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In brief On October 8, 2023, California Governor Gavin Newsom signed two bills into law amending the California Consumer Privacy Act (CCPA). AB 947 classifies citizenship and immigration status as “sensitive personal information” subject to special protections under the CCPA, while AB 1194 strengthens reproductive privacy rights. Both bills carried the unanimous endorsement of the California Privacy Protection Agency. Details for each bill are described below followed by actionable guidance businesses can take to prepare…

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 commercial virtual care platforms (VCPs) in Canada, technologies that allow healthcare practitioners to provide healthcare services to patients remotely. While the study does not constitute binding law or guidance, it is nonetheless noteworthy for operators of VCPs because (1) it identifies practices by commercial operators that the study describes as problematic…

Synthetic datasets could change the way developers train AI models in healthcare. They have the potential to increase the size of training datasets for AI models, whilst protecting patient privacy, but is this really a solution or just hype? We’ve set out 7 things you need to know. 1. What is synthetic data? A synthetic dataset is an “artificial” dataset containing computer-generated data instead of real-word records. In the healthcare setting, the term “synthetic data” is…

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 is a new reporting guideline for clinical trial reports. These new guidelines are aimed at addressing some of the chronic issues which often underlie trial standards for AI, including the use of retrospective datasets, poor standards of reporting and lack of transparency. We’ve described these issues below: 1. Retrospective reports do…

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 now fall beyond the end of the Brexit transition period. This could have a huge impact on the UK’s legal framework for medical device regulation after Brexit. Background The MDR repeals the existing Medical Device Directive 94/32/EEC (“MDD”). The MDR came into force on 25 May 2017, and originally, approved medical…

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 digital health offering in response to COVID‑19, we’ve got you covered on the top legal issues. Take a look at our survey covering key markets like the UK, France, Germany, Italy, Russia and Spain. COVID‑19 is accelerating the adoption of digital health solutions by hospitals and medical institutions around the world.…

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 Human Services (HHS), the agency charged with enforcing the Health Insurance Portability and Accountability Act of 1996 (HIPAA), issued the Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency (“Guidance”). On March 20, OCR issued supplemental guidance on provision of telehealth services in the form…

In this episode of Connect On Tech, your host Brian Hengesbaugh is joined by Ben McLaughlin, Global Chair of Baker McKenzie’s Healthcare & Life Sciences Group. Together Brian and Ben discuss healthcare data in the context of mergers and acquisitions. You will hear: An outline of the major players and issues surrounding acquisition of healthcare data.The number one issue keeping healthcare GCs up at night.Details on regulatory restrictions emerging to protect healthcare data. https://open.spotify.com/episode/51ImY8zLWMKH2IWr2z2PCU Related…