AS5_BUC1

Submitted by sfranconi on Tue, 09/10/2024 - 08:54

The Catalan Public Healthcare System has introduced the initial version of a tool called "Blue Button." This innovative tool is reshaping the European healthcare landscape by enabling citizens to securely access and download their clinical data in a structured XML format.

Despite this first version of the tool, the xShare project will conduct a review of the current state of the Blue Button (BB), and a second version will be implemented, incorporating improvements and expanding its scope.

The business case envisioned for Catalonia includes the following:

  • Evolution and improvement of the xShare Yellow Button tool on the LMS portal/app: This involves improvements (like the ones needed for the medication summary section) and all the required modifications to ensure that the generated IPS is compliance with EEHRxF.
  • Expansion of IPS domains to the maximum extent: Including laboratory results and medical imaging with the corresponding reports.
  • Implementation of the xShare Yellow Button in the private sector: Allowing the generation of the IPS by private healthcare providers, and the exchange of this data with the public ones.
  • Secondary use of data: Proposing a scenario where direct data donation for research is possible (using intermediate tools/platforms).
  • Implementation of an intermediate tool for citizens: That serves as an information viewer and allow merging different downloaded IPS into a single screen.

 

Document Version: 
V1.0
Responsible party: 
Catalonia Region - Spain - add a contact email
Source: 
xShare
As-Is Situation: 

The Catalan Public Healthcare System has developed a tool that affords users the ability to securely download their clinical data for sharing purposes with other healthcare providers. This tool is known as “Blue Button”.

Individuals seeking access to this invaluable data can conveniently download the requisite documents in XML format via the 'Personal Data' section within the La Meva Salut (LMS – Personal Health Record) platform. LMS is a digital, non-transferable query space that allows citizens to consult all their personal healthcare information and use it in a secure and confidential manner.

In this manner, the functionality of the Blue Button has been integrated into LMS, offering Catalan citizens the opportunity to download their International Patient Summary (IPS). The International Patient Summary is a standardized health document that contains essential patient health information. It is designed to facilitate the exchange of patient information across borders and between different healthcare systems, with the goal of improving the quality and continuity of care for individuals who receive medical treatment in different countries. 

The collated patient summary comprises critical medical information, including diagnoses, the medication summary, immunizations, surgical procedures, and allergies. In Catalonia, the offering extends to the inclusion of medical discharge reports.

The current status of the ePrescription system indicates that the prescriptions are internally stored in a structured format. However, citizens are presently only able to download the active prescription in PDF format, while the dispensed prescription remains inaccessible in this format. Looking ahead, there is a consideration to enhance the system so that citizens can download both active and dispensed prescriptions in a structured format or possibly appearing in the respective section of the IPS.

Currently, only iPhone users can access their XML files through the HEALTH app. Unfortunately, there is no intermediary tool available as an information viewer. Regarding the secondary use of data, there is currently no feasible scenario where direct data donation for research is possible using intermediate tools or platforms.

Currently available products/services and its vendors: 
La Meva Salut is the main public PHR App and web portal with Blue Button integrated.
Which health-related standard does your organisation uses and its alignment to the EEHRxF?: 
IPS - CDA R2 L3 HL7 XML format.
Actors/Users and their Roles: 

Citizens

End-users

La Meva Salut

PHR (Personal Health Record) App and web portal

EHR systems

Data providers

Citizen’s mobile phone

Communication tool

 

User Perspective: 
This innovative tool redefines the European healthcare landscape by empowering individuals to securely access and download their clinical data. It not only grants citizens control over their health data but also fosters cross-border collaboration through the International Patient Summary.' This unique initiative sets new standards by enabling the seamless exchange of medical information across borders, bridging language barriers, and ensuring efficient, patient-centric healthcare services in collaboration with multiple European nations. It represents a groundbreaking leap towards the realization of the European Health Data Space's (EHDS) vision, embodying the ideals of data accessibility, privacy, and interoperability.
From the perspective of the users, there will be several outcomes:
• Enhanced Patient Empowerment: Citizens now have immediate, easy, and electronic access to their health data, granting them unprecedented control over their medical information.
• Improved Healthcare Delivery: The exchange of IPS enables healthcare professionals to make informed decisions, especially when treating patients from different countries, thereby enhancing the quality and continuity of care.
• Mitigated Allergy-Related Risks: With access to critical medical data, including allergies, the risk of allergic reactions during treatment is significantly reduced.
• Language Barrier Overcome: The tool addresses language barriers by providing standardized patient health information for healthcare professionals.
• International Collaboration: The IPS collaboration with other European countries, and plans for future expansion, demonstrates Catalonia's commitment to pioneering cross-border healthcare data sharing.
• Legal and Ethical Compliance: The initiative adheres to the GDPR and aligns with the EHDS standards and specifications, ensuring ethical and legal compliance.
System Perspective: 
For both public and private initiatives, the xShare Yellow Button will be included in the citizen’s application/portal frontend. In the case of private ones, this button will use a function of the corresponding backend that will consume a web service published by an integration engine. This integration engine will obtain all the IPS’ data from the database of the provider, and it will transform it into the IPS specification format. Then, the generated IPS will be returned to the application/portal, where the download will start. The backend of the xShare Yellow Button, the integration engine and the provider’s database will be on the same provider’s intranet, for security reasons.
In the case of LMS (aka the public scenario), the button is already available, and all the communication is done within the Catalan Healthcare Intranet (known as Anella Sanitària). Al the public healthcare providers are publishing its clinical data to the Public Catalan EHR System, called Història Clínica Compartida de Catalunya. They use web services and CDA R2 HL7 formatted documents to provide this information. This structured information provided by public healthcare entities is the base used to generate the LMS’ IPS document.
Health Information Domain(s) - HIDs: 
Patient summary
Electronic prescription
Electronic dispensiation
Medical image and image report
Laboratory Results
Discharge report
Scenarios for the xShare Yellow Button: 

HIDs

xShare Yellow Button basic functionality

Maturity

 

Download

One-time share

Linked options

Start TRL

End TRL

Patient summary - public

X

 

 

7

8

Patient summary - private

X

 

 

1

7

Electronic prescription

X

 

 

2

5

Electronic dispensation

X

 

 

2

5

Medical image
and image report

X

 

 

1

5

Laboratory results

X

 

 

1

5

Discharge report

X

 

 

1

5

Telemonitoring

 

 

 

 

 

Care plan

 

 

 

 

 
National/regional strategy: 
Catalonia's strategy involves continuous improvement of the healthcare organization through the intensive use of ICT, ensuring data ownership, data portability and interoperability.
Strategy towards EHDS: 
Empower citizens with control over their data to securely access and download their data. Foster cross-border collaboration through the IPS, ensuring data accessibility, privacy, and interoperability. Promote the participation on the citizen on the secondary use of data.
Business Goals/Benefits and KPIs: 

Catalonia has been carrying out a digitization process in the healthcare sector for over 40 years. During this time, there have been changes in legislation (such as the law on a single medical history created 20 years ago), and new needs have been identified due to the health emergency (such as the COVID-19 pandemic). Experts, researchers, healthcare professionals, and patients advocate for the existence of quality healthcare continuity: that my information be available to those who need to attend to me or wish to generate knowledge for the benefit of all.

Despite this need, currently in Catalonia, personal social and health information from the private sphere is not available. This is why there is a need to create a new scenario in which the citizen is at the centre and resolves this issue: exercising their right to own and share their health data as they see fit.

Additionally, the xShare Yellow Button initiative aligns with the principles of the EHDS by promoting immediate access to health data, adhering to international standards, and promoting cross-border data sharing. This initiative sets a precedent for the potential widespread adoption of similar practices across Europe to enhance healthcare data accessibility, quality, and interoperability.

Access to the IPS is typically granted to authorized healthcare providers and organizations involved in a patient's care. The primary goal of the IPS is to facilitate the exchange of essential health information across different healthcare systems and settings. On the other hand, the xShare Yellow Button promotes the secure sharing and access to personal health information by patients. It allows individuals to have easy and convenient access to their PHR and health-related data. The xShare initiative has been developed to empower patients and promote patient engagement in their own healthcare.

In this way, Catalonia is committed to digital portability based on international standards, allowing citizens to move towards control of their health data: immediate, easy, free, and in an electronic, structured, and reusable format. This initiative is in line with the GDPR and advances toward what is established in the EHDS.

  • KPI1: Number of citizens downloading IPS from LMS >250
  • KPI2: Number of IPS download from private healthcare providers systems > 30
  • KPI3: Private Healthcare organizations involved and informed (not piloting) =350
  • KPI4: Private Healthcare organizations piloting =2
  • KPI5: Number of healthcare professionals involved on the piloting =150

 

Application: 
The xShare Yellow Button will be integrated on La Meva Salut portal/app. Additionally in the case of private sector, it will be integrated on the portal/app of private health providers
Data Preconditions: 
As a data precondition, it is necessary that private healthcare providers have in their systems all the data set that conforms the obligatory sections of the IPS definition. This data needs to be available in a structured format, and it also needs to be mapped to the controlled vocabularies indicated in the IPS specification.
System Preconditions: 
As a system precondition, it is necessary that private healthcare providers have a mobile application or a portal where patients can consult their medical data. This tool needs to be integrated, using secure web services, with the EHR system of the provider.
User Preconditions: 
The user must be registered on La Meva Salut portal/app, as well as in the portal/app of the corresponding private healthcare provider.
Trigger: 
The user needs to have his health data to share it in different scenarios: 1. Share his health data with other medical professionals to ensure continuity of care. 2. Provide data for research. 3. Receive cross-border medical assistance or in emergency medical situations. The user accesses the health portal, uses the xShare Yellow Button, and downloads their IPS to share it with whoever he chooses.
Challenges/Limitations: 
Citizen Utilization: The adoption and usage rate of the Blue Button tool among citizens, signifying the extent to which individuals are empowered to manage their health data.
Cross-Border Collaboration: The extent of collaboration and adoption of the International Patient Summary among European member states.
Adoption of IPS/xShare Yellow Button on the private sector: IPS has been only implemented and adopted in Public Health Systems, so the private sector would need to adopt it in order to be able to exchange data in the same structured way.
Ease of Use: The ease and accessibility of the tool for both citizens and healthcare professionals.
Data Security: The successful safeguarding of patient data to maintain privacy and data security.
Availability of additional or intermediate tools: like a viewer for the IPS; a tool for merging all IPS onto one single screen; a tool for data cession for secondary use of data; a tool for direct sharing the IPS, etc.
Involved stakeholders in the BUC definition: 
IT experts, public healthcare administrations, private healthcare associations.
Application of pseudonymisation filters: 
Yes
Basic Workflow: 

Scenario 1: A Catalan citizen has travelled to Madeira. During her vacation, she felt unwell and sought treatment at a health centre. This citizen has a chronic illness and currently takes four different types of medication. To ensure that the emergency doctor treating her in Madeira has all the relevant health information, she accesses to the La Meva Salud mobile application, where she has the xShare Yellow Button available. This button allows her to download her IPS, which she saves on her mobile phone. She emails this document to the doctor in Madeira, ensuring that the treatment she receives aligns with her chronic illness and current medication.

Preconditions:

  • The citizen has a Catalan Personal Identification Number (called CIP – Codi d’Identificació Personal).
  • The citizen has downloaded LMS in her mobile phone.
  • The citizen has access to LMS mobile application.
  • The citizen has downloaded an IPS Viewer in her mobile phone.
  • The citizen has access to the IPS Viewer mobile application.
  • The emergency doctor of Madeira has created an EHR for the Catalan citizen, in the Madeira centre information system.

Steps:

1.The Catalan citizen opens LMS mobile application in her mobile phone.

2.The citizen clicks the access button (“Accedir”).

3.The citizen choses the CIP option to authenticate herself.

4.The citizen introduces her CIP and password and clicks the access button (“Accedir”).

5.The citizen accepts the welcome message, and access to the main menu.

6.The citizen clicks the profile button to access to a secondary menu.

7.The citizen selects Personal Data on the menu ("Dades Personals”) and access to her demographic information.

8.The citizen scrolls down the screen until the data exchange section ("Dades de salut per compartir xShare Yellow Button”) and clicks the download option ("Descàrrega”).

9.The citizen selects the language of the IPS that she wants to download.

10.The citizen clicks the download option ("Descàrrega”).

11.The IPS is downloaded and stored in the citizen’s mobile phone filesystem (in CDA R2 L3 HL7 XML format).

12.The citizen opens the IPS Viewer mobile application on her mobile phone.

13.The citizen access to the main menu and clicks the import button ("Importar resum”).

14.The citizen clicks on the navigate button (“Selecciona fitxer…”). 

15.The citizen looks for the previously downloaded IPS.

16.The citizen selects the IPS(s) that wants to import to the IPS Viewer.

17.The IPS(s) is(are) imported to the IPS Viewer mobile application.

18.The citizen returns to the IPS Viewer mobile application main menu.

19.The citizen clicks the sharing button ("Compartir resum”).

20.The citizen sees a list with all the available IPS.

21.The citizen choses one or more IPS.

22.The citizen clicks the mail sending option “Compartir resum(s) per correu electrònic”. 

23.The citizen introduces the mail of the emergency doctor that is attending her.

24.The citizen clicks on send button (“Enviar”).

25.The emergency doctor receives the IPS via email.

26.The doctor downloads the IPS(s) file(s) into his or her computer filesystem.

27.The doctor imports the downloaded IPS(s) to the EHR of the Catalan citizen.

28.The doctor reads the incorporated information and can align the new treatment with the current medications that the citizen is taking for her chronic disease.

Scenario 2: A Catalan citizen has been undergoing specific gynaecological treatment at a private hospital in Catalonia. She experienced a severe complication during childbirth, leading to surgery and subsequent treatment follow-up. CT scans and blood tests have been conducted, and she has been prescribed medication. Since her case was handled in a private centre, her primary care physician lacks information about everything that has happened to this citizen. The citizen, wanting her medical information in her public healthcare EHR (Electronic Health Record), downloads her IPS from the private hospital app and sends it to her doctor through La Meva Salut's e-consultation service.

Preconditions:

  • The private healthcare provider has a PHR mobile application for its patients.
  • The citizen has downloaded the PHR application in her mobile phone.
  • The citizen has access to the PHR mobile application.
  • The citizen has downloaded the IPS Viewer in her mobile phone.
  • The citizen has access to the IPS Viewer mobile application.
  • The citizen has a Catalan Personal Identification Number (called CIP – Codi d’Identificació Personal).
  • The citizen has downloaded LMS in her mobile phone.
  • The citizen has access to LMS mobile application.
  • The e-consultation functionality of LMS is integrated in the primary care EHR system.

 

Steps:

1.The Catalan citizen opens the PHR mobile application in her mobile phone.

2.The citizen introduces her National Identifier and password and clicks the access button (“Accedir”).

3.The citizen access to the main menu.

4.The citizen clicks the personal data button ("Dades salut”).

5.The citizen access to the sharing data screen ("Dades de salut per compartir - xShare Yellow Button”) 

6.The citizen selects the language of the IPS that she wants to download.

7.The citizen elects the language of the IPS that she wants to download.

8.The citizen clicks the download option ("Descàrrega”).

9.The IPS is downloaded and stored in the citizen’s mobile phone filesystem (in CDA R2 L3 HL7 XML format).

10.The citizen opens the IPS Viewer mobile application on her mobile phone.

11.The citizen access to the main menu and clicks the import button ("Importar resum”).

12.The citizen clicks on the navigate button (“Tria un fitxer…”). 

13.The citizen looks for the previously downloaded IPS.

14.The citizen selects the IPS that wants to import to the IPS Viewer.

15.The IPS is imported to the IPS Viewer mobile application.

16.The citizen returns to the IPS Viewer mobile application main menu.

17.The citizen clicks the sharing button ("Compartir resum”).

18.The citizen sees a list with all the available IPS.

19.The citizen choses one or more IPS.

20.The citizen clicks the mail sending option “Compartir resum(s) per correu electrònic”. 

21.The citizen introduces the mail of the primary care doctor that is attending her.

22.The citizen clicks on sending button (“Enviar”).

23.The primary care doctor receives the IPS via email.

24.The doctor downloads the IPS file into his or her computer filesystem.

25.The doctor imports the downloaded IPS to the EHR of the Catalan citizen.

26.The doctor reads the incorporated information.

Scenario 3: A citizen discovers that he has a rare type of disease. Currently, different research groups are recruiting patients and seeking participants for a clinical study to advance understanding of this disease. The citizen downloads his IPS and uses an intermediate app installed on his personal mobile to check available research projects matching his profile. He securely sends his IPS to participate in a clinical study.

Preconditions:

  • The citizen has his IPSs downloaded in his mobile phone filesystem.
  • The citizen has downloaded an intermediate mobile application to share his data with research projects.
  • The citizen has access to the intermediate mobile application to share his data with research projects.

Steps:

2.The citizen opens the intermediate app on his mobile phone.

3.The citizen introduces his user and password into the corresponding fields.

4.The citizen clicks the access button ("Accedir”).

5.The citizen accesses to the main menu of the intermediate app.

6.The citizen clicks the clinical trial button ("Assajos clínics”).

7.The citizen sees all the available clinical trials.

8.The citizen clicks on one specific clinical trial.

9.The citizen sees the detail of the information of the clinical trial (like name, participants, responsible organization, dates, objective, etc.).

10.The citizen clicks on the sharing data button “Compartir dades de salut”.

11.The citizen clicks on the navigate button (“Tria un fitxer…”). 

12.The citizen looks for the previously downloaded IPS.

13.The citizen selects one or more IPS.

14.IPSs are shared with the clinical trial in an anonymised manner through the intermediate app.

 

Alternative Workflows: 

Scenario 1:

•3.a.1 The citizen choses the National Identifier option to authenticate himself (“DNI, NIE o passaport”).

•3.a.2 The citizen introduces her National Identifier and password and clicks the access button (“Accedir”).

•3.a.3. The flow continuous in step 5.

•3.b.1 The citizen choses the option fingerprint authentication (“Accedir amb empremta”).

•3.b.2 The citizen uses the mobile phone fingerprint recognition capabilities to access.

•3.b.3 The flow continuous in step 5.

Scenario 2:

•10.a.1 The Catalan citizen opens LMS mobile application in her mobile phone.

•10.a.2 The citizen clicks the access button (“Accedir”).

•10.a.3 The citizen choses the CIP option to authenticate herself (see scenario 1 for alternative authentication methods).

•10.a.4 The citizen introduces her CIP and password and clicks the access button (“Accedir”).

•10.a.5 The citizen accepts the welcome message, and access to the main menu.

•10.a.6 The citizen clicks e-consultation button.

•10.a.7 The citizen clicks the primary care e-consultation button.

•10.a.8 The citizen indicates that is attaching her IPS in the corresponding fields ("Motiu consulta” “Descripció” “Adjuntar fitxer 1”).

•10.a.9 The citizen clicks on the navigate button (“Tria un fitxer…”). 

•10.a.10 The citizen looks for the previously downloaded IPS.

•10.a.11 The citizen selects the IPS(s) that wants to import to the IPS Viewer.

•10.a.12 The citizen clicks the sending button (“Enviar”).

•10.a.13 The primary care doctor receives the IPS(s) via the e-consultation functionality, which is integrated in the EHR system.

•10.a.14 The primary care doctor incorporates the received IPS(s) into the EHR of the citizen.

•10.a.15 The flow continuous in step 26.

Scenario 3:

•8.a.1 The citizen clicks on the return option, so he returns to the list of clinical trials.

•8.a.2 The flow continuous in step 7.

•6.a.1 The citizen uses the search field to look for a specific clinical trial.

•6.a.2 The citizen sees all the available clinical trials, matching the search criteria.

•6.a.3 The flow continuous in step 6.