Recital 44

In order to guarantee the effective exercise by patients of their rights under this Regulation, healthcare providers developing and using an EHR system ‘in-house’ to carry out internal activities without placing it on the market in return for payment or remuneration should also comply with this Regulation. In that context, such healthcare providers should comply with all requirements applicable to manufacturers as regards such EHR systems that are developed ‘in-house’ and that such healthcare providers put into service. However, given that the healthcare providers may need additional time to prepare for compliance with this Regulation, those requirements should only apply to such systems after an extended transitional period.