Regulation

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...
AI generated image of a brain implant on a brain
By  Jessica Hagen 02:13 pm December 16, 2024
The U.S. Securities and Exchange Commission (SEC) has reopened an investigation into Elon Musk's brain-computer implant company Neuralink, according to a letter Musk posted on X penned by his attorney and directed at SEC chair Gary Gensler.  Musk also mocked the SEC in a post saying it was "just another weaponized institution doing political dirty work." The letter, published on Dec. 12, also...
Healthcare provider holding a tablet
By  Jessica Hagen 12:33 pm December 12, 2024
MobiHealthNews asked executives from across the digital health industry – in places from Fortune 500 companies to emerging startups – to share their biggest takeaways from 2024. Their responses highlight a diverse range of perspectives and insights. In part one of this two-part series on the biggest takeaways of the year, explore executives' thoughts on key trends, including the growing focus on...
Nurse standing in the clinical setting
By  Jessica Hagen 03:59 pm November 27, 2024
Safety-focused large language model company Hippocratic AI has been issued its first patent by the U.S. Patent Office, which includes the company's LLM innovations incorporated into its safety-focused LLM built with a constellation architecture dubbed Polaris. Hippocratic AI's generative AI solution focuses on nondiagnostic healthcare tasks such as medication onboarding and monthly reconciliation...