amendment list, 5 April 2023
European Health Data Space
Document CJ43-AM-745471 · (COM(2022)0197 – C911202 – 2022/0140(COD))
Committee on the Environment, Public Health and Food Safety Committee on Civil Liberties, Justice and Home Affairs
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Amendment 2134
Kateřina Konečná
Proposal for a regulation
Annex I – Table A - MAIN CHARACTERISTICS OF ELECTRONIC HEALTH DATA CATEGORIES
| Text proposed by the Commission | |
| 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 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 report | Electronic health data related to the use of or produced 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. |
| Amendment | |
| 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 patient summary shall be harmonized across Member States and include a minimum data set that can be expanded to include disease-specific data. 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 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 18a (new) Blood type |
| 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 report | Electronic health data related to the use of or produced 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. |
Or. en
Justification
This amendment aims to promote patients' understanding and control of their personal health data. The blood type is a relevant type of data that should be added to the priority categories of health data.
Amendment 2135
Billy Kelleher
Proposal for a regulation
Annex I – Table A - MAIN CHARACTERISTICS OF ELECTRONIC HEALTH DATA CATEGORIES
Read the rest (22 paragraphs)
| Text proposed by the Commission | |
| 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 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 report | Electronic health data related to the use of or produced 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. |
| Amendment | |
| 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 report | Electronic health data related to the use of or produced 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. |
Or. en
Amendment 2136
Lucia Ďuriš Nicholsonová
Susana Solís Pérez
Proposal for a regulation
Annex I – Table A - MAIN CHARACTERISTICS OF ELECTRONIC HEALTH DATA CATEGORIES
| Text proposed by the Commission | |
| 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 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 report | Electronic health data related to the use of or produced 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. |
| Amendment | |
| 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 5a. (new) Blood type 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 12. Current and relevant past medicines 13. Social history observations related to health 14. Pregnancy history 15. Patient provided data, including liwing wills 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 18a (new) History of donations in line with Regulation XXXX/XXXX (SOHO Regulation) |
| 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 report and medical test results | Electronic health data related to the use of or produced by technologies that are used to view the human body or parts thereof, as well as to monitor functions of organs (such as EG or holter monitors) 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. |
Or. en
Amendment 2137
Tilly Metz
Patrick Breyer
Proposal for a regulation
Annex I – Table A - MAIN CHARACTERISTICS OF ELECTRONIC HEALTH DATA CATEGORIES
| Text proposed by the Commission | |
| 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 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 report | Electronic health data related to the use of or produced 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. |
| Amendment | |
| 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 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. Medical procedures 11. Functional status 12. Current and relevant past medicines 12a (new) Blood type 13. Lifestyle observations related to health 14. Pregnancy history 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 report | Electronic health data related to the use of or produced 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. |
| 6a (new) Patient provided data | Additional information provided by the patient directly in the EHR, marked as not validated by healthcare professional. |
Or. en
Amendment 2138
Sara Cerdas
Proposal for a regulation
Annex I – Table A - MAIN CHARACTERISTICS OF ELECTRONIC HEALTH DATA CATEGORIES
| Text proposed by the Commission | |
| 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 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 report | Electronic health data related to the use of or produced 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. |
| Amendment | |
| 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 patient summary shall be harmonised across Member States and include a minimum data set that can be expanded to include disease-specific data. 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 in an international classification coding system 8. Textual information related to medical history 9. Medical devices and implants 10. Medical procedures 11. Functional status 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 report | Electronic health data related to the use of or produced 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. |
| 6a. (new) Medical directives | Electronic health data related to the legal documentation that states a person’s wishes about receiving medical care if that person is no longer able to make medical decisions because of a serious illness or injury and that may also give a person (such as a spouse, relative, or friend) the authority to make medical decisions in such situations. Electronic health data related to the patient's will and consent in specific medical acts. |
Or. en