Regulation

Doctor wearing blue scrubs and holding their face mask
By  Jessica Hagen 03:29 pm March 7, 2025
LAS VEGAS - At the 2025 HIMSS Global Conference & Exhibition here, Tom Leary, senior vice president and head of government relations at HIMSS, and Jonathan French, senior director of public policy and content development at HIMSS, discussed the organization's role in progressing health technology policy in government.  In their talk, "Forecasting the Global Policy Landscape in 2025," the pair...
Herko Coomans, international digital health coordinator at the Ministry of Health
By  Jessica Hagen 02:36 pm March 6, 2025
LAS VEGAS - At the 2025 HIMSS Global Conference & Exhibition here, Herko Coomans, international digital health coordinator at the Ministry of Health, Welfare and Sport, highlighted the work of the Global Digital Health Partnership (GDHP) worldwide and the aim of the organization. During his talk, "Digital Health Policy Collaboration on a Global Scale with the GDHP," Coomans said, "Every...
Google's Pixel Watch 3
By  Jessica Hagen 02:21 pm February 26, 2025
Google has received FDA clearance for its loss of pulse detection feature available on Pixel Watch 3.  The loss of pulse detection technology checks for an individual's pulse. Once it detects signs of a loss of pulse, it activates infrared and red lights to search for additional pulse signals. A motion sensor then checks for signs of movement.  An AI algorithm then analyzes the pulse and movement...
Food and Drug Administration building
By  Jessica Hagen 11:22 am February 19, 2025
Food and Drug Administration (FDA) staffers reviewing Elon Musk's Neuralink were among those fired as part of widespread layoffs within the Agency. Musk is in charge of the new Department of Government Efficiency (DOGE), which is directing workforce cuts throughout numerous government agencies. According to a Reuters report, the cuts affected 20 individuals within the FDA's Office of Neurological...
AI robot digital image
By  Jessica Hagen 05:48 pm February 6, 2025
The European Union has released Guidelines to provide legal clarity on the prohibited uses of AI within the EU AI Act to ensure effective, consistent and uniform application and protect European citizens' rights and safety. The EU AI Act, which outlines regulations for the development, market placement, implementation and use of artificial intelligence in the European Union, came into effect in...
AI Optics Sentinel Camera
By  Anthony Vecchione 03:05 pm January 31, 2025
AI Optics, an AI-enabled medical device company, has received FDA 510(k) clearance for its Sentinel Camera. The handheld retinal imaging system captures high-quality images of the human eye, helping to address gaps in retinal disease screening through a portable and accessible tool. The aim of the Sentinel Camera is to enable point-of-care retinal imaging that would eliminate the need for some...
Ashkan Afkhami, managing director and senior partner and global leader of healthcare at BCG X
By  Jessica Hagen 12:35 pm January 24, 2025
Boston Consulting Group's Ashkan Afkhami, managing director and senior partner and global leader of healthcare at BCG X, sat down with MobiHealthNews outside of the JPM Healthcare Conference to discuss the strengths and weaknesses of America's health system – and his take on the importance of trust, governance and iterative development with the rise of AI adoption. MobiHealthNews: Where does the...
Business person signing a document
By  Jessica Hagen 12:01 pm January 21, 2025
On his first day in office of his second term, President Donald Trump revoked Joe Biden's 2023 executive order, which aimed to establish standards for the safe, secure and trustworthy development of AI across various sectors, including healthcare. Among its many provisions, Biden's order directed the U.S. Department of Health and Human Services (HHS) to establish a safety program "to help ensure...
Panelists at Boston Consulting Group event
By  Jessica Hagen 12:54 pm January 16, 2025
At a Boston Consulting Group (BCG) event in San Francisco during the JPM Healthcare Conference taking place this week, panelists discussed the government's role in advancing AI technology and government oversight of the technology with the changing administration.  Micky Tripathi, assistant secretary for technology policy, national coordinator for health IT and chief AI officer for the U.S....
Five businesspersons sitting around a table with two of them shaking hands
By  Jessica Hagen 08:00 am December 27, 2024
Executives across the digital health sector shared their insights with MobiHealthNews on whether mergers and acquisitions will continue to play a major role in the industry in 2025. Many pointed to factors such as shifts in the political climate, company valuations and large organizations seeking to expand their portfolios as potential drivers of increased M&A activity. Sean Mehra, cofounder...