mHealth is one of the big promises worldwide to reduce costs of healthcare and empower patients. The challenges in mHealth are roughly the same in the EU and US: watch Rock Health’s Halle Tecco’s speech in the Stanford Technology Ventures Program identifies systemic challenges facing healthcare in America and shares examples of companies working to address these […]
Further to my recent post about e-labeling and my appeal to take more account of the specific mHealth market needs I had a discussion with another devices expert who suggested that the majority of medical apps will be in class I anyhow, in which case these apps can be used safely without instructions, because the Medical Devices Directive […]
Just before last weekend the final e-labelling regulation was published in the Official Journal of the EU, see right here. As you will see when you run a compare (like I did) there is absolutely no change compared to the last version that was available among stakeholders. For that reason, I will not repeat all […]