• Maryland: FDA has proposed a new framework for regulating AI-based software that is used as a medical device and can continue learning and adapting after entering the market. According to the agency, the framework focuses on a "predetermined change control plan," which would allow manufacturers to submit an upfront plan about how an AI algorithm is expected to change over time instead of filing a new premarket submission for every update. The framework includes two components: "SaMD pre-specifications," or the types of modifications a manufacturer expects and an "algorithm change protocol" or details about how the modifications will be made safely. Any changes outside of the plan would still require a new premarket submission. In recent years, FDA has taken steps to regulate AI-enabled devices, starting with a draft guidance on machine learning-enabled devices in 2023 and a broader draft guidance in 2025 that covered the full design process from development to postmarket monitoring. (Jeffries, Becker's Health IT, 8/18)
• Missouri: Drew Asher, Centene's current CFO, will step down from his role on Dec. 31 before retiring at the end of 2027. Asher has served as the organization's CFO since 2021 and oversaw it through years of turbulence due to growing medical costs. Chris Neczypor, who is currently CFO of Lincoln Financial, will join Centene next month and take over the CFO position on Jan. 1. Neczypor and Asher will work together to support the leadership transition until Asher's retirement. "Our organization will benefit from his [Neczypor's] expertise, energy and perspective as we deliver on Centene's next phase of transformation and growth," said Centene CEO Sarah London in a release. (Hughes, Healthcare Dive, 8/17)
• Pennsylvania: UHS has finalized its $835 million acquisition of Talkspace, a virtual behavioral care provider. According to Talkspace CEO Jon Cohen, the organization will retain its brand, structure, and broader strategic impact, but the biggest impact will be new opportunities for both UHS and Talkspace to bidirectionally refer patients and cover the full continuum of behavior care, including ED visits, inpatient admission, and medication management. "The next big step for Talkspace was really to get more referrals … from health systems, physician practices — part of the healthcare continuum that we hadn't made a really big dent in, quite honestly," Cohen said. "Everybody was coming to us for our contractual relationships and because we were in-network with the providers, so that's how most people found us. Now with this, we open up a very large channel of other parts of the healthcare system, healthcare continuum, that can refer to us." (Muoio, Fierce Healthcare, 8/17)

Hear from three behavioral health leaders about how they’re approaching digital health, workforce, crisis care, and, of course, financial sustainability in behavioral healthcare.