Article 13
Registration of personal electronic health data; data quality
In short: Member States shall ensure that healthcare providers stores and processes relevant health data in an electronic format.
- Member States shall ensure that, where electronic health data are processed for the provision of healthcare, healthcare providers register
the relevant personal electronic health data falling fully or partially under at least the priority categories of personal electronic health
data referred to in Article 14 in an electronic format in an EHR system.
- When processing data in an electronic format, healthcare providers shall ensure that the personal electronic health data of the natural
persons under their treatment are updated with information related to the healthcare.
- Where personal electronic health data are registered in a Member State of treatment that differs from the Member State of affiliation of
the natural person concerned, the Member State of treatment shall ensure that the registration is performed under the identification data of
the natural person in the Member State of affiliation.
- By 26 March 2027, the Commission shall, by means of a [Article 13(4)] implementing acts,
determine data quality requirements, including in relation to
semantics, uniformity, consistency, accuracy and completeness, for the registration of personal electronic health data in an EHR system as
relevant. Those implementing acts shall be adopted in accordance with the examination procedure referred
to in Article 98(2).
- When personal electronic health data are registered or updated, the electronic health records shall identify the health professional
and healthcare provider that carried out such registration or update, and the time at which such registration or update was carried out.
Member States may require other aspects of data registration to be recorded.
Discussion
According to
article 30, section 2, manufacturers of EHR systems shall ensure that procedures are in place to ensure that the design, development and deployment of the harmonised software
components of an EHR system continue to comply with the essential requirements. A good practice to achieve this is to develop and validate a product under a QMS. A well-functioning
QMS enables the manufacturer to be in control of the quality of its products, and, in case of software development, to be in control of all the changes in product and in the context. Besides,
a QMS may help manufacturers to respond more easily to an evaluation by a Market Surveillance Authority. A QMS is not mandated by the EHDS Regulation. A QMS certified under accreditation in accordance with ISO 9001, ISO 13485, or an equivalent
standard is considered to be a best practice. The scope of the QMS should include the development, production, and modification of the software system.
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Ringholm bv is a group of European experts in the field of messaging standards and systems integration in healthcare IT.
We provide the industry's most advanced training courses and consulting on healthcare information exchange standards.
