In brief In September 2024, Texas’ Attorney General announced a “first-of-its-kind” settlement with a healthcare generative artificial intelligence (“Gen AI”) company over what it…
In brief On October 8, 2023, California Governor Gavin Newsom signed two bills into law amending the California Consumer Privacy Act (CCPA). AB 947…
In Fall 2022, the Office of the Privacy Commissioner of Canada (OPC) published a study it had funded on the privacy implications of direct-to-patient…
Synthetic datasets could change the way developers train AI models in healthcare. They have the potential to increase the size of training datasets for…
New guidelines have been published on clinical trials for AI health solutions. The SPIRIT-AI extension relates to clinical trials protocols, and the CONSORT-AI extension…
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on medical device standalone software last month. We’ve set out our top 5 takeaways from the new guidance
Delay of MDR Implementation and its Implications for Brexit The recent postponement of the Medical Device Regulation 2017/745 (“MDR”) means its full application will…
Are you developing a digital health solution with cross-border reach? Whether your company is new to the digital health space, or enhancing its existing…
In response to the COVID-19 global pandemic, on March 17, 2020, the Office of Civil Rights (OCR) at the US Department of Health and…
In this episode of Connect On Tech, your host Brian Hengesbaugh is joined by Ben McLaughlin, Global Chair of Baker McKenzie’s Healthcare & Life…