Government & Policy
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.
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.
A new law passed in New York and legislation introduced in Ohio are just two of the latest examples of a legislative push to expand insurance coverage for biomarker testing.
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.
The hospital "failed to handle its patients’ health information with care," said Attorney General Letitia James. It has pledged to update its policies on third-party tools, ensure deletion of PHI gathered by those tools and boost its privacy safeguards.
The HHS 405(d) program has new resources to help small to large healthcare organizations navigate what's important when implementing cyber insurance.
The DOJ announced that the FBI also has decryptor keys for Blackcat ransomware victims and will "prioritize disruptions" as it works to "dismantle the ecosystem fueling cybercrime."
One venture capitalist predicts big news for genAI in healthcare next year, but also expects more government intervention to help protect against patient safety risks and provider liability.