Compliance & Legal

The American Hospital Association questions the agency's calculations, and said the proposed information blocking penalties could threaten the financial viability of many small and rural hospitals.

With guidelines and rules for healthcare AI coming from the FDA, ONC, OCR, the White House and others, how will this regulatory framework change in 2024? Bryant Godfrey, partner at Foley Hoag, offers some thoughts.  

For all its potential benefits for healthcare, it's still critical to understand how patient data is being collected and used for AI models, says Sara Shanti, a partner in Sheppard Mullin's Chicago-based Corporate Practice Group.

The Medical Group Management Association says ONC's proposed rules add undue financial burden to practices and would affect the delivery of Medicare and value-based care.

Andreessen Horowitz investment partner Jay Rughani discusses the paper he and his colleagues published recently about clinical use cases of AI, and outlined steps regulators should take for reimbursing providers using the technology.

With HTI-1 finalized, EHR vendors will have to tackle electronic case reporting while providers must look ahead and get social determinants of health into their workflows, says Don Rucker, chief strategy officer for 1upHealth.  

The year ahead will see policies evolving along with the tech, says Brigid Bondoc, partner and life sciences attorney at Morrison Foerster, who discusses regulatory approaches that foster innovation while protecting safety.  

The watchdog agency said that it found the existing coordination agreement does not reflect "organizational and procedural changes," including the FDA's authority to find that medical devices in use violate federal law.