Regulation

Dr. Erik Langhoff, chief medical officer and consultant for the Bronx Regional Health Information Organization, discusses how the agency is addressing safety and efficacy in AI.

Also, a project developing AI for early periodontal disease detection has received over $1 million in grant funding from the Australian government.

Smile Digital Health will integrate MCG Path, a FHIR-based application programming interface offering, with Smile's CMS Suite.

Dr. Doug Fridsma, former ONC chief science officer and current chief medical informatics officer at Health Universe, discusses GPT-5, including HIPAA compliance, FDA oversight and potential risks for patients uploading healthcare data.

Lee Kim, HIMSS senior principal of cybersecurity and privacy, spoke with MobiHealthNews about GPT-5 use in healthcare. She emphasized that patient safety and cybersecurity must remain top priorities for developers.

ArteraAI Prostate uses digital pathology images from a patient’s biopsy to predict potential long-term outcomes of their prostate cancer.

ArteraAI Prostate forecasts potential long-term outcomes of a patient's prostate cancer biopsy slide based on digital pathology images.

The company's CEO defended its feature as a wellness tool under the 21st Century Cures Act, combating the FDA’s claim that it qualifies as a regulated medical device.

The feature will be available via new iOS and watchOS updates, one year after the U.S. International Trade Commission banned Apple from selling its Series 9, Series 10 and Ultra 2 watches.

Nyxoah is in the midst of a lawsuit brought on by Inspire Medical Systems alleging infringement of several patents related to its recently-cleared offering, Genio.