Regulation

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.

The Conference Board's principal economic policy analyst PJ Tabit says that while the plan is helpful, it is not a comprehensive framework for how to regulate AI.

Also, Neurophet will tap into Roche's data to further improve its brain scan analysis AI.

The EU says makers and distributors of health-related app stores or applications will now be considered medical device makers and must adhere to associated regulations.