Recent proposals to increase the regulation of healthcare IT tools, which do not fall under current rules for medical devices, are continuing to divide opinion among health professionals. The European Commission (EC) has been calling for healthcare IT certification since publishing a Green Paper on mHealth last year, but these recommendations were heavily contested at eHealth Week in Latvia.
Despite such opposition, the EC is currently revising guidelines for medical devices and plans to clarify what constitutes life, or well-being apps, as opposed to medical devices, in order to improve safety. However, industry insiders argue the key is not more certification, which might stifle creativity, but more compliance with international standards.
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