Proposal for a regulation
Annex I – Table A - MAIN CHARACTERISTICS OF ELECTRONIC HEALTH DATA CATEGORIES
Electronic health data category Main characteristics of electronic health data included under the category 1. Patient summary Electronic health data that includes important clinical facts related to an identified person and that is essential for the provision of safe and efficient healthcare to that person. The following information is part of a patient summary: 1. Personal details 2. Contact information 3. Information on insurance 4. Allergies 5. Medical alerts 6. Vaccination/prophylaxis information, possibly in the form of a vaccination card 7. Current, resolved, closed or inactive problems 8. Textual information related to medical history 9. Medical devices and implants 10. Procedures 11. Functional status 11a (new) Prescription, dispensation and administration of current and past medications across the continuum of care, including, hospital and ambulatory/day hospitals 12. Current and relevant past medicines 13. Social history observations related to health 14. Pregnancy history 15. Patient provided data 16. Observation results pertaining to the health condition 17. Plan of care 18. Information on a rare disease such as details about the impact or characteristics of the disease 2. Electronic prescription Electronic health data constituting a prescription for a medicinal product as defined in Article 3(k) of Directive 2011/24/EU. 3. Electronic dispensation Information on the supply of a medicinal product to a natural person by a pharmacy based on an electronic prescription. 4. Medical image and image Electronic health data related to the use of or produced report by technologies that are used to view the human in order to prevent, diagnose, monitor, or treat medical conditions. 5. Laboratory result Electronic health data representing results of studies performed notably through in vitro diagnostics such as clinical biochemistry, haematology, transfusion medicine, microbiology, immunology, and others, and including, where relevant, reports supporting the interpretation of the results. 6. Discharge report Electronic health data related to a healthcare encounter or episode of care and including essential information about admission, treatment and discharge of a natural person.