The U.K. Medicines and Health Care Products Regulatory Agency has provided guidance on what does and does not constitute a regulated digital mental health technology, but developers should be aware that promotional claims could push a product from the unregulated to the regulated category.

South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help establish standards on the technology’s applications in the medical field.

U.S. federal law is still lacking where AI is concerned, but California’s attorney general issued a bulletin that elevates the legal hazards of AI in medical use. The bulletin says that AI tools may not supplant a physician’s decision-making, a provision that would seem to render some FDA-cleared products illegal there.

In what represents the first PCT filing emerging in the name of Ayble Health Inc., protection is sought for a system for adaptive, multi-level processing of health data to be used in the individualized management of immune-mediated inflammatory diseases such as inflammatory bowel disease and irritable bowel syndrome.

Neu Health Ltd. received $2 million in funding from Cedars-Sinai Intellectual Property Company and Oxford Science Enterprises (OSE) to bring its platform, designed for Parkinson’s disease and dementia care, into the U.S.

Eyebright Medical Technology (Beijing) Co. Ltd. is expanding its position in China’s phakic intraocular lens (IOL) market, gaining the National Medical Products Administration (NMPA) approval of its Loong Crystal PR phakic IOL product for myopia in adults in January 2025.

South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help establish standards on the technology’s applications in the medical field.

Glooko Inc. and Hedia ApS launched an integrated software solution in the U.K. to support people with diabetes who require advanced doses of bolus insulin. The solution combines Glooko’s diabetes monitoring platform with Hedia’s diabetes dosing recommendation app to deliver personalized insulin dosing advice to people with type 1 and type 2 diabetes.

Brainaurora Medical Technology Ltd. debuted on the Hong Kong stock exchange Jan. 8 with a HK$583.18 million (US$74.93 million) IPO, offering about 181.11 million shares at HK$3.22 per share.

Makers of digital health apps are not often subject to the provisions of the Health Insurance Portability and Accountability Act (HIPAA), but any such liabilities may soon become more onerous. The Department of Health and Human Services released a draft update for HIPAA cybersecurity mandates – the final version of which is sure to be accompanied by much more vigorous enforcement.