On 15 July 2016, the European Commission updated MEDDEV 2.1/6 (the “MEDDEV Guidance), its medical device guidance on the qualification and classification of stand alone software used in the healthcare setting. The updated version replaces an earlier version of MEDDEV 2.1/6 issued by the European Commission in January 2012. MEDDEV 2.1/6 generally stands as a … Continue Reading
On April 5, the Federal Trade Commission (FTC), in conjunction with the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS), released a new web-based interactive tool to assist mobile health app developers in navigating applicable federal laws and regulations in the areas of advertising and marketing, medical devices, and … Continue Reading
Following a 2014 mHealth consultation and two open stakeholder meetings in 2015 (see here and here), the European Commission has announced the formation of a new working group aiming to draft guidelines on mHealth app data quality.… Continue Reading
A new post on Covington’s Inside Medical Devices blog discusses a new portal recently launched by HHS seeking questions from mobile health application developers. The platform allows for individuals to both submit and review questions on the HIPAA implications of these mobile health applications. To read the post, click here.… Continue Reading
