with the agency, the Food and Drug Administration Deputy Commissioner Frank Yiannas discussed its latest efforts to “leverage new and emerging technologies to prevent contamination and rapidly trace the origin of a tainted food to its source.”

FDA announced the New Era of Smarter Food Safety initiative in April 2019, and the agency will hold an public meeting on the program October 21.

Key excerpts from the interview:

This isn’t just a slogan or a tagline. Instead, it’s a new approach to food safety, one that recognizes and builds on the progress made in the past, but also incorporates the use of new technologies that are being used in society and business sectors all around us. These include blockchain, sensor technology, the Internet of Things, and Artificial Intelligence to create a more digital, traceable, and safer food system. This new approach creates shared value for all stakeholders — farmers, food producers, regulators, consumers, and the planet.
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That said, while technology is an important part of Smarter Food Safety, it’s more than that. It’s about simpler, more effective and modern approaches and processes. It’s about leadership and creativity. It’s also about working within and outside of FDA to foster a food safety culture that transcends borders between the public and private sector.
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In my view, today’s food system is amazing, but it does have one major Achilles heel: A lack of traceability and transparency.
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When it comes to food traceability, some are stuck in a past in which each segment in the food system is responsible for keeping track of food, one step forward to identify where the food has gone and one step back to identify the source. And it’s largely done on paper. However, with the emergence of new digital technologies, the proliferation of the Internet of Things, and the continued advancement of sensor technology, many believe the one-step forward and one-step back model of food traceability is an outdated paradigm for the 21st Century.
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When FSMA was conceived and launched, it brought people to the table, both public and private partners. A New Era of Smarter Food Safety is doing the same. Now we plan to accelerate based on that foundation. How do we continue to modify and adapt? I foresee a more digital, data-driven, and transparent system that’s more precise and efficient.
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The future of government technology procurement

Posted on July 8, 2015July 7, 2015 by Luke Fretwell

The General Services Administration and 18F recently held an open request for quotation related to a new blanket purchase agreement for a federal marketplace for agile delivery services. The transparency throughout the entire process was refreshing and provides a window into the future of procurement as well as what FedBizOpps could and should be.

The RFQ asked companies to provide a working prototype with code submitted in a public GitHub repository that could be viewed, watched, forked or downloaded at any time. Timestamps built into GitHub’s commit timeline publicly exposed when a company began working and when and whether it “submitted” its final version within the allocated timeframe.

The objective of the BPA, according to 18F, was “to shift the software procurement paradigm” from a waterfall-based development model with a long, tedious approach to acquisition that typically favors large, established inside-Beltway vendors to one that encourages small business participation, and that required all companies to work in the open, using GitHub to expose not just the code, but how the teams worked together and documented their efforts.

CivicActions (full disclosure: I work for them) participated in the process, and I played a role in developing parts of the front-end and productizing the end result, which was SideEffect.io, an adverse affect comparison tool that leveraged open data from the Food and Drug Administration’s OpenFDA initiative (GitHub repo here).

Having played a minor role on the team and having an odd appreciation for how government IT leaders are working to modernize technology procurement, the process was fascinating to watch both from how GSA and 18F pushed this out and managed, but also an inside perspective on how one company responded and worked together (FCW’s Zach Noble has a great write-up on how the CivicActions team worked, the tools used and its general philosophy going into it).

My general takeaway is that this is the future of the request for information/quote/proposal process. In the future, much like what I prototyped at OpenFBO, for each procurement request, there will be repo-like tools that fully expose public input and questions, allow internal and external stakeholders to easily “watch” for updates, attach bids or quotes with an opportunity for feedback, all of which would eventually turn into the repo for developing the end product.

As GSA and 18F, and hopefully other federal, state and local agencies, continue to refine this process, whether it’s via GitHub or a Git-like platform, you can be sure this is the future of how government will procure custom-built software and services.

GovFresh guide to openFDA

Posted on September 7, 2014September 7, 2014 by Luke Fretwell

Photo: FDA / Michael J. Ermarth

The U.S. Food and Drug Administration’s openFDA initiative aims to “make it easier for web developers, researchers, and the public to access large, important public health datasets.”

Initial areas of focus include adverse event and recall enforcement reports and product labeling data (see “Drugs,” “Devices,” “Foods“). It currently provides an application programming interface of information that was previously unavailable or easily-accessible to the public, including millions of reports submitted to the FDA from 2004 to 2013.

History

The U.S. Department of Health and Human Services identified “Open FDA” as a priority in its open government “Plan Version 3.0.” Led by the FDA’s Office of Informatics and Technology Innovation, the project began in March 2013 and launched a public beta in June 2014.

Timeline

March 2013: Taha Kass-Hout named FDA chief health informatics officer.
March 2013: Work on openFDA begins.
July 2013: White House Presidential Innovation Fellows join to support openFDA development.
December 2013: FDA creates the Office of Informatics and Technology Innovation lead by Kass-Hout.
June 2014: openFDA launches in beta.

Quotable

“The openFDA initiative leverages new technologies and methods to unlock the tremendous public data and resources available from the FDA in a user-friendly way. OpenFDA is a valuable resource that will help those in the private and public sectors use FDA public data to spur innovation, advance academic research, educate the public, and protect public health.”

– FDA Chief Operating Officer and Acting Chief Information Officer Walter S. Harris

“In the past, these vast datasets could be difficult for industry to access and to use. Pharmaceutical companies, for example, send hundreds of Freedom of Information Act (FOIA) requests to FDA every year because that has been one of the ways they could get this data. Other methods called for downloading large amounts of files encoded in a variety of formats or not fully documented, or using a website to point-and-click and browse through a database – all slow and labor-intensive processes.”

– FDA Chief Health Informatics Officer Taha Kass-Hout

GovFresh

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