Italian adoption site Use-Case

A Monasterio Hospital discharges a patient at the end of an encounter, where he/she was diagnosed and treated for a disease. 

The discharging physician and nurse create on Hospital’s EHR (Monasterio C7 ISA) the discharge summary, reporting relevant information about the ward period extracted from the EHR itself: patient history and allergies, physical examination, lab data, administered drugs and therapeutics, procedures reports, instrumental examination reports, diagnostic imaging report, etc.  

The document also contains prescriptions and indications for the patient to be used at home, and it is intended also for the patient’s GP as recipient. 

The discharging physician digitally sign the pdf version of the discharge document (embedded in a structured HL7 CDA R2) in the EHR platform and print a hard copy for the patient. 

Before leaving the Hospital, the patient receives a hard copy printed version of the discharge document, while the digitally signed version is available in the App/Portal connected with the Hospital. 

The patient is capable to view the pdf document in the Monasterio App/Portal, either using credentials assigned by the Hospital or the National eIDAS authentication system. 

From the App/Portal the patient can save the pdf document in the smartphone or computer but cannot use its structured data (HL7 CDA) for any kind of automatic processing, nor send it to another Hospital. 

C7-ISA EHR system, developed by Monasterio since 1999, medical device. Patient App/portal was developed in 2019 and used since 2020.

Currently using HL7 V2, V3 (CDA), FHIR R4, FHIR R5, SCP, DICOM (Waveform), OHDSI-CDM-OMOP.

Patients users

The advantage is the new capability to export a whole set of structured data, contained in a report/summary, and provide this content to another PHR/App/Patient-portal system of their choice (according to the availability on the market of new interoperable systems), or to provide the downloaded content to another healthcare provider of their choice, also in another country, with the possibility to exchange it without an internet connection but directly and simply using Bluetooth/NFC connection with the new provider, just like the usage of a smartphone in a financial transactions.

The patient can also create a backup copy of some document, to be safely stored in a system of his/her preference.

The patient can donate his/her data to support a medical study.

Physicians/Nurses users (HCP)

The advantage is to be sure of the usage of data not only as readable document but as structured dataset potentially importable in EHR systems of other providers; this last feature saves a lot of time and potential errors of HCPs when patients’ data are directly imported into the Hospitals’ EHR system. HCP can also check if the documents are unaltered, and trace their provenance, authors, and versions.

Researcher

The researcher/research organization can receive health data voluntarily donated by the patients, following the current regulations (patient’s consents, anonymisation, storage, etc.) and if authorized by the ethical committee, where applicable.

The patient should be uniquely identified in a clear, safe, and easy way. This can include authentication processes provided by centralized regional/national platform, as well as distributed systems (digital ID card). To provide the maximum flexibility of the button, it can be associated to a single or multiple documents to be exported: a discharge summary, a set of diagnostic report, an IPS or a whole EHR. The existing platform should embed the xShare Yellow Button in a clear a visible way, standardized in the format, colour and description text and referenced to the dataset or document to be exported. The behaviour of the button should trigger the creation of a standardized set of resources in HL7 FHIR containing the document associated to the button. The EHR is developed by FTGM since 1998, and now based on DB modelled on HL7 V3 and FHIR data model. The C7 ISA EHR is certified as medical device by TUV class IIa. The C7 ISA EHR is the regional system used by all the Hospitals in Tuscany region, with 4 million patients.

• Electronic prescription
• Medical image and image report
• Laboratory Results
• Discharge report

The next two years a new National EHR System will be implemented, according to the EEHRxF.

The Hellenic Ministry of Health and IDIKA participate to the Actions for Primary and Secondary use of Health Data, as to be aware of the work progress in EHDS and prepare for taking actions to conform the National EHR System to the EHDS Regulation.

The use case is executed to: 

• Support the control on data flow, allowing the patient to restrict sections on data exchange considered sensitive by the patient (with exposure to medical errors in presence of incomplete information). 
• Support data portability (GDPR art.20). 
• Fill the gap created by the lack of direct connection (no network connection, no trusted communication channels) between potentially interoperable systems, connecting two systems supporting the same integration standard through the exchange of the (file) exported dataset.  
• Support data exchange in air-gapped systems. 
• Support digital data backup, according to patient’s preferences. 

• Evaluation of Post Study System Usability Questionnaire (PSSUQ), pre and post xShare Yellow Button usage, by patients: expected rate > 50/100. 

• Number of downloaded datasets: > 20. 

(note: total number of FTGM patients in C7 ISA EHR = 462,000 patients spanning in a 25-year period, see ARCA in OHDSI registry for updates). 

The xShare Yellow Button will be implemented in the user interface of the patient’s personal private section of the Monasterio App/Portal. The Monasterio App/Portal is integrated with the Hospital’s EHR (C7 ISA).

All data coming from a healthcare provider must support medico-legal validity.

The PHR/App/Portal is connected to the EHR system of a healthcare provider, or to a network of providers, or to a regional/national EHR system.

Data stored and visualized in the App/Portal must be safe and unaltered and resilient to cyberattacks.

All the information is related to its source/producer/author, where source is the person (including the patient) or organisation that provided the info (not necessarily the original author/producer) and takes (i.e., is accountable) of the information content; Producer organisation is the organisation that the author belongs to; Author is the person (or device, in case of automatic production) that produced and validate the information.

All the exchanged health information related to its producer/author, is versioned, timestamped.

The Healthcare provider cannot repudiate the produced health information.

Structured data use common vocabularies when expressing concepts, and, if local vocabulary is used, exist a translation in the common vocabularies.

The Patient owns a smartphone/tablet/PC and installs the App/Portal on it.

Each healthcare organization involved has a digital identity that may be represented within the PHR/App/Portal and is trusted by the PHR/App/Portal (e.g., The Healthcare Organization is registered in eIDAS as an Entity).

The data integration platform is available to support the conversion and translation of structured and unstructured information, and it is configured for the healthcare provider and its local vocabularies and their translations in common vocabularies.

The Patient gave his/her approval to the App/Portal to store and manage his/her personal health data and to share them only with people explicitly authorized by the patient, and for periods authorized by the patient.

The Patient had a previous encounter with the Healthcare Organization supporting the Standard, for remote access to the patient’s health records maintained by the Organization.

Every action performed on health data by means of the PHR/App/Portal is registered (logged) and associated permanently with the unique identification of the involved patient and (HCP or patient) author/actor.

The patient can configure on his/her PHR/App/Portal the data he/she desires to hide/avoid in the data export of xShare Yellow Button. A disclaimer warns the patient in the risks that this action could produce in his/her care.

After the patient discharge and the creation of a discharge summary, the patient pushes the xShare Yellow Button to download the discharge summary (/a set of information of his/her preference).

• The medical data might need translation/representation in a different language, in cross border care: unstructured data should rely on a certified tool to translate correctly medical data in the EU natural languages. Common dictionaries should have official translations of codes in all the EU natural languages. The lack of these features might hamper continuity of care in a cross-border scenario.
• The data contained in the EHR and PHR/App/Portal are safe and unaltered and represent a legal ground on which HCPs (and patients) rely for diagnosis/treatment/prognosis/prevention.
• The HCP can verify the origin and validity of the information shared by the patient.
• How to support a reliable data exchange without a strong patient authentication/identification (no EIDAS).
• How to support data download/exchange made by a patient’s caregiver (e.g. parent).
• How to support data download for large medical image (CT scan, FMRI, etc).
• How to support GENERIC data donation for medical research with xShare (ALL data, incl. imaging, needs to be anonymised or pseudonymised).
• How to implement partial data export, selected by the patient or defined by a study.

Patients, Physicians, Nurses, ICT.

According to the defined/approved clinical study.

Workflow Precondition: 

1. The patient owns a set of credentials to access his/her App/Portal. 
2. Patient is ready for discharge. 
3. The author HCP creates the Discharge Summary in the EHR. 
4. The author HCP signs digitally in the EHR the Discharge Summary. 
5. The HCP prints a paper copy of the discharge summary. 
6. The patient receives the paper copy of the discharge summary. 
7. The patient accesses the App/Portal using his/her personal credential. 
8. The App/Portal visualizes the list of documents and data available, including the last Discharge Summary produced. 
9. The patient selects the Discharge Summary on the App/Portal. 

Workflow:

1. The patient clicks on the xShare Yellow Button. 
2. The PHR asks a confirmation on the download location. 
3. Upon confirmation, the App/Portal invokes the EHR service for the creation of the Discharge Summary in the EEHRxF format and receive the structured data. 
4. The App/Portal writes the EEHRxF data in the location selected by the patient, with a timestamp and provenance description. 
5. The App/Portal signals to the patient the completion of the xShare Yellow Button operation. 

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