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French medicines regulator produces first in Europe medical devices cybersecurity guidelines
European Union, France - July 24 2019 France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released Draft Guidelines…
HHS Extends Comment Period for Proposed Rules on Patient Access and Interoperability
USA - April 30 2019 On April 19, 2019, the Department of Health and Human Services (HHS) announced a 30-day extension, until June 3, 2019, to the comment period for two…
HHS Clarifies HIPAA Liability for EHR System Developers that Transfer Data to Health Apps
USA - April 26 2019 On Friday, April 19, 2019, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) explained in an FAQ the circumstances…
FDA Outlines Proposed Framework for Regulating Artificial Intelligence Software
USA - April 12 2019 In a recent post on the Covington Digital Health blog, we analyze FDA’s recently-released proposed regulatory approach for medical devices that use…
UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation
European Union, United Kingdom, USA - March 7 2019 On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance (available here) setting out the…
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