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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…