FDA Eyes Global AI Partnerships to Safeguard Patient Data
The Center for Devices and Radiological Health director warns Congress of national security implications if the U.S. restricts AI development in medical settings.

The Food and Drug Administration (FDA) is embracing artificial intelligence and working with international allies and partners to safeguard patient data and ensure the integrity of medical devices, agency experts told the Health Subcommittee Hearing on FDA Regulation of Drugs, Biologics and Devices last week.
Center for Devices and Radiological Health (CDRH) Director Jeff Shuren said FDA has addressed cybersecurity vulnerabilities by working with industry partners to update cybersecurity requirements for medical devices in compliance with the Consolidated Appropriations Act of 2022.
Despite progress, CDRH identified that laboratory-developed tests — in vitro diagnostic products manufactured by laboratories and used in a single clinical laboratory — remain vulnerable to cybersecurity threats.
There is a critical need for greater oversight of these tests to ensure the innovation of safe and effective medical devices, Shuren added.
“We monitor several [vulnerabilities] at any given time, but there is still a weakness in laboratory developed tests,” Shuren said. “We have put out communications where we found vulnerabilities in platforms being used by non-labs and labs, but we only found out about it because it was used by non-labs. We made the manufacturer tell the labs, otherwise they would’ve never known.”
CDRH is enhancing efforts to ensure that patches are provided to biomedical departments of hospitals and their service suppliers. Shuren said that working closely with industry partners is key to ensuring the implementation of necessary security measures and timely patching vulnerabilities.
“This begins with designing devices in a way that allows them to be patchable,” Shuren said. “That’s what we work on with companies to assure that they’ve got the right measures in place. Then as we learn about problems and patches, we help yield that out.”
Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni emphasized the need for greater transparency within the supply chain to hold stakeholders accountable and address impending shortages in a timely manner.
“We would welcome having more authorities that would allow us to have greater transparency on the supply chain, “ Cavazzoni said. “Greater transparency on the supply chain is certainly a tool that would really add to our limited toolbelt, so far.”
Shuren also noted that there are national security implications if the U.S. restricts AI development, emphasizing the need to embrace emerging technologies to remain the global leader in innovation. He said it’s important for FDA to facilitate AI development for medical systems in ways that are both safe and effective for patients.
He added that FDA is working with international partner governments to prevent duplication of requirements for companies that are marketing devices with AI.
“Much of our work for international harmonization on AI occurs in a group called the International Medical Device Regulators Forum,” Shuren said. “Typically in the AI space and digital health, when there are needs for changes in policies, we not only start here in the U.S., but we also take it to this group because all the countries are struggling with the same issues.”
Through efforts of fostering international collaboration, the group is now working on a globally harmonized policy regarding the lifecycle management approach for AI medical devices, Shuren said.
“We are trying to move [innovation] through as rapidly as we can while maintaining our gold standard,” added Center for Biologics Evaluation and Research Director Peter Marks. “We are always trying to do better, and that’s a commitment we have.”
Beyond collaboration with industry partners and international allies, Shuren also emphasized the importance of government to help safely harness AI technologies and locate cybersecurity vulnerabilities.
“At the end of the day, if we want industry to be innovative and get innovations to people who need them, government has to be innovative too,” Shuren said.
This is a carousel with manually rotating slides. Use Next and Previous buttons to navigate or jump to a slide with the slide dots
-
AI Foundations Driving Government Efficiency
Federal agencies are modernizing systems, managing risk and building trust to scale responsible AI and drive government efficiency.
40m watch -
Trump Executive Order Boosts HBCUs Role in Building Federal Tech Workforce
The executive order empowers HBCUs to develop tech talent pipelines and expand access to federal workforce opportunities.
3m read -
Navy Memo Maps Tech Priorities for the Future Fight
Acting CTO’s memo outlines critical investment areas, from AI and quantum to cyber and space, as part of an accelerated modernization push.
5m read -
DOD Can No Longer Assume Superiority in Digital Warfare, Officials Warn
The DOD must make concerted efforts to address cyber vulnerabilities to maintain the tactical edge, military leaders said at HammerCon 2025.
4m read -
New NSF Program Cultivates the Future of NextG Networks
The agency’s new VINES program looks to tackle key challenges like energy efficiency and future-proofing wireless tech.
21m watch -
Tracking CIOs in Trump's Second Term
Stay informed on the latest shifts in federal technology leadership as new CIOs are appointed and President Trump's second term takes shape.
6m read -
DHA CDAO Spearheads Master Data Catalog to Boost Transparency
Jesus Caban plans to boost DHA's data maturity through a new master data catalog, governance frameworks and inventory of tech tools.
5m read -
IHS Prepares to Deploy PATH EHR at Pilot Sites in 2026
IHS targets PATH EHR pilot in 2026, emphasizing governance, collaboration and interoperability as key pillars of the modernization strategy.
4m read -
Trump Orders Spark Government-Wide Acquisition Overhaul
As Trump pushes for a faster, simpler procurement system, agencies are leveraging AI and adapting strategies to meet new requirements.
5m read -
Inside Oak Ridge National Lab’s Pioneer Approach to AI
Energy Department’s Oak Ridge National Lab transforms AI vulnerabilities into strategic opportunities for national defense.
22m listen -
A Look at Federal Zero Trust Transformation
Recent developments from CISA and DOD show how government is advancing zero trust quickly.
20m read -
Modernization Strategies to Enable Energy Innovation
Lawrence Berkeley National Lab and Maximus experts explore the modernization strategies driving digital transformation and operational resilience within the energy sector.
33m watch