Last week, the Washington Post reported the Centers for Medicare and Medicaid is “going all in on AI.” But it’s not the only federal health agency doing so.

FDA Commissioner Marty Makary, an embattled pick who was confirmed on March 25 last year, sat down for an interview with Healthcare Brew to talk about how AI is already in use at the agency (though there have been anonymous complaints about some of the tools) and how pivotal he believes it is for the pharmaceutical industry. He also shared about his plans for the technology, including long-term goals for making drug approval more efficient using AI.

This interview has been edited for clarity and length.

I heard you mention at the JPMorgan Healthcare Conference in San Francisco in early January that the FDA has built 150 new AI systems. What are these tools exactly, and how do they work?

We asked the developer community at the FDA…to think creatively about any workstream that they can improve with technology, and specifically AI.

We got 181 submissions, and they were across all sorts of workflows at the agency. For example, document processing, automating parts of the review, triaging the submission, ensuring that the formatting is correct. That tends to be a very tedious task that’s done by humans. But now our scientific reviewers have the option to have that done with AI help…It helps them look for safety signals. Some of the tools are really quality assessment. Some help with manufacturing by targeting the high-yield areas of manufacturing. A lot of workflow optimization, compliance support, research.

See the full conversation here.—CM

Ever wonder why airport security has signs that discourage violence against its workers, but some emergency departments don’t?

Healthcare leaders say that’s because they aren’t sure how to phrase the signs without getting in trouble with regulators.

“The most basic element of prevention is often out of reach—that is, signage that sets expectations for respectful behavior and emphasizes that violence toward staff, patients, or visitors is unacceptable and could have consequences,” reads a Jan. 20 letter from medical societies and trade groups to the Centers for Medicare and Medicaid Services (CMS).

Forty-eight states have laws that outline penalties for violence against healthcare workers, ranging from fines to felony charges, as of June 2024.

The letter asked for clear written guidance with guardrails and examples of appropriate signage. As of publication the groups haven’t heard back from CMS, Laura Wooster, one of the letter’s leaders and the associate executive director of advocacy and practice affairs at medical society the American College of Emergency Physicians (ACEP), told Healthcare Brew over email.

Experts are split on whether a sign would make a difference.—CC

The cyberattack against medtech company Stryker isn’t quite like other major cybersecurity events we’ve seen in the healthcare industry in recent years. This attack is part of Iran’s response against the US to the war in the Middle East.

On March 11, an Iran-linked threat actor called Handala (suspected by Israeli cybersecurity experts to be tied to the Iranian Ministry of Intelligence and Security) disrupted Stryker’s internal Microsoft network, the company shared in a statement, prompting the company to initiate a cybersecurity “response plan” and an internal investigation, per a Securities and Exchange Commission filing.

But crucially, this could be also a sign of more to come within this war, cybersecurity experts have said.

“You can’t look at this cyberattack in a vacuum. It’s direct retaliation tied to the broader conflict with Iran,” Erik Pupo, director of commercial health IT advisory at tech consultancy Guidehouse, told us via email.

This could spell potential disaster for hospitals.—NO